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2. Subcutaneous versus intravenous nivolumab for renal cell carcinoma

Author

Albiges, L., Bourlon, M.T., Chacón, M., Cutuli, H.J., Chuken, Y.A.L., Żurawski, B., Mota, J.M., Magri, I., Burotto, M., Luz, M., de Menezes, J., Ruiz, E.P.Y., Fu, S., Richardet, M., Valderrama, B.P., Maruzzo, M., Bracarda, S., Breckenridge, M., Vezina, H.E., Rathod, D., Yu, Z., Zhao, Y., Dixon, M., Perumal, D., and George, S.

Published
2024
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3. An Italian multicenter retrospective real-life analysis of patients with brain metastases from renal cell carcinoma: the BMRCC study

Author

Internò, V., Massari, F., Rudà, R., Maiorano, B.A., Caffo, O., Procopio, G., Bracarda, S., Atzori, F., Passarelli, A., Bersanelli, M., Stellato, M., Fornarini, G., Galli, L., Ortega, C., Zanardi, E., Incorvaia, L., Facchini, G., Giron Berrios, J.R., Ricotta, R., Santoni, M., Funaioli, C., Trerotoli, P., Porta, C., and Rizzo, M.

Published
2023
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4. Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program

Author

Rebuzzi, S.E., Signori, A., Buti, S., Banna, G.L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, D., Tortora, G., Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, F., Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, A., Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., and Fornarini, G.

Published
2022
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5. TROP-2, NECTIN-4 and predictive biomarkers in sarcomatoid and rhabdoid bladder urothelial carcinoma

Author

Brunelli, M., Gobbo, S., Malpeli, G., Sirgiovanni, G., Caserta, C., Munari, E., Francesconi, S., Calio, A., Martignoni, G., Cimadamore, A., Veccia, A., Antonelli, A., Tucci, M., Pierconti, Francesco, Hattab, I. M., Eccher, A., Ascani, S., Milella, M., Buffoni, L., Cheng, L., Bracarda, S., Pierconti F. (ORCID:0000-0003-0951-4131), Brunelli, M., Gobbo, S., Malpeli, G., Sirgiovanni, G., Caserta, C., Munari, E., Francesconi, S., Calio, A., Martignoni, G., Cimadamore, A., Veccia, A., Antonelli, A., Tucci, M., Pierconti, Francesco, Hattab, I. M., Eccher, A., Ascani, S., Milella, M., Buffoni, L., Cheng, L., Bracarda, S., and Pierconti F. (ORCID:0000-0003-0951-4131)

Abstract

Introduction. The surface protein TROP-2/TACSTD2 and the cell adhesion protein NECTIN-4/NECTIN4 are responsible for the efficacy of anticancer therapies based on antibody- drug conjugates (ADC) targeting intracellular microtubules. In contrast with common histologic subtypes of bladder urothelial carcinoma (BUC), little is known of TROP-2 and NECTIN-4 expression in sarcomatoid and rhabdoid BUC. Aims. In this study, we aimed to analyze TROP-2 and NECTIN-4 expression and additional predictive biomarkers by immunohistochemistry and fluorescence in situ hybridization (FISH) on 35 undifferentiated BUC (28 sarcomatoid and 7 rhabdoid). Wide genomic investigation was also performed on 411 BUC cases of the PanCancer Atlas, focusing on genes related to the microtubule pathways. Results. Seven of 35 (20%) undifferentiated BUC showed expression of TROP-2. NECTIN-4 was expressed in 10 cases (29%). Seven cases (20%) co-expressed TROP-2 and NECTIN-4. HER-2 FISH was amplified in 5 cases (14%) while HER-2 immunoexpression was observed in 14 cases (40%). PD-L1 scored positive for combined proportion score (CPS) in 66% of cases and for tumor proportion score (TPS) in 51% of cases. Pan-NTRK1-2/3 was elevated in 9 cases (26%) and FGFR-2/3 was broken in 7 of 35 cases (20%). Of 28 sarcomatoid BUC, 9 (32%) were negative for all (TROP-2, NECTIN-4, PD-L1, HER-2, FGFR and pan-NTRK) biomarkers and 3 (11%) expressed all five biomarkers. Among cases with rhabdoid dedifferentiation, 1 of 7 (14%) showed activation of all biomarkers, whereas 2 of 7 (28%) showed none. The mRNA analysis identified microtubulerelated genes and pathways suitable for combined ADC treatments in BUC. Conclusion. Sarcomatoid and rhabdoid BUC do harbor positive expression of the ADC targets TROP-2 or NECTIN-4 in a relatively modest subset of cases, whereas the majority do not. Different combinations of other positive biomarkers may help the choice of medical therapies. Overall, these findings have important clinical implica

Published
2024

6. STereotactic Ablative RadioTherapy in NEWly Diagnosed and Recurrent Locally Advanced Non-Small Cell Lung Cancer Patients Unfit for ConcurrEnt RAdio-Chemotherapy: Early Analysis of the START-NEW-ERA Non-Randomised Phase II Trial

Author

Arcidiacono, F., Anselmo, P., Casale, M., Zannori, C., Ragusa, M., Mancioli, F., Marchetti, G., Loreti, F., Italiani, M., Bracarda, S., Maranzano, E., and Trippa, F.

Subjects
Cancer Research, Radiation, Oncology, Radiology, Nuclear Medicine and imaging
Abstract

This is a single arm phase 2 trial (Clinical trials.gov NCT05291780) to assess local control (LC) and safety of SAbR in patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC) unfit for concurrent chemo-radiation therapy (ChT-RT).Neoadjuvant ChT was prescribed in fit patients. The tumor volume included primary tumor and any regionally positive node/s. The coprimary study endpoints were LC and safety.Between December 31, 2015, and December 31, 2020, 50 patients with LA-NSCLC were enrolled. Histology was squamous cell carcinoma and adenocarcinoma (ADC) in 52% and 48%, respectively. Forty (80%) patients had ultracentral tumor. Twenty-seven (54%) received neoadjuvant ChT and 7 (14%) adjuvant durvalumab. Median prescribed dose was 45 Gy (range, 35-55) and 40 Gy (35-45) in 5 daily fractions to tumor and node/s, respectively. After a median follow-up of 38 months (range, 12-80), 19 (38%) patients had experienced local recurrence (LR) at a median time of 13 months (range, 7-34). The median LR-free survival (FS) was not reached (95% confidence interval [CI], 28 to not reached). The 1-, 2-, and 3-year LR-FS rates were 86% ± 5%, 66% ± 7%, and 56% ± 8%, respectively. At last follow-up, 33 (66%) patients were alive. Median overall survival (OS) was 55 months (95% CI, 43-55 months). The 1-, 2-, and 3-year OS rates were 94% ± 3%, 79% ± 6%, and 72% ± 7%, respectively. No patients developed ≥ grade (G) 3 toxicity. ADC (hazard ratio [HR], 3.61; 95% CI, 1.15-11.35) was a significant predictor of better LC, while OS was significantly conditioned by smaller planning target volumes (HR, 1.004; 95% CI, 1.001-1.010) and tumor, node, and metastasis stage (HR, 4.8; 95% CI, 1.34-17).Patients with LA-NSCLC treated with SABR had optimal LC and promising OS in absence of ≥G3 toxicity. Our early outcomes would suggest the feasibility of using this approach in patients with LA-NSCLC unfit for concurrent ChT-RT.

Published
2023

7. Implementation of preventive and predictive BRCA testing in patients with breast, ovarian, pancreatic, and prostate cancer: a position paper of Italian Scientific Societies

Author

Russo, A, Incorvaia, L, Capoluongo, E, Tagliaferri, P, Gori, S, Cortesi, L, Genuardi, M, Turchetti, D, De Giorgi, U, Di Maio, M, Barberis, M, Dessena, M, Del Re, M, Lapini, A, Luchini, C, Jereczek-Fossa, B, Sapino, A, Cinieri, S, Beretta, G, Bella, M, Bracarda, S, Colombo, N, Conteduca, V, Del Mastro, L, Galvano, A, Gristina, V, Guarneri, V, La Verde, N, Lorusso, D, Marchetti, P, Normanno, N, Ottini, L, Pensabene, M, Pignata, S, Procopio, G, Ricevuto, E, Silvestris, N, Tassone, P, Tucci, M, Donato, V, Carrara, S, Paiella, S, Gentilini, O, Gunelli, R, Nicolis, F, Buttitta, F, Colecchia, M, Fassan, M, Malapelle, U, Marchetti, A, Marchio, C, Scarpa, A, Truini, M, Zamboni, G, Gion, M, Trevisiol, C, Gronchi, A, Danesi, R, Di Marco, V, Carrera, P, Ghiorzo, P, Pasini, B, Varesco, L, Artibani, W, Ludovico, G, Campanella, O, Vatrano, S, Tagliafico, E, Russo A., Incorvaia L., Capoluongo E., Tagliaferri P., Gori S., Cortesi L., Genuardi M., Turchetti D., De Giorgi U., Di Maio M., Barberis M., Dessena M., Del Re M., Lapini A., Luchini C., Jereczek-Fossa B. A., Sapino A., Cinieri S., Beretta G., Bella M. A., Bracarda S., Colombo N., Conteduca V., Del Mastro L., Galvano A., Gristina V., Guarneri V., La Verde N., Lorusso D., Marchetti P., Normanno N., Ottini L., Pensabene M., Pignata S., Procopio G., Ricevuto E., Silvestris N., Tassone P., Tucci M., Donato V., Carrara S., Paiella S., Gentilini O., Gunelli R., Nicolis F., Buttitta F., Colecchia M., Fassan M., Malapelle U., Marchetti A., Marchio C., Scarpa A., Truini M., Zamboni G., Gion M., Trevisiol C., Gronchi A., Danesi R., Di Marco V., Carrera P., Ghiorzo P., Pasini B., Varesco L., Artibani W., Ludovico G., Campanella O., Vatrano S., Tagliafico E., Russo, A, Incorvaia, L, Capoluongo, E, Tagliaferri, P, Gori, S, Cortesi, L, Genuardi, M, Turchetti, D, De Giorgi, U, Di Maio, M, Barberis, M, Dessena, M, Del Re, M, Lapini, A, Luchini, C, Jereczek-Fossa, B, Sapino, A, Cinieri, S, Beretta, G, Bella, M, Bracarda, S, Colombo, N, Conteduca, V, Del Mastro, L, Galvano, A, Gristina, V, Guarneri, V, La Verde, N, Lorusso, D, Marchetti, P, Normanno, N, Ottini, L, Pensabene, M, Pignata, S, Procopio, G, Ricevuto, E, Silvestris, N, Tassone, P, Tucci, M, Donato, V, Carrara, S, Paiella, S, Gentilini, O, Gunelli, R, Nicolis, F, Buttitta, F, Colecchia, M, Fassan, M, Malapelle, U, Marchetti, A, Marchio, C, Scarpa, A, Truini, M, Zamboni, G, Gion, M, Trevisiol, C, Gronchi, A, Danesi, R, Di Marco, V, Carrera, P, Ghiorzo, P, Pasini, B, Varesco, L, Artibani, W, Ludovico, G, Campanella, O, Vatrano, S, Tagliafico, E, Russo A., Incorvaia L., Capoluongo E., Tagliaferri P., Gori S., Cortesi L., Genuardi M., Turchetti D., De Giorgi U., Di Maio M., Barberis M., Dessena M., Del Re M., Lapini A., Luchini C., Jereczek-Fossa B. A., Sapino A., Cinieri S., Beretta G., Bella M. A., Bracarda S., Colombo N., Conteduca V., Del Mastro L., Galvano A., Gristina V., Guarneri V., La Verde N., Lorusso D., Marchetti P., Normanno N., Ottini L., Pensabene M., Pignata S., Procopio G., Ricevuto E., Silvestris N., Tassone P., Tucci M., Donato V., Carrara S., Paiella S., Gentilini O., Gunelli R., Nicolis F., Buttitta F., Colecchia M., Fassan M., Malapelle U., Marchetti A., Marchio C., Scarpa A., Truini M., Zamboni G., Gion M., Trevisiol C., Gronchi A., Danesi R., Di Marco V., Carrera P., Ghiorzo P., Pasini B., Varesco L., Artibani W., Ludovico G., Campanella O., Vatrano S., and Tagliafico E.

Abstract

Constitutional BRCA1/BRCA2 pathogenic or likely pathogenic variants (PVs) are associated with an increased risk for developing breast and ovarian cancers. Current evidence indicates that BRCA1/2 PVs are also associated with pancreatic cancer, and that BRCA2 PVs are associated with prostate cancer risk. The identification of carriers of constitutional PVs in the BRCA1/2 genes allows the implementation of individual and family prevention pathways, through validated screening programs and risk-reducing strategies. According to the relevant and increasing therapeutic predictive implications, the inclusion of BRCA testing in the routine management of patients with breast, ovarian, pancreatic and prostate cancers represent a key requirement to optimize medical or surgical therapeutic and prevention decision-making, and access to specific anticancer therapies. Therefore, accurate patient selection, the use of standardized and harmonized procedures, and adherence to homogeneous testing criteria, are essential elements to implement BRCA testing in clinical practice. This consensus position paper has been developed and approved by a multidisciplinary Expert Panel of 64 professionals on behalf of the AIOM–AIRO–AISP–ANISC–AURO–Fondazione AIOM–SIAPEC/IAP–SIBioC–SICO–SIF–SIGE–SIGU–SIU–SIURO–UROP Italian Scientific Societies, and a patient association (aBRCAdaBRA Onlus). The working group included medical, surgical and radiation oncologists, medical and molecular geneticists, clinical molecular biologists, surgical and molecular pathologists, organ specialists such as gynecologists, gastroenterologists and urologists, and pharmacologists. The manuscript is based on the expert consensus and reports the best available evidence, according to the current eligibility criteria for BRCA testing and counseling, it also harmonizes with current Italian National Guidelines and Clinical Recommendations.

Published
2022

8. OC-0763 SAbR in LA-NSCLC patients unfit for concurrent ChT-RT: START-NEW-ERA non-randomised phase II trial

Author

Arcidiacono, F., primary, Anselmo, P., additional, Casale, M., additional, Zannori, C., additional, Loreti, F., additional, Ragusa, M., additional, Enrico, B., additional, Mancioli, F., additional, Marchetti, G., additional, Italiani, M., additional, Fabiani, S., additional, Guida, A., additional, Tassi, V., additional, Caprera, C., additional, Corsi, M., additional, Bracarda, S., additional, Maranzano, E., additional, and Trippa, F., additional

Published
2023
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9. 1469P Efficacy and safety of pembrolizumab/axitinib combination in metastatic renal cell carcinoma (mRCC): A multicentric prospective analysis (ProPAXI study)

Author

Guida, A., primary, Maruzzo, M., additional, Lai, E., additional, Bimbatti, D., additional, Pierantoni, F., additional, Dionese, M., additional, Caserta, C., additional, Mosillo, C., additional, Calandrella, M.L., additional, Macrini, S., additional, Fornarini, G., additional, Zanardi, E., additional, Damassi, A., additional, Calabrò, F., additional, Cerbone, L., additional, Astore, S., additional, Galli, L., additional, and Bracarda, S., additional

Published
2022
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10. LBA73 Study EV-103 Cohort K: Antitumor activity of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC)

Author

Rosenberg, J.E., primary, Milowsky, M., additional, Ramamurthy, C., additional, Mar, N., additional, McKay, R.R., additional, Friedlander, T., additional, Ferrario, C., additional, Bracarda, S., additional, George, S., additional, Moon, H., additional, Geynisman, D., additional, Petrylak, D.P., additional, Borchiellini, D., additional, Burgess, E.F., additional, Rey, J.P. Maroto, additional, Carret, A-S., additional, Yu, Y., additional, Guseva, M.V., additional, Moreno, B. Homet, additional, and O'Donnell, P.H., additional

Published
2022
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12. 1691P Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Updated efficacy and safety results from CheckMate 67T

Author

Albiges, L., Bourlon de los Rios, M.T., Chacon, M., Cutuli, H.J., Lopez Chuken, Y.A., Mota, J., Magri, I., Burotto, M., Luz, M.D.A., Menezes, J., Yanez Ruiz, E.P., Maruzzo, M., Bracarda, S., Breckenridge, M., Rathod, D., Yu, Z., Vezina, H., and George, S.

Published
2024
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14. 1655P Association of location of BRCA1/2 pathogenic variants with benefit from PARP-inhibitors in metastatic castration-resistant prostate cancers: Results from the PROGRESS study

Author

Incorvaia, L., Maruzzo, M., Basso, U., Antonuzzo, L., Rizzo, M., Conteduca, V., Messina, C., Bracarda, S., Mammone, G., Scagliarini, S., Maiorano, B.A., Santoni, M., Facchini, G., Lipari, H., Formisano, L., Malapelle, U., Bazan Russo, T.D., Puglisi, M., Bazan, V., and Russo, A.

Published
2024
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15. Predictive ability of a drug-based score in patients with advanced non-small-cell lung cancer receiving first-line immunotherapy

Author

Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, Cortellini A, Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, and Cortellini A

Abstract

Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This ‘drug score’ was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1–2 and poor risk with score 3–4. Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non–small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy). Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab coh

Published
2021

16. Post-progression outcomes of NSCLC patients with PD-L1 expression ≥ 50% receiving first-line single-agent pembrolizumab in a large multicentre real-world study

Author

Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, Porzio G, Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, and Porzio G

Abstract

Background: Treatment sequencing with first-line immunotherapy, followed by second-line chemotherapy, is still a viable option for NSCLC patients with PD-L1 expression ≥50%. Methods: We evaluated post-progression treatment pathways in a large real-world cohort of metastatic NSCLC patients with PD-L1 expression ≥ 50% treated with first-line pembrolizumab monotherapy. Results: Overall, 974 patients were included. With a median follow-up of 22.7 months (95%CI: 21.6–38.2), the median overall survival (OS) of the entire population was 15.8 months (95%CI: 13.5–17.5; 548 events). At the data cutoff, among the 678 patients who experienced disease progression, 379 (55.9%) had not received any further treatment, and 359 patients (52.9%) had died. Patients who did not receive post-progression therapies were older (p = 0.0011), with a worse ECOG-PS (p < 0.0001) and were on corticosteroids prior to pembrolizumab (p = 0.0024). At disease progression, 198 patients (29.2%) received a switched approach and 101 (14.9%) received pembrolizumab ByPD either alone (64 [9.4%]) or in combination with local ablative treatments (37 [5.5%]) (LATs). After a random-case control matching according to ECOG-PS, CNS metastases, bone metastases, and (previous) best response to pembrolizumab, patients receiving pembrolizumab ByPD plus LATs were confirmed to have a significantly longer post-progression OS compared to patients receiving pembrolizumab ByPD alone 13.9 months versus 7.8 months (p = 0.0179) 241 patients (35.5%) among the 678 who had experienced PD, received a second-line systemic treatment (regardless of previous treatment beyond PD). As compared to first-line treatment commencement, patients’ features at the moment of second-line initiation showed a significantly higher proportion of patients aged under 70 years (p = 0.0244), with a poorer ECOG-PS (p < 0.0001) and having CNS (p = 0.0001), bone (p = 0.0266) and liver metastases (p = 0.0148). Conclusions: In the real-world scenario NSC

Published
2021

17. How radical prostatectomy procedures have changed over the last 10 years in Italy: a comparative analysis based on more than 1500 patients participating in the MIRROR-SIU/LUNA and the Pros-IT CNR study

Author

Gacci, M., Artibani, W., Bassi, P., Bertoni, F., Bracarda, S., Briganti, A., Carmignani, G., Carmignani, L., Conti, G., Corvo, R., De Nunzio, C., Fusco, F., Graziotti, P., Greco, I., Maggi, S., Magrini, S. M., Mirone, V., Montironi, R., Morgia, G., Muto, G., Noale, M., Pecoraro, S., Porreca, A., Ricardi, U., Russi, E., Russo, G., Salonia, A., Simonato, A., Serni, S., Tomasini, D., Tubaro, A., Zagonel, V., Crepaldi, G., Conti, G. N., Alitto, A. R., Ambrosi, E., Antonelli, A., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buglione, M., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini Francolini, D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., Decosimo, N., Cristiano, O., Rolando, D. A., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli Esposti, C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simeone, C., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Triggiani, L., Trinchieri, A., Trodella, L., Luca, E., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Acanfora, F., Aiello, E., Alchiede, S., Altieri, V., Anceschi, C., Aragona, F., Balloni, F., Barasolo, E., Barba, G., Bartoletti, R., Bigazzi, B., Belgrano, E., Salvatore, S., Battaglia, M., Bellei, L., Bettin, A., Bianchi, G., Bombieri, L., Brancato, T., Breda, G., Caggiano, S., Calabro, A., Caldironi, M., Campo, B., Capobianco, S., Capparelli, F., Carbone, A., Carlo, D., Catanzaro, F., Ciaraldi, F., Cicalese, V., Corbu, C., Cosciani Cunico, S., Cosentino, V., Crimi, A., Cucchiarale, G., Cuscuna, D., Damiano, R., D'Armiento, M., De Dominicis, C., De Grande, G., Del Boca, C., D'Elia, A., De Mayo, E., De Martin, M., Di Clemente, L., Di Meo, S., Di Monaco, G., Di Nicola, G., Di Silverio, A., Di Silverio, F., Fabri, F., Falsaperla, M., Fanciullacci, F., Ferrari, G., Fiaccavento, G., Filoni, A., Fontana, D., Fontana, G., Ghabin, H., Frea, B., Gaboardi, F., Gentile, V., Giandotti, M., Grasso, M., Grosso, G., Guazzieri, S., Isaia, A., Landi, G., Landolfi, R., Larcher, P., Laurenti, C., Lavelli, D., Leidi, G. L., Lembo, A., Leoni, S., Maffei, N., Maffezzini, M., Martinengo, C., Manieri, C., Martorana, G., Mazza, R., Medica, M., Melloni, D., Miano, L., Micheli, E., Milesi, R., Minervini, M. S., Minocci, D., Molon, A., Morello, P., Motta, M., Narcisi, F., Nicita, G., Palermo, S., Paoluzzi, M., Pompa, P., Porena, M., Raciti, G., Rizzotto, A., Rocco, F., Romano, M., Rossini, L., Russo, G. R., Salvioni, R., Sandri, S., Savoca, G., Selli, C., Selvaggi, F. P., Sercia, F., Tallarigo, C., Tanello, M., Tasca, A., Tenaglia, R., Tensi, M., Terrone, C., Tralce, L., Vagge, A., Valenti, P., Varaldo, M., Vespasiani, G., Vicentini, C., Vicirca, F., Vigano, P., Zaccone, V., Zartar, C., Gacci, M., Artibani, W., Bassi, P., Bertoni, F., Bracarda, S., Briganti, A., Carmignani, G., Carmignani, L., Conti, G., Corvo, R., De Nunzio, C., Fusco, F., Graziotti, P., Greco, I., Maggi, S., Magrini, S. M., Mirone, V., Montironi, R., Morgia, G., Muto, G., Noale, M., Pecoraro, S., Porreca, A., Ricardi, U., Russi, E., Russo, G., Salonia, A., Simonato, A., Serni, S., Tomasini, D., Tubaro, A., Zagonel, V., Crepaldi, G., Conti, G. N., Alitto, A. R., Ambrosi, E., Antonelli, A., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buglione, M., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini Francolini, D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., Decosimo, N., Cristiano, O., Rolando, D. A., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli Esposti, C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simeone, C., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Triggiani, L., Trinchieri, A., Trodella, L., Luca, E., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Acanfora, F., Aiello, E., Alchiede, S., Altieri, V., Anceschi, C., Aragona, F., Balloni, F., Barasolo, E., Barba, G., Bartoletti, R., Bigazzi, B., Belgrano, E., Salvatore, S., Battaglia, M., Bellei, L., Bettin, A., Bianchi, G., Bombieri, L., Brancato, T., Breda, G., Caggiano, S., Calabro, A., Caldironi, M., Campo, B., Capobianco, S., Capparelli, F., Carbone, A., Carlo, D., Catanzaro, F., Ciaraldi, F., Cicalese, V., Corbu, C., Cosciani Cunico, S., Cosentino, V., Crimi, A., Cucchiarale, G., Cuscuna, D., Damiano, R., D'Armiento, M., De Dominicis, C., De Grande, G., Del Boca, C., D'Elia, A., De Mayo, E., De Martin, M., Di Clemente, L., Di Meo, S., Di Monaco, G., Di Nicola, G., Di Silverio, A., Di Silverio, F., Fabri, F., Falsaperla, M., Fanciullacci, F., Ferrari, G., Fiaccavento, G., Filoni, A., Fontana, D., Fontana, G., Ghabin, H., Frea, B., Gaboardi, F., Gentile, V., Giandotti, M., Grasso, M., Grosso, G., Guazzieri, S., Isaia, A., Landi, G., Landolfi, R., Larcher, P., Laurenti, C., Lavelli, D., Leidi, G. L., Lembo, A., Leoni, S., Maffei, N., Maffezzini, M., Martinengo, C., Manieri, C., Martorana, G., Mazza, R., Medica, M., Melloni, D., Miano, L., Micheli, E., Milesi, R., Minervini, M. S., Minocci, D., Molon, A., Morello, P., Motta, M., Narcisi, F., Nicita, G., Palermo, S., Paoluzzi, M., Pompa, P., Porena, M., Raciti, G., Rizzotto, A., Rocco, F., Romano, M., Rossini, L., Russo, G. R., Salvioni, R., Sandri, S., Savoca, G., Selli, C., Selvaggi, F. P., Sercia, F., Tallarigo, C., Tanello, M., Tasca, A., Tenaglia, R., Tensi, M., Terrone, C., Tralce, L., Vagge, A., Valenti, P., Varaldo, M., Vespasiani, G., Vicentini, C., Vicirca, F., Vigano, P., Zaccone, V., Zartar, C., Gacci M., Artibani W., Bassi P., Bertoni F., Bracarda S., Briganti A., Carmignani G., Carmignani L., Conti G., Corvo R., De Nunzio C., Fusco F., Graziotti P., Greco I., Maggi S., Magrini S.M., Mirone V., Montironi R., Morgia G., Muto G., Noale M., Pecoraro S., Porreca A., Ricardi U., Russi E., Russo G., Salonia A., Simonato A., Serni S., Tomasini D., Tubaro A., Zagonel V., Crepaldi G., Conti G.N., Alitto A.R., Ambrosi E., Antonelli A., Aristei C., Bardari F., Bardoscia L., Barra S., Bartoncini S., Basso U., Becherini C., Bellavita R., Bergamaschi F., Berlingheri S., Berruti A., Borghesi M., Bortolus R., Borzillo V., Bosetti D., Bove G., Bove P., Brausi M., Bruni A., Bruno G., Brunocilla E., Buffoli A., Buglione M., Buttigliero C., Cacciamani G., Caldiroli M., Cardo G., Carrieri G., Castelli E., Castrezzati E., Catalano G., Cattarino S., Catucci F., Cavallini Francolini D., Ceccarini O., Celia A., Chiancone F., Chini T., Cianci C., Cisternino A., Collura D., Corbella F., Corinti M., Corsi P., Cortese F., Corti L., deCosimo N., Cristiano O., Rolando D.A., Da Pozzo L., D'Agostino D., D'Elia C., Dandrea M., De Angelis M., De Angelis P., De Cobelli O., De Concilio B., De Lisa A., De Luca S., De Stefani A., Deantoni C.L., Degli Esposti C., Destito A., Detti B., Di Muzio N., Di Stasio A., Di Stefano C., Di Trapani D., Difino G., Falivene S., Farullo G., Fedelini P., Ferrari I., Ferrau F., Ferro M., Fodor A., Fontana F., Francesca F., Francolini G., Frata P., Frezza G., Gabriele P., Galeandro M., Garibaldi E., Gennari P.G., Gentilucci A., Giacobbe A., Giussani L., Giusti G., Gontero P., Guarneri A., Guida C., Gurioli A., Huqi D., Imbimbo C., Ingrosso G., Iotti C., Italia C., La Mattina P., La Rocca R., Lamanna E., Lastrucci L., Lazzari G., Liberale F., Liguori G., Lisi R., Lohr F., Lombardo R., Lovisolo J.A., Ludovico G.M., Macchione N., Maggio F., Malizia M., Manasse G., Mandoliti G., Mantini G., Marafioti L., Marciello L., Marconi A.M., Martilotta A., Marzano S., Masciullo S., Maso G., Massenzo A., Mazzeo E., Mearini L., Medoro S., Mole R., Monesi G., Montanari E., Montefiore F., Montesi G., Moro G., Muscas G., Musio D., Muto P., Muzzonigro G., Napodano G., Negro C.L.A., Nidini M., Ntreta M., Orsatti M., Palazzolo C., Palumbo I., Parisi A., Parma P., Pavan N., Pericolini M., Pinto F., Pistone A., Pizzuti V., Platania A., Polli C., Pomara G., Ponti E., Porcaro A.B., Porpiglia F., Pugliese D., Pycha A., Raguso G., Rampini A., Randone D.F., Roboldi V., Roscigno M., Ruggieri M.P., Ruoppo G., Sanseverino R., Santacaterina A., Santarsieri M., Santoni R., Scagliarini S., Scagliotti G.V., Scanzi M., Scarcia M., Schiavina R., Sciarra A., Sciorio C., Scolaro T., Scuzzarella S., Selvaggio O., Serao A., Signor M.A., Silvani M., Silvano G., Silvestris F., Simeone C., Simone V., Spagnoletti G., Spinelli M.G., Squillace L., Tombolini V., Toninelli M., Triggiani L., Trinchieri A., Trodella L., Luca E., Trombetta C., Tronnolone L., Tucci M., Urzi D., Valdagni R., Valeriani M., Vanoli M., Vitali E., Volpe A., Zaramella S., Zeccolini G., Zini G., Acanfora F., Aiello E., Alchiede S., Altieri V., Anceschi C., Aragona F., Balloni F., Barasolo E., Barba G., Bartoletti R., Bigazzi B., Belgrano E., Salvatore S., Battaglia M., Bellei L., Bettin A., Bianchi G., Bombieri L., Brancato T., Breda G., Caggiano S., Calabro A., Caldironi M., Campo B., Capobianco S., Capparelli F., Carbone A., Carlo D., Catanzaro F., Ciaraldi F., Cicalese V., Corbu C., Cosciani Cunico S., Cosentino V., Crimi A., Cucchiarale G., Cuscuna D., Damiano R., D'Armiento M., De Dominicis C., De Grande G., Del Boca C., D'Elia A., De Mayo E., De Martin M., Di Clemente L., Di Meo S., Di Monaco G., Di Nicola G., Di Silverio A., Di Silverio F., Fabri F., Falsaperla M., Fanciullacci F., Ferrari G., Fiaccavento G., Filoni A., Fontana D., Fontana G., Ghabin H., Frea B., Gaboardi F., Gentile V., Giandotti M., Grasso M., Grosso G., Guazzieri S., Isaia A., Landi G., Landolfi R., Larcher P., Laurenti C., Lavelli D., Leidi G.L., Lembo A., Leoni S., Maffei N., Maffezzini M., Martinengo C., Manieri C., Martorana G., Mazza R., Medica M., Melloni D., Miano L., Micheli E., Milesi R., Minervini M.S., Minocci D., Molon A., Morello P., Motta M., Narcisi F., Nicita G., Palermo S., Paoluzzi M., Pompa P., Porena M., Raciti G., Rizzotto A., Rocco F., Romano M., Rossini L., Russo G.R., Salvioni R., Sandri S., Savoca G., Selli C., Selvaggi F.P., Sercia F., Tallarigo C., Tanello M., Tasca A., Tenaglia R., Tensi M., Terrone C., Tralce L., Vagge A., Valenti P., Varaldo M., Vespasiani G., Vicentini C., Vicirca F., Vigano P., Zaccone V., Zartar C., Gacci, Mauro, Artibani, Walter, Bassi, Pierfrancesco, Bertoni, Filippo, Bracarda, Sergio, Briganti, Alberto, Carmignani, Giorgio, Carmignani, Luca, Conti, Giario, Corvò, Renzo, De Nunzio, Cosimo, Fusco, Ferdinando, Graziotti, Pierpaolo, Greco, Isabella, Maggi, Stefania, Magrini, Stefano Maria, Mirone, Vincenzo, Montironi, Rodolfo, Morgia, Giuseppe, Muto, Giovanni, Noale, Marianna, Pecoraro, Stefano, Porreca, Angelo, Ricardi, Umberto, Russi, Elvio, Russo, Giorgio, Salonia, Andrea, Simonato, Alchiede, Serni, Sergio, Tomasini, Davide, Tubaro, Andrea, Zagonel, Vittorina, and Crepaldi, Gaetano

Subjects
Male, Nephrology, medicine.medical_specialty, Time Factors, Urology, medicine.medical_treatment, 030232 urology & nephrology, Lymph node dissection, Logistic regression, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Internal medicine, LUNA study, Biopsy, Humans, Medicine, Prospective Studies, Nerve sparing, Lymph node, Aged, Prostatectomy, medicine.diagnostic_test, business.industry, MIRROR SIU/LUNA study, Lymph node dissection, MIRROR SIU/LUNA study, Nerve sparing, Pros-IT CNR study, Prostate cancer, Robotic procedures, Prostatic Neoplasms, Cancer, Pros-IT CNR study, Middle Aged, medicine.disease, MIRROR SIU, Dissection, Robotic procedures, Logistic Models, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, business
Abstract

Purpose Therapeutic strategies for prostate cancer (PCa) have been evolving dramatically worldwide. The current article reports on the evolution of surgical management strategies for PCa in Italy. Methods The data from two independent Italian multicenter projects, the MIRROR-SIU/LUNA (started in 2007, holding data of 890 patients) and the Pros-IT-CNR project (started in 2014, with data of 692 patients), were compared. Differences in patients' characteristics were evaluated. Multivariable logistic regression models were used to identify characteristics associated with robot-assisted (RA) procedure, nerve sparing (NS) approach, and lymph node dissection (LND). Results The two cohorts did not differ in terms of age and prostate-specific antigen (PSA) levels at biopsy. Patients enrolled in the Pros-IT-CNR project more frequently were submitted to RA (58.8% vs 27.6%,p < 0.001) and NS prostatectomy (58.4% vs. 52.9%,p = 0.04), but received LND less frequently (47.7% vs. 76.7%,p < 0.001), as compared to the MIRROR-SIU/LUNA patients. At multivariate logistic models, Lower Gleason Scores (GS) and PSA levels were significantly associated with RA prostatectomy in both cohorts. As for the MIRROR-SIU/LUNA data, clinical T-stage was a predictor for NS (OR = 0.07 for T3, T4) and LND (OR = 2.41 for T2) procedures. As for Pros-IT CNR data, GS >= (4 + 3) and positive cancer cores >= 50% were decisive factors both for NS (OR 0.29 and 0.30) and LND (OR 7.53 and 2.31) strategies. Conclusions PCa management has changed over the last decade in Italian centers: RA and NS procedures without LND have become the methods of choice to treat newly medium-high risk diagnosed PCa.

Published
2021

18. Overview of potential determinants of radical prostatectomy versus radiation therapy in management of clinically localized prostate cancer: results from an Italian, prospective, observational study (the Pros-IT CNR study)

Author

Antonelli, A, Palumbo, C, Noale, M, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Bruni, A, Corvò, R, Gacci, M, Magrini, S, Montironi, R, Porreca, A, Tubaro, A, Zagonel, V, Maggi, S, Alitto, A, Ambrosi, E, Aristei, C, Barbieri, M, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Berruti, A, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruno, G, Brunocilla, E, Buffoli, A, Buglione, M, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini Francolini, D, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, De Nunzio, C, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Andrea, D, Dandrea, M, De Angelis, M, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli Esposti, C, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Fabiano, M, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari, P, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico, G, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi, A, Martillotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mazzeo, E, Mearini, L, Medoro, S, Molè, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone, D, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliotti, G, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Serni, S, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simeone, C, Simone, V, Spagnoletti, G, Spinelli, M, Squillace, L, Tombolini, V, Toninelli, M, Triggiani, L, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzì, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Zaramella, S, Zeccolini, G, Zini, G, Antonelli A, Palumbo C, Noale M, Artibani W, Bassi P, Bertoni F, Bracarda S, Bruni A, Corvò R, Gacci M, Magrini SM, Montironi R, Porreca A, Tubaro A, Zagonel V, Alitto AR, Ambrosi E, Aristei C, Barbieri M, Bardari F, Bardoscia L, Barra S, Bartoncini S, Basso U, Becherini C, Bellavita R, Bergamaschi F, Berlingheri S, Berruti A, Borghesi M, Bortolus R, Borzillo V, Bosetti D, Bove G, Bove P, Brausi M, Bruno G, Brunocilla E, Buffoli A, Buglione M, Buttigliero C, Cacciamani G, Caldiroli M, Cardo G, Carmignani G, Carrieri G, Castelli E, Castrezzati E, Catalano G, Cattarino S, Catucci F, Cavallini Francolini D, Ceccarini O, Celia A, Chiancone F, Chini T, Cianci C, Cisternino A, Collura D, Corbella F, Corinti M, Corsi P, Cortese F, Corti L, De Nunzio C, Cristiano O, D'angelillo R, Da Pozzo L, D'agostino D, D'andrea D, Dandrea M, De Angelis M, De Cobelli O, De Concilio B, De Lisa A, De Luca S, De Stefani A, Deantoni CL, Degli Esposti C, Destito A, Detti B, Di Muzio N, Di Stasio A, Di Stefano C, Di Trapani D, Difino G, Fabiano M, Falivene S, Farullo G, Fedelini P, Ferrari I, Ferrau F, Ferro M, Fodor A, Fontana F, Francesca F, Francolini G, Frata P, Frezza G, Gabriele P, Galeandro M, Garibaldi E, Gennari PG, Gentilucci A, Giacobbe A, Giussani L, Giusti G, Gontero P, Guarneri A, Guida C, Gurioli A, Huqi D, Imbimbo C, Ingrosso G, Iotti C, Italia C, La Mattina P, Lamanna E, Lastrucci L, Lazzari G, Liberale F, Liguori G, Lisi R, Lohr F, Lombardo R, Lovisolo J, Ludovico GM, Macchione N, Maggio F, Malizia M, Manasse G, Mandoliti G, Mantini G, Marafioti L, Marciello L, Marconi AM, Martillotta A, Marzano S, Masciullo S, Maso G, Massenzo A, Mazzeo E, Mearini L, Medoro S, Molè R, Monesi G, Montanari E, Montefiore F, Montesi G, Morgia G, Moro G, Muscas G, Musio D, Muto P, Muzzonigro G, Napodano G, Negro CL, Nidini M, Ntreta M, Orsatti M, Palazzolo C, Palumbo I, Parisi A, Parma P, Pavan N, Pericolini M, Pinto F, Pistone A, Pizzuti V, Platania A, Polli C, Pomara G, Ponti E, Porcaro AB, Porpiglia F, Pugliese D, Pycha A, Raguso G, Rampini A, Randone DF, Roboldi V, Roscigno M, Ruggieri MP, Ruoppo G, Sanseverino R, Santacaterina A, Santarsieri M, Santoni R, Scagliotti GV, Scanzi M, Scarcia M, Schiavina R, Sciarra A, Sciorio C, Scolaro T, Scuzzarella S, Selvaggio O, Serao A, Serni S, Signor MA, Silvani M, Silvano G, Silvestris F, Simeone C, Simone V, Spagnoletti G, Spinelli MG, Squillace L, Tombolini V, Toninelli M, Triggiani L, Trinchieri A, Trodella LE, Trodella L, Trombetta C, Tronnolone L, Tucci M, Urzì D, Valdagni R, Valeriani M, Vanoli M, Vitali E, Zaramella S, Zeccolini G, Zini G., Antonelli, A, Palumbo, C, Noale, M, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Bruni, A, Corvò, R, Gacci, M, Magrini, S, Montironi, R, Porreca, A, Tubaro, A, Zagonel, V, Maggi, S, Alitto, A, Ambrosi, E, Aristei, C, Barbieri, M, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Berruti, A, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruno, G, Brunocilla, E, Buffoli, A, Buglione, M, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini Francolini, D, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, De Nunzio, C, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Andrea, D, Dandrea, M, De Angelis, M, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli Esposti, C, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Fabiano, M, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari, P, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico, G, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi, A, Martillotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mazzeo, E, Mearini, L, Medoro, S, Molè, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone, D, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliotti, G, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Serni, S, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simeone, C, Simone, V, Spagnoletti, G, Spinelli, M, Squillace, L, Tombolini, V, Toninelli, M, Triggiani, L, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzì, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Zaramella, S, Zeccolini, G, Zini, G, Antonelli A, Palumbo C, Noale M, Artibani W, Bassi P, Bertoni F, Bracarda S, Bruni A, Corvò R, Gacci M, Magrini SM, Montironi R, Porreca A, Tubaro A, Zagonel V, Alitto AR, Ambrosi E, Aristei C, Barbieri M, Bardari F, Bardoscia L, Barra S, Bartoncini S, Basso U, Becherini C, Bellavita R, Bergamaschi F, Berlingheri S, Berruti A, Borghesi M, Bortolus R, Borzillo V, Bosetti D, Bove G, Bove P, Brausi M, Bruno G, Brunocilla E, Buffoli A, Buglione M, Buttigliero C, Cacciamani G, Caldiroli M, Cardo G, Carmignani G, Carrieri G, Castelli E, Castrezzati E, Catalano G, Cattarino S, Catucci F, Cavallini Francolini D, Ceccarini O, Celia A, Chiancone F, Chini T, Cianci C, Cisternino A, Collura D, Corbella F, Corinti M, Corsi P, Cortese F, Corti L, De Nunzio C, Cristiano O, D'angelillo R, Da Pozzo L, D'agostino D, D'andrea D, Dandrea M, De Angelis M, De Cobelli O, De Concilio B, De Lisa A, De Luca S, De Stefani A, Deantoni CL, Degli Esposti C, Destito A, Detti B, Di Muzio N, Di Stasio A, Di Stefano C, Di Trapani D, Difino G, Fabiano M, Falivene S, Farullo G, Fedelini P, Ferrari I, Ferrau F, Ferro M, Fodor A, Fontana F, Francesca F, Francolini G, Frata P, Frezza G, Gabriele P, Galeandro M, Garibaldi E, Gennari PG, Gentilucci A, Giacobbe A, Giussani L, Giusti G, Gontero P, Guarneri A, Guida C, Gurioli A, Huqi D, Imbimbo C, Ingrosso G, Iotti C, Italia C, La Mattina P, Lamanna E, Lastrucci L, Lazzari G, Liberale F, Liguori G, Lisi R, Lohr F, Lombardo R, Lovisolo J, Ludovico GM, Macchione N, Maggio F, Malizia M, Manasse G, Mandoliti G, Mantini G, Marafioti L, Marciello L, Marconi AM, Martillotta A, Marzano S, Masciullo S, Maso G, Massenzo A, Mazzeo E, Mearini L, Medoro S, Molè R, Monesi G, Montanari E, Montefiore F, Montesi G, Morgia G, Moro G, Muscas G, Musio D, Muto P, Muzzonigro G, Napodano G, Negro CL, Nidini M, Ntreta M, Orsatti M, Palazzolo C, Palumbo I, Parisi A, Parma P, Pavan N, Pericolini M, Pinto F, Pistone A, Pizzuti V, Platania A, Polli C, Pomara G, Ponti E, Porcaro AB, Porpiglia F, Pugliese D, Pycha A, Raguso G, Rampini A, Randone DF, Roboldi V, Roscigno M, Ruggieri MP, Ruoppo G, Sanseverino R, Santacaterina A, Santarsieri M, Santoni R, Scagliotti GV, Scanzi M, Scarcia M, Schiavina R, Sciarra A, Sciorio C, Scolaro T, Scuzzarella S, Selvaggio O, Serao A, Serni S, Signor MA, Silvani M, Silvano G, Silvestris F, Simeone C, Simone V, Spagnoletti G, Spinelli MG, Squillace L, Tombolini V, Toninelli M, Triggiani L, Trinchieri A, Trodella LE, Trodella L, Trombetta C, Tronnolone L, Tucci M, Urzì D, Valdagni R, Valeriani M, Vanoli M, Vitali E, Zaramella S, Zeccolini G, and Zini G.

Abstract

BACKGROUND: We assessed patients and tumor characteristics, as well as health-related quality of life (HRQoL) items, associated with curative intent treatment decision-making in clinically localized prostate cancer (PCa) patients. METHODS: Clinically localized PCa treated with either radical prostatectomy (RP) or radiation therapy (RT) within 12 months from diagnosis were abstracted from The PROState cancer monitoring in ITaly, from the National Research Council (Pros-IT CNR) database. Multivariable logistic regression (MLR) models predicting RT vs. RP were fitted, after adjustment for HRQoL items, patients and tumor characteristics. RESULTS: Of 1041 patients, 631 (60.2%) were treated with RP and 410 (39.8%) with RT. Relative to RT, RP patients were younger age (mean age 64.5±6.6 vs. 71.4±4.9, P<0.001) and had higher rates of D’Amico low-intermediate risk groups (31.8 vs. 21.9% low, 46.3% vs. 43.5% intermediate and 21.9% vs. 34.6% high risk, P<0.001). Overall, 93.2% of RP patients were enrolled by urologists and 82.7% of RT patients by radiation oncologists. RP patients had generally higher means values of HRQoL items. In MLR models, higher RT rates were independently associated with more advanced age (odds ratio [OR] 6.14, P<0.001) and BMI≥30 kg/m2 (OR 1.78, P<0.001). Conversely, lower rates of RT were independently associated with married (OR 0.55, P=0.01) and worker status (OR 0.52, P=0.004), enrollment in academic centers (OR 0.59, P=0.005) and higher physical composite score (OR 0.88, P=0.03) and baseline sexual function items (OR 0.92, P<0.001). CONCLUSIONS: Most patients with clinically localized prostate cancer undergoing definitive treatment at Italian institutions receive RP instead of RT. Moreover, those who are younger, married, working, as well as those with better physical and sexual function are more likely to undergo surgery.

Published
2020

19. Compassionate Use Program of Ipilimumab and Nivolumab in Intermediate or Poor Risk Metastatic Renal Cell Carcinoma: A Large Multicenter Italian Study

Author

Basso, U., Paolieri, F., Rizzo, M., De Giorgi, U., Bracarda, S., Antonuzzo, L., Atzori, F., Cartenì, G., Procopio, G., Fratino, L., D’Arcangelo, M., Fornarini, G., Zucali, P., Cusmai, A., Santoni, M., Pipitone, S., Carella, C., Panni, S., Deppieri, F. M., Zagonel, V., and Tortora, Giampaolo

Subjects
Settore MED/06 - ONCOLOGIA MEDICA, cancer
Abstract

This is a retrospective analysis on the safety and activity of compassionate Ipilimumab and Nivolumab (IPI-NIVO) administered to patients with metastatic Renal Cell Carcinoma (mRCC) with intermediate or poor International Metastatic RCC Database Consortium (IMDC) score as a first-line regimen. IPI was infused at 1 mg/kg in combination with Nivolumab 3 mg/kg every three weeks for four doses, followed by maintenance Nivolumab (240 or 480 mg flat dose every two or four weeks, respectively) until disease progression or unacceptable toxicity. A total of 324 patients started IPI-NIVO at 86 Italian centers. Median age was 62 years, 68.2% IMDC intermediate risk. Primary tumor had been removed in 65.1% of patients. Two hundred and twenty patients (67.9%) completed the four IPI-NIVO doses. Investigator-assessed overall response rate was 37.6% (2.8% complete). Twelve-month survival rate was 66.8%, median progression-free survival was 8.3 months. Grade 3 or 4 treatment-related adverse events occurred in 67 patients (26.9%). IMDC intermediate risk, nephrectomy, BMI ≥ 25 kg/m

Published
2022

20. Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program

Author

Rebuzzi, S. E., Signori, A., Buti, S., Banna, G. L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, Diana, Tortora, Giampaolo, Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, Francesco, Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, Antonio, Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., Fornarini, G., Giannarelli D., Tortora G. (ORCID:0000-0002-1378-4962), Atzori F., Astone A. (ORCID:0000-0001-9572-309X), Rebuzzi, S. E., Signori, A., Buti, S., Banna, G. L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, Diana, Tortora, Giampaolo, Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, Francesco, Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, Antonio, Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., Fornarini, G., Giannarelli D., Tortora G. (ORCID:0000-0002-1378-4962), Atzori F., and Astone A. (ORCID:0000-0001-9572-309X)

Abstract

Background: The Meet-URO score allowed a more accurate prognostication than the International Metastatic RCC Database Consortium (IMDC) for patients with pre-treated metastatic renal cell carcinoma (mRCC) by adding the pre-treatment neutrophil-to-lymphocyte ratio and presence of bone metastases.Materials and methods: A post hoc analysis was carried out to validate the Meet-URO score on the overall survival (OS) of patients with IMDC intermediate-poor-risk mRCC treated with first-line nivolumab plus ipilimumab within the prospective Italian Expanded Access Programme (EAP). We additionally considered progression-free survival (PFS) and disease response rates. Harrell's c-index was calculated to compare the accuracy of survival prediction.Results: Overall the EAP included 306 patients, with a median follow-up of 12.2 months, median OS was not reached, 1-year OS was 66.8% and median PFS was 7.9 months. By univariable analysis, both the IMDC score and the two additional variables of the Meet-URO score were associated with either OS or PFS (P < 0.001 for all comparisons). The four Meet-URO risk groups (G) had 1-year OS of 92%, 72%, 50% and 21% for G2 (29.1% of patients), G3 (28.8%), G4 (33.0%) and G5 (9.1%), respectively. OS was significantly shorter in each consecutive G (P = 0.001 for G3, P < 0.001 for both G4 and G5 compared to G2). Similarly, Meet-URO Gs 2-5 showed decreasing median PFS and response rates. The Meet-URO score showed the highest c-index for both OS (0.73) and PFS (0.67). Limitations include the post hoc nature of this analysis and the lack of a comparative arm to assess predictive value.Conclusion: The Meet-URO score appeared to show better prognostic classification than the IMDC alone in patients with mRCC at IMDC intermediate-poor risk treated with first-line nivolumab and ipilimumab.

Published
2022

22. Health-related quality of life 24 months after prostate cancer diagnosis: an update from the Pros-IT CNR prospective observational study

Author

Palumbo, C, Bruni, A, Antonelli, A, Artibani, W, Bassi, P, Bertoni, F, Borghetti, P, Bracarda, S, Cicchetti, A, Corvò, R, Gacci, M, Ingrosso, G, Magrini, S, Maruzzo, M, Mirone, V, Montironi, R, Muto, G, Noale, M, Porreca, A, Russi, E, Triggiani, L, Tubaro, A, Valdagni, R, Maggi, S, Conti, G, Pros-IT CNR Study Group, and D'Angelillo, R

Subjects
Settore MED/36, Settore MED/06
Published
2022

23. The waiting time for prostate cancer treatment in Italy: analysis from the PROS-IT CNR Study

Author

Gacci, M, Greco, I, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Briganti, A, Carmignani, G, Carmignani, L, Conti, G, Corvò, R, DE Nunzio, C, Fusco, F, Graziotti, P, Maggi, S, Magrini, S, Mirone, V, Montironi, R, Muto, G, Noale, M, Pecoraro, S, Porreca, A, Ricardi, U, Russi, E, Salonia, A, Simonato, A, Serni, S, Tubaro, A, Zagonel, V, Crepaldi, G, Pros-IT CNR Study Group, D'Angelillo, R, Gacci, Mauro, Greco, Isabella, Artibani, Walter, Bassi, Pierfrancesco, Bertoni, Filippo, Bracarda, Sergio, Briganti, Alberto, Carmignani, Giorgio, Carmignani, Luca, Conti, Giario, Corvò, Renzo, De Nunzio, Cosimo, Fusco, Ferdinando, Graziotti, Pierpaolo, Maggi, Stefania, Magrini, Stefano M, Mirone, Vincenzo, Montironi, Rodolfo, Muto, Giovanni, Noale, Marianna, Pecoraro, Stefano, Porreca, Angelo, Ricardi, Umberto, Russi, Elvio, Salonia, Andrea, Simonato, Alchiede, Serni, Sergio, Tubaro, Andrea, Zagonel, Vittorina, and Crepaldi, Gaetano

Subjects
Waiting time, Male, medicine.medical_specialty, Waiting Lists, Urology, Lymph node metastasis, Androgen deprivation therapy, Settore MED/06, Prostate cancer, Percutaneous Coronary Intervention, prostate cancer, radical prostatectomy, screening, Quality of life, Settore MED/36, Internal medicine, medicine, Humans, Waiting lists, Prostatic neoplasms, Prostatectomy, Radiotherapy, Androgens, Prostate, Quality of Life, Prostatic Neoplasms, Surgical approach, business.industry, screening, Cancer, prostate cancer, medicine.disease, radical prostatectomy, Nephrology, T-stage, Positive Surgical Margin, business
Abstract

Background Prostate cancer (PCa) is the second most common neoplasm in male patients. To date, there's no certain indication about the maximum waiting time (WT) acceptable for treatment beginning and the impact on oncological and functional outcomes has not been well established. Methods Data from the National Research Council PCa monitoring multicenter project in Italy (Pros-IT CNR) were prospectively collected and analyzed. WT was defined as the time from the bioptical diagnosis of PCa to the first treatment received. Patients were divided in two groups, using a time frame of 90 days. Quality of life was measured through the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and of the Short-Form Health Survey (SF-12). The occurrence of upgrading, upstaging, presence of lymph node metastasis and positive surgical margins at the final histopathological diagnosis, and PSA at 12 months follow-up were evaluated. Results The overall median WT was 93 days. The logistic multivariable model confirmed that age, being resident in Southern regions of Italy and T staging at diagnosis were significantly associated with a WT >90 days. At 6 months from diagnosis the mean SF-12 score for the emotionalpsychological component was significantly lower in WT ≥ 90 days group (p=0.0428). Among patients treated with surgical approach, no significant differences in oncological outcomes were found in the two groups. Conclusions In our study age, clinical T stage and provenance from Southern regions of Italy are associated with a WT > 90 days. WT might have no impact on functional and oncological outcome.

Published
2022

27. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†

Author

Kramar, A., Negrier, S., Sylvester, R., Joniau, S., Mulders, P., Powles, T., Bex, A., Bonnetain, F., Bossi, A., Bracarda, S., Bukowski, R., Catto, J., Choueiri, T. K., Crabb, S., Eisen, T., El Demery, M., Fitzpatrick, J., Flamand, V., Goebell, P. J., Gravis, G., Houédé, N., Jacqmin, D., Kaplan, R., Malavaud, B., Massard, C., Melichar, B., Mourey, L., Nathan, P., Pasquier, D., Porta, C., Pouessel, D., Quinn, D., Ravaud, A., Rolland, F., Schmidinger, M., Tombal, B., Tosi, D., Vauleon, E., Volpe, A., Wolter, P., Escudier, B., Filleron, T., Kramar, Andrew, Sylvester, Richard, Filleron, Thomas, Negrier, Sylvie, Joniau, Steven, Mulders, Peter, Powles, Thomas, Escudier, Bernard, Bex, Axel, Bonnetain, Franck, Bossi, Alberto, Braccarda, Sergio, Bukowski, Ronald, Catto, James, Choueiri, Toni, Crabb, Simon, Eisen, Tim, El Demery, Mounira, Fitzpatrick, John, Flamand, Vincent, Goebell, Peter J., Gravis, Gwendael, Houédé, Nadine, Jacqmin, Didier, Kaplan, Richard, Malavaud, Bernard, Massard, Christophe, Melichar, Bohuslav, Mourey, Loïc, Nathan, Paul, Pasquier, David, Porta, Camillo, Pouessel, Damien, Quinn, David, Ravaud, Alain, Rolland, Frédéric, Schmidinger, Manuela, Tombal, Bertrand, Tosi, Diego, Vauleon, Elodie, Volpe, Alessandro, and Wolter, Pascal

Published
2015
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28. Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR)

Author

Buglione, M, Noale, M, Bruni, A, Antonelli, A, Bertoni, F, Corvo, R, Ricardi, U, Borghetti, P, Maddalo, M, Simeone, C, Mazzeo, E, Porreca, A, Serni, S, Bassi, P, Gacci, M, Mirone, V, Montironi, R, Tubaro, A, Berruti, A, Conti, G, Maggi, S, Magrini, S, Triggiani, L, Crepaldi, G, Artibani, W, Bracarda, S, Graziotti, P, Russi, E, Muto, G, Pecoraro, S, Zagonel, V, Alitto, A, Ambrosi, E, Aristei, C, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruno, G, Brunocilla, E, Buffoli, A, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini, F, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, de Nunzio, C, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Elia, C, Dandrea, M, De Angelis, M, De Angelis, P, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli, E, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari, P, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, La Rocca, R, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico, G, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi, A, Martilotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mearini, L, Medoro, S, Mole, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone, D, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliarini, S, Scagliotti, G, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simone, V, Spagnoletti, G, Spinelli, M, Squillace, L, Tombolini, V, Toninelli, M, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzi, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Volpe, A, Zaramella, S, Zeccolini, G, Zini, G, Buglione M., Noale M., Bruni A., Antonelli A., Bertoni F., Corvo R., Ricardi U., Borghetti P., Maddalo M., Simeone C., Mazzeo E., Porreca A., Serni S., Bassi P., Gacci M., Mirone V., Montironi R., Tubaro A., Berruti A., Conti G. N., Maggi S., Magrini S. M., Triggiani L., Crepaldi G., Artibani W., Bracarda S., Graziotti P., Russi E., Muto G., Pecoraro S., Zagonel V., Alitto A. R., Ambrosi E., Aristei C., Bardari F., Bardoscia L., Barra S., Bartoncini S., Basso U., Becherini C., Bellavita R., Bergamaschi F., Berlingheri S., Borghesi M., Bortolus R., Borzillo V., Bosetti D., Bove G., Bove P., Brausi M., Bruno G., Brunocilla E., Buffoli A., Buttigliero C., Cacciamani G., Caldiroli M., Cardo G., Carmignani G., Carrieri G., Castelli E., Castrezzati E., Catalano G., Cattarino S., Catucci F., Cavallini F. D., Ceccarini O., Celia A., Chiancone F., Chini T., Cianci C., Cisternino A., Collura D., Corbella F., Corinti M., Corsi P., Cortese F., Corti L., de Nunzio C., Cristiano O., D'angelillo R. M., Da Pozzo L., D'agostino D., D'elia C., Dandrea M., De Angelis M., De Angelis P., De Cobelli O., De Concilio B., De Lisa A., De Luca S., De Stefani A., Deantoni C. L., Degli E. C., Destito A., Detti B., Di Muzio N., Di Stasio A., Di Stefano C., Di Trapani D., Difino G., Falivene S., Farullo G., Fedelini P., Ferrari I., Ferrau F., Ferro M., Fodor A., Fontana F., Francesca F., Francolini G., Frata P., Frezza G., Gabriele P., Galeandro M., Garibaldi E., Gennari P. G., Gentilucci A., Giacobbe A., Giussani L., Giusti G., Gontero P., Guarneri A., Guida C., Gurioli A., Huqi D., Imbimbo C., Ingrosso G., Iotti C., Italia C., La Mattina P., La Rocca R., Lamanna E., Lastrucci L., Lazzari G., Liberale F., Liguori G., Lisi R., Lohr F., Lombardo R., Lovisolo J. A. J., Ludovico G. M., Macchione N., Maggio F., Malizia M., Manasse G., Mandoliti G., Mantini G., Marafioti L., Marciello L., Marconi A. M., Martilotta A., Marzano S., Masciullo S., Maso G., Massenzo A., Mearini L., Medoro S., Mole R., Monesi G., Montanari E., Montefiore F., Montesi G., Morgia G., Moro G., Muscas G., Musio D., Muto P., Muzzonigro G., Napodano G., Negro C. L. A., Nidini M., Ntreta M., Orsatti M., Palazzolo C., Palumbo I., Parisi A., Parma P., Pavan N., Pericolini M., Pinto F., Pistone A., Pizzuti V., Platania A., Polli C., Pomara G., Ponti E., Porcaro A. B., Porpiglia F., Pugliese D., Pycha A., Raguso G., Rampini A., Randone D. F., Roboldi V., Roscigno M., Ruggieri M. P., Ruoppo G., Sanseverino R., Santacaterina A., Santarsieri M., Santoni R., Scagliarini S., Scagliotti G. V., Scanzi M., Scarcia M., Schiavina R., Sciarra A., Sciorio C., Scolaro T., Scuzzarella S., Selvaggio O., Serao A., Signor M. A., Silvani M., Silvano G., Silvestris F., Simone V., Spagnoletti G., Spinelli M. G., Squillace L., Tombolini V., Toninelli M., Trinchieri A., Trodella L. E., Trodella L., Trombetta C., Tronnolone L., Tucci M., Urzi D., Valdagni R., Valeriani M., Vanoli M., Vitali E., Volpe A., Zaramella S., Zeccolini G., Zini G., Buglione, M, Noale, M, Bruni, A, Antonelli, A, Bertoni, F, Corvo, R, Ricardi, U, Borghetti, P, Maddalo, M, Simeone, C, Mazzeo, E, Porreca, A, Serni, S, Bassi, P, Gacci, M, Mirone, V, Montironi, R, Tubaro, A, Berruti, A, Conti, G, Maggi, S, Magrini, S, Triggiani, L, Crepaldi, G, Artibani, W, Bracarda, S, Graziotti, P, Russi, E, Muto, G, Pecoraro, S, Zagonel, V, Alitto, A, Ambrosi, E, Aristei, C, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruno, G, Brunocilla, E, Buffoli, A, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini, F, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, de Nunzio, C, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Elia, C, Dandrea, M, De Angelis, M, De Angelis, P, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli, E, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari, P, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, La Rocca, R, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico, G, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi, A, Martilotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mearini, L, Medoro, S, Mole, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone, D, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliarini, S, Scagliotti, G, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simone, V, Spagnoletti, G, Spinelli, M, Squillace, L, Tombolini, V, Toninelli, M, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzi, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Volpe, A, Zaramella, S, Zeccolini, G, Zini, G, Buglione M., Noale M., Bruni A., Antonelli A., Bertoni F., Corvo R., Ricardi U., Borghetti P., Maddalo M., Simeone C., Mazzeo E., Porreca A., Serni S., Bassi P., Gacci M., Mirone V., Montironi R., Tubaro A., Berruti A., Conti G. N., Maggi S., Magrini S. M., Triggiani L., Crepaldi G., Artibani W., Bracarda S., Graziotti P., Russi E., Muto G., Pecoraro S., Zagonel V., Alitto A. R., Ambrosi E., Aristei C., Bardari F., Bardoscia L., Barra S., Bartoncini S., Basso U., Becherini C., Bellavita R., Bergamaschi F., Berlingheri S., Borghesi M., Bortolus R., Borzillo V., Bosetti D., Bove G., Bove P., Brausi M., Bruno G., Brunocilla E., Buffoli A., Buttigliero C., Cacciamani G., Caldiroli M., Cardo G., Carmignani G., Carrieri G., Castelli E., Castrezzati E., Catalano G., Cattarino S., Catucci F., Cavallini F. D., Ceccarini O., Celia A., Chiancone F., Chini T., Cianci C., Cisternino A., Collura D., Corbella F., Corinti M., Corsi P., Cortese F., Corti L., de Nunzio C., Cristiano O., D'angelillo R. M., Da Pozzo L., D'agostino D., D'elia C., Dandrea M., De Angelis M., De Angelis P., De Cobelli O., De Concilio B., De Lisa A., De Luca S., De Stefani A., Deantoni C. L., Degli E. C., Destito A., Detti B., Di Muzio N., Di Stasio A., Di Stefano C., Di Trapani D., Difino G., Falivene S., Farullo G., Fedelini P., Ferrari I., Ferrau F., Ferro M., Fodor A., Fontana F., Francesca F., Francolini G., Frata P., Frezza G., Gabriele P., Galeandro M., Garibaldi E., Gennari P. G., Gentilucci A., Giacobbe A., Giussani L., Giusti G., Gontero P., Guarneri A., Guida C., Gurioli A., Huqi D., Imbimbo C., Ingrosso G., Iotti C., Italia C., La Mattina P., La Rocca R., Lamanna E., Lastrucci L., Lazzari G., Liberale F., Liguori G., Lisi R., Lohr F., Lombardo R., Lovisolo J. A. J., Ludovico G. M., Macchione N., Maggio F., Malizia M., Manasse G., Mandoliti G., Mantini G., Marafioti L., Marciello L., Marconi A. M., Martilotta A., Marzano S., Masciullo S., Maso G., Massenzo A., Mearini L., Medoro S., Mole R., Monesi G., Montanari E., Montefiore F., Montesi G., Morgia G., Moro G., Muscas G., Musio D., Muto P., Muzzonigro G., Napodano G., Negro C. L. A., Nidini M., Ntreta M., Orsatti M., Palazzolo C., Palumbo I., Parisi A., Parma P., Pavan N., Pericolini M., Pinto F., Pistone A., Pizzuti V., Platania A., Polli C., Pomara G., Ponti E., Porcaro A. B., Porpiglia F., Pugliese D., Pycha A., Raguso G., Rampini A., Randone D. F., Roboldi V., Roscigno M., Ruggieri M. P., Ruoppo G., Sanseverino R., Santacaterina A., Santarsieri M., Santoni R., Scagliarini S., Scagliotti G. V., Scanzi M., Scarcia M., Schiavina R., Sciarra A., Sciorio C., Scolaro T., Scuzzarella S., Selvaggio O., Serao A., Signor M. A., Silvani M., Silvano G., Silvestris F., Simone V., Spagnoletti G., Spinelli M. G., Squillace L., Tombolini V., Toninelli M., Trinchieri A., Trodella L. E., Trodella L., Trombetta C., Tronnolone L., Tucci M., Urzi D., Valdagni R., Valeriani M., Vanoli M., Vitali E., Volpe A., Zaramella S., Zeccolini G., and Zini G.

Abstract

Background There are several treatments available to newly diagnosed prostate cancer (PCA) patients. Although surgery and radiotherapy (RT) with or without androgen deprivation therapy (ADT) are widely adopted treatment options for localized PCA together with active surveillance (AS), there is no consensus nor randomised trials on treatment selection, prospective quality of life (QOL), along with toxicity outcomes and according to treatment modality in the Italian population. The current study aimed to describe clinical-therapeutic features and QOL at PCA diagnosis, according to different treatment patterns in a large prospective, Italian population, enrolled in the Pros-IT CNR study. Methods The Pros-IT CNR is an on-going national, multicenter, observational, prospective study on patients affected by PCA who have been referred by 97 Italian Urology, Radiation Oncology and Medical Oncology facilities participating in the project. The possible relationships between the treatment patterns reported in the 6 month follow-up case report form and patients’ features at diagnosis were evaluated using exploratory multiple correspondence analysis (MCA) and other data analysis method. Results At diagnosis, surgery and AS patients were significantly younger, had fewer comorbidities, lower PSA levels and Gleason Score (GS) values; they were also diagnosed at an earlier stage of disease with respect to the RT or ADT patients who showed significantly worse QoL scores at the time of diagnosis. Conclusions An analysis of the data collected at baseline and 6 months later uncovered substantial differences in ages, comorbidities, clinical and QOL features in the various treatment groups. These findings do not fully reflect the current PCA treatment guidelines and suggest the need for a multidisciplinary consensus guideline to ameliorate both the counselling and treatments of PCA patients.

Published
2019

29. Impact of Surgical Approach on Patient-Reported Outcomes after Radical Prostatectomy: A Propensity Score-Weighted Analysis from a Multicenter, Prospective, Observational Study (The Pros-IT CNR Study)

Author

Antonelli, A, Palumbo, C, Noale, M, Porreca, A, Maggi, S, Simeone, C, Bassi, P, Bertoni, F, Bracarda, S, Buglione, M, Conti, G, Corvo, R, Gacci, M, Mirone, V, Montironi, R, Triggiani, L, Tubaro, A, Artibani, W, Crepaldi, G, Graziotti, P, Russi, E, Magrini Stefano, M, Muto, G, Pecoraro, S, Ricardi, U, Zagonel, V, Alitto Anna, R, Ambrosi, E, Aristei, C, Barbieri, M, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Berruti, A, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruni, A, Bruno, G, Brunocilla, E, Buffoli, A, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini, F, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, de Cosimo, N, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Elia, C, Dandrea, M, De Angelis, M, De Angelis, P, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli Esposti, C, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari Pietro, G, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico Giuseppe, M, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi Alberto, M, Martilotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mazzeo, E, Mearini, L, Medoro, S, Mole, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone Donato, F, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliarini, S, Scagliotti Giorgio, V, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Serni, S, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simone, V, Spagnoletti, G, Spinelli Matteo, G, Squillace, L, Tombolini, V, Toninelli, M, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzi, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Volpe, A, Zaramella, S, Zeccolini, G, Zini, G, Antonelli A., Palumbo C., Noale M., Porreca A., Maggi S., Simeone C., Bassi P., Bertoni F., Bracarda S., Buglione M., Conti G. N., Corvo R., Gacci M., Mirone V., Montironi R., Triggiani L., Tubaro A., Artibani W., Crepaldi G., Graziotti P., Russi E., Magrini Stefano M., Muto G., Pecoraro S., Ricardi U., Zagonel V., Alitto Anna R., Ambrosi E., Aristei C., Barbieri M., Bardari F., Bardoscia L., Barra S., Bartoncini S., Basso U., Becherini C., Bellavita R., Bergamaschi F., Berlingheri S., Berruti A., Borghesi M., Bortolus R., Borzillo V., Bosetti D., Bove G., Bove P., Brausi M., Bruni A., Bruno G., Brunocilla E., Buffoli A., Buttigliero C., Cacciamani G., Caldiroli M., Cardo G., Carmignani G., Carrieri G., Castelli E., Castrezzati E., Catalano G., Cattarino S., Catucci F., Cavallini F. D., Ceccarini O., Celia A., Chiancone F., Chini T., Cianci C., Cisternino A., Collura D., Corbella F., Corinti M., Corsi P., Cortese F., Corti L., de Cosimo N., Cristiano O., D'Angelillo R., Da Pozzo L., D'agostino D., D'Elia C., Dandrea M., De Angelis M., De Angelis P., De Cobelli O., De Concilio B., De Lisa A., De Luca S., De Stefani A., Deantoni C. L., Degli Esposti C., Destito A., Detti B., Di Muzio N., Di Stasio A., Di Stefano C., Di Trapani D., Difino G., Falivene S., Farullo G., Fedelini P., Ferrari I., Ferrau F., Ferro M., Fodor A., Fontana F., Francesca F., Francolini G., Frata P., Frezza G., Gabriele P., Galeandro M., Garibaldi E., Gennari Pietro G., Gentilucci A., Giacobbe A., Giussani L., Giusti G., Gontero P., Guarneri A., Guida C., Gurioli A., Huqi D., Imbimbo C., Ingrosso G., Iotti C., Italia C., La Mattina P., Lamanna E., Lastrucci L., Lazzari G., Liberale F., Liguori G., Lisi R., Lohr F., Lombardo R., Lovisolo J. A. J., Ludovico Giuseppe M., Macchione N., Maggio F., Malizia M., Manasse G., Mandoliti G., Mantini G., Marafioti L., Marciello L., Marconi Alberto M., Martilotta A., Marzano S., Masciullo S., Maso G., Massenzo A., Mazzeo E., Mearini L., Medoro S., Mole R., Monesi G., Montanari E., Montefiore F., Montesi G., Morgia G., Moro G., Muscas G., Musio D., Muto P., Muzzonigro G., Napodano G., Negro C. L. A., Nidini M., Ntreta M., Orsatti M., Palazzolo C., Palumbo I., Parisi A., Parma P., Pavan N., Pericolini M., Pinto F., Pistone A., Pizzuti V., Platania A., Polli C., Pomara G., Ponti E., Porcaro A. B., Porpiglia F., Pugliese D., Pycha A., Raguso G., Rampini A., Randone Donato F., Roboldi V., Roscigno M., Ruggieri M. P., Ruoppo G., Sanseverino R., Santacaterina A., Santarsieri M., Santoni R., Scagliarini S., Scagliotti Giorgio V., Scanzi M., Scarcia M., Schiavina R., Sciarra A., Sciorio C., Scolaro T., Scuzzarella S., Selvaggio O., Serao A., Serni S., Signor M. A., Silvani M., Silvano G., Silvestris F., Simone V., Spagnoletti G., Spinelli Matteo G., Squillace L., Tombolini V., Toninelli M., Trinchieri A., Trodella L. E., Trodella L., Trombetta C., Tronnolone L., Tucci M., Urzi D., Valdagni R., Valeriani M., Vanoli M., Vitali E., Volpe A., Zaramella S., Zeccolini G., Zini G., Antonelli, A, Palumbo, C, Noale, M, Porreca, A, Maggi, S, Simeone, C, Bassi, P, Bertoni, F, Bracarda, S, Buglione, M, Conti, G, Corvo, R, Gacci, M, Mirone, V, Montironi, R, Triggiani, L, Tubaro, A, Artibani, W, Crepaldi, G, Graziotti, P, Russi, E, Magrini Stefano, M, Muto, G, Pecoraro, S, Ricardi, U, Zagonel, V, Alitto Anna, R, Ambrosi, E, Aristei, C, Barbieri, M, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Berruti, A, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruni, A, Bruno, G, Brunocilla, E, Buffoli, A, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini, F, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, de Cosimo, N, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Elia, C, Dandrea, M, De Angelis, M, De Angelis, P, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli Esposti, C, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari Pietro, G, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico Giuseppe, M, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi Alberto, M, Martilotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mazzeo, E, Mearini, L, Medoro, S, Mole, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone Donato, F, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliarini, S, Scagliotti Giorgio, V, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Serni, S, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simone, V, Spagnoletti, G, Spinelli Matteo, G, Squillace, L, Tombolini, V, Toninelli, M, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzi, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Volpe, A, Zaramella, S, Zeccolini, G, Zini, G, Antonelli A., Palumbo C., Noale M., Porreca A., Maggi S., Simeone C., Bassi P., Bertoni F., Bracarda S., Buglione M., Conti G. N., Corvo R., Gacci M., Mirone V., Montironi R., Triggiani L., Tubaro A., Artibani W., Crepaldi G., Graziotti P., Russi E., Magrini Stefano M., Muto G., Pecoraro S., Ricardi U., Zagonel V., Alitto Anna R., Ambrosi E., Aristei C., Barbieri M., Bardari F., Bardoscia L., Barra S., Bartoncini S., Basso U., Becherini C., Bellavita R., Bergamaschi F., Berlingheri S., Berruti A., Borghesi M., Bortolus R., Borzillo V., Bosetti D., Bove G., Bove P., Brausi M., Bruni A., Bruno G., Brunocilla E., Buffoli A., Buttigliero C., Cacciamani G., Caldiroli M., Cardo G., Carmignani G., Carrieri G., Castelli E., Castrezzati E., Catalano G., Cattarino S., Catucci F., Cavallini F. D., Ceccarini O., Celia A., Chiancone F., Chini T., Cianci C., Cisternino A., Collura D., Corbella F., Corinti M., Corsi P., Cortese F., Corti L., de Cosimo N., Cristiano O., D'Angelillo R., Da Pozzo L., D'agostino D., D'Elia C., Dandrea M., De Angelis M., De Angelis P., De Cobelli O., De Concilio B., De Lisa A., De Luca S., De Stefani A., Deantoni C. L., Degli Esposti C., Destito A., Detti B., Di Muzio N., Di Stasio A., Di Stefano C., Di Trapani D., Difino G., Falivene S., Farullo G., Fedelini P., Ferrari I., Ferrau F., Ferro M., Fodor A., Fontana F., Francesca F., Francolini G., Frata P., Frezza G., Gabriele P., Galeandro M., Garibaldi E., Gennari Pietro G., Gentilucci A., Giacobbe A., Giussani L., Giusti G., Gontero P., Guarneri A., Guida C., Gurioli A., Huqi D., Imbimbo C., Ingrosso G., Iotti C., Italia C., La Mattina P., Lamanna E., Lastrucci L., Lazzari G., Liberale F., Liguori G., Lisi R., Lohr F., Lombardo R., Lovisolo J. A. J., Ludovico Giuseppe M., Macchione N., Maggio F., Malizia M., Manasse G., Mandoliti G., Mantini G., Marafioti L., Marciello L., Marconi Alberto M., Martilotta A., Marzano S., Masciullo S., Maso G., Massenzo A., Mazzeo E., Mearini L., Medoro S., Mole R., Monesi G., Montanari E., Montefiore F., Montesi G., Morgia G., Moro G., Muscas G., Musio D., Muto P., Muzzonigro G., Napodano G., Negro C. L. A., Nidini M., Ntreta M., Orsatti M., Palazzolo C., Palumbo I., Parisi A., Parma P., Pavan N., Pericolini M., Pinto F., Pistone A., Pizzuti V., Platania A., Polli C., Pomara G., Ponti E., Porcaro A. B., Porpiglia F., Pugliese D., Pycha A., Raguso G., Rampini A., Randone Donato F., Roboldi V., Roscigno M., Ruggieri M. P., Ruoppo G., Sanseverino R., Santacaterina A., Santarsieri M., Santoni R., Scagliarini S., Scagliotti Giorgio V., Scanzi M., Scarcia M., Schiavina R., Sciarra A., Sciorio C., Scolaro T., Scuzzarella S., Selvaggio O., Serao A., Serni S., Signor M. A., Silvani M., Silvano G., Silvestris F., Simone V., Spagnoletti G., Spinelli Matteo G., Squillace L., Tombolini V., Toninelli M., Trinchieri A., Trodella L. E., Trodella L., Trombetta C., Tronnolone L., Tucci M., Urzi D., Valdagni R., Valeriani M., Vanoli M., Vitali E., Volpe A., Zaramella S., Zeccolini G., and Zini G.

Abstract

Background: To report health-related quality of life outcomes as assessed by validated patient-reported outcome measures (PROMs) after radical prostatectomy (RP).-Methods: This study analyzed patients treated with RP within The PROState cancer monitoring in Italy, from the National Research Council (Pros-IT CNR). Italian versions of Short-Form Heath Survey and university of California los Angeles-prostate cancer index questionnaires were administered. PROMs were physical composite scores, mental composite scores and urinary, bowel, sexual functions and bothers (UF/B, BF/B, SF/B). Baseline unbalances were controlled with propensity scores and stabilized inverse weights; differences in PROMs between different RP approaches were estimated by mixed models. Results: Of 541 patients treated with RP, 115 (21%) received open RP (ORP), 90 (17%) laparoscopic RP (LRP) and 336 (61%) robot-assisted RP (RARP). At head-to-head-comparisons, RARP showed higher 12-month UF vs. LRP (interaction treatment ∗ time p = 0.03) and 6-month SF vs. ORP (p < 0.001). At 12-month from surgery, 67, 73 and 79% of patients used no pad for urinary loss in ORP, LRP and RARP respectively (no differences for each comparison). Conversely, 16, 27 and 40% of patients declared erections firm enough for sexual intercourse in ORP, LRP and RARP respectively (only significant difference for ORP vs. RARP, p = 0.0004). Conclusions: Different RP approaches lead to significant variations in urinary and sexual PROMs, with a general trend in favour of RARP. However, their clinical significance seems limited.

Published
2019

30. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, Bidoli, P, De Giorgi U, Cartenì G, Giannarelli D, Basso U, Galli L, Cortesi E, Caserta C, Pignata S, Sabbatini R, Bearz A, Buti S, Lo Re G, Berruti A, Bracarda S, Cognetti F, Rastelli F, Fornarini G, Porta C, Turci D, Sternberg CN, Procopio G, Bidoli P, De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, Bidoli, P, De Giorgi U, Cartenì G, Giannarelli D, Basso U, Galli L, Cortesi E, Caserta C, Pignata S, Sabbatini R, Bearz A, Buti S, Lo Re G, Berruti A, Bracarda S, Cognetti F, Rastelli F, Fornarini G, Porta C, Turci D, Sternberg CN, Procopio G, and Bidoli P

Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

31. Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR)

Author

Buglione, M., Noale, M., Bruni, A., Antonelli, A., Bertoni, F., Corvo, R., Ricardi, U., Borghetti, P., Maddalo, M., Simeone, C., Mazzeo, E., Porreca, A., Serni, S., Bassi, P., Gacci, M., Mirone, V., Montironi, R., Tubaro, A., Berruti, A., Conti, G. N., Maggi, S., Magrini, S. M., Triggiani, L., Crepaldi, G., Artibani, W., Bracarda, S., Graziotti, P., Russi, E., Muto, G., Pecoraro, S., Zagonel, V., Alitto, A. R., Ambrosi, E., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruno, G., Brunocilla, E., Buffoli, A., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carmignani, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini, F. D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., de Nunzio, C., Cristiano, O., D'Angelillo, R. M., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli, E. C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A. J., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Morgia, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Trinchieri, A., Trodella, L. E., Trodella, L., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Buglione, M., Noale, M., Bruni, A., Antonelli, A., Bertoni, F., Corvo, R., Ricardi, U., Borghetti, P., Maddalo, M., Simeone, C., Mazzeo, E., Porreca, A., Serni, S., Bassi, P., Gacci, M., Mirone, V., Montironi, R., Tubaro, A., Berruti, A., Conti, G. N., Maggi, S., Magrini, S. M., Triggiani, L., Crepaldi, G., Artibani, W., Bracarda, S., Graziotti, P., Russi, E., Muto, G., Pecoraro, S., Zagonel, V., Alitto, A. R., Ambrosi, E., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruno, G., Brunocilla, E., Buffoli, A., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carmignani, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini, F. D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., de Nunzio, C., Cristiano, O., D'Angelillo, R. M., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli, E. C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A. J., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Morgia, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Trinchieri, A., Trodella, L. E., Trodella, L., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Buglione, M, Noale, M, Bruni, A, Antonelli, A, Bertoni, F, Corvo, R, Ricardi, U, Borghetti, P, Maddalo, M, Simeone, C, Mazzeo, E, Porreca, A, Serni, S, Bassi, P, Gacci, M, Mirone, V, Montironi, R, Tubaro, A, Berruti, A, Conti, G, Maggi, S, Magrini, S, Triggiani, L, Crepaldi, G, Artibani, W, Bracarda, S, Graziotti, P, Russi, E, Muto, G, Pecoraro, S, Zagonel, V, Alitto, A, Ambrosi, E, Aristei, C, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruno, G, Brunocilla, E, Buffoli, A, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini, F, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, de Nunzio, C, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Elia, C, Dandrea, M, De Angelis, M, De Angelis, P, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli, E, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari, P, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, La Rocca, R, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico, G, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi, A, Martilotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mearini, L, Medoro, S, Mole, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone, D, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliarini, S, Scagliotti, G, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simone, V, Spagnoletti, G, Spinelli, M, Squillace, L, Tombolini, V, Toninelli, M, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzi, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Volpe, A, Zaramella, S, Zeccolini, G, and Zini, G

Subjects
Male, European People, medicine.medical_treatment, Cancer Treatment, prospective study (Pros-IT CNR), Androgen deprivation therapy, Prostate cancer, 0302 clinical medicine, Quality of life, 80 and over, Medicine and Health Sciences, Ethnicities, 030212 general & internal medicine, Prospective Studies, Stage (cooking), Prospective cohort study, Case report form, Aged, 80 and over, Multidisciplinary, Prostate Cancer, Prostate Diseases, Middle Aged, 3. Good health, Italian People, Surgical Oncology, Treatment Outcome, Oncology, Italy, 030220 oncology & carcinogenesis, PCA treatment guidelines, prostate cancer, quality of life, surgery and radiotherapy, Critical Pathways, Medicine, Human, Research Article, Clinical Oncology, medicine.medical_specialty, Science, Urology, Surgical and Invasive Medical Procedures, 03 medical and health sciences, Diagnostic Medicine, Internal medicine, medicine, Cancer Detection and Diagnosis, Humans, Aged, business.industry, Neoplasm Grading, Prostatic Neoplasms, Quality of Life, Cancers and Neoplasms, medicine.disease, Radiation therapy, Prospective Studie, Genitourinary Tract Tumors, Prostatic Neoplasm, People and Places, Observational study, Population Groupings, Clinical Medicine, business
Abstract

Background There are several treatments available to newly diagnosed prostate cancer (PCA) patients. Although surgery and radiotherapy (RT) with or without androgen deprivation therapy (ADT) are widely adopted treatment options for localized PCA together with active surveillance (AS), there is no consensus nor randomised trials on treatment selection, prospective quality of life (QOL), along with toxicity outcomes and according to treatment modality in the Italian population. The current study aimed to describe clinical-therapeutic features and QOL at PCA diagnosis, according to different treatment patterns in a large prospective, Italian population, enrolled in the Pros-IT CNR study. Methods The Pros-IT CNR is an on-going national, multicenter, observational, prospective study on patients affected by PCA who have been referred by 97 Italian Urology, Radiation Oncology and Medical Oncology facilities participating in the project. The possible relationships between the treatment patterns reported in the 6 month follow-up case report form and patients' features at diagnosis were evaluated using exploratory multiple correspondence analysis (MCA) and other data analysis method. Results At diagnosis, surgery and AS patients were significantly younger, had fewer comorbidities, lower PSA levels and Gleason Score (GS) values; they were also diagnosed at an earlier stage of disease with respect to the RT or ADT patients who showed significantly worse QoL scores at the time of diagnosis. Conclusions An analysis of the data collected at baseline and 6 months later uncovered substantial differences in ages, comorbidities, clinical and QOL features in the various treatment groups. These findings do not fully reflect the current PCA treatment guidelines and suggest the need for a multidisciplinary consensus guideline to ameliorate both the counselling and treatments of PCA patients.

Published
2019

32. Impact of Surgical Approach on Patient-Reported Outcomes after Radical Prostatectomy: A Propensity Score-Weighted Analysis from a Multicenter, Prospective, Observational Study (The Pros-IT CNR Study)

Author

Antonelli, A., Palumbo, C., Noale, M., Porreca, A., Maggi, S., Simeone, C., Bassi, P., Bertoni, F., Bracarda, S., Buglione, M., Conti, G. N., Corvò, R., Gacci, M., Mirone, V., Montironi, R., Triggiani, L., Tubaro, A., Artibani, W., Crepaldi, G., Graziotti, P., Russi, E., Magrini, Stefano, Muto, M., Pecoraro, G., Ricardi, S., Zagonel, U., Alitto, Anna, Ambrosi, R., Aristei, E., Barbieri, C., Bardari, M., Bardoscia, F., Barra, L., Bartoncini, S., Basso, S., Becherini, U., Bellavita, C., Bergamaschi, R., Berlingheri, F., Berruti, S., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carmignani, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini, F. D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., Cosimo, De, Cristiano, N., D'Angelillo, O., Pozzo, Da, D'Agostino, L., D'Elia, D., Dandrea, C., Angelis, De, Cobelli, De, Concilio, De, Lisa, De, Luca, De, Stefani, De, Deantoni, A., C. L., Degli, Esposti, Destito, C., Detti, A., Muzio, Di, Stasio, Di, Stefano, Di, Trapani, Di, Difino, D., Falivene, G., Farullo, S., Fedelini, G., Ferrari, P., Ferraù, I., Ferro, F., Fodor, M., Fontana, A., Francesca, F., Francolini, F., Frata, G., Frezza, P., Gabriele, G., Galeandro, P., Garibaldi, M., Gennari, Pietro, Gentilucci, G., Giacobbe, A., Giussani, A., Giusti, L., Gontero, G., Guarneri, P., Guida, A., Gurioli, C., Huqi, A., Imbimbo, D., Ingrosso, C., Iotti, G., Italia, C., Mattina, La, Lamanna, P., Lastrucci, E., Lazzari, L., Liberale, G., Liguori, F., Lisi, G., Lohr, R., Lombardo, F., Lovisolo, R., J. A. J., Ludovico, Giuseppe, Macchione, M., Maggio, N., Malizia, F., Manasse, M., Mandoliti, G., Mantini, G., Marafioti, G., Marciello, L., Marconi, Alberto, Martilotta, M., Marzano, A., Masciullo, S., Maso, S., Massenzo, G., Mazzeo, A., Mearini, E., Medoro, L., Molè, S., Monesi, R., Montanari, G., Montefiore, E., Montesi, F., Morgia, G., Moro, G., Muscas, G., Musio, G., Muto, D., Muzzonigro, P., Napodano, G., Negro, G., Nidini, C. L. A., Ntreta, M., Orsatti, M., Palazzolo, M., Parisi, I., Parma, A., Pavan, P., Pericolini, N., Pinto, M., Pistone, F., Pizzuti, A., Platania, V., Polli, A., Pomara, C., Ponti, G., Porcaro, E., Porpiglia, A. B., Pugliese, F., Pycha, D., Raguso, A., Rampini, G., Randone, Donato, Roboldi, F., Roscigno, V., Ruggieri, M., Ruoppo, M. P., Sanseverino, G., Santacaterina, R., Santarsieri, A., Santoni, M., Scagliarini, R., Scagliotti, Giorgio, Scanzi, V., Scarcia, M., Schiavina, M., Sciarra, R., Sciorio, A., Scolaro, C., Scuzzarella, T., Selvaggio, S., Serao, O., Serni, A., Signor, S., Silvani, M. A., Silvano, M., Silvestris, G., Simone, F., Spagnoletti, V., Spinelli, Matteo, Squillace, G., Tombolini, L., Toninelli, V., Trinchieri, M., Trodella, A., Trodella, L. E., Trombetta, L., Tronnolone, C., Tucci, L., Urzì, M., Valdagni, D., Valeriani, R., Vanoli, M., Vitali, M., Volpe, E., Zaramella, A., Zeccolini, S., Zini, G., Antonelli, A., Palumbo, C., Noale, M., Porreca, A., Maggi, S., Simeone, C., Bassi, P., Bertoni, F., Bracarda, S., Buglione, M., Conti, G. N., Corvo, R., Gacci, M., Mirone, V., Montironi, R., Triggiani, L., Tubaro, A., Artibani, W., Crepaldi, G., Graziotti, P., Russi, E., Magrini Stefano, M., Muto, G., Pecoraro, S., Ricardi, U., Zagonel, V., Alitto Anna, R., Ambrosi, E., Aristei, C., Barbieri, M., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carmignani, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini, F. D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., de Cosimo, N., Cristiano, O., D'Angelillo, R., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli Esposti, C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari Pietro, G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A. J., Ludovico Giuseppe, M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi Alberto, M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Morgia, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone Donato, F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti Giorgio, V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Serni, S., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simone, V., Spagnoletti, G., Spinelli Matteo, G., Squillace, L., Tombolini, V., Toninelli, M., Trinchieri, A., Trodella, L. E., Trodella, L., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Antonelli, A, Palumbo, C, Noale, M, Porreca, A, Maggi, S, Simeone, C, Bassi, P, Bertoni, F, Bracarda, S, Buglione, M, Conti, G, Corvo, R, Gacci, M, Mirone, V, Montironi, R, Triggiani, L, Tubaro, A, Artibani, W, Crepaldi, G, Graziotti, P, Russi, E, Magrini Stefano, M, Muto, G, Pecoraro, S, Ricardi, U, Zagonel, V, Alitto Anna, R, Ambrosi, E, Aristei, C, Barbieri, M, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Berruti, A, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruni, A, Bruno, G, Brunocilla, E, Buffoli, A, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini, F, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, de Cosimo, N, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Elia, C, Dandrea, M, De Angelis, M, De Angelis, P, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli Esposti, C, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari Pietro, G, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico Giuseppe, M, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi Alberto, M, Martilotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mazzeo, E, Mearini, L, Medoro, S, Mole, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone Donato, F, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliarini, S, Scagliotti Giorgio, V, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Serni, S, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simone, V, Spagnoletti, G, Spinelli Matteo, G, Squillace, L, Tombolini, V, Toninelli, M, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzi, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Volpe, A, Zaramella, S, Zeccolini, G, and Zini, G

Subjects
Male, Patient-reported outcome measures, Prostate cancer, Quality of life, Radical prostatectomy, Sexual function, Urinary function, Patient Reported Outcome Measure, medicine.medical_treatment, 030232 urology & nephrology, Longitudinal Studie, Aged, Data Collection, Humans, Italy, Longitudinal Studies, Middle Aged, Patient Reported Outcome Measures, Prospective Studies, Prostate, Prostatectomy, Prostatic Neoplasms, Quality of Life, Retrospective Studies, Robotic Surgical Procedures, Surveys and Questionnaires, Treatment Outcome, Propensity Score, 0302 clinical medicine, Retrospective Studie, Medicine, Surveys and Questionnaire, Prospective cohort study, Patient-reported outcome measure, 030220 oncology & carcinogenesis, Human, medicine.medical_specialty, Robotic Surgical Procedure, Urology, 03 medical and health sciences, Clinical significance, business.industry, Retrospective cohort study, Prospective Studie, Propensity score matching, Prostatic Neoplasm, Observational study, business
Abstract

Background: To report health-related quality of life outcomes as assessed by validated patient-reported outcome measures (PROMs) after radical prostatectomy (RP). ­Methods: This study analyzed patients treated with RP within The PROState cancer monitoring in Italy, from the National Research Council (Pros-IT CNR). Italian versions of Short-Form Heath Survey and university of California los Angeles-prostate cancer index questionnaires were administered. PROMs were physical composite scores, mental composite scores and urinary, bowel, sexual functions and bothers (UF/B, BF/B, SF/B). Baseline unbalances were controlled with propensity scores and stabilized inverse weights; differences in PROMs between different RP approaches were estimated by mixed models. Results: Of 541 patients treated with RP, 115 (21%) received open RP (ORP), 90 (17%) laparoscopic RP (LRP) and 336 (61%) robot-assisted RP (RARP). At head-to-head ­comparisons, RARP showed higher 12-month UF vs. LRP (interaction treatment * time p = 0.03) and 6-month SF vs. ORP (p < 0.001). At 12-month from surgery, 67, 73 and 79% of patients used no pad for urinary loss in ORP, LRP and RARP respectively (no differences for each comparison). Conversely, 16, 27 and 40% of patients declared erections firm enough for sexual intercourse in ORP, LRP and RARP respectively (only significant difference for ORP vs. RARP, p = 0.0004). Conclusions: Different RP approaches lead to significant variations in urinary and sexual PROMs, with a general trend in favour of RARP. However, their clinical significance seems limited.

Published
2019

33. 696P Is it possible to improve the prognostic ability of the IMDC score? Validation of the Meet-URO score in metastatic renal cell carcinoma (mRCC) patients (pts) receiving first-line nivolumab plus ipilimumab in the Italian Expanded Access Program (EAP)

Author

Rebuzzi, S.E., primary, Signori, A., additional, Maruzzo, M., additional, Tortora, G., additional, Galli, L., additional, Rizzo, M., additional, De Giorgi, U., additional, Antonuzzo, L., additional, Bracarda, S., additional, Cartenì, G., additional, Atzori, F., additional, Tamberi, S., additional, Procopio, G., additional, Fratino, L., additional, Santoni, M., additional, Baldessari, C., additional, Astone, A., additional, Calabro', F., additional, Buti, S., additional, and Fornarini, G., additional

Published
2021
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34. 716TiP IMvigor011: A global, double-blind, randomised phase III study of atezolizumab (atezo; anti–PD-L1) vs placebo (pbo) as adjuvant therapy in patients (pts) with high-risk muscle-invasive bladder cancer (MIBC) who are circulating tumour (ct)DNA+ post cystectomy

Author

Powles, T.B., primary, Gschwend, J.E., additional, Bracarda, S., additional, Castellano, D., additional, Gross-Goupil, M., additional, Bjerggaard Jensen, J., additional, Kann, A., additional, Nishiyama, H., additional, Makaroff, L., additional, Lassidi, H., additional, Mariathasan, S., additional, Zhang, J., additional, Degaonkar, V., additional, and Bellmunt, J., additional

Published
2021
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35. 585P Safety analysis of the phase III IPATential150 trial of ipatasertib (ipat) plus abiraterone (abi) in patients with metastatic castration-resistant prostate cancer (mCRPC)

Author

Sternberg, C.N., primary, Bracarda, S., additional, de Bono, J.S., additional, Sweeney, C., additional, Chi, K.N., additional, Olmos, D., additional, Sandhu, S.K., additional, Massard, C., additional, Garcia, J., additional, Schenkel, F., additional, Chen, G., additional, Harris, A., additional, Hinton, H., additional, and Matsubara, N., additional

Published
2021
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36. Sunitinib administered on 2/1 schedule in patients with metastatic renal cell carcinoma: the RAINBOW analysis

Author

Bracarda, S., Iacovelli, R., Boni, L., Rizzo, M., Derosa, L., Rossi, M., Galli, L., Procopio, G., Sisani, M., Longo, F., Santoni, M., Morelli, F., Di Lorenzo, G., Altavilla, A., Porta, C., Camerini, A., Escudier, B., Martignetti, Angelo, Ricotta, Riccardo, Gasparro, Donatello, Sabbatini, Roberto, Ceresoli, Giovanni Luca, Mosca, Alessandra, Santini, Daniele, Caserta, Claudia, Cavanna, Luigi, Massari, Francesco, Sava, Teodoro, Boni, Corrado, Verzoni, Elena, Cartenì, Giacomo, and Hamzaj, Alketa

Published
2015
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41. Disease-specific and general health-related quality of life in newly diagnosed prostate cancer patients: The Pros-IT CNR study

Author

Porreca, A, Noale, M, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Conti, G, Corvò, R, Gacci, M, Graziotti, P, Magrini, S, Mirone, V, Montironi, R, Muto, G, Pecoraro, S, Ricardi, U, Russi, E, Tubaro, A, Zagonel, V, Crepaldi, G, Maggi, S, Da Pozzo, L, Porreca A, Noale M, Artibani W, Bassi PF, Bertoni F, Bracarda S, Conti GN, Corvò R, Gacci M, Graziotti P, Magrini SM, Mirone V, Montironi R, Muto G, Pecoraro S, Ricardi U, Russi E, Tubaro A, Zagonel V, Crepaldi G, Maggi S, Da Pozzo L, Porreca, A, Noale, M, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Conti, G, Corvò, R, Gacci, M, Graziotti, P, Magrini, S, Mirone, V, Montironi, R, Muto, G, Pecoraro, S, Ricardi, U, Russi, E, Tubaro, A, Zagonel, V, Crepaldi, G, Maggi, S, Da Pozzo, L, Porreca A, Noale M, Artibani W, Bassi PF, Bertoni F, Bracarda S, Conti GN, Corvò R, Gacci M, Graziotti P, Magrini SM, Mirone V, Montironi R, Muto G, Pecoraro S, Ricardi U, Russi E, Tubaro A, Zagonel V, Crepaldi G, Maggi S, and Da Pozzo L

Abstract

Background: The National Research Council (CNR) prostate cancer monitoring project in Italy (Pros-IT CNR) is an observational, prospective, ongoing, multicentre study aiming to monitor a sample of Italian males diagnosed as new cases of prostate cancer. The present study aims to present data on the quality of life at time prostate cancer is diagnosed. Methods: One thousand seven hundred five patients were enrolled. Quality of life is evaluated at the time cancer was diagnosed and at subsequent assessments via the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and the Short Form Health Survey (SF-12). Results: At diagnosis, lower scores on the physical component of the SF-12 were associated to older ages, obesity and the presence of 3+ moderate/severe comorbidities. Lower scores on the mental component were associated to younger ages, the presence of 3+ moderate/severe comorbidities and a T-score higher than one. Urinary and bowel functions according to UCLA-PCI were generally good. Almost 5% of the sample reported using at least one safety pad daily to control urinary loss; less than 3% reported moderate/severe problems attributable to bowel functions, and sexual function was a moderate/severe problem for 26.7%. Diabetes, 3+ moderate/severe comorbidities, T2 or T3-T4 categories and a Gleason score of eight or more were significantly associated with lower sexual function scores at diagnosis. Conclusions: Data collected by the Pros-IT CNR study have clarified the baseline status of newly diagnosed prostate cancer patients. A comprehensive assessment of quality of life will allow to objectively evaluate outcomes of different profile of care.

Published
2018

42. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Petrylak, D.P. de Wit, R. Chi, K.N. Drakaki, A. Sternberg, C.N. Nishiyama, H. Castellano, D. Hussain, S.A. Fléchon, A. Bamias, A. Yu, E.Y. van der Heijden, M.S. Matsubara, N. Alekseev, B. Necchi, A. Géczi, L. Ou, Y.-C. Coskun, H.S. Su, W.-P. Bedke, J. Gakis, G. Percent, I.J. Lee, J.-L. Tucci, M. Semenov, A. Laestadius, F. Peer, A. Tortora, G. Safina, S. Garcia del Muro, X. Rodriguez-Vida, A. Cicin, I. Harputluoglu, H. Tagawa, S.T. Vaishampayan, U. Aragon-Ching, J.B. Hamid, O. Liepa, A.M. Wijayawardana, S. Russo, F. Walgren, R.A. Zimmermann, A.H. Hozak, R.R. Bell-McGuinn, K.M. Powles, T. Wong, S.-L.S. Tan, T.H. Hovey, E.J. Clay, T.D. Wan Ng, S.S. Rutten, A. Machiels, J.-P. Dumez, H. Cheng, S.Y.-S. Ferrario, C. Sengeloev, L. Jensen, N.V. Thibault, C. Laguerre, B. Joly, F. Culine, S. Becht, C. Niegisch, G. Stöckle, M. Grimm, M.-O. Schwentner, C.A. Schultze-Seemann, W. Kalofonos, H. Mavroudis, D. Papandreou, C. Karavasilis, V. Révész, J. Rosenbaum, E. Leibowitz-Amit, R. Kejzman, D. Sarid, D. Scagliotti, G.V. Bracarda, S. Massari, F. Osawa, T. Miyajima, N. Shinohara, N. Fukuta, F. Ohyama, C. Obara, W. Yamashita, S. Tomita, Y. Kawai, K. Fukasawa, S. Oyama, M. Yonese, J. Nagata, M. Uemura, M. Nishimura, K. Kawakita, M. Tsunemori, H. Hashine, K. Inokuchi, J. Yokomizo, A. Nagamori, S. Lee, H.J. Park, S.H. Rha, S.Y. Kim, Y.J. Lee, Y.-G. Vazquez Cortés, L. Lorena Urzua Flores, C. Blaisse, R.J.B. Erdkamp, F.L.G. Aarts, M.J.B. Wojcik-Tomaszewska, J. Tomczak, P. Sikora-Kupis, B. Schenker, M. Herzal, A.A. Udrea, A.A. Karlov, P. Fomkin, R. Gajate Borau, P. Grande, E. Delgado Mignorance, J.I. Su, Y.-L. Li, J.-R. Lin, C.-L. Lin, C.-C. Yeh, S.-P. Erman, M. Urun, Y. Golovko, Y. Bondarenko, I. Sinielnikov, I. Crabb, S.J. Syndikus, I. Huddart, R. Sundar, S. Chowdhury, S. Sarwar, N. Flaig, T.W. Pan, C.X. Schwarz, J.K. Cultrera, J.L. Acs, P.I. Hainsworth, J.D. Herms, B.T. Lawler, W.E. Lowe, T.E.

Abstract

Background: Ramucirumab—an IgG1 vascular endothelial growth factor receptor 2 antagonist—plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. Methods: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m2 (60 mg/m2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. Findings: Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5–13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3–4·8] vs 2·8 months [2·6–2·9]; HR 0·696 [95% CI 0·573–0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9–11·4) in the ramucirumab group versus 7·9 months (7·0–9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724–1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group. Interpretation: Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. Funding: Eli Lilly and Company. © 2020 Elsevier Ltd

Published
2020

43. Multidisciplinary teams for the proper management of patients with genitourinary tumors: When topics set scientific societies’ agenda

Author

Magnani, T, Bracarda, S, D'Angelillo, R, Artibani, W, Barni, S, Beretta, G, Brausi, M, Caffo, O, Corvò, R, Gallucci, M, Gunelli, R, Mirone, V, Novara, G, Pinto, C, Russi, E, Santoni, R, Tomirotti, M, Volpe, A, Conti, G, Valdagni, R, 2, 1, Magnani, Tiziana, Bracarda, Sergio, D'Angelillo, Rolando M, Artibani, Walter, Barni, Sandro, Beretta, Giordano, Brausi, Maurizio, Caffo, Orazio, Corvò, Renzo, Gallucci, Michele, Gunelli, Roberta, Mirone, Vincenzo, Novara, Giacomo, Pinto, Carmine, Russi, Elvio, Santoni, Riccardo, Tomirotti, Maurizio, Volpe, Alessandro, Conti, Giario, and Valdagni, Riccardo

Subjects
Societies, Scientific, Cancer Research, genitourinary tumors, Genitourinary tumors, consensus conference, multidisciplinary approach, multidisciplinary team, statements, Medical Oncology, Settore MED/06, 030218 nuclear medicine & medical imaging, Task (project management), 03 medical and health sciences, 0302 clinical medicine, Settore MED/36, Multidisciplinary approach, Humans, Set (psychology), Italy, Health Policy, Urogenital Neoplasms, Health policy, Medical education, Genitourinary system, Consensus conference, Scientific, General Medicine, Genitourinary tumor, Oncology, 030220 oncology & carcinogenesis, Economic evaluation, Societies, Working group, Psychology
Abstract

Introduction: The multidisciplinary management of oncologic patients is identified as the bottom line element of quality in tumor care. Methods: In 2015, 7 Italian scientific societies representing the specialists involved in the diagnosis and treatment of genitourinary tumors joined efforts in the Italian uro-oncologic multidisciplinary teams (MDTs) project. The aims were to promote the reorganization of genitourinary cancer care, switching to a multidisciplinary approach, reach a consensus on the core elements for the setup of MDTs in genitourinary oncology, and support health policy makers and managers in remodeling of the assistance and care of uro-oncologic patients on a national level. Results: The first activity was the setup of 5 working groups, given the task of exploring selected topics: general principles, organization of MDTs, minimal requirements, economic evaluation, and relations with authorities. The groups participated in the writing of a document that was approved by the scientific societies and published on their web sites. Moreover, a few items summarizing the extensive document were approved in the first MDT Consensus Conference held in Milan in December 2015. Conclusions: The experience of this initial phase led to the opening of the team to other professionals and societies, in line with a correct management of patients with genitourinary tumors, which need a multidisciplinary as well as a multiprofessional approach with emerging techniques and procedures, and with a new project work package on genitourinary paths of care and indicators.

Published
2018

44. 126P Chemotherapy and stereotactic ablative radiotherapy in newly diagnosed and recurrent locally advanced non-small cell lung cancer patients unfit for concurrent radiochemotherapy: Sub-analysis and update of START-NEW-ERA non-randomised phase II trial

Author

Arcidiacono, F., Anselmo, P., Casale, M., Zannori, C., Loreti, F., Italiani, M., Enrico, B., Fabiani, S., Marchetti, G., Tassi, V., Mancioli, F.A., Muti, M., Guida, A., Bracarda, S., Ragusa, M., Maranzano, E., and Trippa, F.

Published
2023
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46. FOLFOXIRI in combination with panitumumab as first-line treatment in quadruple wild-type (KRAS, NRAS, HRAS, BRAF) metastatic colorectal cancer patients: a phase II trial by the Gruppo Oncologico Nord Ovest (GONO)

Author

Fornaro, L., Lonardi, S., Masi, G., Loupakis, F., Bergamo, F., Salvatore, L., Cremolini, C., Schirripa, M., Vivaldi, C., Aprile, G., Zaniboni, A., Bracarda, S., Fontanini, G., Sensi, E., Lupi, C., Morvillo, M., Zagonel, V., and Falcone, A.

Published
2013
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47. 721P Ipilimumab and nivolumab compassionate use program in metastatic renal cell carcinoma patients with intermediate or poor IMDC risk score: The large multicenter Italian study

Author

Basso, U., primary, Paolieri, F., additional, Porta, C.G., additional, De Giorgi, U., additional, Bracarda, S., additional, Antonuzzo, L., additional, Atzori, F., additional, Cartenì, G., additional, Procopio, G., additional, Fratino, L., additional, D'Arcangelo, M., additional, Fornarini, G., additional, Zucali, P.A., additional, Cusmai, A., additional, Santoni, M., additional, Baldessari, C., additional, Naglieri, E., additional, Panni, S., additional, Zagonel, V., additional, and Tortora, G., additional

Published
2020
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48. LBA4 IPATential150: Phase III study of ipatasertib (ipat) plus abiraterone (abi) vs placebo (pbo) plus abi in metastatic castration-resistant prostate cancer (mCRPC)

Author

de Bono, J.S., primary, Bracarda, S., additional, Sternberg, C.N., additional, Chi, K.N., additional, Olmos, D., additional, Sandhu, S., additional, Massard, C., additional, Matsubara, N., additional, Alekseev, B., additional, Gafanov, R., additional, Parnis, F., additional, Buchschacher, G.L., additional, Corrales, L., additional, Borre, M., additional, Vasconcelos Alves, G., additional, Garcia, J., additional, Harle-Yge, M-L., additional, Chen, G., additional, Wongchenko, M.J., additional, and Sweeney, C., additional

Published
2020
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50. Pros-IT CNR: an Italian prostate cancer monitoring project

Author

Noale, M, Maggi, S, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Conti, G, Corvò, R, Gacci, M, Graziotti, P, Magrini, S, Maurizi Enrici, R, Mirone, V, Da Pozzo, L, and Pros-IT CNR study, G, Noale M, Maggi S, Artibani W, Bassi PF, Bertoni F, Bracarda S, Conti GN, Corvò R, Gacci M, Graziotti P, Magrini SM, Maurizi Enrici R, Mirone V, Da Pozzo L, and Pros-IT CNR study group, Noale, M, Maggi, S, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Conti, G, Corvò, R, Gacci, M, Graziotti, P, Magrini, S, Maurizi Enrici, R, Mirone, V, Da Pozzo, L, and Pros-IT CNR study, G, Noale M, Maggi S, Artibani W, Bassi PF, Bertoni F, Bracarda S, Conti GN, Corvò R, Gacci M, Graziotti P, Magrini SM, Maurizi Enrici R, Mirone V, Da Pozzo L, and and Pros-IT CNR study group

Abstract

Aims: The Pros-IT CNR project aims to monitor a sample of Italian males ≥18 years of age who have been diagnosed in the participating centers with incident prostate cancer, by analyzing their clinical features, treatment protocols and outcome results in relation to quality of life. Methods: Pros-IT CNR is an observational, prospective, multicenter study. The National Research Council (CNR), Neuroscience Institute, Aging Branch (Padua) is the promoting center. Ninety-seven Italian centers located throughout Italy were involved. The field study began in September 1, 2014. Subjects eligible were diagnosed with biopsy-verified prostate cancer, naïve. A sample size of 1500 patients was contemplated. A baseline assessment including anamnestic data, clinical history, risk factors, the initial diagnosis, cancer staging information and quality of life (Italian UCLA Prostate Cancer Index; SF-12 Scale) was completed. Six months after the initial diagnosis, a second assessment evaluating the patient’s health status, the treatment carried out, and the quality of life will be made. A third assessment, evaluating the treatment follow-up and the quality of life, will be made 12 months after the initial diagnosis. The 4th, 5th, 6th and 7th assessments, similar to the third, will be completed 24, 36, 48 and 60 months after the initial diagnosis, respectively, and will include also a Food Frequency Questionnaire and the Physical Activity Scale for the Elderly. Discussion: The study will provide information on patients’ quality of life and its variations over time in relation to the treatments received for the prostate cancer.

Published
2017

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