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1. Correlation of body composition by computerized tomography and metabolic parameters with survival of nivolumab-treated lung cancer patients

Author

Magri V, Gottfried T, Di Segni M, Urban D, Peled M, Daher S, Stoff R, Bar J, and Onn A

Subjects
BMI, Albumin, Immunotherapy, Weight, Prognosis, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Valentina Magri1,*, Teodor Gottfried2,*, Mattia Di Segni3,4, Damien Urban2, Michael Peled5, Sameh Daher2, Ronen Stoff2, Jair Bar2,6,*, Amir Onn5,6,* 1Dipartimento di Scienze Radiologiche, Oncologiche ed Anatomo-Patologiche, Umberto I, Policlinico di Roma, Sapienza, - Università di Roma, Rome, Italy; 2Thoracic Oncology Unit, Institute of Oncology, Sheba Medical Center, Ramat Gan 5262000, Israel; 3Dipartimento di Scienze Radiologiche, Oncologiche ed Anatomo-Patologiche, Sapienza, Umberto I, Policlinico di Roma - Università di Roma, Rome, Italy; 4U.O.C. Diagnostica per Immagini, Presidio Ospedaliero San Paolo, Rome, Italy; 5Institute of Pulmonology, Sheba Medical Center, Ramat Gan 5262000, Israel; 6Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel*These authors contributed equally to this workCorrespondence: Michael PeledInstitute of Pulmonology, Sheba Medical Center, HaShomer, Ramat Gan 5262000, IsraelTel +972 3 530 8420Fax +972 3 530 8420Email Michael.peled@sheba.health.gov.ilPurpose: Weight loss is a well-recognized prognostic parameter for survival of lung cancer patients. Computerized-tomography (CT)-based analysis of body composition and blood-based metabolic evaluation are promising prognostic tools. We aimed to assess the correlation between albumin, body mass index (BMI), skeletal muscle mass index (SMI), fat-free mass index (FFMI), fat mass index (FMI) and weight change, as well as their correlation with survival of lung cancer patients on nivolumab treatment.Methods: Data were retrospectively collected. Weight was measured at a diagnosis of stage 4 disease and before start of nivolumab. Albumin levels were measured before starting nivolumab. BMI, SMI, FFMI, and FMI were evaluated from CT scans performed at start of nivolumab. Overall survival (OS) was from starting of nivolumab to death or censured at last follow-up. Statistical analysis was done to identify correlation between the various factors and between those factors and survival.Results: Forty-six patients with advanced non-small cell lung cancer (NSCLC) were included. Median follow-up was 22 months. Pathology was Adenocarcinoma/Squamous/non-other specified in 25/15/6 respectively. All patients received nivolumab as an advanced-line treatment for stage IV NSCLC. We observed a significant correlation of weight loss (P=0.01, HR=2.85) and albumin (P=0.043, HR=0.34) with OS in multivariate analysis. A significant correlation was found between BMI to SMI, FFMI, FMI, and weight change.Conclusion: Weight loss and low albumin levels are significant negative prognostic factors for NSCLC patients on immunotherapy. CT-based parameters of body composition remain to be proven as more reliable than standard clinical parameters.Keywords: BMI, albumin, immunotherapy, weight, prognosis more...

Published
2019

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3. Effect of alpha-adrenoceptor antagonists on sexual function. A systematic review and meta-analysis

Author

Bapir, R. Bhatti, K.H. Eliwa, A. García-Perdomo, H.A. Gherabi, N. Hennessey, D. Magri, V. Mourmouris, P. Ouattara, A. Perletti, G. Philipraj, J. Trinchieri, A. Buchholz, N. and Bapir, R. Bhatti, K.H. Eliwa, A. García-Perdomo, H.A. Gherabi, N. Hennessey, D. Magri, V. Mourmouris, P. Ouattara, A. Perletti, G. Philipraj, J. Trinchieri, A. Buchholz, N. more...

Abstract

Background: Alpha-adrenoreceptor antagonists or alpha-blockers are used in the treatment of hypertension, in the therapy of benign prostatic hyperplasia and in medical expulsive treatment of ureteral stones. These agents may affect the sexual function, with differences between drugs within the same class, depending on their selectivity for receptor subtypes. The aim of this review was to analyze the effects of alpha-blockers on sexual function. Materials and methods: We conducted a systematic review and meta-analysis by searching PubMed, EMBASE and other databases for randomized controlled trials (RCTs) reporting sexual adverse effects in patients treated with alpha-blockers. Odds ratios for sexual dysfunction were calculated using random effects Mantel-Haenszel statistics. Results: Out of 608 records retrieved, 75 eligible RCTs were included in the meta-analysis. Compared with placebo, alpha-blockers were associated with increased odds of ejaculatory disorders both in patients with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH) (OR: 7.53, 95% CI: 3.77-15.02, Z = 5.73, p < 0.00001, I2 = 55%) and in patients with ureteral stones (OR: 2.88, 95% CI: 1.50-5.44, Z = 3.19, p < 0.001, I2 = 31%). Uroselective alpha-blockers showed higher odds of ejaculatory disorders. Conversely, nonselective alpha-blockers were not associated with higher odds of ejaculatory dysfunction. Silodosin was associated with increased odds of ejaculatory dysfunction compared with tamsulosin (OR: 3.52, 95% CI: 2.18-5.68, 15 series, 1512 participants, Z = 5.15, p < 0.00001, I2 = 0%). Naftopidil and alfuzosin showed lower odds of ejaculatory dysfunction compared to uroselective alpha-blockers. No statistically significant differences in the odds of erectile dysfunction were observed when alpha-blockers were compared to placebo. © 2022 Edizioni Scripta Manent s.n.c.. All rights reserved. more...

Published
2022

4. Risk of urinary stone formation associated to proton pump inhibitors: A systematic review and metanalysis

Author

Bapir, R. Bhatti, K.H. Eliwa, A. Garcia-Perdomo, H.A. Gherabi, N. Hennessey, D. Magri, V. Mourmouris, P. Ouattara, A. Perletti, G. Philipraj, J. Stamatiou, K. Tolani, M.A. Tzelves, L. Trinchieri, A. Buchholz, N. and Bapir, R. Bhatti, K.H. Eliwa, A. Garcia-Perdomo, H.A. Gherabi, N. Hennessey, D. Magri, V. Mourmouris, P. Ouattara, A. Perletti, G. Philipraj, J. Stamatiou, K. Tolani, M.A. Tzelves, L. Trinchieri, A. Buchholz, N. more...

Abstract

Objective: Proton pump inhibitors are widely used as treatment of acid-related disorders. They are considered safe although their long-term use has been associated with some adverse effects including an increased propensity for urinary calculi formation. The aim of this study was to systematically review available data from studies evaluating the association of PPIs and nephrolithiasis Materials and methods: We searched two electronic databases (PubMed and EMBASE) for cohort studies or case-control studies evaluating the relationship between treatment with proton pump inhibitors and the risk of stone formation published up to 31 October 2022. The overall association of PPIs and urinary calculi was analyzed using a random effects model (RevMan5). The quality of the included studies was assessed using the Newcastle-Ottawa Quality Assessment Scale. Results: A total of 550 studies were retrieved; 7 were selected by title and abstract screening; after removal of duplicates, 4 records were evaluated by full-text examination. An additional study was retrieved by handsearching the references included in screened studies. In the unadjusted analysis, the odds of urinary calculi were greater in subjects taking PPIs compared to controls (unadjusted OR = 2.10, 95% CI 1.74-2.52, p < 0.00001). The pooled odds ratio of two case-control studies confirmed that use of PPIs increased the odds of urinary calculi compared with non-use (OR 2.44, 95% CI 2.29 to 2.61). Pooled analysis of three cohort studies evaluating incident nephrolithiasis showed an overall hazard ratio estimate of 1.34 (95% CI = 1.28-1.40). One study found lower urinary citrate and urinary magnesium levels in subjects exposed to PPIs. The Newcastle-Ottawa Quality Assessment Scale scores ranged between 6 and 8. Conclusions: PPIs showed an association with urinary calculi in patients included in the studies included in this review. If these data will be confirmed in adequately powered randomized trials, clinicians may more...

Published
2022

5. Efficacy of overactive neurogenic bladder treatment: A systematic review of randomized controlled trials

Author

Bapir, R. Bhatti, K.H. Eliwa, A. Garcia-Perdomo, H.A. Gherabi, N. Hennessey, D. Magri, V. Mourmouris, P. Ouattara, A. Perletti, G. Philipraj, J. Stamatiou, K. Trinchieri, A. Buchholz, N. and Bapir, R. Bhatti, K.H. Eliwa, A. Garcia-Perdomo, H.A. Gherabi, N. Hennessey, D. Magri, V. Mourmouris, P. Ouattara, A. Perletti, G. Philipraj, J. Stamatiou, K. Trinchieri, A. Buchholz, N. more...

Abstract

Background: Overactive bladder (OAB) symptoms of frequency, urgency and urge incontinence are frequently associated with known neurological diseases like multiple sclerosis (MS), spinal cord injury (SCI), Parkinson's disease (PD), stroke. Objective: The aim of our study was to review the efficacy of pharmacological and non-pharmacological treatments for neurogenic overactive bladder. Materials and methods: We searched two electronic databases (PubMed and EMBASE) for randomized controlled trials focusing on pharmacological and non-pharmacological medical treatments for overactive bladder symptoms associated with neurological diseases published up to 30 April 2022. Results: A total of 157 articles were retrieved; 94 were selected by title and abstract screening; after removal of 17 duplicates, 77 records were evaluated by full-text examination. Sixty-two studies were finally selected. The articles selected for review focused on the following interventions: anticholinergics (n = 9), mirabegron (n = 5), comparison of different drugs (n = 3), cannabinoids (n = 2), intravesical instillations (n = 3), botulinum toxin (n = 16), transcutaneous tibial nerve stimulation (TTNS) (n = 6), acupuncture (n = 2), transcutaneous electrical nerve stimulation TENS (n = 4), pelvic floor muscle training (PEMT) (n = 10), others (n = 2). Anticholinergics were more effective than placebo in decreasing the number of daily voids in patients with PD (mean difference IMDI-1.16, 95% CI -1.80 to- 0.52, 2 trials, 86 patients, p < 0.004), but no significant difference from baseline was found for incontinence episodes and nocturia. Mirabegron was more effective than placebo in increasing the cystometric capacity in patients with MS (mean difference jMDj 89.89 mL, 95 % CI 29.76 to 150.01, 2 trials, 98 patients, p < 0.003) but no significant difference was observed for symptom scores and bladder diary parameters. TTNS was more effective than its sham-control in decreasing the number of noctu more...

Published
2022

6. An organoid model of colorectal circulating tumor cells with stem cell features, hybrid EMT state and distinctive therapy response profile

Author

De Angelis, M. L., Francescangeli, F., Nicolazzo, C., Signore, M., Giuliani, Alessandro, Colace, L., Boe, A., Magri, V., Baiocchi, M., Ciardi, A., Scarola, F., Spada, M., La Torre, F., Gazzaniga, P., Biffoni, M., De Maria Marchiano, Ruggero, Zeuner, A., Giuliani A., De Maria R. (ORCID:0000-0003-2255-0583), De Angelis, M. L., Francescangeli, F., Nicolazzo, C., Signore, M., Giuliani, Alessandro, Colace, L., Boe, A., Magri, V., Baiocchi, M., Ciardi, A., Scarola, F., Spada, M., La Torre, F., Gazzaniga, P., Biffoni, M., De Maria Marchiano, Ruggero, Zeuner, A., Giuliani A., and De Maria R. (ORCID:0000-0003-2255-0583) more...

Abstract

Background: Circulating tumor cells (CTCs) are responsible for the metastatic dissemination of colorectal cancer (CRC) to the liver, lungs and lymph nodes. CTCs rarity and heterogeneity strongly limit the elucidation of their biological features, as well as preclinical drug sensitivity studies aimed at metastasis prevention. Methods: We generated organoids from CTCs isolated from an orthotopic CRC xenograft model. CTCs-derived organoids (CTCDOs) were characterized through proteome profiling, immunohistochemistry, immunofluorescence, flow cytometry, tumor-forming capacity and drug screening assays. The expression of intra- and extracellular markers found in CTCDOs was validated on CTCs isolated from the peripheral blood of CRC patients. Results: CTCDOs exhibited a hybrid epithelial-mesenchymal transition (EMT) state and an increased expression of stemness-associated markers including the two homeobox transcription factors Goosecoid and Pancreatic Duodenal Homeobox Gene-1 (PDX1), which were also detected in CTCs from CRC patients. Functionally, CTCDOs showed a higher migratory/invasive ability and a different response to pathway-targeted drugs as compared to xenograft-derived organoids (XDOs). Specifically, CTCDOs were more sensitive than XDOs to drugs affecting the Survivin pathway, which decreased the levels of Survivin and X-Linked Inhibitor of Apoptosis Protein (XIAP) inducing CTCDOs death. Conclusions: These results indicate that CTCDOs recapitulate several features of colorectal CTCs and may be used to investigate the features of metastatic CRC cells, to identify new prognostic biomarkers and to devise new potential strategies for metastasis prevention. more...

Published
2022

7. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., Vici P., Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., and Vici P. more...

Abstract

We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients more...

Published
2020

8. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience

Author

Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti L., Giordano A., Michelotti A., Mazzotta M., Natoli C., Gamucci T., De Angelis C., Landucci E., Diodati L., Iezzi L., Mentuccia L., Fabbri A., Barba M., Sanguineti G., Marchetti P., Tomao S., Mariani L., Paris I., Lorusso V., Vallarelli S., Cassano A., Airoldi F., Orlandi A., Moscetti L., Sergi D., Sarobba M. G., Tonini G., Santini D., Sini V., Veltri E., Vaccaro A., Ferrari L., De Tursi M., Tinari N., Grassadonia A., Greco F., Botticelli A., La Verde N., Zamagni C., Rubino D., Cortesi E., Magri V., Pomati G., Scagnoli S., Capomolla E., Kayal R., Scinto A. F., Corsi D., Cazzaniga M., Laudadio L., Forciniti S., Mancini M., Carbognin L., Seminara P., Barni S., Samaritani R., Roselli M., Portarena I., Russo A., Ficorella C., Cannita K., Carpano S., Pistelli M., Berardi R., De Maria R., Sperduti I., Ciliberto G., Vici P., Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti L., Giordano A., Michelotti A., Mazzotta M., Natoli C., Gamucci T., De Angelis C., Landucci E., Diodati L., Iezzi L., Mentuccia L., Fabbri A., Barba M., Sanguineti G., Marchetti P., Tomao S., Mariani L., Paris I., Lorusso V., Vallarelli S., Cassano A., Airoldi F., Orlandi A., Moscetti L., Sergi D., Sarobba M. G., Tonini G., Santini D., Sini V., Veltri E., Vaccaro A., Ferrari L., De Tursi M., Tinari N., Grassadonia A., Greco F., Botticelli A., La Verde N., Zamagni C., Rubino D., Cortesi E., Magri V., Pomati G., Scagnoli S., Capomolla E., Kayal R., Scinto A. F., Corsi D., Cazzaniga M., Laudadio L., Forciniti S., Mancini M., Carbognin L., Seminara P., Barni S., Samaritani R., Roselli M., Portarena I., Russo A., Ficorella C., Cannita K., Carpano S., Pistelli M., Berardi R., De Maria R., Sperduti I., Ciliberto G., and Vici P. more...

Abstract

Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained. more...

Published
2019

9. Oncotype DX Predictive Nomogram for Recurrence Score Output: The Novel System ADAPTED01 Based on Quantitative Immunochemistry Analysis

Author

Marazzi, Fabio, Barone, R., Masiello, V., Magri, V., Mule, A., Santoro, Angela, Cacciatori, F., Boldrini, Luca, Franceschini, Gianluca, Moschella, F., Naso, G., Tomao, S., Gambacorta, Maria Antonietta, Mantini, Giovanna, Masetti, Riccardo, Smaniotto, Daniela, Valentini, Vincenzo, Marazzi F., Santoro A. (ORCID:0000-0002-6964-5152), Boldrini L., Franceschini G. (ORCID:0000-0002-2950-3395), Gambacorta M. A. (ORCID:0000-0001-5455-8737), Mantini G. (ORCID:0000-0001-5303-4499), Masetti R. (ORCID:0000-0002-7520-9111), Smaniotto D. (ORCID:0000-0002-1246-8001), Valentini V. (ORCID:0000-0003-4637-6487), Marazzi, Fabio, Barone, R., Masiello, V., Magri, V., Mule, A., Santoro, Angela, Cacciatori, F., Boldrini, Luca, Franceschini, Gianluca, Moschella, F., Naso, G., Tomao, S., Gambacorta, Maria Antonietta, Mantini, Giovanna, Masetti, Riccardo, Smaniotto, Daniela, Valentini, Vincenzo, Marazzi F., Santoro A. (ORCID:0000-0002-6964-5152), Boldrini L., Franceschini G. (ORCID:0000-0002-2950-3395), Gambacorta M. A. (ORCID:0000-0001-5455-8737), Mantini G. (ORCID:0000-0001-5303-4499), Masetti R. (ORCID:0000-0002-7520-9111), Smaniotto D. (ORCID:0000-0002-1246-8001), and Valentini V. (ORCID:0000-0003-4637-6487) more...

Abstract

A correlation between phenotypical tumor characteristics, quantitative classical immunohistochemistry (IHC), and recurrence score (RS) from Oncotype DX results was used to develop a decision supporting system for clinical use. We created a freely available nomogram based on quantitative IHC results that allows prediction of RS ≤ 25 or ≤ 20. Prospective studies will test this application in clinical practice. more...

Published
2020

10. Impact of BMI on HER2+ metastatic breast cancer patients treated with pertuzumab and/or trastuzumab emtansine. Real-world evidence

Author

Krasniqi, E, Pizzuti, L, Barchiesi, G, Sergi, D, Carpano, S, Botti, C, Kayal, R, Sanguineti, G, Marchetti, P, Botticelli, A, Marinelli, D, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Tomao, S, Tonini, G, Santini, D, Michelotti, A, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Cazzaniga, M, Moscetti, L, Fabbri, A, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Garufi, C, Di Stefano, P, Mirabelli, R, Veltri, E, Paris, I, Giotta, F, Lorusso, V, Landucci, E, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Valerio, M, Berardi, R, Pistelli, M, Cannita, K, Zamagni, C, Garrone, O, Baldini, E, Livi, L, Meattini, I, Del Medico, P, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Villa, A, Sperduti, I, Mazzotta, M, Barba, M, Giordano, A, Vici, P, Krasniqi, Eriseld, Pizzuti, Laura, Barchiesi, Giacomo, Sergi, Domenico, Carpano, Silvia, Botti, Claudio, Kayal, Ramy, Sanguineti, Giuseppe, Marchetti, Paolo, Botticelli, Andrea, Marinelli, Daniele, Gamucci, Teresa, Natoli, Clara, Grassadonia, Antonino, Tinari, Nicola, Tomao, Silverio, Tonini, Giuseppe, Santini, Daniele, Michelotti, Aandrea, Mentuccia, Lucia, Vaccaro, Aangela, Magnolfi, Emanuela, Gelibter, Alain, Magri, Valentina, Cortesi, Enrico, D'Onofrio, Loretta, Cassano, Alessandra, Cazzaniga, Marina, Moscetti, Luca, Fabbri, Agnese, Scinto, Angelo Fedele, Corsi, Domenico, Carbognin, Luisa, Bria, Emilio, La Verde, Nicla, Garufi, Carlo, Di Stefano, Pia, Mirabelli, Rossana, Veltri, Enzo, Paris, Ida, Giotta, Francesco, Lorusso, Vito, Landucci, Elisa, Ficorella, Corrado, Roselli, Mario, Adamo, Vincenzo, Ricciardi, Giuseppina, Russo, Antonio, Valerio, Maria Rosaria, Berardi, Rossana, Pistelli, Mirco, Cannita, Katia, Zamagni, Claudio, Garrone, Ornella, Baldini, Editta, Livi, Lorenzo, Meattini, Icro, Del Medico, Pietro, Generali, Daniele, De Maria, Ruggero, Risi, Emanuela, Ciliberto, Gennaro, Villa, Alice, Sperduti, Isabella, Mazzotta, Marco, Barba, Maddalena, Giordano, Antonio, Vici, Patrizia, Krasniqi, E, Pizzuti, L, Barchiesi, G, Sergi, D, Carpano, S, Botti, C, Kayal, R, Sanguineti, G, Marchetti, P, Botticelli, A, Marinelli, D, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Tomao, S, Tonini, G, Santini, D, Michelotti, A, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Cazzaniga, M, Moscetti, L, Fabbri, A, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Garufi, C, Di Stefano, P, Mirabelli, R, Veltri, E, Paris, I, Giotta, F, Lorusso, V, Landucci, E, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Valerio, M, Berardi, R, Pistelli, M, Cannita, K, Zamagni, C, Garrone, O, Baldini, E, Livi, L, Meattini, I, Del Medico, P, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Villa, A, Sperduti, I, Mazzotta, M, Barba, M, Giordano, A, Vici, P, Krasniqi, Eriseld, Pizzuti, Laura, Barchiesi, Giacomo, Sergi, Domenico, Carpano, Silvia, Botti, Claudio, Kayal, Ramy, Sanguineti, Giuseppe, Marchetti, Paolo, Botticelli, Andrea, Marinelli, Daniele, Gamucci, Teresa, Natoli, Clara, Grassadonia, Antonino, Tinari, Nicola, Tomao, Silverio, Tonini, Giuseppe, Santini, Daniele, Michelotti, Aandrea, Mentuccia, Lucia, Vaccaro, Aangela, Magnolfi, Emanuela, Gelibter, Alain, Magri, Valentina, Cortesi, Enrico, D'Onofrio, Loretta, Cassano, Alessandra, Cazzaniga, Marina, Moscetti, Luca, Fabbri, Agnese, Scinto, Angelo Fedele, Corsi, Domenico, Carbognin, Luisa, Bria, Emilio, La Verde, Nicla, Garufi, Carlo, Di Stefano, Pia, Mirabelli, Rossana, Veltri, Enzo, Paris, Ida, Giotta, Francesco, Lorusso, Vito, Landucci, Elisa, Ficorella, Corrado, Roselli, Mario, Adamo, Vincenzo, Ricciardi, Giuseppina, Russo, Antonio, Valerio, Maria Rosaria, Berardi, Rossana, Pistelli, Mirco, Cannita, Katia, Zamagni, Claudio, Garrone, Ornella, Baldini, Editta, Livi, Lorenzo, Meattini, Icro, Del Medico, Pietro, Generali, Daniele, De Maria, Ruggero, Risi, Emanuela, Ciliberto, Gennaro, Villa, Alice, Sperduti, Isabella, Mazzotta, Marco, Barba, Maddalena, Giordano, Antonio, and Vici, Patrizia more...

Abstract

Body mass index (BMI) is a main indicator of obesity and its association with breast cancer is well established. However, little is known in the metastatic setting, especially in HER2-positive patients. We assessed the influence of BMI on clinical outcomes of patients treated with pertuzumab and/or trastuzumab emtansine (T-DM1) for HER2+ metastatic breast cancer (mBC). BMI was addressed as a categorical variable, being classified on the basis of the following ranges, that is, 18.5–24.9, 25–29.9, and 30.0–34.9, namely, normal weight, overweight, and Class I obesity. The outcomes chosen were progression-free survival to first-line chemotherapy (PFS1) and overall survival (OS). Overall (N = 709), no impact of BMI was observed on PFS1 (p =.15), while BMI ≥ 30 was associated with worse OS (p =.003). In subjects who progressed to first line (N = 575), analyzing data across PFS1 quartiles and strata of disease burden, BMI predicted lower PFS1 in patients within the I PFS1 quartile and with the lowest disease burden (p =.001). Univariate analysis showed a detrimental effect of BMI ≥ 30 on OS for women within the I PFS1 quartile (p =.03). Results were confirmed in multivariate analysis. According to PFS1 quartiles a higher percentage of patients with high BMI and low disease burden progressed within 6 months of therapy. The effect of BMI on prognosis was also confirmed in multivariate analysis of OS for overall population. In our cohort, a BMI ≥ 30 correlated with worse OS in patients with HER2+ mBC who received pertuzumab and/or T-DM1 but had no impact on PFS to first line. BMI predicted worse I PFS1 quartile. more...

Published
2020

11. Influence of dietary energy intake on nephrolithiasis - A meta-analysis of observational studies

Author

Perletti, G., Magri, V., Ferraro, P. M., Montanari, E., Trinchieri, A., Ferraro P. M. (ORCID:0000-0002-1379-022X), Perletti, G., Magri, V., Ferraro, P. M., Montanari, E., Trinchieri, A., and Ferraro P. M. (ORCID:0000-0002-1379-022X) more...

Abstract

Objective: Obesity has been associated with an increased risk of kidney stone formation. The presence of obesity is due to an imbalance between energy intake and energy consumption resulting from physical activity and resting metabolic rate. The purpose of this meta-analysis was to assess the differences in dietary energy intake levels between patients developing urinary stones versus healthy individuals. Materials and methods: Medline/PubMed and EMBASE databases search was performed using the terms “urolithiasis”, “kidney stones*”, “calcul*”, “energy”, “calor*”, “intake”, “food”, “kilojoule/kjoule”, “Kilocal*/kcal” from January 1st, 2000, and were assessed as up to date on September 30th, 2019. Results: After having screened 1.782 records, four studies were included in the meta-analysis. The total population was 467.063, including 453.078 healthy men and/or women and 13.985 men and/or women affected by nephrolithiasis. When energy intake data were pooled irrespective of the sex of participants, mean calory intake values were significantly higher in nephrolithiasis patients, compared to healthy individuals. The mean difference (MD) was 39.16 kcal (95% CI 18.53 to 59.78, p = 0.0002, random-effects model, inverse-variance weighing). The odds ratio for this comparison - calculated from the standardized mean difference - is significant (OR = 1.946; 95% CI: 1.869 to 5.561). Conclusions: Patients affected by urolithiasis show a significantly higher energy intake in various patient populations (USA, China and Korea) including subjects of both sexes. The relevance of this finding should be confirmed by studies in populations showing different and diverse dietary patterns, and by evaluating energy consumption linked to physical activity and metabolic rate in renal stone formers. more...

Published
2020

12. Palbociclib plus fulvestrant or everolimus plus exemestane for pretreated advanced breast cancer with lobular histotype in er+/her2− patients: A propensity score-matched analysis of a multicenter retrospective patient series

Author

Orlandi, Armando, Iattoni, E., Pizzuti, L., Fabbri, A., Botticelli, A., Di Dio, Carmela, Palazzo, A., Garufi, Giovanna, Indellicati, G., Alesini, D., Carbognin, L., Paris, Ida, Vaccaro, Ascanio Giuseppe, Moscetti, L., Fabi, A., Magri, V., Naso, G., Cassano, Alessandra, Vici, P., Giannarelli, D., Franceschini, Gianluca, Marchetti, P., Bria, Emilio, Tortora, Giampaolo, Orlandi A. (ORCID:0000-0001-5253-4678), Di Dio C., Garufi G., Paris I., Vaccaro A., Cassano A. (ORCID:0000-0002-3311-7163), Franceschini G. (ORCID:0000-0002-2950-3395), Bria E. (ORCID:0000-0002-2333-704X), Tortora G. (ORCID:0000-0002-1378-4962), Orlandi, Armando, Iattoni, E., Pizzuti, L., Fabbri, A., Botticelli, A., Di Dio, Carmela, Palazzo, A., Garufi, Giovanna, Indellicati, G., Alesini, D., Carbognin, L., Paris, Ida, Vaccaro, Ascanio Giuseppe, Moscetti, L., Fabi, A., Magri, V., Naso, G., Cassano, Alessandra, Vici, P., Giannarelli, D., Franceschini, Gianluca, Marchetti, P., Bria, Emilio, Tortora, Giampaolo, Orlandi A. (ORCID:0000-0001-5253-4678), Di Dio C., Garufi G., Paris I., Vaccaro A., Cassano A. (ORCID:0000-0002-3311-7163), Franceschini G. (ORCID:0000-0002-2950-3395), Bria E. (ORCID:0000-0002-2333-704X), and Tortora G. (ORCID:0000-0002-1378-4962) more...

Abstract

Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in combination with endocrine therapy (ET) show meaningful efficacy and tolerability in patients with metastatic breast cancer (MBC), but the optimal sequence of ET has not been established. It is not clear if patients with lobular breast carcinomas (LBC) derive the same benefits when receiving second line CDK4/6i. This retrospective study compared the efficacy of palbociclib plus fulvestrant (PALBO–FUL) with everolimus plus exemestane (EVE–EXE) as second-line ET for hormone-resistant metastatic LBC. From 2013 to 2018, patients with metastatic LBC positivity for estrogen and/or progesterone receptors and HER2/neu negativity, who had relapsed during adjuvant hormonal therapy or first-line hormonal treatment, were enrolled from six centers in Italy in this retrospective study. A total of 74 out of 376 patients (48 treated with PALBO–FUL and 26 with EVE–EXE) with metastatic LBC were eligible for inclusion. Progression-free survival (PFS) was longer in patients receiving EVE–EXE compared with PALBO–FUL (6.1 vs. 4.5 months, univariate HR 0.58, 95% CI 0.35–0.96; p = 0.025). On the propensity score (PS) analysis, PFS was confirmed to be significantly longer for patients treated with EVE–EXE compared to PALBO–FUL (6.0 vs. 4.6 months, p = 0.04). This retrospective analysis suggests that EVE–EXE is more effective than PALBO–FUL for second line ET of metastatic LBC, allowing us to speculate on the optimal therapeutic sequence. more...

Published
2020

13. Impact of BMI on HER2+ metastatic breast cancer patients treated with pertuzumab and/or trastuzumab emtansine. Real-world evidence

Author

Krasniqi, E., Pizzuti, L., Barchiesi, G., Sergi, D., Carpano, S., Botti, C., Kayal, R., Sanguineti, G., Marchetti, P., Botticelli, A., Marinelli, D., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Tomao, S., Tonini, Gerolamo, Santini, D., Michelotti, A., Mentuccia, L., Vaccaro, Ascanio Giuseppe, Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, Alessandra, Cazzaniga, M., Moscetti, L., Fabbri, A., Scinto, A. F., Corsi, Domenico Cristiano, Carbognin, L., Bria, Emilio, La Verde, N., Garufi, C., Di Stefano, P., Mirabelli, R., Veltri, E., Paris, Ida, Giotta, F., Lorusso, V., Landucci, E., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, Walter, Russo, A., Valerio, M. R., Berardi, R., Pistelli, M., Cannita, K., Zamagni, C., Garrone, O., Baldini, E., Livi, L., Meattini, I., Del Medico, P., Generali, Daniele, De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Villa, Angela Ida, Sperduti, I., Mazzotta, M., Barba, M., Giordano, Alessandro, Vici, P., Tonini G., Vaccaro A., Cassano A. (ORCID:0000-0002-3311-7163), Corsi D., Bria E. (ORCID:0000-0002-2333-704X), Paris I., Ricciardi G. (ORCID:0000-0002-5655-688X), Generali D. (ORCID:0000-0003-2480-3855), De Maria R. (ORCID:0000-0003-2255-0583), Villa A. (ORCID:0000-0003-0679-334X), Giordano A. (ORCID:0000-0002-6978-0880), Krasniqi, E., Pizzuti, L., Barchiesi, G., Sergi, D., Carpano, S., Botti, C., Kayal, R., Sanguineti, G., Marchetti, P., Botticelli, A., Marinelli, D., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Tomao, S., Tonini, Gerolamo, Santini, D., Michelotti, A., Mentuccia, L., Vaccaro, Ascanio Giuseppe, Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, Alessandra, Cazzaniga, M., Moscetti, L., Fabbri, A., Scinto, A. F., Corsi, Domenico Cristiano, Carbognin, L., Bria, Emilio, La Verde, N., Garufi, C., Di Stefano, P., Mirabelli, R., Veltri, E., Paris, Ida, Giotta, F., Lorusso, V., Landucci, E., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, Walter, Russo, A., Valerio, M. R., Berardi, R., Pistelli, M., Cannita, K., Zamagni, C., Garrone, O., Baldini, E., Livi, L., Meattini, I., Del Medico, P., Generali, Daniele, De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Villa, Angela Ida, Sperduti, I., Mazzotta, M., Barba, M., Giordano, Alessandro, Vici, P., Tonini G., Vaccaro A., Cassano A. (ORCID:0000-0002-3311-7163), Corsi D., Bria E. (ORCID:0000-0002-2333-704X), Paris I., Ricciardi G. (ORCID:0000-0002-5655-688X), Generali D. (ORCID:0000-0003-2480-3855), De Maria R. (ORCID:0000-0003-2255-0583), Villa A. (ORCID:0000-0003-0679-334X), and Giordano A. (ORCID:0000-0002-6978-0880) more...

Abstract

Body mass index (BMI) is a main indicator of obesity and its association with breast cancer is well established. However, little is known in the metastatic setting, especially in HER2-positive patients. We assessed the influence of BMI on clinical outcomes of patients treated with pertuzumab and/or trastuzumab emtansine (T-DM1) for HER2+ metastatic breast cancer (mBC). BMI was addressed as a categorical variable, being classified on the basis of the following ranges, that is, 18.5–24.9, 25–29.9, and 30.0–34.9, namely, normal weight, overweight, and Class I obesity. The outcomes chosen were progression-free survival to first-line chemotherapy (PFS1) and overall survival (OS). Overall (N = 709), no impact of BMI was observed on PFS1 (p =.15), while BMI ≥ 30 was associated with worse OS (p =.003). In subjects who progressed to first line (N = 575), analyzing data across PFS1 quartiles and strata of disease burden, BMI predicted lower PFS1 in patients within the I PFS1 quartile and with the lowest disease burden (p =.001). Univariate analysis showed a detrimental effect of BMI ≥ 30 on OS for women within the I PFS1 quartile (p =.03). Results were confirmed in multivariate analysis. According to PFS1 quartiles a higher percentage of patients with high BMI and low disease burden progressed within 6 months of therapy. The effect of BMI on prognosis was also confirmed in multivariate analysis of OS for overall population. In our cohort, a BMI ≥ 30 correlated with worse OS in patients with HER2+ mBC who received pertuzumab and/or T-DM1 but had no impact on PFS to first line. BMI predicted worse I PFS1 quartile. more...

Published
2020

14. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Pizzuti, L., Krasniqi, E., Barchiesi, G., Della Giulia, M., Izzo, F., Sanguineti, G., Marchetti, P., Mazzotta, M., Giusti, R., Botticelli, A., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Iezzi, L., Tomao, S., Tomao, F., Tonini, G., Santini, D., Astone, Antonio, Michelotti, A., De Angelis, C., Mentuccia, L., Vaccaro, A., Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, Alessandra, Rossi, E., Cazzaniga, M., Moscetti, L., Omarini, C., Piacentini, F., Fabbri, M. A., Scinto, A. F., Corsi, D., Carbognin, L., Bria, Emilio, La Verde, N., Samaritani, R., Garufi, C., Barni, S., Mirabelli, R., Sarmiento, R., Veltri, E. M., D'Auria, G., Paris, I., Giotta, F., Lorusso, V., Cardillo, F., Landucci, E., Mauri, M., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, G. R. R., Russo, A., Berardi, R., Pistelli, M., Fiorio, E., Cannita, K., Sini, V., D'Ostilio, N., Foglietta, J., Greco, F., Zamagni, C., Garrone, O., Di Cocco, B., Baldini, E., Livi, L., Desideri, I., Meattini, I., Sarobba, G., Del Medico, P., De Tursi, M., Generali, D., De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Sperduti, I., Villa, A., Barba, M., Di Leo, A., Vici, P., Astone A. (ORCID:0000-0001-9572-309X), Cassano A. (ORCID:0000-0002-3311-7163), Bria E. (ORCID:0000-0002-2333-704X), De Maria R. (ORCID:0000-0003-2255-0583), Pizzuti, L., Krasniqi, E., Barchiesi, G., Della Giulia, M., Izzo, F., Sanguineti, G., Marchetti, P., Mazzotta, M., Giusti, R., Botticelli, A., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Iezzi, L., Tomao, S., Tomao, F., Tonini, G., Santini, D., Astone, Antonio, Michelotti, A., De Angelis, C., Mentuccia, L., Vaccaro, A., Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, Alessandra, Rossi, E., Cazzaniga, M., Moscetti, L., Omarini, C., Piacentini, F., Fabbri, M. A., Scinto, A. F., Corsi, D., Carbognin, L., Bria, Emilio, La Verde, N., Samaritani, R., Garufi, C., Barni, S., Mirabelli, R., Sarmiento, R., Veltri, E. M., D'Auria, G., Paris, I., Giotta, F., Lorusso, V., Cardillo, F., Landucci, E., Mauri, M., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, G. R. R., Russo, A., Berardi, R., Pistelli, M., Fiorio, E., Cannita, K., Sini, V., D'Ostilio, N., Foglietta, J., Greco, F., Zamagni, C., Garrone, O., Di Cocco, B., Baldini, E., Livi, L., Desideri, I., Meattini, I., Sarobba, G., Del Medico, P., De Tursi, M., Generali, D., De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Sperduti, I., Villa, A., Barba, M., Di Leo, A., Vici, P., Astone A. (ORCID:0000-0001-9572-309X), Cassano A. (ORCID:0000-0002-3311-7163), Bria E. (ORCID:0000-0002-2333-704X), and De Maria R. (ORCID:0000-0003-2255-0583) more...

Abstract

We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients. more...

Published
2020

15. Gram-positive microorganisms isolated during Chronic Bacterial Prostatitis investigation

Author

Stamatiou, K, Magri, V, Perletti, G, Rekleiti, N, Lacroix, R, and Moschouris, H

Subjects
prostate, prostate, Prostatitis, Chronic Bacterial Prostatitis, Fluoroquinolones, Levofloxacin, Macrolides, Azithromycin, Gram-positive pathogens, Enterococcus faecalis, Coagulase-negative Staphylococci, Chronic Bacterial Prostatitis, Gram-positive pathogens, Enterococcus faecalis, Levofloxacin, Azithromycin, Coagulase-negative Staphylococci, Prostatitis, Fluoroquinolones
Published
2019

16. OncotypeDX® predictive nomogram for recurrence score output: A machine learning system based on quantitative immunochemistry analysis - ADAPTED01

Author

Marazzi, F., primary, Masiello, V., additional, Barone, R., additional, Magri, V., additional, Mulé, A., additional, Santoro, A., additional, Cacciatori, F., additional, Boldrini, L., additional, Franceschini, G., additional, Moschella, F., additional, Naso, G., additional, Tomao, S., additional, Mantini, G., additional, Masetti, R., additional, Smaniotto, D., additional, and Valentini, V., additional more...

Published
2019
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17. OncotypeDX (R) predictive nomogram for recurrence score output: A machine learning system based on quantitative immunochemistry analysis-ADAPTED01

Author

Marazzi, Fabio, Masiello, V, Barone, R, Magri, V, Mule, A, Santoro, Angela, Cacciatori, F, Boldrini, Luca, Franceschini, Gianluca, Moschella, Francesca, Naso, G, Tomao, S, Mantini, Giovanna, Masetti, Riccardo, Smaniotto, Daniela, Valentini, Vincenzo, Marazzi, F, Santoro, A (ORCID:0000-0002-6964-5152), Boldrini, L, Franceschini, G (ORCID:0000-0002-2950-3395), Moschella, F, Mantini, G (ORCID:0000-0001-5303-4499), Masetti, R (ORCID:0000-0002-7520-9111), Smaniotto, D (ORCID:0000-0002-1246-8001), Valentini, V (ORCID:0000-0003-4637-6487), Marazzi, Fabio, Masiello, V, Barone, R, Magri, V, Mule, A, Santoro, Angela, Cacciatori, F, Boldrini, Luca, Franceschini, Gianluca, Moschella, Francesca, Naso, G, Tomao, S, Mantini, Giovanna, Masetti, Riccardo, Smaniotto, Daniela, Valentini, Vincenzo, Marazzi, F, Santoro, A (ORCID:0000-0002-6964-5152), Boldrini, L, Franceschini, G (ORCID:0000-0002-2950-3395), Moschella, F, Mantini, G (ORCID:0000-0001-5303-4499), Masetti, R (ORCID:0000-0002-7520-9111), Smaniotto, D (ORCID:0000-0002-1246-8001), and Valentini, V (ORCID:0000-0003-4637-6487) more...

Abstract

No abstract availablle

Published
2019

19. Abstract P4-13-07: SEQUERPLUS: A multicenter real practice observational study investigating the endocrine-based (E) therapies sequential approach in hormonal receptor positive (HR+) HER2 negative (-) metastatic breast cancer (MBC)

Author

Fabi, A, primary, Giannarelli, D, additional, Botticelli, A, additional, Scagnoli, S, additional, Pellegrino, A, additional, Fabbri, A, additional, Corsi, D, additional, Magri, V, additional, Pizzuti, L, additional, Paris, I, additional, Bruni, V, additional, Pace, R, additional, Lanzetta, G, additional, Stani, S, additional, Moscetti, L, additional, Marchetti, P, additional, Piesco, G, additional, Cognetti, F, additional, and Rossi, V, additional more...

Published
2019
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20. Abstract P5-12-08: Not presented

Author

Botticelli, A, primary, Cerbelli, B, additional, Pisano, A, additional, Naso, G, additional, Monti, M, additional, Ascierto, PA, additional, Costarelli, L, additional, Magri, V, additional, Mauri, M, additional, Pignataro, MG, additional, Campagna, D, additional, Pernazza, A, additional, Nuti, M, additional, Fortunato, L, additional, Della Rocca, C, additional, D'Amati, G, additional, and Marchetti, P, additional more...

Published
2019
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21. Effectiveness of trastuzumab emtansine (TDM1) in patients with HER2-positive advanced breast cancer (ABC) progressing after taxane plus pertuzumab plus trastuzumab

Author

Conte, B., primary, Fabi, A., additional, Poggio, F., additional, Blondeaux, E., additional, Dellepiane, C., additional, D'Alonzo, A., additional, Staiano, A., additional, Buono, G., additional, Arpino, G., additional, Magri, V., additional, Naso, G., additional, Presti, D., additional, Mura, S., additional, Fontana, A., additional, Cognetti, F., additional, Molinelli, C., additional, Pastorino, S., additional, Bighin, C., additional, Lambertini, M., additional, and Del Mastro, L., additional more...

Published
2018
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22. P1.15-01 Radiotherapy (RT) and Nivolumab in Non-Small-Cell Lung Cancer (NSCLC): A Multicenter Real-Life Experience

Author

Bassanelli, M., primary, Giannarelli, D., additional, Ricciuti, B., additional, Magri, V., additional, Cecere, F.L., additional, Roberto, M., additional, Giacinti, S., additional, Barucca, V., additional, Cassese, R., additional, De Giglio, A., additional, Scagnoli, S., additional, Milella, M., additional, Santarelli, M., additional, Bengala, C., additional, Ruggeri, E.M., additional, Marchetti, P., additional, Cognetti, F., additional, Gelibter, A., additional, Cortesi, E., additional, Chiari, R., additional, and Ceribelli, A., additional more...

Published
2018
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24. Comparative effects of Folfirinox and Gemcitabine/nab-paclitaxel as first and second line chemotherapy for metastatic pancreatic cancer: single choice or sequence

Author

Caponnetto, S., primary, Gelibter, A., additional, Mosillo, C., additional, Magri, V., additional, Scagnoli, S., additional, Pomati, G., additional, Piesco, G., additional, Verkhovskaya, S., additional, Pisegna, S., additional, Sirgiovanni, G., additional, Napoli, V., additional, Buscicchio, D., additional, Iannantuono, G.M., additional, Marinelli, D., additional, Mammone, G., additional, Pannunzio, S., additional, Nicolo', E., additional, Stefani, A., additional, Astorino, V., additional, Mancini, M., additional, and Cortesi, E., additional more...

Published
2017
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25. Αιμοσπερμία: Πολύ κακό για το τίποτα;.

Author

Σταματίου, Κ., Magri, V., Μαρίνης, Α., Perletti, G., and Χριστόπουλος, Γ.

Abstract

The term hematospermia is defined as the presence of red blood cells in the semen. It is a rare symptom; however its presence is annoying and worrying for patients. The actual incidence of hematospermia is unknown; however, it appears to be more common in men under the age of 40 and in the majority of cases is due to benign causes. Although rare, malignant conditions associated with hematospermia should be investigated before definitive diagnosis in men over 40 years of age with risk factors (eg, history of cancer, known disorders of the urogenital system, bleeding disorders) and men with complications related symptoms. In these men hematospermia usually recurs and may not respond to treatment. In men younger than 40 without risk factors, hematospermia is often self-limited and does not require further evaluation or treatment. [ABSTRACT FROM AUTHOR] more...

Published
2019

27. Prolactin as a potential negative predictive factor in metastatic non-small cell lung cancers (NSCLC) patients in treatment with Nivolumab (NIVO)

Author

Caponnetto, S., primary, Mancini, M., additional, Manai, C., additional, Magri, V., additional, Iannantuono, G.M., additional, Pellegrino, D., additional, Mosillo, C., additional, Piesco, G., additional, Pomati, G., additional, Scagnoli, S., additional, Urbano, F., additional, Verkhovskaya, S., additional, Barchiesi, G., additional, Zancla, S., additional, and Cortesi, E., additional more...

Published
2016
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28. Prolactin as a possible predictive factor in metastatic non-small cell lung cancers (NSCLC) patients in treatment with Nivolumab (NIVO)

Author

Caponnetto, S., primary, Mancini, M.L., additional, Scagnoli, S., additional, Barchiesi, G., additional, Mosillo, C., additional, Iannantuono, G.M., additional, Verkhovskaia, S., additional, Magri, V., additional, Piesco, G., additional, Pomati, G., additional, Pellegrino, D., additional, Urbano, F., additional, Zancla, S., additional, Manai, C., additional, and Cortesi, E., additional more...

Published
2016
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29. 326P - Effectiveness of trastuzumab emtansine (TDM1) in patients with HER2-positive advanced breast cancer (ABC) progressing after taxane plus pertuzumab plus trastuzumab

Author

Conte, B., Fabi, A., Poggio, F., Blondeaux, E., Dellepiane, C., D'Alonzo, A., Staiano, A., Buono, G., Arpino, G., Magri, V., Naso, G., Presti, D., Mura, S., Fontana, A., Cognetti, F., Molinelli, C., Pastorino, S., Bighin, C., Lambertini, M., and Del Mastro, L. more...

Published
2018
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30. Influence of infection on the distribution patterns of NIH-chronic prostatitis symptom index scores in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)

Author

Magri, V. Wagenlehner, F.M.E. Marras, E. Van Till, J.W.O. Houbiers, J. Panagopoulos, P. Petrikkos, G.L. Perletti, G.

Abstract

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a complex condition for which the etiological determinants are still poorly defined. To better characterize the diagnostic and therapeutic profile of patients, an algorithm known as UPOINT was created, addressing six major phenotypic domains of CP/CPPS, specifically the urinary (U), psycho-social (P), organ-specific (O), infection (I), neurological/systemic (N) and muscular tenderness (T) domains. An additional sexual dysfunction domain may be included in the UPOINT(S) system. The impact of the infection domain on the severity of CP/CPPS symptoms is a controversial issue, due to the contradictory results of different trials. The aim of the present retrospective study was to further analyze the extent to which a positive infection domain of UPOINTS may modify the pattern of CP/CPPS symptom scores, assessed with the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). In a cohort of 935 patients that was divided on the basis of the presence or absence of prostatic infection, more severe clinical symptoms were shown by the patients with infection (median NIH total score: 24 versus 20 points in uninfected patients; P more...

Published
2013

31. Safety analysis, correlation with response and previous treatments of the association of everolimus (EVE) and exemestane (EXE) in 181 metastatic breast cancer patients (MBC)

Author

Moscetti, L., primary, Vici, P., additional, Sperduti, I., additional, Palleschi, M., additional, Magri, V., additional, Iezzi, L., additional, Fabbri, M.A., additional, D'Onofrio, L., additional, Mentuccia, L., additional, Vaccaro, A., additional, Trenta, P., additional, Ramponi, S., additional, Roma, C., additional, and Ruggeri, E.M., additional more...

Published
2015
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32. D27 - Comparative effects of Folfirinox and Gemcitabine/nab-paclitaxel as first and second line chemotherapy for metastatic pancreatic cancer: single choice or sequence

Author

Caponnetto, S., Gelibter, A., Mosillo, C., Magri, V., Scagnoli, S., Pomati, G., Piesco, G., Verkhovskaya, S., Pisegna, S., Sirgiovanni, G., Napoli, V., Buscicchio, D., Iannantuono, G.M., Marinelli, D., Mammone, G., Pannunzio, S., Nicolo', E., Stefani, A., Astorino, V., Mancini, M., and Cortesi, E. more...

Published
2017
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36. Efficacy of Chemotherapy (CHT) Beyond Tyrosine Kinases Inhibitors (TKI) in Advanced Non Small Cell Lung Cancer (NSCLC) Patients (PTS) Unselected for Epidermal Growth Factor Receptor (EGFR) Mutation

Author

Trenta, P., primary, Iacovelli, R., additional, Palazzo, A., additional, Pellegrino, D., additional, Mosillo, C., additional, Rubini, F., additional, Prete, A., additional, Magri, V., additional, De Benedetto, A., additional, and Cortesi, E., additional more...

Published
2012
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40. Entre écrit et oral - L'anaphore rhétorique dans le discours de campagne. L'exemple de N. Sarkozy

Author

Magri Véronique

Subjects
Social Sciences
Abstract

L'anaphore rhétorique est ici définie comme répétition à l'initiale d'une unité textuelle, qu'il s'agisse d'un segment de phrase ou d'une phrase entière. Figure de construction de type microstrural et variété élémentaire de répétition, l'anaphore rhétorique peut servir de base à des figures macrostructurales d'amplification. Le corpus d'étude est composé des discours de campagne de Nicolas Sarkozy prononcés entre décembre 2006 et mai 2007, genre hybride situé entre écrit et oral. L'anaphore rhétorique, figure récurrente du discours de Sarkozy, a paru pouvoir fonctionner comme point de convergence entre discours oral et écrit, à la fois au niveau structurel, sémantico-pragmatique et intersubjectif du message écrit et parlé. Elle joue un rôle dans la structuration textuelle mais aussi dans la construction de l'espace intersubjectif, en intervenant dans les procédés de négociations discursives à l'oeuvre dans tout discours. Cette étude propose une approche renouvelée de l'anaphore rhétorique, en particulier par les cadres méthodologiques où elle se situe qui croisent pragmatique, syntaxe et textométrie, par les conclusions également qui proposent l'analyse de l'anaphore rhétorique comme forme-sens signifiante dans un genre donné. Elle ouvre à une réflexion épistémologique sur le genre textuel particulier du discours de campagne, genre hybride situé entre écrit et oral. L'étude propose d'abord une mise en perspective des critères définitionnels. Procédé intraphrastique et interphrastique, la figure joue un rôle comme marqueur prosodique. Elle est évaluée par sa portée, autrement dit la distance entre une occurrence et sa reprise en écho. La méthodologie emprunte ensuite à l'analyse quantitative pour apprécier la ductilité du procédé et repérer les formules-clé ou les patrons syntaxiques caractéristiques des discours. Enfin, est mesurée son incidence dans la cohésion et la cohérence textuelle pour en souligner le caractère paradoxal : outil de cohésion apparent, l'anaphore rhétorique s'apparente à l'énumération par listes qui procède par empilement et instaure une lecture ou une écoute tabulaire du texte. L'approche pragmatique du procédé démontre que l'anaphore rhétorique active une référence ostensive et construit un univers de référence en co-énonciation, qui emprunte des schémas de l'oral. Les holophrases pourquoi tant de haine, vous en avez assez, ça ne peut plus durer, fonctionnent comme préconstruits et comme moteurs d'une chaîne sympathique entre locuteur et public, au sens rhétorique et même musical du terme. Sur le plan référentiel enfin, l'anaphore rhétorique construit un monde par répétition ; elle propose une vision partielle du monde qui s'assène comme monde authentique et objectif, à la faveur des stéréotypes martelés ou des structures figées. Figure de structuration, d'amplification, d'assertivité, et marqueur prosodique, l'anaphore rhétorique s'affirme comme forme-sens, matrice ou archétype des discours de Nicolas Sarkozy. more...

Published
2014
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41. Critical issues in chronic prostatitis

Author

Magri, V., Perletti, G., Riccardo Bartoletti, Cai, T., Emelyanova, I., Mehik, A., Morgia, G., Skerk, V., Trinchieri, A., Wagenlehner, F. M. E., and Naber, K. G.

Subjects
Chronic prostatitis
Abstract

In the last decade, an impressive amount of clinical research data has shed new light on pathogenesis and management of the chronic prostatitis syndrome. A new classification and a validated symptom score have enabled urologists worldwide to speak a "common language", thus greatly improving the amount and quality of focused research in this field. In Europe, a large number of groups and experts have been actively involved in this research, and have developed in many cases a genuine view on prostatitis and chronic pelvic pain etiology, diagnosis and treatment. The present paper, written by a panel of researchers from Europe and Far East Russia, reviews the most recent findings, discusses the most controversial contemporary topics on prostatitis syndromes, and highlights a number of unresolved issues requiring further research and study. more...

42. Paraphrases, périphrases, antonomases et désignation de l’altérité

Author

Magri Véronique

Subjects
Social Sciences
Abstract

La paraphrase a des affinités avec la périphrase en ce qu’elles servent toutes deux le processus de nomination du référent par une opération de substitution extensive, saisie à un point différent de sa réalisation. La paraphrase propose la substitution, la périphrase l’impose. La reformulation du nom commun exogène joue sur les deux processus. Celle du nom propre de lieux peut être assimilée à la figure de l’antonomase. Les trois processus, périphrase, paraphrase et antonomase seront envisagés dans un continuum dynamique comme spécifiques du récit de voyage. La paraphrase propose une reformulation alternative; la périphrase remplace le terme exogène par un énoncé qui assure la désignation directe. L’antonomase est plus complexe puisqu’elle désigne l’objet du monde exogène par l’emploi d’un nom propre lui-même reformulé. more...

Published
2018
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43. Impact of BMI on HER2+ metastatic breast cancer patients treated with pertuzumab and/or trastuzumab emtansine. Real-world evidence

Author

Aangela Vaccaro, Antonio Giordano, Marina Elena Cazzaniga, Antonio Russo, Maddalena Barba, Emilio Bria, Corrado Ficorella, Claudio Botti, Nicla La Verde, Clara Natoli, Valentina Magri, Loretta D'Onofrio, Carlo Garufi, Ruggero De Maria, Maria Rosaria Valerio, Gennaro Ciliberto, Mario Roselli, A. Fabbri, Emanuela Magnolfi, Giuseppina Rosaria Rita Ricciardi, Patrizia Vici, Alessandra Cassano, Emanuela Risi, Isabella Sperduti, Daniele Generali, Daniele Marinelli, Vito Lorusso, Teresa Gamucci, Lorenzo Livi, Giuseppe Tonini, Antonino Grassadonia, Editta Baldini, Marco Mazzotta, Luca Moscetti, Silverio Tomao, Claudio Zamagni, Silvia Carpano, Ornella Garrone, Icro Meattini, Giuseppe Sanguineti, Eriseld Krasniqi, Lucia Mentuccia, Katia Cannita, Daniele Santini, Rossana Mirabelli, Enzo Veltri, Domenico Sergi, Aandrea Michelotti, Alice Villa, Nicola Tinari, Vincenzo Adamo, A. Botticelli, Ramy Kayal, Mirco Pistelli, Domenico Corsi, Pietro Del Medico, Rossana Berardi, Enrico Cortesi, Giacomo Barchiesi, Alain Gelibter, Ida Paris, Elisa Landucci, Pia Di Stefano, Laura Pizzuti, Paolo Marchetti, Luisa Carbognin, Francesco Giotta, A.F. Scinto, Krasniqi, E, Pizzuti, L, Barchiesi, G, Sergi, D, Carpano, S, Botti, C, Kayal, R, Sanguineti, G, Marchetti, P, Botticelli, A, Marinelli, D, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Tomao, S, Tonini, G, Santini, D, Michelotti, A, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Cazzaniga, M, Moscetti, L, Fabbri, A, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Garufi, C, Di Stefano, P, Mirabelli, R, Veltri, E, Paris, I, Giotta, F, Lorusso, V, Landucci, E, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Valerio, M, Berardi, R, Pistelli, M, Cannita, K, Zamagni, C, Garrone, O, Baldini, E, Livi, L, Meattini, I, Del Medico, P, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Villa, A, Sperduti, I, Mazzotta, M, Barba, M, Giordano, A, Vici, P, Eriseld K., Laura P., Giacomo B., Domenico S., Silvia C., Claudio B., Ramy K., Giuseppe S., Paolo M., Andrea B., Daniele M., Teresa G., Clara N., Antonino G., Nicola T., Silverio T., Giuseppe T., Daniele S., Aandrea M., Lucia M., Aangela V., Emanuela M., Alain G., Valentina M., Enrico C., Loretta D., Alessandra C., Marina C., Luca M., Agnese F., Angelo Fedele S., Domenico C., Luisa C., Emilio B., Nicla L.V., Carlo G., Pia D.S., Rossana M., Enzo V., Ida P., Francesco G., Vito L., Elisa L., Corrado F., Mario R., Vincenzo A., Giuseppina R., Antonio R., Maria Rosaria V., Rossana B., Mirco P., Katia C., Claudio Z., Ornella G., Editta B., Lorenzo L., Icro M., Pietro D.M., Daniele G., Ruggero D.M., Emanuela R., Gennaro C., Alice V., Isabella S., Marco M., Maddalena B., Antonio G., and Patrizia V. more...

Subjects
0301 basic medicine, Oncology, Physiology, Receptor, ErbB-2, Clinical Biochemistry, Ado-Trastuzumab Emtansine, Settore MED/06, body mass index, HER2-positive metastatic breast cancer, pertuzumab, trastuzumab emtansine, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Agents, Immunological, Aged, 80 and over, education.field_of_study, Univariate analysis, Middle Aged, Metastatic breast cancer, Progression-Free Survival, Quartile, 030220 oncology & carcinogenesis, Disease Progression, Female, Pertuzumab, medicine.drug, Adult, medicine.medical_specialty, Population, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Breast cancer, Settore MED/04 - PATOLOGIA GENERALE, Internal medicine, medicine, Humans, Obesity, education, Aged, business.industry, nutritional and metabolic diseases, Cell Biology, Overweight, medicine.disease, 030104 developmental biology, chemistry, Trastuzumab emtansine, MED/06 - ONCOLOGIA MEDICA, business, Body mass index
Abstract

Body mass index (BMI) is a main indicator of obesity and its association with breast cancer is well established. However, little is known in the metastatic setting, especially in HER2-positive patients. We assessed the influence of BMI on clinical outcomes of patients treated with pertuzumab and/or trastuzumab emtansine (T-DM1) for HER2+ metastatic breast cancer (mBC). BMI was addressed as a categorical variable, being classified on the basis of the following ranges, that is, 18.5-24.9, 25-29.9, and 30.0-34.9, namely, normal weight, overweight, and Class I obesity. The outcomes chosen were progression-free survival to first-line chemotherapy (PFS1) and overall survival (OS). Overall (N = 709), no impact of BMI was observed on PFS1 (p = .15), while BMI ≥ 30 was associated with worse OS (p = .003). In subjects who progressed to first line (N = 575), analyzing data across PFS1 quartiles and strata of disease burden, BMI predicted lower PFS1 in patients within the I PFS1 quartile and with the lowest disease burden (p = .001). Univariate analysis showed a detrimental effect of BMI ≥ 30 on OS for women within the I PFS1 quartile (p = .03). Results were confirmed in multivariate analysis. According to PFS1 quartiles a higher percentage of patients with high BMI and low disease burden progressed within 6 months of therapy. The effect of BMI on prognosis was also confirmed in multivariate analysis of OS for overall population. In our cohort, a BMI ≥ 30 correlated with worse OS in patients with HER2+ mBC who received pertuzumab and/or T-DM1 but had no impact on PFS to first line. BMI predicted worse I PFS1 quartile. more...

Published
2020

44. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Isacco Desideri, G. Tonini, Emanuela Magnolfi, L. Pizzuti, Jennifer Foglietta, Marina Elena Cazzaniga, Adamo, Patrizia Vici, Enrico Cortesi, Emanuela Risi, G. D'Auria, Loretta D'Onofrio, Mario Roselli, Isabella Sperduti, N. Tinari, Nicola D’Ostilio, A. Vaccaro, Icro Meattini, Federica Tomao, Giacomo Barchiesi, B Di Cocco, F Cardillo, Enzo Veltri, Claudia Omarini, Mirco Pistelli, Clara Natoli, Carlo Garufi, E. Landucci, M. Mauri, Rosanna Mirabelli, Federico Piacentini, Domenico Corsi, A.F. Scinto, Alice Villa, Alain Gelibter, C. De Angelis, Marco Mazzotta, Gennaro Ciliberto, Claudio Zamagni, Giuseppe Sanguineti, Fiorentino Izzo, Elizabeth H. Baldini, Rossana Berardi, Grr Ricciardi, Maddalena Barba, Ornella Garrone, Ida Paris, Luisa Carbognin, A. Botticelli, Giuseppina Sarobba, Silverio Tomao, Antonio Astone, Lucia Mentuccia, P Del Medico, Lorusso, Daniele Santini, M. Della Giulia, Riccardo Samaritani, Francesco Giotta, Alessandra Cassano, Laura Iezzi, Maria Agnese Fabbri, R De Maria, Eriseld Krasniqi, Raffaele Giusti, Sini, Lorenzo Livi, Ernesto Rossi, Andrea Michelotti, Emilio Bria, A Di Leo, Luca Moscetti, Corrado Ficorella, Antonino Grassadonia, Roberta Sarmiento, Katia Cannita, Filippo Greco, Sandro Barni, Elena Fiorio, Teresa Gamucci, Magri, Antonio Russo, M. De Tursi, N. La Verde, Daniele Generali, Paolo Marchetti, Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, and Vici, P more...

Subjects
Oncology, Cancer Research, Multivariate analysis, Settore MED/06 - Oncologia Medica, Receptor, ErbB-2, T-DM1, Estrogen receptor, 0302 clinical medicine, ErbB-2, Trastuzumab, Receptors, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Molecular Targeted Therapy, Neoplasm Metastasis, Cancer Therapy and Prevention, Progesterone, Aged, 80 and over, advanced breast cancer, Tumor, real world, Middle Aged, Prognosis, Metastatic breast cancer, Immunohistochemistry, Gene Expression Regulation, Neoplastic, trastuzumab, Receptors, Estrogen, 030220 oncology & carcinogenesis, Female, HER2 positive, pertuzumab, Adult, Aged, Biomarkers, Tumor, Breast Neoplasms, Humans, Neoplasm Staging, Receptors, Progesterone, Pertuzumab, medicine.drug, Receptor, medicine.medical_specialty, T‐DM1, chemotherapy, 03 medical and health sciences, Breast cancer, Settore MED/04 - PATOLOGIA GENERALE, Internal medicine, medicine, Neoplastic, business.industry, medicine.disease, Estrogen, Settore CHIM/08 - Chimica Farmaceutica, Gene Expression Regulation, MED/06 - ONCOLOGIA MEDICA, business, Biomarkers, Hormone
Abstract

We analyzed data from 738 HER2‐positive metastatic breast cancer (mbc) patients treated with pertuzumab‐based regimens and/or T‐DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression‐free survival at first‐line (mPFS1) was 12 months. Pertuzumab as first‐line conferred longer mPFS1 compared to other first‐line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second‐line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T‐DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs‐negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T‐DM1 in second‐line after pertuzumab were significantly lower compared to pertuzumab‐naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment‐related outcomes of HER2‐positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2‐positive (mbc) patients., What's new? About half of breast cancers positive for human epidermal growth factor (HER2) also express hormone receptors but the impact of hormone receptor status on the success of HER2‐directed treatments is not fully explored. Here the authors retrospectively assessed tumor behavior and treatment outcomes in 738 women with HER2+ metastatic breast cancer treated with new generation anti‐HER2 agents. Distinct hormone receptor expression patterns significantly affected the progression free and overall survival, justifying further studies to define optimal treatment regimens and the interplay between hormone receptor and HER2 signaling. more...

Published
2020

45. Clinical Multigene Panel Sequencing Identifies Distinct Mutational Association Patterns in Metastatic Colorectal Cancer

Author

Paola Infante, Arianna Nicolussi, Francesca Fabretti, Gianluca Canettieri, Carlotta Liccardi, Umberto Malapelle, Mahdavian Yasaman, Giancarlo Troncone, Valentina Magri, Paola Paci, Francesca Belardinilli, Edoardo Milanetti, Stefano Di Giulio, Pasquale Pisapia, Caterina Bonfiglio, Anna Coppa, Francesco Pepe, Carlo Capalbo, Silvia Mezi, Pasquale Sibilio, Domenico Raimondo, Angela Gradilone, Marialaura Petroni, Giuseppe Giannini, Sonia Coni, Belardinilli, F., Capalbo, C., Malapelle, U., Pisapia, P., Raimondo, D., Milanetti, E., Yasaman, M., Liccardi, C., Paci, P., Sibilio, P., Pepe, F., Bonfiglio, C., Mezi, S., Magri, V., Coppa, A., Nicolussi, A., Gradilone, A., Petroni, M., Di Giulio, S., Fabretti, F., Infante, P., Coni, S., Canettieri, G., Troncone, G., and Giannini, G. more...

Subjects
0301 basic medicine, Cancer Research, molecular stratification, mCRC, NGS, molecular stratification, mutation, genes, Colorectal cancer, Disease, Computational biology, Gene mutation, Biology, lcsh:RC254-282, Tumor heterogeneity, DNA sequencing, 03 medical and health sciences, 0302 clinical medicine, medicine, Epigenetics, gene, genes, Gene, Original Research, Oncogene, COMPUTATIONAL AND SYSTEMS BIOLOGY, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, digestive system diseases, 030104 developmental biology, Oncology, mCRC, 030220 oncology & carcinogenesis, NGS, mutation
Abstract

Extensive molecular characterization of human colorectal cancer (CRC) via Next Generation Sequencing (NGS) indicated that genetic or epigenetic dysregulation of a relevant, but limited, number of molecular pathways typically occurs in this tumor. The molecular picture of the disease is significantly complicated by the frequent occurrence of individually rare genetic aberrations, which expand tumor heterogeneity. Inter- and intratumor molecular heterogeneity is very likely responsible for the remarkable individual variability in the response to conventional and target-driven first-line therapies, in metastatic CRC (mCRC) patients, whose median overall survival remains unsatisfactory. Implementation of an extensive molecular characterization of mCRC in the clinical routine does not yet appear feasible on a large scale, while multigene panel sequencing of most commonly mutated oncogene/oncosuppressor hotspots is more easily achievable. Here, we report that clinical multigene panel sequencing performed for anti-EGFR therapy predictive purposes in 639 formalin-fixed paraffin-embedded (FFPE) mCRC specimens revealed previously unknown pairwise mutation associations and a high proportion of cases carrying actionable gene mutations. Most importantly, a simple principal component analysis directed the delineation of a new molecular stratification of mCRC patients in eight groups characterized by non-random, specific mutational association patterns (MAPs), aggregating samples with similar biology. These data were validated on a The Cancer Genome Atlas (TCGA) CRC dataset. The proposed stratification may provide great opportunities to direct more informed therapeutic decisions in the majority of mCRC cases. more...

Published
2019
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46. Nutraceutical treatment and prevention of benign prostatic hyperplasia and prostate cancer

Author

T. Tony Cai, Kostantinos Stamatiou, Alberto Trinchieri, Francesco Saverio Robustelli Della Cuna, Gianpaolo Perletti, Olta Allkanjari, Annabella Vitalone, Giorgio Ivan Russo, Gaetano Larganà, Arrigo F G Cicero, Vittorio Magri, Gian Maria Busetto, and Cicero AF, Allkanjari O, Busetto GM, Cai T, Larganà G, Magri V, Perletti G, Robustelli Della Cuna FS, Russo GI, Stamatiou K, Trinchieri A, Vitalone A. more...

Subjects
Male, 030232 urology & nephrology, Prostatic Hyperplasia, lcsh:RC870-923, PSA LEVELS, chemistry.chemical_compound, Prostate cancer, DOUBLE-BLIND, 0302 clinical medicine, Lycopene, Prostate, QUALITY-OF-LIFE, Medicine and Health Sciences, Serenoa repens, 030219 obstetrics & reproductive medicine, Traditional medicine, LONG-TERM EFFICACY, Medicinal plant, food and beverages, Urtica dioica, PELVIC, DIETARY PATTERNS, medicine.anatomical_structure, 5α-reduc-tase, Antiproliferative effect, Benign prostatic hyperplasia, Beta-sitosterol, Cucurbita pepo, Palmitoylethanolamide, Pollen extract, Polyphenols, Pygeum africanum, Selenium, 5 alpha-reductase, Finasteride, 5α-reductase, medicine.drug, Serenoa repen, Polyphenol, Urology, Prostatitis, Prostatic Diseases, 03 medical and health sciences, SERENOA-REPENS, Nutraceutical, Tamsulosin, medicine, Humans, cancer, 5αreductase, Plants, Medicinal, business.industry, Plant Extracts, URINARY-TRACT SYMPTOMS, SAW PALMETTO EXTRACT, Prostatic Neoplasms, PAIN SYNDROME, lcsh:Diseases of the genitourinary system. Urology, medicine.disease, antiproliferative effect, benign prostatic hyperplasia, beta-sitosterol, cucurbita pepo, lycopene, medicinal plant, palmitoylethanolamide, pollen extract, polyphenols, prostate, prostate cancer, pygeum africanum, selenium, serenoa repens, urtica dioica, POLLEN-EXTRACT, chemistry, Dietary Supplements, business, Phytotherapy
Abstract

During the last years, pharmaceutical innovations in primary care are dramatically less frequent and will be even more rare in the next future. In this context, preclinical and clinical research oriented their interest toward natural compounds efficacy and safety, supporting the development of a new “nutraceutical” science. Medicinal plants, in the form of plant parts or extracts of them, are commonly used for the treatment of prostate diseases such as benign hypertrophy, prostatitis and chronic pelvic pain syndrome. The pharmacological properties searched for the treatment of prostatic diseases are anti-androgenic, anti-estrogenic, antiproliferative, antioxidant and anti-inflammatory. The most studied and used medicinal plants are Serenoa repens, Pygeum africanum and Urtica dioica. Other promising plants are Cucurbita pepo, Epilobium spp, Lycopersum esculentum, Secale cereale, Roystonea regia, Vaccinium macrocarpon. In parallel, epidemiological studies demonstrated that diet may play an important role on incidence and development of prostatic diseases. The Mediterranean diet is rich of elements with anti-oxidant properties that act as a protective factor for prostatic cancer. Similarly, low intake of animal protein, high intake of fruits and vegetable, lycopene and zinc are a protective factor for benign prostatic hyperplasia (BPH). Serenoa repens in the treatment of symptoms of BPH has been tested either alone or, more frequently, in combination with other medicinal plants, alpha-blockers and inhibitors of 5- alpha reductase (5-ARI). Recent meta-analyses found the effectiveness of Serenoa repens similar or inferior of that of finasteride and tamsulosin but clearly higher than that of placebo in the treatment of mild and moderate low urinary tract symptoms (LUTS), nocturia and discomfort. Clinical trials showed potential synergistic effect of Serenoa repens with other medicinal plants and drugs. In addition to Serenoa repens, there are many other medicinal plants for which clinical evidence is still controversial. Urtica dioica, Pygeum africanum and Curcubita pepo can be considered as an adjunct to the common therapies and their use is supported by studies showing improvement of symptoms and flowmetric indices. Lycopene and selenium are natural products with antioxidant and anti-inflammatory action. The combination of lycopene and selenium with Serenoa repens was able to reduce inflammation in histological prostate sections and to further improve symptom scores and urinary flow in patients with BPH on tamsulosin treatment. Similar effects could be obtained with the use of other carotenoids, such as astaxanthin, and/or zinc. Efficacy on symptoms of patients with BPH of some polyphenols such as quercitin, equol and curcumin have been demonstrated by clinical studies. Pollen extract is a mixture of natural components able to inhibit several cytokines and prostaglandin and leukotriene synthesis resulting in a potent anti-inflammatory effect. Pollen extracts significantly improve symptoms, pain, and quality of life in patients affected by chronic pelvic pain syndrome and chronic prostatitis. Beta-sitosterol is a sterol able to improve urinary symptoms and flow measures, but not to reduce the size of the prostate gland. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide-signaling molecule with anti-inflammatory and neuroprotective effects that can have an interesting role in the management of chronic pelvic pain syndrome and chronic urological pain. Finally, several plant-based products have been subjected to preclinical, in vitro and in vivo, investigations for their potential pharmacological activity against prostate cancer. Some epidemiological studies or clinical trials evaluated the effects of beverages, extracts or food preparations on the risk of prostate cancer. Some plant species deserved more intense investigation, such as Camelia sinensis (green or black tea), Solanum lycopersicum (common tomato), Punica granatum (pomegranate), Glycine max (common soy) and Linum usitatissimum (linen). more...

Published
2019

47. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience

Author

Michele De Tursi, Marco Mazzotta, Armando Orlandi, Marina Elena Cazzaniga, Enrico Cortesi, Maddalena Barba, Laura Iezzi, Giuseppe Tonini, E. Landucci, Lucio Laudadio, Domenico Sergi, Alessandra Cassano, Giuseppe Sanguineti, Nicla La Verde, Riccardo Samaritani, Patrizia Seminara, Antonio Russo, Claudio Zamagni, Simone Scagnoli, Valentina Magri, Ramy Kayal, Enzo Veltri, Francesca Aroldi, Clara Natoli, Ilaria Portarena, Samantha Forciniti, Laura Ferrari, Lucia Mentuccia, Gennaro Ciliberto, Daniele Santini, Teresa Gamucci, Filippo Greco, Silvia Carpano, Mario Roselli, Sandro Barni, A. Fabbri, Isabella Sperduti, A. Vaccaro, Ida Paris, Daniela Rubino, Ruggero De Maria, Patrizia Vici, Claudia De Angelis, Giulia Pomati, Luisa Carbognin, Simona Vallarelli, Antonino Grassadonia, Mirco Pistelli, A.F. Scinto, Katia Cannita, Andrea Michelotti, Domenico Corsi, E. Capomolla, Corrado Ficorella, Nicola Tinari, Vito Lorusso, Rossana Berardi, Andrea Botticelli, Antonio Giordano, Silverio Tomao, Laura Pizzuti, Paolo Marchetti, Maria Giuseppina Sarobba, Valentina Sini, Luca Moscetti, Lucrezia Diodati, Maria Vincenza Mancini, Luciano Mariani, Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti, Laura, Giordano, Antonio, Michelotti, Andrea, Mazzotta, Marco, Natoli, Clara, Gamucci, Teresa, De Angelis, Claudia, Landucci, Elisabetta, Diodati, Lucrezia, Iezzi, Laura, Mentuccia, Lucia, Fabbri, Agnese, Barba, Maddalena, Sanguineti, Giuseppe, Marchetti, Paolo, Tomao, Silverio, Mariani, Luciano, Paris, Ida, Lorusso, Vito, Vallarelli, Simona, Cassano, Alessandra, Airoldi, Francesca, Orlandi, Armando, Moscetti, Luca, Sergi, Domenico, Sarobba, Maria Giuseppina, Tonini, Giuseppe, Santini, Daniele, Sini, Valentina, Veltri, Enzo, Vaccaro, Angela, Ferrari, Laura, De Tursi, Michele, Tinari, Nicola, Grassadonia, Antonino, Greco, Filippo, Botticelli, Andrea, La Verde, Nicla, Zamagni, Claudio, Rubino, Daniela, Cortesi, Enrico, Magri, Valentina, Pomati, Giulia, Scagnoli, Simone, Capomolla, Elisabetta, Kayal, Ramy, Scinto, Angelo Fedele, Corsi, Domenico, Cazzaniga, Marina, Laudadio, Lucio, Forciniti, Samantha, Mancini, Maria, Carbognin, Luisa, Seminara, Patrizia, Barni, Sandro, Samaritani, Riccardo, Roselli, Mario, Portarena, Ilaria, Russo, Antonio, Ficorella, Corrado, Cannita, Katia, Carpano, Silvia, Pistelli, Mirco, Berardi, Rossana, De Maria, Ruggero, Sperduti, Isabella, Ciliberto, Gennaro, and Vici, Patrizia more...

Subjects
Male, 0301 basic medicine, Oncology, Pyridines, Receptor, ErbB-2, Physiology, Clinical Biochemistry, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Exemestane, Antineoplastic Combined Chemotherapy Protocols, advanced breast cancer, hormonal therapy, endocrine resistance, palbociclib, real-world setting, Breast, Aged, 80 and over, advanced breast cancer, hormonal therapy, Middle Aged, Treatment Outcome, Receptors, Estrogen, 030220 oncology & carcinogenesis, Toxicity, Female, Receptors, Progesterone, medicine.drug, Adult, Cell Biology, medicine.medical_specialty, Breast Neoplasms, Palbociclib, Neutropenia, Disease-Free Survival, 03 medical and health sciences, Internal medicine, medicine, Humans, Aged, Everolimus, Settore MED/06 - ONCOLOGIA MEDICA, business.industry, Cancer, medicine.disease, Confidence interval, 030104 developmental biology, chemistry, MED/06 - ONCOLOGIA MEDICA, business, Hormone
Abstract

Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained. more...

Published
2019

48. A Simplified Genomic Profiling Approach Predicts Outcome in Metastatic Colorectal Cancer

Author

Silvia Pecorari, Alessandra Anna Prete, Giancarlo Troncone, Francesca Belardinilli, Marco Filetti, Edoardo Milanetti, Beatrice Cardinali, Pasquale Pisapia, Marialaura Petroni, Giuseppe Giannini, Caterina Bonfiglio, Valentina Magri, Anna Coppa, Mariarosaria Colella, Gianluca Canettieri, Matteo Santoni, Enrico Cortesi, Carlo Capalbo, Arianna Nicolussi, Valeria Colicchia, Umberto Malapelle, Paolo Marchetti, Domenico Raimondo, Flavia Longo, Alessandra Tessitore, Paola Infante, Silvia Mezi, Virginia Valentini, Diana Bellavia, Paola Paci, Capalbo, C., Belardinilli, F., Raimondo, D., Milanetti, E., Malapelle, U., Pisapia, P., Magri, V., Prete, A., Pecorari, S., Colella, M., Coppa, A., Bonfiglio, C., Nicolussi, A., Valentini, V., Tessitore, A., Cardinali, Ilaria, Petroni, Cristina, Infante, P., Santoni, M., Filetti, M., Colicchia, V., Paci, P., Mezi, S., Longo, F., Cortesi, E., Marchetti, P., Troncone, G., Bellavia, Salvatore, Canettieri, G., and Giannini, G. more...

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Combination therapy, Colorectal cancer, precision medicine, Druggability, Disease, Gene mutation, chemotherapy, lcsh:RC254-282, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, predictive, Gene, business.industry, Ng, COMPUTATIONAL AND SYSTEMS BIOLOGY, Precision medicine, Omics, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, 030104 developmental biology, 030220 oncology & carcinogenesis, NGS, genomic profiling, business
Abstract

The response of metastatic colorectal cancer (mCRC) to the first-line conventional combination therapy is highly variable, reflecting the elevated heterogeneity of the disease. The genetic alterations underlying this heterogeneity have been thoroughly characterized through omic approaches requiring elevated efforts and costs. In order to translate the knowledge of CRC molecular heterogeneity into a practical clinical approach, we utilized a simplified Next Generation Sequencing (NGS) based platform to screen a cohort of 77 patients treated with first-line conventional therapy. Samples were sequenced using a panel of hotspots and targeted regions of 22 genes commonly involved in CRC. This revealed 51 patients carrying actionable gene mutations, 22 of which carried druggable alterations. These mutations were frequently associated with additional genetic alterations. To take into account this molecular complexity and assisted by an unbiased bioinformatic analysis, we defined three subgroups of patients carrying distinct molecular patterns. We demonstrated these three molecular subgroups are associated with a different response to first-line conventional combination therapies. The best outcome was achieved in patients exclusively carrying mutations on TP53 and/or RAS genes. By contrast, in patients carrying mutations in any of the other genes, alone or associated with mutations of TP53/RAS, the expected response is much worse compared to patients with exclusive TP53/RAS mutations. Additionally, our data indicate that the standard approach has limited efficacy in patients without any mutations in the genes included in the panel. In conclusion, we identified a reliable and easy-to-use approach for a simplified molecular-based stratification of mCRC patients that predicts the efficacy of the first-line conventional combination therapy. more...

Published
2019
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49. A cosine based validation measure for Document Clustering

Author

BALBI, SIMONA, SPANO, MARIA, Misuraca, Michelangelo, Mayaffre, D., Poudat C., Vanni L., Magri V., Follette P., Balbi, Simona, Misuraca, Michelangelo, and Spano, Maria

Subjects
Cluster Validation, K-means, Cosine Similarity, Compactness, Separation
Abstract

Document Clustering is the peculiar application of cluster analysis methods on huge documentary databases. Document Clustering aims at organizing a large quantity of unlabelled documents into a smaller number of meaningful and coherent clusters, similar in content. One of the main unsolved problems in clustering literature is the lack of a reliable methodology to evaluate results, although a wide variety of validation measures has been proposed. If those measures are often unsatisfactory when dealing with numerical databases, they definitely underperform in Document Clustering. This paper proposes a new validation measure. After introducing the most common approaches to Document Clustering, our attention is focused on Spherical K-means, do to its strict connection with the Vector Space Model, typical of Information Retrieval. Since Spherical K-means adopts a cosine-based similarity measure, we propose a validation measure based on the same criterion. The new measure effectiveness is shown in the frame of a comparative study, by involving 13 different corpora (usually used in literature for comparing different proposals) and 15 validation measures. more...

Published
2016

50. Chlamydia trachomatis infection is related to premature ejaculation in chronic prostatitis patients: results from a cross-sectional study

Author

T. Tony Cai, Vincenzo Mirone, Gianpaolo Perletti, Vittorio Magri, Riccardo Bartoletti, Francesca Pisano, Sandra Mazzoli, Gianni Malossini, Nicola Mondaini, Paolo Gontero, Carolina D'Elia, Paolo Verze, Cai, T, Pisano, F, Magri, V, Verze, P, Mondaini, N, D'Elia, C, Malossini, G, Mazzoli, S, Perletti, G, Gontero, P, Mirone, V, and Bartoletti, R. more...

Subjects
Male, Chlamydia trachomatis, Cross-sectional study, Endocrinology, Diabetes and Metabolism, medicine.disease_cause, Acquired early ejaculation, Chlamydiatrachomatis, NIH-CPSI, PEDT, Premature ejaculation, Quality of life, Adult, Antibodies, Bacterial, Chlamydia Infections, Chronic Disease, DNA, Bacterial, Epidemiologic Methods, Humans, Immunoglobulin A, Middle Aged, Premature Ejaculation, Prostatitis, Quality of Life, Young Adult, Urology, Obstetrics and Gynecology, Reproductive Medicine, Medicine (all), Group B, Chlamydia Infection, Endocrinology, Young adult, Bacterial, Psychiatry and Mental health, Chronic bacterial prostatitis, Epidemiologic Method, medicine.symptom, Acquired Early Ejaculation, Human, medicine.medical_specialty, Antibodies, DNA, Prostatiti, Internal medicine, medicine, Chlamydia trachomati, business.industry, medicine.disease, Sexual dysfunction, business
Abstract

Chronic bacterial prostatitis (CBP) is reported to be a common finding in men with acquired premature ejaculation (PE). The impact of different pathogens on PE development in chronic prostatitis patients is, however, unknown.To assess a possible link between CBP caused by Chlamydia trachomatis (Ct) and PE.A consecutive series of 317 patients with clinical and instrumental diagnosis of CBP due to Ct was enrolled (group A) and compared with data obtained from a control group of 639 patients with CBP caused by common uropathogen bacteria (group B). Prostatitis symptoms were investigated with the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), while the ejaculatory status of patients was assessed using the PE Diagnostic Tool (PEDT).All participants were asked to complete the NIH-CPSI, the International Index of Erectile Function-15 erectile function domain (IIEF-15-EFD), the PEDT, and the Short Form (SF)-36 questionnaires.Patient groups A and B had comparable scores of NIH-CPSI (P = 0.07), IPSS (P = 0.32), and IIEF-15-EFD (P = 0.33) tests. PE was assessed in 118 patients in group A (37.2%) and in 73 subjects in group B (11.5%). The two groups are different in terms of PE prevalence (P 0.0002). Compared with group B, group A showed significantly higher scores of the PEDT test (11.3 [±2.6] vs. 4.5 [±2.9], P 0.0001) and lower scores of the SF-36 tool (96.5 [±1.1] vs. 99.7 [±1.3], P 0.0001). In our multivariate model assessment, being positive for a Ct infection marker was independently associated with the PEDT score even after adjusting for age, smoking habit, body mass index, and education level (adjusted odds ratio = 3.21; 95% confidence interval: 2.02-4.27; P 0.003).Patients affected by CBP due to Ct infection reported higher prevalence of PE and lower quality of life when compared with patients affected by CBP caused by traditional uropathogenic bacteria. more...

Published
2014