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52. A Prospective, Real-World, Multinational Study of Naloxegol for Patients with Cancer Pain Diagnosed with Opioid-Induced Constipation—The NACASY Study

Author

Davies, A. Cinieri, S. Dupoiron, D. Fernandez, S.E. Leclerc, J. Montesarchio, V. Mystakidou, K. Serna, J. Tack, J. on behalf of the NACASY Study Group

Abstract

The Naloxegol Cancer Study (NACASY) was a multinational European study aimed to evaluate the 4-week safety and efficacy of naloxegol in a real-world setting in patients with cancer pain diagnosed with opioid-induced constipation. The primary safety endpoint was the incidence of adverse events leading to study discontinuation. We recruited 170 patients who received at least one dose of naloxegol (i.e., safety population). Out of 170 patients, 20 (11.8%, 95%CI 6.9–16.6) discontinued the study due to adverse events, and, of them, 12 (7.1%, 95%CI 3.2–10.9%) were study discontinuations due to naloxegol-related adverse events. From 76 patients subjects who had completed both 4 weeks of treatment and 28 days of the diary, 55 patients (72.4%, 95% CI 62.3–82.4%) were regarded as responders (i.e., showed ≥3 bowel-movements per week and an increase of ≥1 bowel-movement over baseline) to naloxegol treatment. The Patient Assessment of Constipation— Quality of Life Questionnaire total score and all its subscales improved from baseline to 4 weeks of follow up. Our findings support and provide new evidence about the beneficial effect of naloxegol in terms of improvement of constipation and quality-of-life in patients with cancer-related pain and opioid-induced constipation and show a safety profile consistent with previous pivotal and real-world studies. © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Published
2022

53. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S. Lorusso, D. Joly, F. Gallo, C. Colombo, N. Sessa, C. Bamias, A. Salutari, V. Selle, F. Frezzini, S. De Giorgi, U. Pautier, P. Bologna, A. Orditura, M. Dubot, C. Gadducci, A. Mammoliti, S. Ray-Coquard, I.L. Zafarana, E. Breda, E. Favier, L. Ardizzoia, A. Cinieri, S. Largillier, R. Sambataro, D. Guardiola, E. Lauria, R. Pisano, C. Raspagliesi, F. Scambia, G. Daniele, G. Perrone, F. Joly, F. Gallo, C. Colombo, N. Sessa, C. Bamias, A. Salutari, V. Selle, F. Frezzini, S. Bologna, A. Orditura, M. Dubot, C. Gadducci, A. Mammoliti, S. Zafarana, E. Breda, E. Favier, L. Ardizzoia, A. Cinieri, S. Largillier, R. Sambataro, D. Guardiola, E. Lauria, R. Pisano, C. Raspagliesi, F. Scambia, G. Daniele, G. Perrone, F. MITO16b/MANGO-OV2/ENGOT-ov17 Investigators

Abstract

Background: Bevacizumab is approved in combination with chemotherapy for the treatment of ovarian cancer, either in first-line therapy or for patients with recurrent disease not previously treated with the same drug. We aimed to test the value of continuing bevacizumab beyond progression after first-line treatment with the same drug. Methods: In our open-label, randomised, phase 3 trial done at 82 sites in four countries, we enrolled women (aged ≥18 years) who had previously received first-line platinum-based therapy including bevacizumab, and had recurrent (≥6 months since last platinum dose), International Federation of Gynaecology and Obstetrics stage IIIB–IV ovarian cancer with an Eastern Cooperative Oncology Group performance status 0–2. Patients were randomly assigned (1:1) to receive a carboplatin-based doublet intravenously (carboplatin area under the concentration curve [AUC] 5 on day 1 plus paclitaxel 175 mg/m2 on day 1, every 21 days; carboplatin AUC 4 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8, every 21 days; or carboplatin AUC 5 on day 1 plus pegylated liposomal doxorubicin 30 mg/m2 on day 1, every 28 days), or a carboplatin-based doublet plus bevacizumab (10 mg/kg intravenous every 14 days combined with pegylated liposomal doxorubicin–carboplatin, or 15 mg/kg every 21 days combined with gemcitabine–carboplatin or paclitaxel–carboplatin). Evaluable disease according to RECIST 1.1 guidelines was required before randomisation. Randomisation was done through the trial website with a minimisation procedure, stratified by centre, time of recurrence, performance status, and type of second-line chemotherapy. The primary endpoint was investigator-assessed progression-free survival, analysed on an intention-to-treat basis. Safety was assessed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov, NCT01802749 and EudraCT 2012-004362-17. Findings: Between Dec 6, 2013, and Nov 11, 2016, 406 patients were recruited (203 [50%] assigned to the bevacizumab group and 203 [50%] to the standard chemotherapy group). 130 patients (64%) in the bevacizumab group and 131 (65%) in the standard chemotherapy group had progressed after receiving a last dose of platinum more than 12 months before, and 146 patients (72%) in the bevacizumab group and 147 (72%) in the standard chemotherapy group had progressed after completion of first-line bevacizumab maintenance. 161 participants (79%) progressed in the standard chemotherapy group, as did 143 (70%) in the bevacizumab group. Median progression-free survival was 8·8 months (95% CI 8·4–9·3) in the standard chemotherapy group and 11·8 months (10·8–12·9) in the bevacizumab group (hazard ratio 0·51, 95% CI 0·41–0·65; log-rank p

Published
2021

58. 739P Efficacy and safety of maintenance olaparib and bevacizumab (bev) in ovarian cancer (OC) patients (pts) aged ≥65 years (y) from the PAOLA-1/ENGOT-ov25 first-line trial

Author

Sabatier, Renaud, Vicier, Cécile, Garnier, Séverine, Guille, Arnaud, Carbuccia, Nadine, Isambert, Nicolas, Dalenc, Florence, Robert, Marie, Levy, Christelle, Pakradouni, Jihane, Adelaïde, José, Chaffanet, Max, Sfumato, Patrick, Mamessier, Emilie, Bertucci, François, Goncalves, Anthony, Mezni, Essia, Evans, Catherine Karine, Chinot, Olivier, Loschi, Alain, Arnaud, Sylvie, Mellinas, Marie, Bay, Jacques-Olivier, Bouleuc, Carole, Firmin, Nelly, Gandemer, Virginie, Magne, Nicolas, Orbach, Daniel, Penel, Nicolas, Rodrigues, Manuel, Thiery-Vuillemin, Antoine, Wislez, Marie, L’allemain, Gilles, Robert, Jacques, Colombo, Nicoletta, Dubot, Coraline, Lorusso, Domenica, Caceres, M. Valeria, Hasegawa, Kosei, Shapira-Frommer, Ronnie, Tewari, Krishnansu, Salman, Pamela, Hoyos Usta, Edwin, Yañez, Eduardo, Gümüş, Mahmut, Olivera Hurtado de Mendoza, Mivael, Samouëlian, Vanessa, Castonguay, Vincent, Arkhipov, Alexander, Toker, Sarper, Li, Kan, Keefe, Stephen, Monk, Bradley, Oaknin, Ana, Tinker, Anna, Gilbert, Lucy, Mathews, Cara, Brown, Jubilee, Barretina-Ginesta, Maria-Pilar, Moreno, Victor, Gravina, Adriano, Abdeddaim, Cyril, Banerjee, Susana, Guo, Wei, Danaee, Hadi, Im, Ellie, de Nonneville, Alexandre, Zemmour, Christophe, Frank, Sophie, Joly, Florence, Ray-Coquard, Isabelle, Costaz, Hèlène, Classe, Jean-Marc, Floquet, Anne, de La Motte Rouge, Thibault, Colombo, Pierre-Emmanuel, Sauterey, Baptiste, Leblanc, Eric, Pomel, Christophe, Marchal, Frédéric, Barranger, Emmanuel, Savoye, Aude-Marie, Guillemet, Cécile, Petit, Thierry, Pautier, Patricia, Rouzier, Roman, Gladieff, Laurence, Simon, Gaëtane, Courtinard, Coralie, Rousset-Rouviere, Sandrine, Rochigneux, Philippe, Chrétien, Anne-Sophie, Fattori, Stéphane, Gorvel, Laurent, Provansal, Magali, Lambaudie, Eric, Olive, Daniel, Martin, Johan, Guérin, Mathilde, Monneur, Audrey, Tassy, Louis, Tarpin, Carole, Extra, Jean-Marc, Viret, Frédéric, Pierga, Jean-Yves, Curé, Hervé, Abulnaja, Rakan, Bidard, François-Clément, Mari, Roxane, Narducci, Fabrice, Cappiello, Maria-Antonietta, Rousseau, Fréderique, Blache, Guillaume, Birnbaum, Daniel, Cropet, C., Montegut, C., Frindte, J., Cinieri, S., Guerra-Alia, E.M., Bogner, G., Yoshida, H., Vergote, I., Hietanen, S., Largillier, R., Canzler, U., Gratet, A., Marmé, F., Pujade-Lauraine, E., Favier, L., Ray-Coquard, I.L., Department of Medical Oncology, Institut Paoli-Calmettes, 232 Boulevard Sainte Marguerite, 13009 Marseille, France., Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Oncology, medicine.medical_specialty, Bevacizumab, business.industry, First line, [SDV.CAN]Life Sciences [q-bio]/Cancer, Hematology, medicine.disease, Olaparib, chemistry.chemical_compound, chemistry, Internal medicine, Medicine, business, Ovarian cancer, medicine.drug
Abstract

International audience; 5548 Background: Ovarian cancer is the leading cause of death by gynecological cancer. Complete surgery remains one of the main prognostic factors. Laparoscopic exploration is mandatory to assess surgical resectability at diagnosis or after neoadjuvant chemotherapy. However, there is no clinical or biological marker that can correctly predict resectability and may be able to avoid a second laparoscopic exploration for initially unresectable diseases. Our aim was to assess circulating tumor DNA (ctDNA) value as a predictive non-invasive marker of evolution towards resectability for patients with epithelial ovarian cancer receiving first-line chemotherapy. Methods: We explored in this work one of the secondary objectives of the CIDOC study (NCT03302884). CIDOC is a multicenter prospective study aiming to explore ctDNA value as early marker of disease relapse after first-line treatment for epithelial ovarian cancer. Patients with mucinous histology or early stages not requiring chemotherapy are excluded. Plasma samples are collected at diagnosis, during neoadjuvant chemotherapy, and during follow-up. After DNA extraction, panel-based next generation sequencing is performed on both tumor samples and germline DNA, and somatic mutations of interest are selected for ctDNA monitoring. ctDNA analyses are conducted using droplet digital PCR (BioRad QX200) by measuring the variant allele fraction (VAF) of previously identified mutations. Results: This intermediary analysis has included 47 patients diagnosed between March 2017 and December 2019. Median age was 69 years old (48 – 84). Most of the patients had advanced disease (89.4% stage FIGO III or IV), serous histology (94.8%), and high grade tumor (92.3%). Most of the patients underwent complete interval cytoreductive surgery (76.3% vs 17.4% complete upfront surgery). Most of the tumors had TP53 mutations (85.1%), following by alterations involving DNA repair genes (38.3%). Median cell-free DNA concentration at baseline was 0.38 ng/µL (0 – 12.8). ctDNA was identified in 92.1% of patients at baseline with a median VAF of 1.84% (0 – 42.52%). ctDNA VAF was correlated to the peritoneal dissemination ( p= 0.039) assessed with the peritoneal cancer index. ctDNA clearance after preoperative chemotherapy tended to be correlated to achievement of complete interval surgery for patients receiving neoadjuvant chemotherapy ( p= 0.108). Conclusions: ctDNA may be a promising non-invasive marker to assess peritoneal cancer spreading and to predict surgical resectability after neoadjuvant chemotherapy. If confirmed in larger populations, this may enable to avoid additional surgical explorations for patients who remain ctDNA positive after chemotherapy. Clinical trial information: NCT03302884.

Published
2021

59. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Author

Ciardiello, F., Normanno, N., Martinelli, E., Troiani, T., Pisconti, S., Cardone, C., Nappi, A., Bordonaro, A. R., Rachiglio, M., Lambiase, M., Latiano, T. P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., Rizzi, D., De Vita, F., Orditura, M., Colucci, G., Maiello, E., Iaffaioli, Vincenzo, Nasti, Guglielmo, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Di Maggio, Gabriele, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, and Aieta, Michele

Published
2016
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60. Effect on quality of life of cisplatin added to single-agent chemotherapy as first-line treatment for elderly patients with advanced non-small cell lung cancer: Joint analysis of MILES-3 and MILES-4 randomised phase 3 trials

Author

Morabito, A, Piccirillo, M, Maione, P, Luciani, A, Cavanna, L, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Morgillo, F, Burgio, M, Ferrara, D, Rosetti, F, Bianco, R, Artioli, F, Cortinovis, D, Gebbia, V, Fregoni, V, Mencoboni, M, Sandomenico, C, Rossi, A, Montanino, A, Manzo, A, Rocco, G, Arenare, L, Daniele, G, Signoriello, S, Gallo, C, Perrone, F, Gridelli, C, Morabito A, Piccirillo MC, Maione P, Luciani A, Cavanna L, Bonanno L, Filipazzi V, Leo S, Cinieri S, Morgillo F, Burgio MA, Ferrara D, Rosetti F, Bianco R, Artioli F, Cortinovis D, Gebbia V, Fregoni V, Mencoboni M, Sandomenico C, Rossi A, Montanino A, Manzo A, Rocco G, Arenare L, Daniele G, Signoriello S, Gallo C, Perrone F, Gridelli C., Morabito, A, Piccirillo, M, Maione, P, Luciani, A, Cavanna, L, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Morgillo, F, Burgio, M, Ferrara, D, Rosetti, F, Bianco, R, Artioli, F, Cortinovis, D, Gebbia, V, Fregoni, V, Mencoboni, M, Sandomenico, C, Rossi, A, Montanino, A, Manzo, A, Rocco, G, Arenare, L, Daniele, G, Signoriello, S, Gallo, C, Perrone, F, Gridelli, C, Morabito A, Piccirillo MC, Maione P, Luciani A, Cavanna L, Bonanno L, Filipazzi V, Leo S, Cinieri S, Morgillo F, Burgio MA, Ferrara D, Rosetti F, Bianco R, Artioli F, Cortinovis D, Gebbia V, Fregoni V, Mencoboni M, Sandomenico C, Rossi A, Montanino A, Manzo A, Rocco G, Arenare L, Daniele G, Signoriello S, Gallo C, Perrone F, and Gridelli C.

Abstract

Objectives: To evaluate the effect on quality of life (QOL)of the addition of cisplatin to single-agent chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer (NSCLC)enrolled in two parallel phase 3 trials, MILES-3 and MILES-4. Patients and methods: Advanced NSCLC pts, >70 years old, performance status (PS)0–1, were eligible. Patients were randomly assigned to chemotherapy without or with cisplatin. EORTC QLQ C30 and LC13 questionnaires were planned at baseline, end of cycle 1 and end of cycle 2 in both trials and were used for joint QOL analysis. Trial-specific data including questionnaires at non-shared time-points were used for additional analyses. Intention-to-treat strategy was applied. Analyses were adjusted for baseline QOL, stage, performance status, gender, age, size of centre, trial, histotype and non-platinum companion drug. Results: Overall, 458/531 pts (86%)answered baseline questionnaire and missing rates over treatment were slightly higher among patients receiving cisplatin. Mean change in sore mouth after cycle 2 was worse with cisplatin (P = 0.02). The size of differences between arms was in the small-medium range for peripheral neuropathy and alopecia (0.25 and 0.31 after one and 0.28 and 0.36 after two cycles, respectively)and for nausea/vomiting, sore mouth and dysphagia after two cycles (0.26, 0.38 and 0.25, respectively)always in the direction of worsening with cisplatin. Using a 10% change from baseline as clinically relevant threshold to categorize response, there was no significant difference between the arms. Time to deterioration of sore mouth and alopecia, with progression/death as competitive risk, was shorter with cisplatin (HR 1.72 95%CI 1.02–2.89, P = 0.04 and HR 1.84 95%CI 1.09–3.10, P = 0.02, respectively). Conclusion: The addition of cisplatin to single agent chemotherapy worsens sore mouth and alopecia and does not improve any QOL items in elderly patients with advanced NSCLC.

Published
2019

61. Eribulin Mesylate as Third or Subsequent Line Chemotherapy for Elderly Patients with Locally Recurrent or Metastatic Breast Cancer: A Multicentric Observational Study of GIOGer (Italian Group of Geriatric Oncology)-ERIBE

Author

Leo, S, Arnoldi, E, Repetto, L, Coccorullo, Z, Cinieri, S, Fedele, P, Cazzaniga, M, Lorusso, V, Latorre, A, Campanella, G, Ciccarese, M, Accettura, C, Pisconti, S, Rinaldi, A, Brunetti, C, Raffaele, M, Coltelli, L, Spazzapan, S, Fratino, L, Petrucelli, L, Biganzoli, L, Leo S., Arnoldi E., Repetto L., Coccorullo Z., Cinieri S., Fedele P., Cazzaniga M., Lorusso V., Latorre A., Campanella G., Ciccarese M., Accettura C., Pisconti S., Rinaldi A., Brunetti C., Raffaele M., Coltelli L., Spazzapan S., Fratino L., Petrucelli L., Biganzoli L., Leo, S, Arnoldi, E, Repetto, L, Coccorullo, Z, Cinieri, S, Fedele, P, Cazzaniga, M, Lorusso, V, Latorre, A, Campanella, G, Ciccarese, M, Accettura, C, Pisconti, S, Rinaldi, A, Brunetti, C, Raffaele, M, Coltelli, L, Spazzapan, S, Fratino, L, Petrucelli, L, Biganzoli, L, Leo S., Arnoldi E., Repetto L., Coccorullo Z., Cinieri S., Fedele P., Cazzaniga M., Lorusso V., Latorre A., Campanella G., Ciccarese M., Accettura C., Pisconti S., Rinaldi A., Brunetti C., Raffaele M., Coltelli L., Spazzapan S., Fratino L., Petrucelli L., and Biganzoli L.

Abstract

Background: Metastatic breast cancer (MBC) is highly prevalent in middle-aged or elderly patients. Eribulin is a nontaxane microtubule inhibitor, approved for the treatment of pretreated MBC. This multicentric study (sponsored by GIOGer, Italian Group for Geriatric Oncology) was designed to assess the efficacy and tolerability of eribulin, according to parameters usually used in geriatric oncology. Subjects, Materials, and Methods: An observational study was conducted on 50 consecutive elderly patients with MBC. The primary endpoint was to evaluate the change in items score of comprehensive geriatric assessment (CGA) and health-related quality of life (HRQL). Italian versions of the CGA and HRQL questionnaires were administered at baseline, before the third and fifth cycles, and then every three cycles until treatment discontinuation. Secondary endpoints were efficacy and safety. Results: Overall, both EQ-5D scores and EQ-5D-3 L visual analogic scale did not significantly change from baseline; the percentage of subjects without problems doing usual activities tended to decrease during treatment (p for linear trend.018), and the percentage of patients with minor problems performing usual activities tended to increase (p for linear trend.012). Among CGA items, Instrumental Activities of Daily Living tended to decrease during treatment and Geriatric Depression Scale tended to increase. After 12 months follow-up, 24 patients (out of 47) showed clinical benefits; median progression-free survival was 4.49 months (2.10–10.33) and median OS was 7.31 months (3.70–14.03). The treatment was associated with mild toxicity. Conclusion: Eribulin treatment preserved quality of life and geriatric parameters included in the CGA, except for instrumental functioning and geriatric depression, in elderly patients with MBC. Implications for Practice: A collaboration between oncologist and geriatric specialists is essential in the management of patients with metastatic breast cancer, who a

Published
2019

62. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

Cazzaniga, M, Pinotti, G, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Fiorentini, G, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Melegari, E, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cicchiello, F, Riva, F, Vallini, I, Mazza, M, Bonfadini, C, Bordin, E, Canicatti, M, Cappuccio, F, Collova, E, De Angelis, C, Desorte, R, Donati, S, Drudi, G, Galanti, D, Mocerino, C, Orlando, L, Pellegrino, B, Pizzuti, L, Ridolfi, C, Rocca, A, Sarti, D, Spagnoletti, I, Tinari, N, Vandone, A, Vizzini, L, Cazzaniga M. E., Pinotti G., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Fiorentini G., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Melegari E., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., Cicchiello F., Riva F., Vallini I., Mazza M., Bonfadini C., Bordin E., Canicatti M., Cappuccio F., Collova E., De Angelis C., Desorte R., Donati S., Drudi G., Galanti D., Mocerino C., Orlando L., Pellegrino B., Pizzuti L., Ridolfi C., Rocca A., Sarti D., Spagnoletti I., Tinari N., Vandone A., Vizzini L., Cazzaniga, M, Pinotti, G, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Fiorentini, G, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Melegari, E, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cicchiello, F, Riva, F, Vallini, I, Mazza, M, Bonfadini, C, Bordin, E, Canicatti, M, Cappuccio, F, Collova, E, De Angelis, C, Desorte, R, Donati, S, Drudi, G, Galanti, D, Mocerino, C, Orlando, L, Pellegrino, B, Pizzuti, L, Ridolfi, C, Rocca, A, Sarti, D, Spagnoletti, I, Tinari, N, Vandone, A, Vizzini, L, Cazzaniga M. E., Pinotti G., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Fiorentini G., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Melegari E., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., Cicchiello F., Riva F., Vallini I., Mazza M., Bonfadini C., Bordin E., Canicatti M., Cappuccio F., Collova E., De Angelis C., Desorte R., Donati S., Drudi G., Galanti D., Mocerino C., Orlando L., Pellegrino B., Pizzuti L., Ridolfi C., Rocca A., Sarti D., Spagnoletti I., Tinari N., Vandone A., and Vizzini L.

Abstract

Metronomic chemotherapy (mCHT) refers to the minimum biologically effective dose of a chemotherapy agent given as a continuous dosing regimen, with no prolonged drug-free breaks, that leads to antitumor activity. Aim of the present study is to describe the use of mCHT in a retrospective cohort of metastatic breast cancer (MBC) patients in order to collect data regarding the different types and regimens of drugs employed, their efficacy and safety. Between January 2011 and December 2016, data of 584 metastatic breast cancer patients treated with mCHT were collected. The use of VRL-based regimens increased during the time of observation (2011: 16.8% - 2016: 29.8%), as well as CTX-based ones (2011: 17.1% - 2016: 25.6%), whereas CAPE-based and MTX-based regimens remained stable. In the 1st-line setting, the highest ORR and DCR were observed for VRL-based regimens (single agent: 44% and 88%; combination: 36.7% and 82.4%, respectively). Assuming VRL-single agent as the referee treatment (median PFS: 7.2 months, 95% CI: 5.3–10.3), the longest median PFS were observed in VRL-combination regimens (9.5, 95%CI 88.8–11.3, HR = 0.72) and in CAPE-single agent (10.7, 95%CI 8.3–15.8, HR = 0.70). The VICTOR-6 study provides new data coming from the real-life setting, by adding new information regarding the use of mCHT as an option of treatment for MBC patients.

Published
2019

63. Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial

Author

Lorusso, D, Ferrandina, G, Colombo, N, Pignata, S, Pietragalla, A, Sonetto, C, Pisano, C, Lapresa, M, Savarese, A, Tagliaferri, P, Lombardi, D, Cinieri, S, Breda, E, Sabatucci, I, Sabbatini, R, Conte, C, Cecere, S, Maltese, G, Scambia, G, Lorusso D., Ferrandina G., Colombo N., Pignata S., Pietragalla A., Sonetto C., Pisano C., Lapresa M. T., Savarese A., Tagliaferri P., Lombardi D., Cinieri S., Breda E., Sabatucci I., Sabbatini R., Conte C., Cecere S. C., Maltese G., Scambia G., Lorusso, D, Ferrandina, G, Colombo, N, Pignata, S, Pietragalla, A, Sonetto, C, Pisano, C, Lapresa, M, Savarese, A, Tagliaferri, P, Lombardi, D, Cinieri, S, Breda, E, Sabatucci, I, Sabbatini, R, Conte, C, Cecere, S, Maltese, G, Scambia, G, Lorusso D., Ferrandina G., Colombo N., Pignata S., Pietragalla A., Sonetto C., Pisano C., Lapresa M. T., Savarese A., Tagliaferri P., Lombardi D., Cinieri S., Breda E., Sabatucci I., Sabbatini R., Conte C., Cecere S. C., Maltese G., and Scambia G.

Abstract

Objective: Increased Vascular Endothelial Growth Factor Receptor (VEGF) expression in endometrial cancer (EC) is associated with a poor prognosis. Preliminary clinical data reported Bevacizumab effectiveness in EC both as single agent and in combination with chemotherapy. Methods: In a phase II trial, patients with advanced (FIGO stage III-IV) or recurrent EC were randomized to receive Carboplatin-Paclitaxel standard dose for 6–8 cycles vs Carboplatin-Paclitaxel and Bevacizumab 15 mg/kg in combination with chemotherapy and maintenance until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS). Results: 108 patients were randomized; PFS (10.5 vs 13.7 months, HR 0.84 p = 0.43), overall response rate (ORR 53.1% vs 74.4%) and overall survival (OS) (29.7 vs 40.0 months, HR 0.71 p = 0.24) resulted in a non-significant increase in Bevacizumab treated patients. The PFS increase became significant when an exploratory analysis with the Breslow test was used. Moreover, patients treated with Bevacizumab experienced a significant increase in 6-month disease control rate (70.4% vs 90.7%). Cardiovascular events were more frequent in the experimental arm (“de novo” grade ≥2 hypertension 21% vs 0% and grade ≥2 thromboembolic events 11% vs 2% in the Bevacizumab vs standard treatment arm, respectively). Conclusions: Bevacizumab combined with chemotherapy in the treatment of advanced/recurrent EC failed to demonstrate a significant increase in PFS in the MITO END-2 trial. Nevertheless, these preliminary data suggests some effectiveness of the antiangiogenic agent which merits further exploration in a larger population with a better molecular characterization.

Published
2019

64. 167 Safety and quality of life of first-line maintenance olaparib plus bevacizumab in older patients with advanced ovarian cancer in the PAOLA-1 trial

Author

Montégut, C, primary, Falandry, C, additional, Cinieri, S, additional, Montane, L, additional, Rousseau, F, additional, Joly, F, additional, Frindte, J, additional, Mosconi, AM, additional, Guerra-Alia, E, additional, Schauer, C, additional, Fujiwara, H, additional, Vergote, IB, additional, Parma, G, additional, Lindahl, G, additional, Anota, A, additional, Canzler, U, additional, Marmé, F, additional, Pujade-Lauraine, E, additional, Ray-Coquard, I, additional, and Sabatier, R, additional

Published
2021
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67. MITO16b/MANGO–OV2/ENGOT–ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S, Lorusso, D, Joly, F, Gallo, C, Colombo, N, Sessa, C, Bamias, A, Salutari, V, Selle, F, Frezzini, S, De Giorgi, U, Pautier, P, Bologna, A, Orditura, M, Dubot, C, Gadducci, A, Mammoliti, S, Ray-Coquard, I, Zafarana, E, Breda, E, Favier, L, Ardizzoia, A, Cinieri, S, Largillier, R, Sambataro, D, Guardiola, E, Lauria, R, Pisano, C, Raspagliesi, F, Scambia, G, Daniele, G, and Perrone, F

Published
2021

68. Cytoreductive surgery followed by chemotherapy and olaparib maintenance in BRCA 1/2 mutated recurrent ovarian cancer: A retrospective MITO group study

Author

Cecere, S. C., Musacchio, L., Bartoletti, M., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Naglieri, E., Scollo, P., Marchetti, Claudia, Raspagliesi, F., Greggi, S., Cinieri, S., Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Martinelli, F., De Matteis, E., Cardalesi, C., Loizzi, V., Perniola, G., Carella, C., Scandurra, G., Giannone, G., Pignata, S., Salutari V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), Scambia G. (ORCID:0000-0003-2758-1063), Cecere, S. C., Musacchio, L., Bartoletti, M., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Naglieri, E., Scollo, P., Marchetti, Claudia, Raspagliesi, F., Greggi, S., Cinieri, S., Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Martinelli, F., De Matteis, E., Cardalesi, C., Loizzi, V., Perniola, G., Carella, C., Scandurra, G., Giannone, G., Pignata, S., Salutari V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Introduction The role of cytoreductive surgery in the poly-ADP ribose polymerase inhibitors era is not fully investigated. We evaluated the impact of surgery performed prior to platinum-based chemotherapy followed by olaparib maintenance in platinum-sensitive BRCA-mutated recurrent ovarian cancer. Methods This retrospective study included platinum-sensitive recurrent ovarian cancer BRCA-mutated patients from 13 Multicenter Italian Trials in Ovarian cancer and gynecological malignancies centers treated between September 2015 and May 2019. The primary outcomes were progression-free survival and overall survival. Data on post-progression treatment was also assessed. Results Among 209 patients, 72 patients (34.5%) underwent cytoreductive surgery followed by platinum-based chemotherapy and olaparib maintenance, while 137 patients (65.5%) underwent chemotherapy treatment alone. After a median follow-up of 37.3 months (95% CI: 33.4 to 40.8), median progression-free survival in the surgery group was not reached, compared with 11 months in patients receiving chemotherapy alone (P<0.001). Median overall survival was nearly double in patients undergoing surgery before chemotherapy (55 vs 28 months, P<0.001). Post-progression therapy was assessed in 127 patients: response rate to chemotherapy was 29.2%, 8.8%, and 9.0% in patients with platinum-free interval >12 months, between 6 and 12 months, and <6 months, respectively. Conclusion Cytoreductive surgery performed before platinum therapy and olaparib maintenance was associated with longer progression-free survival and overall survival in BRCA-mutated platinum-sensitive relapsed ovarian cancer patients. In accordance with our preliminary results, the response rate to chemotherapy given after progression during olaparib was associated with platinum-free interval.

Published
2021

74. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, Gerardo, primary, Lonardi, Sara, additional, Galli, Fabio, additional, Di Bartolomeo, Maria, additional, Ronzoni, Monica, additional, Zampino, Maria G., additional, Banzi, Maria, additional, Zaniboni, Alberto, additional, Pasini, Felice, additional, Bozzarelli, Silvia, additional, Garattini, Silvio K., additional, Ferrari, Daris, additional, Montesarchio, Vincenzo, additional, Mambrini, Andrea, additional, Ciuffreda, Libero, additional, Galli, Francesca, additional, Pusceddu, Valeria, additional, Carlomagno, Chiara, additional, Bidoli, Paolo, additional, Amoroso, Domenico, additional, Bochicchio, Anna M., additional, Frassineti, Luca, additional, Corsi, Domenico, additional, Bilancia, Domenico, additional, Pastorino, Alessandro, additional, De Stefano, Alfonso, additional, Labianca, Roberto, additional, Bilancia, D., additional, Rosati, G., additional, Montesarchio, V., additional, Iaffaioli, R.V., additional, Nasti, G., additional, Daniele, B., additional, Zagonel, V., additional, Lonardi, S., additional, Pella, N., additional, Aprile, G., additional, Pasini, F., additional, Marchetti, Roma P., additional, Romiti, A., additional, Ciuffreda, L., additional, Ferrari, D., additional, Foa, P., additional, Zaniboni, A., additional, Labianca, R., additional, Mosconi, S., additional, Sobrero, A., additional, Bidoli, P., additional, Cazzaniga, M., additional, Beretta, G.D., additional, Corsi, D.C., additional, Cortesi, E., additional, Barni, S., additional, Petrelli, F., additional, Allione, P., additional, D'Arco, A.M., additional, Valmadre, G., additional, Piazza, E., additional, Veltri, E., additional, Ramus, G. Vietti, additional, Giustini, L., additional, Tumulo, S., additional, Cascinu, S., additional, Granetto, C., additional, Testore, F., additional, Giordano, M., additional, Moroni, M., additional, Di Seri, M., additional, Nuzzo, A., additional, Angelelli, L., additional, Gori, S., additional, Farina, G., additional, Aglietta, M., additional, Franchi, R., additional, Comandé, M., additional, Giordani, P., additional, Tonini, G., additional, Bucci, E., additional, Ballestrero, A., additional, Benasso, M., additional, Graiff, C., additional, Bravi, S., additional, Caffo, O., additional, Silva, R.R., additional, Frontini, L., additional, Rota, S., additional, Cozzi, L., additional, Cantore, M., additional, Maiello, E., additional, Cinieri, S., additional, Silvestris, N., additional, Romito, S., additional, Gebbia, V., additional, Banzi, M., additional, Santoro, A., additional, Artioli, F., additional, Mattioli, R., additional, Contu, A., additional, Di Costanzo, F., additional, Leonardi, F., additional, Cavanna, L., additional, Passalacqua, R., additional, Amoroso, D., additional, Sozzi, P., additional, D'Amico, M., additional, Amadori, D., additional, Frassineti, L., additional, Turci, D., additional, Ravaioli, A., additional, Pasquini, E., additional, Gambi, A., additional, Faedi, M., additional, Cruciani, G., additional, Bajetta, E., additional, Di Bartolomeo, M., additional, Gianni, L., additional, Ronzoni, M., additional, Ionta, M.T., additional, Massidda, B., additional, Scartozzi, M., additional, Zampino, M.G., additional, Bochicchio, A.M., additional, Ciarlo, A., additional, Di Leo, A., additional, Frustaci, S., additional, Rangoni, G., additional, Arizzoia, A., additional, Pavesi, L., additional, Verusio, C., additional, Pinotti, G., additional, Iop, A., additional, De Placido, S., additional, Carlomagno, C., additional, Adamo, V., additional, Ficorella, C., additional, Natale, D., additional, Greco, E., additional, Rulli, E., additional, Galli, F., additional, Poli, D., additional, Porcu, L., additional, and Torri, V., additional

Published
2021
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75. Cisplatin-Based First-Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: Joint Analysis of MILES-3 and MILES-4 Phase III Trials

Author

Gridelli, C, Morabito, A, Cavanna, L, Luciani, A, Maione, P, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Ciardiello, F, Burgio, M, Bilancia, D, Cortinovis, D, Rosetti, F, Bianco, R, Gebbia, V, Artioli, F, Bordonaro, R, Fregoni, V, Mencoboni, M, Nelli, F, Riccardi, F, di Isernia, G, Costanzo, R, Rocco, G, Daniele, G, Signoriello, S, Piccirillo, M, Gallo, C, Perrone, F, Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, Perrone F., Gridelli, C, Morabito, A, Cavanna, L, Luciani, A, Maione, P, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Ciardiello, F, Burgio, M, Bilancia, D, Cortinovis, D, Rosetti, F, Bianco, R, Gebbia, V, Artioli, F, Bordonaro, R, Fregoni, V, Mencoboni, M, Nelli, F, Riccardi, F, di Isernia, G, Costanzo, R, Rocco, G, Daniele, G, Signoriello, S, Piccirillo, M, Gallo, C, Perrone, F, Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, and Perrone F.

Abstract

Purpose: To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods: Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed a of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results: From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion: The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.

Published
2018

76. Management of hepatitis C positive patients undergoing active treatment for malignancies: A position paper from the Associazione Italiana di Oncologia Medica (AIOM) and the Società Italiana di Malattie Infettive e Tropicali (SIMIT)

Author

Bruno, R, Zuccaro, V, Pinto, C, Puoti, M, Gaeta, G, Pagani, A, Taliani, G, Baldanti, F, Cinieri, S, Pedrazzoli, P, Bruno R., Zuccaro V., Pinto C., Puoti M., Gaeta G. B., Pagani A., Taliani G., Baldanti F., Cinieri S., Pedrazzoli P., Bruno, R, Zuccaro, V, Pinto, C, Puoti, M, Gaeta, G, Pagani, A, Taliani, G, Baldanti, F, Cinieri, S, Pedrazzoli, P, Bruno R., Zuccaro V., Pinto C., Puoti M., Gaeta G. B., Pagani A., Taliani G., Baldanti F., Cinieri S., and Pedrazzoli P.

Abstract

Purpose: To develop, on behalf of Associazione Italiana di Oncologia Medica and Società Italiana di Malattie Infettive e Tropicali, evidence-based and practical recommendations for the management of cancer patients who are Hepatitis C virus (HCV)-positive and are undergoing antitumor treatment. Methods: Recommendations were generated by panel of experts selected by the boards of the Societies Associazione Italiana di Oncologia Medica and Società Italiana di Malattie Infettive e Tropicali (4 oncologists and 6 infectious disease and hepatology specialist). The level of evidence and grade or recommendation was assessed according to the Grading of Recommendations Assessment, Development and Evaluation for practice guidelines [5]: A (high), B (moderate), and C (low), together with 2 recommendation levels: 1 (strong), and 2 (weak). Experts provided additional information, which helped greatly in clarifying some issues in the absence of clear-cut information from the literature. The final draft was then submitted to the evaluation of experts and the text modified according to their suggestion and comments. Results: HCV screening rates are low in patients with malignancies. The risk of reactivation or exacerbation of hepatitis C is higher in patients receiving immunosuppressive agents. It may be difficult to discriminate naturally occurring cancer-related complications from true reactivation or exacerbation of hepatitis C and hepatotoxicity due to cancer treatment. No conclusive data are available concerning the appropriate monitoring of liver function and when an antiviral regimen should be proposed. Conclusions: Patients at risk of any flare of HCV-related liver disease during active therapy for cancer should be managed with a multidisciplinary approach where all relevant diagnostic techniques and therapeutic resources are available. Prospective studies are needed to identify optimal strategies for the management of HCV infected cancer patients.

Published
2018

77. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., Zoboli A., De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., and Zoboli A.

Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is regist

Published
2018

83. 1705P SARS-CoV-2 infection among cancer patients receiving antitumor treatment in Italy: A nationwide observational study (CIPOMO ONCO COVID-19)

Author

Negru, M.E., primary, Tondini, C., additional, Pastorino, A., additional, Caccese, M., additional, Cariello, A., additional, Bertolini, A., additional, Buzzatti, G., additional, Cinieri, S., additional, Comandone, A., additional, Grossi, F., additional, Franchini, M., additional, Caffo, O., additional, Garrone, O., additional, Mambrini, A., additional, Leone, F., additional, Chini, C., additional, Agustoni, F., additional, Artioli, F., additional, Blasi, L., additional, and Aschele, C., additional

Published
2020
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84. 1755P The beginning of the COVID-19 era: The perception of oncological patients (pts) in active treatment at the Brindisi and Mauriziano Hospital Oncology Departments

Author

Loparco, D., primary, Di Maio, M., additional, Orlando, L., additional, Dascanio, F., additional, Caliolo, C., additional, Ignazzi, G., additional, Schiavone, P., additional, Lacidogna, G., additional, Quaranta, A., additional, Marino, D., additional, Del Bene, G., additional, Vignani, F., additional, Fedele, P., additional, Sperti, E., additional, Caloro, M., additional, Terzolo, S., additional, D'Amico, M., additional, Bellezza, A., additional, Comite, R., additional, and Cinieri, S., additional

Published
2020
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85. 447P Long term survival with regorafenib: REALITY (real life in Italy) trial - A GISCAD Study

Author

Lai, E., primary, Cremolini, C., additional, Puzzoni, M., additional, Bergamo, F., additional, Zucchelli, G., additional, Libertini, M., additional, Dettori, M., additional, Banzi, M., additional, Boccaccino, A., additional, Cinieri, S., additional, Cavo, A., additional, Piacentini, G., additional, Andreozzi, F., additional, Banna, G.L., additional, Nappo, F., additional, Iachetta, F., additional, Rota, S., additional, Conca, V., additional, Zaniboni, A., additional, and Scartozzi, M., additional

Published
2020
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86. 158TiP BioItaLEE: Molecular features of postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2–) PIK3CA-mutated advanced breast cancer (ABC) on first-line treatment with ribociclib + letrozole and on second-line treatment with alpelisib + fulvestrant

Author

Allegrini, G., primary, Orditura, M., additional, Del Mastro, L., additional, Zamagni, C., additional, Torrisi, R., additional, Guarneri, V., additional, Paris, I., additional, Sarobba, G., additional, Puglisi, F., additional, Colleoni, M.A., additional, Montemurro, F., additional, Zambelli, A., additional, Cazzaniga, M.E., additional, Valerio, M.R., additional, Bianchi, G., additional, Romagnoli, E., additional, Caruso, M., additional, Cinieri, S., additional, Castelletti, D., additional, and Arpino, G., additional

Published
2020
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88. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

Cazzaniga, M.E., primary, Pinotti, G., additional, Montagna, E., additional, Amoroso, D., additional, Berardi, R., additional, Butera, A., additional, Cagossi, K., additional, Cavanna, L., additional, Ciccarese, M., additional, Cinieri, S., additional, Cretella, E., additional, De Conciliis, E., additional, Febbraro, A., additional, Ferraù, F., additional, Ferzi, A., additional, Fiorentini, G., additional, Fontana, A., additional, Gambaro, A.R., additional, Garrone, O., additional, Gebbia, V., additional, Generali, D., additional, Gianni, L., additional, Giovanardi, F., additional, Grassadonia, A., additional, Leonardi, V., additional, Marchetti, P., additional, Melegari, E., additional, Musolino, A., additional, Nicolini, M., additional, Putzu, C., additional, Riccardi, F., additional, Santini, D., additional, Saracchini, S., additional, Sarobba, M.G., additional, Schintu, M.G., additional, Scognamiglio, G., additional, Spadaro, P., additional, Taverniti, C., additional, Toniolo, D., additional, Tralongo, P., additional, Turletti, A., additional, Valenza, R., additional, Valerio, M.R., additional, Vici, P., additional, Clivio, L., additional, Torri, V., additional, Cicchiello, F., additional, Riva, F., additional, Vallini, I., additional, Mazza, M., additional, Bonfadini, C., additional, Bordin, E., additional, Canicattì, M., additional, Cappuccio, F., additional, Collovà, E., additional, De Angelis, C., additional, Desorte, R., additional, Donati, S., additional, Drudi, G., additional, Galanti, D., additional, Mocerino, C., additional, Orlando, L., additional, Pellegrino, B., additional, Pizzuti, L., additional, Ridolfi, C., additional, Rocca, A., additional, Sarti, D., additional, Spagnoletti, I., additional, Tinari, N., additional, Vandone, A., additional, and Vizzini, L., additional

Published
2019
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89. An Italian Delphi study to evaluate consensus on adjuvant endocrine therapy in premenopausal patients with breast cancer: The ERA project 11 Medical and Health Sciences 1112 Oncology and Carcinogenesis 11 Medical and Health Sciences 1103 Clinical Sciences

Author

Pelizzari G., Arpino G., Biganzoli L., Cinieri S., De Laurentiis M., Del Mastro L., Di Leo A., Gori S., Guarneri V., Marchetti P., Puglisi F., Pelizzari, G., Arpino, G., Biganzoli, L., Cinieri, S., De Laurentiis, M., Del Mastro, L., Di Leo, A., Gori, S., Guarneri, V., Marchetti, P., and Puglisi, F.

Subjects
Cancer Research, Ovarian function suppression, Antineoplastic Agents, Hormonal, Delphi Technique, Ovarian Function Test, Premenopausal patient, Aromatase inhibitor, Estrogen Antagonist, Gonadotropin-Releasing Hormone, Tamoxifen, Adjuvant endocrine therapy, Breast cancer, Italy, Premenopause, Oncology, Chemotherapy, Adjuvant, LHRHa, Premenopausal patients, Genetics, Female, Breast Neoplasm, Human
Abstract

Background: Several trials evaluated the role of ovarian function suppression for the adjuvant treatment of premenopausal patients with hormone receptor-positive early breast cancer. Based on the results of the SOFT and TEXT trials, international guidelines recommend the addition of ovarian function suppression to standard adjuvant endocrine therapy for patients at higher risk of relapse. Methods: The ERA project (Evaluation of Risk factors in the Adjuvant treatment of breast cancer in premenopausal patients) was devised with the objective of obtaining a consensus on the identification of risk factors and the use of ovarian function suppression in the adjuvant treatment of these women. To this aim, a panel of 31 Italian oncologists with expertise in breast cancer participated in a Delphi consensus study in June 2017. Results: A total of 29 statements related to prognostic factors, therapeutic strategies and ovarian function suppression were defined and voted to gain final consensus. For each topic we report data supporting the acquired consensus and the relevant issues discussed. Conclusions: The SOFT and TEXT trials have changed the standard adjuvant treatment of premenopausal patients with hormone receptor-positive early breast cancer, but the available treatment options require a careful risk assessment and toxicities evaluation to ensure the greatest clinical benefit for each patient.

Published
2018

91. Metronomic chemotherapy (mCHT) in metastatic triple-negative breast cancer (TNBC) patients: results of the VICTOR-6 study.

Author

Cazzaniga, M. E., Vallini, I., Montagna, E., Amoroso, D., Berardi, R., Butera, A., Cagossi, K., Cavanna, L., Ciccarese, M., Cinieri, S., Cretella, E., De Conciliis, E., Febbraro, A., Ferraù, F., Ferzi, A., Baldelli, A., Fontana, A., Gambaro, A. R., Garrone, O., and Gebbia, V.

Abstract

Purpose: Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting. Methods: We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 or more lines of treatment for the metastatic disease. 45.4% out of 97 TNBC patients received a vinorelbine (VRL)-based regimen, which resulted in the most used type of mCHT, followed by cyclophosphamide (CTX)-based regimens (30.9%) and capecitabine (CAPE)-based combinations (22.7%). Results: Overall response rate (ORR) and disease control rate (DCR) were 17.5% and 64.9%, respectively. Median progression free survival (PFS) and overall survival (OS) were 6.0 months (95% CI: 4.9–7.2) and 12.1 months (95% CI: 9.6–16.7). Median PFS was 6.9 months for CAPE-based regimens (95% CI: 5.0–18.4), 6.1 months (95% CI: 4.0–8.9) for CTX-based and 5.3 months (95% CI: 4.1–9.5) for VRL-based ones. Median OS was 18.2 months (95% CI: 9.1-NE) for CAPE-based regimens and 11.8 months for VRL- (95% CI: 9.3–16.7 and CTX-based ones (95%CI: 8.7–52.8). Tumour response, PFS and OS decreased proportionally in later lines. Conclusion: This analysis represents the largest series of TNBC patients treated with mCHT in a real-life setting and provides further insights into the advantages of using this strategy even in this poor prognosis subpopulation. [ABSTRACT FROM AUTHOR]

Published
2021
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97. Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial

Author

Lorusso, Domenica, Ferrandina, Maria Gabriella, Colombo, N., Pignata, S., Pietragalla, A., Sonetto, C., Pisano, C., Lapresa, M. T., Savarese, A., Tagliaferri, P., Lombardi, Debora Benedetta, Cinieri, S., Breda, E., Sabatucci, I., Sabbatini, R., Conte, C., Cecere, S. C., Maltese, G., Scambia, Giovanni, Lorusso D., Ferrandina G. (ORCID:0000-0003-4672-4197), Lombardi D., Scambia G. (ORCID:0000-0003-2758-1063), Lorusso, Domenica, Ferrandina, Maria Gabriella, Colombo, N., Pignata, S., Pietragalla, A., Sonetto, C., Pisano, C., Lapresa, M. T., Savarese, A., Tagliaferri, P., Lombardi, Debora Benedetta, Cinieri, S., Breda, E., Sabatucci, I., Sabbatini, R., Conte, C., Cecere, S. C., Maltese, G., Scambia, Giovanni, Lorusso D., Ferrandina G. (ORCID:0000-0003-4672-4197), Lombardi D., and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Objective: Increased Vascular Endothelial Growth Factor Receptor (VEGF) expression in endometrial cancer (EC) is associated with a poor prognosis. Preliminary clinical data reported Bevacizumab effectiveness in EC both as single agent and in combination with chemotherapy. Methods: In a phase II trial, patients with advanced (FIGO stage III-IV) or recurrent EC were randomized to receive Carboplatin-Paclitaxel standard dose for 6–8 cycles vs Carboplatin-Paclitaxel and Bevacizumab 15 mg/kg in combination with chemotherapy and maintenance until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS). Results: 108 patients were randomized; PFS (10.5 vs 13.7 months, HR 0.84 p = 0.43), overall response rate (ORR 53.1% vs 74.4%) and overall survival (OS) (29.7 vs 40.0 months, HR 0.71 p = 0.24) resulted in a non-significant increase in Bevacizumab treated patients. The PFS increase became significant when an exploratory analysis with the Breslow test was used. Moreover, patients treated with Bevacizumab experienced a significant increase in 6-month disease control rate (70.4% vs 90.7%). Cardiovascular events were more frequent in the experimental arm (“de novo” grade ≥2 hypertension 21% vs 0% and grade ≥2 thromboembolic events 11% vs 2% in the Bevacizumab vs standard treatment arm, respectively). Conclusions: Bevacizumab combined with chemotherapy in the treatment of advanced/recurrent EC failed to demonstrate a significant increase in PFS in the MITO END-2 trial. Nevertheless, these preliminary data suggests some effectiveness of the antiangiogenic agent which merits further exploration in a larger population with a better molecular characterization.

Published
2019

98. Impact of Metformin Use and Diabetic Status During Adjuvant Fluoropyrimidine-Oxaliplatin Chemotherapy on the Outcome of Patients with Resected Colon Cancer: A TOSCA Study Subanalysis

Author

Vernieri, C, Galli, F, Ferrari, L, Marchetti, P, Lonardi, S, Maiello, E, Iaffaioli, R, Zampino, M, Zaniboni, A, De Placido, S, Banzi, M, Damiani, A, Ferrari, D, Rosati, G, Labianca, R, Bidoli, P, Frassineti, G, Nicolini, M, Pavesi, L, Tronconi, M, Buonadonna, A, Ferrario, S, Re, G, Adamo, V, Tamburini, E, Clerico, M, Giordani, P, Leonardi, F, Barni, S, Ciarlo, A, Cavanna, L, Gori, S, Cinieri, S, Faedi, M, Aglietta, M, Antista, M, Dotti, K, Di Bartolomeo, M, Iaffaioli, RV, Zampino, MG, Labianca, RF, Frassineti, GL, Tronconi, MC, Re, GL, Dotti, KF, Vernieri, C, Galli, F, Ferrari, L, Marchetti, P, Lonardi, S, Maiello, E, Iaffaioli, R, Zampino, M, Zaniboni, A, De Placido, S, Banzi, M, Damiani, A, Ferrari, D, Rosati, G, Labianca, R, Bidoli, P, Frassineti, G, Nicolini, M, Pavesi, L, Tronconi, M, Buonadonna, A, Ferrario, S, Re, G, Adamo, V, Tamburini, E, Clerico, M, Giordani, P, Leonardi, F, Barni, S, Ciarlo, A, Cavanna, L, Gori, S, Cinieri, S, Faedi, M, Aglietta, M, Antista, M, Dotti, K, Di Bartolomeo, M, Iaffaioli, RV, Zampino, MG, Labianca, RF, Frassineti, GL, Tronconi, MC, Re, GL, and Dotti, KF

Abstract

Background: Type 2 diabetes mellitus (T2DM) is associated with increased risk of colon cancer (CC), whereas metformin use seems to be protective. However, the impact of metformin use on the risk of death or disease recurrence after radical surgery for CC remains uncertain. Materials and Methods: This is a substudy conducted in patients with high-risk stage II or stage III CC randomized in the TOSCA trial, which compared 3 versus 6 months of fluoropyrimidine-oxaliplatin adjuvant chemotherapy. Objective of the study was to investigate the impact of metformin exposure during adjuvant chemotherapy on overall survival (OS) and relapse-free survival (RFS). We also evaluated the impact of T2DM or metformin dosage on clinical outcomes. Results: Out of 3,759 patients enrolled in the TOSCA trial, 133 patients with diabetes (9.2%) and 1,319 without diabetes (90.8%) were recruited in this study. After excluding 13 patients with diabetes without information on metformin exposure, 76 patients with T2DM (63.3%) were defined as metformin users and 44 (36.7%) as metformin nonusers. After a median follow-up of 60.4 months, 26 (21.7%) patients relapsed and 16 (13.3%) died. Metformin use was neither associated with OS (adjusted hazard ratio [HR], 1.51; 95% confidence interval [CI], 0.48–4.77; p =.4781) nor with RFS (HR, 1.56; 95% CI, 0.69–3.54; p =.2881). Similarly, we found no association between T2DM or metformin dosage and OS or RFS. Conclusions: Metformin use and T2DM did not impact on OS or RFS in patients with resected CC treated with adjuvant fluoropyrimidine-oxaliplatin chemotherapy. Larger studies and longer follow-up are required to clarify the potential efficacy of metformin in improving the prognosis of patients with CC. Implications for Practice: The role of the antidiabetic drug metformin in colon cancer prevention and treatment is highly debated. While low-dose metformin reduced the incidence of colorectal adenomas in two prospective studies, its effect in patients with

Published
2019

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