PMID- 29956884 OWN - NLM STAT- MEDLINE DCOM- 20190820 LR - 20220331 IS - 1464-410X (Electronic) IS - 1464-4096 (Linking) VI - 123 IP - 1 DP - 2019 Jan TI - Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme. PG - 98-105 LID - 10.1111/bju.14461 [doi] AB - OBJECTIVE: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. PATIENTS AND METHODS: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received >/=1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. RESULTS: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged >/=75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received >/=2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7-6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. CONCLUSION: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. CI - (c) 2018 The Authors BJU International (c) 2018 BJU International Published by John Wiley & Sons Ltd. FAU - De Giorgi, Ugo AU - De Giorgi U AUID- ORCID: 0000-0001-7520-2908 AD - Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola, Italy. FAU - Carteni, Giacomo AU - Carteni G AD - Department of Medical Oncology, Azienda Ospedaliero-Universitaria "A. Cardarelli", Napoli, Italy. FAU - Giannarelli, Diana AU - Giannarelli D AD - Department of Statistics, Regina Elena National Cancer Institute - IRCCS, Rome, Italy. FAU - Basso, Umberto AU - Basso U AD - Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy. FAU - Galli, Luca AU - Galli L AD - Department of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana Spedali Riuniti S. Chiara, Pisa, Italy. FAU - Cortesi, Enrico AU - Cortesi E AD - Department of Medical Oncology, Policlinico Umberto I, Roma, Italy. FAU - Caserta, Claudia AU - Caserta C AD - Department of Medical Oncology, Azienda Ospedaliero-Universitaria di Santa Maria, Terni, Italy. FAU - Pignata, Sandro AU - Pignata S AD - Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Napoli, Italy. FAU - Sabbatini, Roberto AU - Sabbatini R AD - Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy. FAU - Bearz, Alessandra AU - Bearz A AD - Department of Medical Oncology, Istituto Nazionale Tumori - IRCCS, Aviano, Italy. FAU - Buti, Sebastiano AU - Buti S AD - Medical Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. FAU - Lo Re, Giovanni AU - Lo Re G AD - Department of Medical Oncology, CRO Pordenone-S.Vito Oncology, CRO - IRCCS, Aviano, Italy. FAU - Berruti, Alfredo AU - Berruti A AD - Department of Medical Oncology, ASST Spedali Civili di Brescia, Brescia, Italy. FAU - Bracarda, Sergio AU - Bracarda S AD - Department of Medical Oncology, Azienda USL 8, Arezzo, Italy. FAU - Cognetti, Francesco AU - Cognetti F AD - Department of Medical Oncology, Regina Elena National Cancer Institute - IRCCS, Rome, Italy. FAU - Rastelli, Francesca AU - Rastelli F AD - Department of Medical Oncology, Fermo Area Vasta 4, Fermo, Italy. FAU - Fornarini, Giuseppe AU - Fornarini G AD - Department of Medical Oncology, Azienda Ospedaliero-Universitaria San Martino IST - IRCCS, Genova, Italy. FAU - Porta, Camillo AU - Porta C AD - University of Pavia and IRCCS San Matteo University Hospital Foundation, Pavia, Italy. AD - IRCCS San Matteo University Hospital Foundation, Pavia, Italy. FAU - Turci, Daniele AU - Turci D AD - Department of Medical Oncology, Ospedale Santa Maria delle Croci, Ravenna, Italy. FAU - Sternberg, Cora N AU - Sternberg CN AUID- ORCID: 0000-0003-3938-2627 AD - Department of Medical Oncology, San Camillo Forlanini Hospital, Roma, Italy. FAU - Procopio, Giuseppe AU - Procopio G AD - Department of Medical Oncology, Istituto Nazionale Tumori - IRCCS, Milano, Italy. CN - Italian Nivolumab Renal Cell Cancer Early Access Program Group LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180723 PL - England TA - BJU Int JT - BJU international JID - 100886721 RN - 0 (Antineoplastic Agents) RN - 0 (Antineoplastic Agents, Immunological) RN - 0 (Indazoles) RN - 0 (Pyrimidines) RN - 0 (Sulfonamides) RN - 31YO63LBSN (Nivolumab) RN - 7RN5DR86CK (pazopanib) RN - 9HW64Q8G6G (Everolimus) RN - V99T50803M (Sunitinib) MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/therapeutic use MH - Antineoplastic Agents, Immunological/adverse effects/*therapeutic use MH - Bone Neoplasms/*drug therapy/secondary MH - Brain Neoplasms/*drug therapy/secondary MH - Carcinoma, Renal Cell/*drug therapy/secondary MH - Everolimus/therapeutic use MH - Female MH - Humans MH - Indazoles MH - Kidney Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - Nivolumab/adverse effects/*therapeutic use MH - Progression-Free Survival MH - Pyrimidines/therapeutic use MH - Response Evaluation Criteria in Solid Tumors MH - Retreatment MH - Sulfonamides/therapeutic use MH - Sunitinib/therapeutic use MH - Survival Rate OTO - NOTNLM OT - expanded access programme OT - nivolumab OT - real-world experience OT - renal cell cancer FIR - Falcone, A IR - Falcone A FIR - Roila, F IR - Roila F FIR - Cascinu, S IR - Cascinu S FIR - Tirelli, U IR - Tirelli U FIR - Giustini, L IR - Giustini L FIR - Sobrero, A IR - Sobrero A FIR - Cappuzzo, F IR - Cappuzzo F FIR - Tassinari, D IR - Tassinari D FIR - Passalacqua, R IR - Passalacqua R FIR - Pazzola, A IR - Pazzola A FIR - Surico, G IR - Surico G FIR - Maio, M IR - Maio M FIR - Benedetti, G IR - Benedetti G FIR - Barone, C IR - Barone C FIR - Adamo, V IR - Adamo V FIR - Ricevuto, E IR - Ricevuto E FIR - De Censi, A IR - De Censi A FIR - Spada, M IR - Spada M FIR - Tonini, G IR - Tonini G FIR - Pinto, C IR - Pinto C FIR - Ciuffreda, L IR - Ciuffreda L FIR - Ruggeri, E M IR - Ruggeri EM FIR - Bengala, C IR - Bengala C FIR - Scotti, V IR - Scotti V FIR - Fagnani, D IR - Fagnani D FIR - Bonetti, A IR - Bonetti A FIR - Mitterer, M IR - Mitterer M FIR - Castiglione, F IR - Castiglione F FIR - Bidoli, P IR - Bidoli P FIR - Ferrau, F IR - Ferrau F FIR - Crino, L IR - Crino L FIR - Frassoldati, A IR - Frassoldati A FIR - Marchetti, P IR - Marchetti P FIR - Mini, E IR - Mini E FIR - Scoppola, A IR - Scoppola A FIR - Verusio, C IR - Verusio C FIR - Favaretto, A IR - Favaretto A FIR - Di Costanzo, F IR - Di Costanzo F FIR - Fasola, G IR - Fasola G FIR - Merlano, M IR - Merlano M FIR - Artioli, F IR - Artioli F FIR - Di Leo, A IR - Di Leo A FIR - Romito, S IR - Romito S FIR - Maestri, A IR - Maestri A FIR - Giannitto Giorgio, C IR - Giannitto Giorgio C FIR - Ionta, M T IR - Ionta MT FIR - Verderame, F IR - Verderame F FIR - Zampa, G IR - Zampa G FIR - Numico, G IR - Numico G FIR - Minelli, M IR - Minelli M FIR - Tagliaferri, P IR - Tagliaferri P FIR - Foa, P IR - Foa P FIR - Palmiotti, G IR - Palmiotti G FIR - De Placido, S IR - De Placido S FIR - Mattioli, R IR - Mattioli R FIR - Iuliano, F IR - Iuliano F FIR - Defraia, E IR - Defraia E FIR - Siena, S IR - Siena S FIR - Clerico, M IR - Clerico M FIR - Salvagno, L IR - Salvagno L FIR - Ceresoli, G L IR - Ceresoli GL FIR - Bernardo, A IR - Bernardo A FIR - Di Lieto, M IR - Di Lieto M FIR - Moroni, M IR - Moroni M FIR - Maisano, M IR - Maisano M FIR - Scartozzi, M IR - Scartozzi M FIR - Scagliotti, G IR - Scagliotti G FIR - Soraru, M IR - Soraru M FIR - Pepe, S IR - Pepe S FIR - Scaltriti, A IR - Scaltriti A FIR - Gebbia, V IR - Gebbia V FIR - Testa, E IR - Testa E FIR - Lorusso, V IR - Lorusso V FIR - Bordonaro, R IR - Bordonaro R FIR - De Signoribus, G IR - De Signoribus G FIR - Tedde, N IR - Tedde N FIR - Santoro, A IR - Santoro A FIR - Francini, G IR - Francini G FIR - Aondio, G IR - Aondio G EDAT- 2018/06/30 06:00 MHDA- 2019/08/21 06:00 CRDT- 2018/06/30 06:00 PHST- 2018/06/30 06:00 [pubmed] PHST- 2019/08/21 06:00 [medline] PHST- 2018/06/30 06:00 [entrez] AID - 10.1111/bju.14461 [doi] PST - ppublish SO - BJU Int. 2019 Jan;123(1):98-105. doi: 10.1111/bju.14461. Epub 2018 Jul 23.