PMID- 32394047 OWN - NLM STAT- MEDLINE DCOM- 20200930 LR - 20221207 IS - 1437-7772 (Electronic) IS - 1341-9625 (Linking) VI - 25 IP - 8 DP - 2020 Aug TI - Efficacy and safety of nivolumab for renal cell carcinoma in patients over 75 years old from multiple Japanese institutes. PG - 1543-1550 LID - 10.1007/s10147-020-01693-y [doi] AB - PURPOSE: Despite nivolumab being increasingly used for treating metastatic renal cell carcinoma (mRCC), differing findings have been reported about its efficacy and safety in elderly patients. Thus, this study was aimed at evaluating nivolumab's efficacy and safety for treating mRCC in Japanese patients aged >/= 75 years. METHODS: From March 2013 to August 2019, 118 mRCC patients (89 men and 29 women) were treated with nivolumab. The objective response rates (ORRs) were compared between patients aged >/= 75 and < 75 years. Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were also compared between the two age-groups. RESULTS: The median follow-up duration after nivolumab initiation was 10 months. At the time of nivolumab initiation, 22 and 96 patients were aged >/= 75 and < 75 years, respectively. Intergroup differences in patient characteristics except for age were not significant. Furthermore, intergroup differences in ORR (14 vs 23%; P = 0.367), PFS (HR 0.74, 95% CI 0.37-1.51; P = 0.414), and median OS (HR 1.29, 95% CI 0.68-2.46; P = 0.433) were not significant. The incidence of nivolumab discontinuation due to AEs was significantly higher in the >/= 75 years group (27% vs 7%; P = 0.028), although the intergroup difference in the AE incidence rate was not significant (55% vs 43.8%; P = 0.535). CONCLUSIONS: Nivolumab's effectiveness was comparable between the two patient groups, except for early AE-related discontinuation in the >/= 75 year group. FAU - Numakura, Kazuyuki AU - Numakura K AUID- ORCID: 0000-0002-5899-1738 AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. numakura@doc.med.akita-u.ac.jp. FAU - Kobayashi, Mizuki AU - Kobayashi M AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Hatakeyama, Shingo AU - Hatakeyama S AD - Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. FAU - Naito, Sei AU - Naito S AD - Department of Urology, Faculty of Medicine, Yamagata University, Yamagata, Japan. FAU - Horikawa, Yohei AU - Horikawa Y AD - Department of Urology, Japanese Red Cross Akita Hospital, Akita, Japan. FAU - Tanaka, Toshikazu AU - Tanaka T AD - Department of Urology, Aomori Prefectural Central Hospital, Aomori, Japan. FAU - Kamada, Sachiko AU - Kamada S AD - Department of Neurology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Muto, Yumina AU - Muto Y AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Yamamoto, Ryohei AU - Yamamoto R AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Koizumi, Atsushi AU - Koizumi A AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Nara, Taketoshi AU - Nara T AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Kanda, Sohei AU - Kanda S AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Saito, Mitsuru AU - Saito M AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Narita, Shintaro AU - Narita S AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Inoue, Takamitsu AU - Inoue T AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. FAU - Shimoda, Naotake AU - Shimoda N AD - Department of Urology, Japanese Red Cross Akita Hospital, Akita, Japan. FAU - Tsuchiya, Norihiko AU - Tsuchiya N AD - Department of Urology, Faculty of Medicine, Yamagata University, Yamagata, Japan. FAU - Ohyama, Chikara AU - Ohyama C AD - Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. FAU - Habuchi, Tomonori AU - Habuchi T AD - Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20200511 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0 (Antineoplastic Agents, Immunological) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents, Immunological/adverse effects/*therapeutic use MH - Asian People MH - Carcinoma, Renal Cell/*drug therapy/mortality/pathology MH - Female MH - Humans MH - Kidney Neoplasms/*drug therapy/mortality/pathology MH - Male MH - Middle Aged MH - Nivolumab/adverse effects/*therapeutic use MH - Progression-Free Survival MH - Retrospective Studies MH - Survival Rate MH - Treatment Outcome OTO - NOTNLM OT - 75 years or older OT - Efficacy OT - Nivolumab OT - Renal cell carcinoma OT - Tolerability EDAT- 2020/05/13 06:00 MHDA- 2020/10/02 06:00 CRDT- 2020/05/13 06:00 PHST- 2020/02/07 00:00 [received] PHST- 2020/04/29 00:00 [accepted] PHST- 2020/05/13 06:00 [pubmed] PHST- 2020/10/02 06:00 [medline] PHST- 2020/05/13 06:00 [entrez] AID - 10.1007/s10147-020-01693-y [pii] AID - 10.1007/s10147-020-01693-y [doi] PST - ppublish SO - Int J Clin Oncol. 2020 Aug;25(8):1543-1550. doi: 10.1007/s10147-020-01693-y. Epub 2020 May 11.