PMID- 32690620
OWN - NLM
STAT- MEDLINE
DCOM- 20210719
LR  - 20210719
IS  - 2059-7029 (Electronic)
IS  - 2059-7029 (Linking)
VI  - 5
IP  - 4
DP  - 2020 Jul
TI  - Nivolumab treatment of elderly Japanese patients with non-small cell lung cancer: 
      subanalysis of a real-world retrospective observational study (CA209-9CR).
LID - 10.1136/esmoopen-2019-000656 [doi]
LID - e000656
AB  - OBJECTIVES: We conducted a subanalysis of data from the multicentre, 
      retrospective observational Nivolumab Japan Real World (CA209-9CR) study to 
      evaluate nivolumab effectiveness and safety in elderly patients (aged >/=75 years) 
      with advanced/metastatic non-small cell lung cancer. MATERIALS AND METHODS: 
      Medical record data of patients initiating nivolumab treatment between April 2016 
      and December 2016 were collected using electronic data capture from 23 cancer 
      hospitals in Japan between March 2017 and August 2018. Nivolumab treatment data 
      were collected to investigate the treatment patterns by age group (<75 and >/=75 
      years), and the effectiveness and safety of nivolumab treatment. RESULTS: Of the 
      901 patients evaluated, 178 (19.8%) were aged >/=75 years. Overall, patients 
      received a median of five nivolumab treatments regardless of age group. 
      Comparable progression-free survival was observed, with a median of 2.1 months in 
      patients aged <75 years and 2.1 months in patients aged >/=75 years (p=0.5441). No 
      significant differences were found in duration of response, overall response rate 
      or disease control rate between the two age groups. Median overall survival in 
      patients aged <75 and >/=75 years was 14.7 months and 12.3 months, respectively. 
      Grade >/=3 adverse events (AEs) occurred in 29.2% and 28.1% of patients aged 
      <75 and >/=75 years, respectively. Immune-related AEs decreased slightly with 
      increasing age; time to onset and rates of improvement were similar for patients 
      aged <75 and >/=75 years. The most common grade 3-4 AEs were interstitial lung 
      disease in both age groups (4.0% in patients aged <75 years and 2.8% in those 
      aged >/=75 years). Poor performance status was associated with worse outcomes in 
      both age groups. CONCLUSION: Based on Japanese real-world data, the effectiveness 
      and safety of nivolumab were confirmed regardless of age.
CI  - (c) Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No 
      commercial re-use. Published by BMJ on behalf of the European Society for Medical 
      Oncology.
FAU - Okishio, Kyoichi
AU  - Okishio K
AUID- ORCID: 0000-0002-6348-1302
AD  - Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest 
      Medical Center, Sakai, Osaka, Japan okishio.kyoichi.hj@mail.hosp.go.jp.
FAU - Morita, Ryo
AU  - Morita R
AD  - Department of Thoracic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, 
      Japan.
FAU - Shimizu, Junichi
AU  - Shimizu J
AD  - Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, 
      Japan.
FAU - Saito, Haruhiro
AU  - Saito H
AD  - Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Kanagawa, 
      Japan.
FAU - Sakai, Hiroshi
AU  - Sakai H
AD  - Department of Thoracic Oncology, Saitama Cancer Center, Kitaadachi-gun, Saitama, 
      Japan.
FAU - Kim, Young Hak
AU  - Kim YH
AD  - Department of Respiratory Medicine, Kyoto University Hospital, Kyoto, Kyoto, 
      Japan.
FAU - Hataji, Osamu
AU  - Hataji O
AD  - Department of Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Mie, 
      Japan.
FAU - Yomota, Makiko
AU  - Yomota M
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan.
FAU - Nishio, Makoto
AU  - Nishio M
AD  - Department of Thoracic Medical Oncology, The Cancer Institute Hospital of 
      Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.
FAU - Aoe, Keisuke
AU  - Aoe K
AD  - Department of Medical Oncology, National Hospital Organization Yamaguchi-Ube 
      Medical Center, Ube, Yamaguchi, Japan.
FAU - Kanai, Osamu
AU  - Kanai O
AD  - Division of Respiratory Medicine, National Hospital Organization Kyoto Medical 
      Center, Kyoto, Kyoto, Japan.
FAU - Kumagai, Toru
AU  - Kumagai T
AD  - Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, 
      Osaka, Japan.
FAU - Kibata, Kayoko
AU  - Kibata K
AD  - Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, 
      Osaka, Japan.
FAU - Tsukamoto, Hiroaki
AU  - Tsukamoto H
AD  - Department of Respiratory Medicine, National Hospital Organization Himeji Medical 
      Center, Himeji, Hyogo, Japan.
FAU - Oizumi, Satoshi
AU  - Oizumi S
AD  - Department of Respiratory Medicine, National Hospital Organization Hokkaido 
      Cancer Center, Sapporo, Hokkaido, Japan.
FAU - Fujimoto, Daichi
AU  - Fujimoto D
AD  - Department of Respiratory Medicine, Kobe City Medical Center General Hospital, 
      Kobe, Hyogo, Japan.
FAU - Tanaka, Hiroshi
AU  - Tanaka H
AD  - Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, 
      Niigata, Japan.
FAU - Mizuno, Keiko
AU  - Mizuno K
AD  - Department of Pulmonary Medicine, Kagoshima University Hospital, Kagoshima, 
      Kagoshima, Japan.
FAU - Masuda, Takeshi
AU  - Masuda T
AD  - Department of Respiratory Internal Medicine, Hiroshima University Hospital, 
      Hiroshima, Hiroshima, Japan.
FAU - Kozuki, Toshiyuki
AU  - Kozuki T
AD  - Department of Thoracic Oncology and Medicine, National Hospital Organization 
      Shikoku Cancer Center, Matuyama, Ehime, Japan.
FAU - Haku, Takashi
AU  - Haku T
AD  - Respiratory Medicine, Tokushima Prefectural Central Hospital, Tokushima, 
      Tokushima, Japan.
FAU - Suzuki, Hiroyuki
AU  - Suzuki H
AD  - Department of Chest Surgery, Fukushima Medical University, Fukushima, Fukushima, 
      Japan.
FAU - Okamoto, Isamu
AU  - Okamoto I
AD  - Research Institute for Diseases of the Chest, Graduate School of Medical 
      Sciences, Kyushu University, Fukuoka, Fukuoka, Japan.
FAU - Hoshiyama, Hirotoshi
AU  - Hoshiyama H
AD  - Bristol-Myers Squibb K.K, Shinjuku-ku, Tokyo, Japan.
FAU - Yada, Nobumichi
AU  - Yada N
AD  - Ono Pharmaceutical Co., Ltd, Osaka, Osaka, Japan.
FAU - Ohe, Yuichiro
AU  - Ohe Y
AD  - Department of Thoracic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, 
      Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - ESMO Open
JT  - ESMO open
JID - 101690685
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Immunological/therapeutic use
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - Female
MH  - Humans
MH  - Japan
MH  - *Lung Neoplasms/drug therapy
MH  - Male
MH  - Middle Aged
MH  - Nivolumab/therapeutic use
MH  - Retrospective Studies
PMC - PMC7373314
OTO - NOTNLM
OT  - Japan
OT  - elderly
OT  - nivolumab
OT  - non-small cell lung cancer
COIS- Competing interests: KO reports personal fees from Ono Pharmaceutical Co, Ltd and 
      MSD K.K. outside the submitted work; JS reports personal fees from Bristol-Myers 
      Squibb K.K. and Ono Pharmaceutical CO, Ltd outside the submitted work; HS reports 
      grants from Chugai Pharmaceutical Co, Ltd, AstraZeneca K.K. and MSD K.K. and 
      personal fees from Ono Pharmaceutical Co, Ltd, Nippon Boehringer Ingelheim Co, 
      Ltd and Novartis Pharma K.K. outside the submitted work; HS reports personal fees 
      from Ono Pharmaceutical Co, Ltd and Bristol-Myers Squibb K.K. during the conduct 
      of the study, personal fees from Chugai Pharmaceutical Co, Ltd and MSD K.K. 
      outside the submitted work; OS reports other from Ono Pharmaceutical Co, Ltd 
      during the conduct of the study, personal fees and other from Novartis Pharma 
      K.K., Nippon Boehringer Ingelheim Co, Ltd and AstraZeneca K.K. and other from 
      Kyorin Pharmaceutical Co, Ltd, Bayer Health, Daiichi Sankyo Co, Ltd, 
      GlaxoSmithKline K.K. and Ono Pharmaceutical Co, Ltd outside the submitted work; 
      MY reports personal fees from Chugai Pharmaceutical Co, Ltd, Ono Pharmaceutical 
      Co, Ltd and AstraZeneca K.K. outside the submitted work; MN reports grants and 
      non-financial support from Ono Pharmaceutical Co, Ltd during the conduct of the 
      study, grants and personal fees from Ono Pharmaceutical Co, Ltd, Bristol-Myers 
      Squibb K.K., Pfizer Japan Inc, Chugai Pharmaceutical Co, Ltd, Eli Lilly Japan 
      K.K., Taiho Pharmaceutical Co, Ltd, AstraZeneca K.K., MSD K.K., Novartis Pharma 
      K.K., Takeda Pharmaceutical Co, Ltd and Daiichi Sankyo Healthcare Co, Ltd and 
      grants from Merck Serono Co, Ltd (currently Merck Biopharma Co, Ltd) and personal 
      fees from Nippon Boehringer Ingelheim Co, Ltd outside the submitted work; KA 
      reports grants and personal fees from Ono Pharmaceutical Co, Ltd, Bristol-Myers 
      Squibb K.K., AstraZeneca K.K. and Eli Lilly Japan K.K. and grants from MSD K.K. 
      and Novartis Pharma K.K. outside the submitted work; TK reports grants and 
      personal fees from Ono Pharmaceutical Co, Ltd, AstraZeneca K.K., Taiho 
      Pharmaceutical Co, Ltd, MSD K.K., Novartis Pharma K.K., Nippon Boehringer 
      Ingelheim Co, Ltd, Eli Lilly Japan K.K., Pfizer Japan Inc and Chugai 
      Pharmaceutical Co, Ltd, and grants from Takeda Pharmaceutical Co, Ltd, Regeneron 
      Pharmaceuticals, Inc and Merck Serono Co, Ltd (currently Merck Biopharma Co, Ltd) 
      and personal fees from Teijin Pharma Ltd and Bristol-Myers Squibb K.K. outside 
      the submitted work; SO reports grants and personal fees from Bristol-Myers Squibb 
      K.K. and Ono Pharmaceutical Co, Ltd during the conduct of the study, grants and 
      personal fees from AstraZeneca K.K., Chugai Pharmaceutical Co, Ltd and Taiho 
      Pharmaceutical Co, Ltd and grants from Kyowa Hakko Kirin Co, Ltd (currently Kyowa 
      Kirin Co, Ltd) and Merck Serono Co, Ltd (currently Merck Biopharma Co, Ltd) and 
      personal fees from MSD K.K. and Eli Lilly Japan K.K. outside the submitted work; 
      DF reports personal fees from Ono Pharmaceutical Co, Ltd and Bristol-Myers Squibb 
      K.K. during the conduct of the study, personal fees from AstraZeneca K.K., Taiho 
      Pharmaceutical Co, Ltd, Chugai Pharmaceutical Co, Ltd, MSD K.K., Nippon 
      Boehringer Ingelheim Co, Ltd and Eli Lilly Japan K.K. outside the submitted work; 
      HT reports grants and personal fees from Bristol-Myers Squibb K.K., Eli Lilly 
      Japan K.K., MSD K.K., Taiho Pharmaceutical Co, Ltd, Pfizer Japan Inc, Chugai 
      Pharmaceutical Co, Ltd, Ono Pharmaceutical Co, Ltd, AstraZeneca K.K. and Nippon 
      Boehringer Ingelheim Co, Ltd and grants from Merck Serono Co, Ltd (currently 
      Merck Biopharma Co, Ltd) and personal fees from Novartis Pharma K.K. outside the 
      submitted work; TK reports grants and personal fees from Chugai Pharmaceutical 
      Co, Ltd, AstraZeneca K.K., Eli Lilly Japan K.K. and Bristol-Myers Squibb K.K., 
      and personal fees from Taiho Pharmaceutical Co, Ltd, Ono Pharmaceutical Co, Ltd, 
      MSD K.K., Pfizer Japan Inc, Kyowa Hakko Kirin Co, Ltd (currently Kyowa Kirin Co, 
      Ltd), Nippon Boehringer Ingelheim Co, Ltd, and Nippon Kayaku Co, Ltd and grants 
      from Merck Serono Co, Ltd (currently Merck Biopharma Co, Ltd) outside the 
      submitted work; HS reports other from Mebix, Inc during the conduct of the study, 
      personal fees from AstraZeneca K.K. outside the submitted work; IS reports grants 
      from Nippon Boehringer Ingelheim Co, Ltd during the conduct of the study, grants 
      and personal fees from AstraZeneca K.K., Taiho Pharmaceutical Co, Ltd, Nippon 
      Boehringer Ingelheim Co, Ltd, Ono Pharmaceutical Co, Ltd, MSD K.K, Eli Lilly 
      Japan K.K., Bristol-Myers Squibb K.K. and Chugai Pharmaceutical Co, Ltd and 
      grants from Astellas Pharma Inc, Novartis Pharma K.K. and AbbVie GK, and personal 
      fees from Pfizer Japan Inc outside the submitted work; YO reports grants and 
      personal fees from Ono Pharmaceutical Co, Ltd and Bristol-Myers Squibb K.K. 
      during the conduct of the study, grants and personal fees from AstraZeneca K.K., 
      Chugai Pharmaceutical Co, Ltd, Eli Lilly Japan K.K., Pfizer Japan Inc, MSD K.K., 
      Kyorin Pharmaceutical Co, Ltd, Takeda Pharmaceutical Co, Ltd, Novartis Pharma 
      K.K., Taiho Pharmaceutical Co, Ltd, and AbbVie GK, and personal fees from 
      Celltrion Healthcare Co, Ltd, Amgen Inc, and Nippon Boehringer Ingelheim Co, Ltd, 
      and grants from Kissei Pharmaceutical Co, Ltd, Loxo Oncology, Inc, and Janssen 
      Pharmaceutical K.K. outside the submitted work; HH is an employee of 
      Bristol-Myers Squibb K.K.; NY is an employee of Ono Pharmaceutical Co, Ltd; RM, 
      YHK, OS, KK, HT, KM, TM and TH have nothing to declare.
EDAT- 2020/07/22 06:00
MHDA- 2021/07/20 06:00
PMCR- 2020/07/20
CRDT- 2020/07/22 06:00
PHST- 2019/12/10 00:00 [received]
PHST- 2020/02/07 00:00 [revised]
PHST- 2020/02/11 00:00 [accepted]
PHST- 2020/07/22 06:00 [entrez]
PHST- 2020/07/22 06:00 [pubmed]
PHST- 2021/07/20 06:00 [medline]
PHST- 2020/07/20 00:00 [pmc-release]
AID - S2059-7029(20)32635-1 [pii]
AID - esmoopen-2019-000656 [pii]
AID - 10.1136/esmoopen-2019-000656 [doi]
PST - ppublish
SO  - ESMO Open. 2020 Jul;5(4):e000656. doi: 10.1136/esmoopen-2019-000656.