プレジデンシャルセッション
座長：杉尾 賢二1, 光冨 徹哉2（大分大学医学部呼吸器・乳腺外科学講座1, 近畿大学病院Global Research Alliance Center2）
座長：杉尾 賢二1, 光冨 徹哉2（大分大学医学部呼吸器・乳腺外科学講座1, 近畿大学病院Global Research Alliance Center2）
PR-5．Neoadjuvant Nivolumab + Chemotherapy for Resectable NSCLC：CheckMate 816 Japan Subgroup Analysis
*Tetsuya Mitsudomi1・Hiroyuki Ito2・Morihito Okada3・Shunichi Sugawara4・Yutaka Shio5・Keisuke Tomii6・Jiro Okami7・Noriaki Sakakura8・Kaoru Kubota9・Kazuya Takamochi10・Shinji Atagi11・Masahiro Tsuboi12・Satoshi Oizumi13・Norihiko Ikeda14・Yasuhisa Ohde15・Ives Ntambwe16・Junliang Cai16・Javed Mahmood16・Fumihiro Tanaka17
Kindai University Hospital, Osakasayama, Osaka, Japan1；Kanagawa Cancer Center, Yokohama, Kanagawa, Japan2；Hiroshima University Hospital, Minami-Ku Hiroshima, Japan3；Sendai Kousei Hospital, Sendai, Miyagi, Japan4；Fukushima Medical University Hospital, Hikarigaoka, Fukushima, Japan5；Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan6；Osaka International Cancer institute, Osaka, Japan7；Aichi Cancer Center Hospital, Nagoya, Aichi, Japan8；Nippon Medical School Hospital, Bunkyo City, Tokyo, Japan9；Juntendo University Hospital, Bunkyo City, Tokyo, Japan10；National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan（affiliation at the time of study）11；National Cancer Center Hospital East, Kashiwa, Chiba, Japan12；Hokkaido Cancer Center, Sapporo, Hokkaido, Japan13；Tokyo Medical University Hospital, Shinjuku City, Tokyo, Japan14；Shizuoka Cancer Center, Sunto District, Shizuoka, Japan15；Bristol Myers Squibb, Princeton, NJ, USA16；University Of Occupational And Environmental Health Hospital, Kitakyushu, Fukuoka, Japan17
Kindai University Hospital, Osakasayama, Osaka, Japan1；Kanagawa Cancer Center, Yokohama, Kanagawa, Japan2；Hiroshima University Hospital, Minami-Ku Hiroshima, Japan3；Sendai Kousei Hospital, Sendai, Miyagi, Japan4；Fukushima Medical University Hospital, Hikarigaoka, Fukushima, Japan5；Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan6；Osaka International Cancer institute, Osaka, Japan7；Aichi Cancer Center Hospital, Nagoya, Aichi, Japan8；Nippon Medical School Hospital, Bunkyo City, Tokyo, Japan9；Juntendo University Hospital, Bunkyo City, Tokyo, Japan10；National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan（affiliation at the time of study）11；National Cancer Center Hospital East, Kashiwa, Chiba, Japan12；Hokkaido Cancer Center, Sapporo, Hokkaido, Japan13；Tokyo Medical University Hospital, Shinjuku City, Tokyo, Japan14；Shizuoka Cancer Center, Sunto District, Shizuoka, Japan15；Bristol Myers Squibb, Princeton, NJ, USA16；University Of Occupational And Environmental Health Hospital, Kitakyushu, Fukuoka, Japan17
Neoadjuvant nivolumab（N）+chemotherapy（C）significantly improved event-free survival（EFS）and pathological complete response（pCR）vs C in patients（pts）with resectable NSCLC in CheckMate 816（NCT02998528）. Here we report Japanese subgroup results.
Adults with stage IB-IIIA（AJCC 7th ed）resectable NSCLC were randomized to N 360 mg+C Q3W or C Q3W for 3 cycles, followed by surgery. EFS and pCR（both assessed by blinded independent review）in concurrently randomized pts were primary endpoints.
Of 68 pts in the Japanese subgroup, 33 were randomized to N+C and 35 to C. Baseline characteristics were generally balanced between treatment arms；the majority of pts（N+C, 55％；C, 57％）had stage IIIA disease. With a minimum follow-up of 21.5 mo, neoadjuvant N+C improved EFS vs C：median EFS（95％ CI）was 30.6 mo（16.8-not reached［NR］）vs 19.6 mo（8.5-NR）, HR, 0.60（95％ CI, 0.30-1.24）；2-y EFS rate was 64％ vs 44％. The pCR rate was higher with N+C vs C（30.3％ vs 5.7％；odds ratio, 14.01［95％ CI, 1.73-113.22］）. Definitive surgery rates were 94％ with N+C and 83％ with C. Grade 3/4 treatment-related adverse events（AEs）occurred in 19（59％）vs 15（43％）pts with N+C vs C；grade 3/4 surgery-related AEs occurred in 6 pts each,（19％ and 21％, respectively）.
Consistent with the findings in the CheckMate 816 global population, neoadjuvant N+C improved EFS and pCR vs C in the Japanese subgroup. Addition of neoadjuvant N to C did not impede the feasibility of surgery and maintained tolerability. Our results support neoadjuvant N+C as a treatment option for pts with resectable NSCLC in Japan.
Adults with stage IB-IIIA（AJCC 7th ed）resectable NSCLC were randomized to N 360 mg+C Q3W or C Q3W for 3 cycles, followed by surgery. EFS and pCR（both assessed by blinded independent review）in concurrently randomized pts were primary endpoints.
Of 68 pts in the Japanese subgroup, 33 were randomized to N+C and 35 to C. Baseline characteristics were generally balanced between treatment arms；the majority of pts（N+C, 55％；C, 57％）had stage IIIA disease. With a minimum follow-up of 21.5 mo, neoadjuvant N+C improved EFS vs C：median EFS（95％ CI）was 30.6 mo（16.8-not reached［NR］）vs 19.6 mo（8.5-NR）, HR, 0.60（95％ CI, 0.30-1.24）；2-y EFS rate was 64％ vs 44％. The pCR rate was higher with N+C vs C（30.3％ vs 5.7％；odds ratio, 14.01［95％ CI, 1.73-113.22］）. Definitive surgery rates were 94％ with N+C and 83％ with C. Grade 3/4 treatment-related adverse events（AEs）occurred in 19（59％）vs 15（43％）pts with N+C vs C；grade 3/4 surgery-related AEs occurred in 6 pts each,（19％ and 21％, respectively）.
Consistent with the findings in the CheckMate 816 global population, neoadjuvant N+C improved EFS and pCR vs C in the Japanese subgroup. Addition of neoadjuvant N to C did not impede the feasibility of surgery and maintained tolerability. Our results support neoadjuvant N+C as a treatment option for pts with resectable NSCLC in Japan.
第63回日本肺癌学会学術集会 2022年12月開催
