グローバルセッション1
免疫療法
座長：里内美弥子1, 西尾 誠人2（兵庫県立がんセンター呼吸器内科1, がん研究会有明病院呼吸器内科2）
免疫療法
座長：里内美弥子1, 西尾 誠人2（兵庫県立がんセンター呼吸器内科1, がん研究会有明病院呼吸器内科2）
GL1-1．Neoadjuvant Nivolumab + Chemo for Resectable NSCLC：CheckMate 816 Surgical Outcomes in Japanese Pts
*Fumihiro Tanaka1・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・Javed Mahmood16・Junliang Cai16・Tetsuya Mitsudomi17
University Of Occupational And Environmental Health Hospital, Kitakyushu, Fukuoka, 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 city, Osaka, Japan7；Aichi Cancer Center Hospital, Nagoya, Aichi, Japan8；Nippon Medical School Hospital, Bunkyo City, Tokyo, Japan9；Juntendo University Hospital, Tokyo, Japan10；National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan11；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；WW Medical Oncology, Bristol Myers Squibb, Princeton, NJ, USA16；Kindai University Hospital Osakasayama, Osaka, Japan17
University Of Occupational And Environmental Health Hospital, Kitakyushu, Fukuoka, 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 city, Osaka, Japan7；Aichi Cancer Center Hospital, Nagoya, Aichi, Japan8；Nippon Medical School Hospital, Bunkyo City, Tokyo, Japan9；Juntendo University Hospital, Tokyo, Japan10；National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan11；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；WW Medical Oncology, Bristol Myers Squibb, Princeton, NJ, USA16；Kindai University Hospital Osakasayama, Osaka, Japan17
In the phase 3 CheckMate 816（NCT02998528）trial, neoadjuvant nivolumab（N）+chemotherapy（C）significantly improved the primary endpoints of event-free survival（EFS）and pathological complete response（pCR）vs C in patients（pts）with resectable NSCLC, and did not impede the feasibility of surgery. Here we report surgical outcomes in Japanese pts.
Adults with stage IB-IIIA（AJCC 7th ed）resectable NSCLC and no known EGFR/ALK alterations were randomized to receive N 360 mg+C Q3W or C Q3W for 3 cycles followed by definitive surgery within 6 weeks of treatment.
Baseline characteristics were generally balanced between N+C（n=33）vs C（n=35）. Definitive surgery rates were 94％ vs 83％ with N+C vs C；1 vs 4 pts canceled due to disease progression, respectively. Minimally invasive surgery rates were 29％ vs 14％ and conversion（minimally invasive to open）rates were 29％ vs 14％. Lobectomy/pneumonectomy was performed in 94％/6％ vs 66％/14％ in N+C vs C. AEs caused surgery delays in 1 vs 4 pts in N+C vs C. R0 resection was achieved in 87％ vs 83％. Median（IQR）duration of surgery and length of hospitalization for N+C vs C were 207（170-262）vs 261（230-309）min and 11.0（9.0-18.0）vs 13.0（10.5-17.5）days. Grade 3-4 surgery-related adverse events were reported in 19％ vs 21％ in N+C vs C.
Consistent with the all randomized population, neoadjuvant N+C did not impede the feasibility of surgery or completeness of resection, and did not increase surgical complications. These data, along with improvement in EFS and pCR, support N+C as a potential neoadjuvant option in this subpopulation.
Adults with stage IB-IIIA（AJCC 7th ed）resectable NSCLC and no known EGFR/ALK alterations were randomized to receive N 360 mg+C Q3W or C Q3W for 3 cycles followed by definitive surgery within 6 weeks of treatment.
Baseline characteristics were generally balanced between N+C（n=33）vs C（n=35）. Definitive surgery rates were 94％ vs 83％ with N+C vs C；1 vs 4 pts canceled due to disease progression, respectively. Minimally invasive surgery rates were 29％ vs 14％ and conversion（minimally invasive to open）rates were 29％ vs 14％. Lobectomy/pneumonectomy was performed in 94％/6％ vs 66％/14％ in N+C vs C. AEs caused surgery delays in 1 vs 4 pts in N+C vs C. R0 resection was achieved in 87％ vs 83％. Median（IQR）duration of surgery and length of hospitalization for N+C vs C were 207（170-262）vs 261（230-309）min and 11.0（9.0-18.0）vs 13.0（10.5-17.5）days. Grade 3-4 surgery-related adverse events were reported in 19％ vs 21％ in N+C vs C.
Consistent with the all randomized population, neoadjuvant N+C did not impede the feasibility of surgery or completeness of resection, and did not increase surgical complications. These data, along with improvement in EFS and pCR, support N+C as a potential neoadjuvant option in this subpopulation.
第63回日本肺癌学会学術集会 2022年12月開催
