Masanobu Takahashi1, Ken Kato2, Morihito Okada3, Keisho Chin4, Shigenori Kadowaki5, Yasuo Hamamoto6, Yuichiro Doki7, Yutaro Kubota8, Hisato Kawakami9, Takashi Ogata10, Hiroki Hara11, Manabu Muto12, Yuichiro Nakashima13, Ryu Ishihara14, Masahiro Tsuda15, Satoru Motoyama16, Mamoru Kodani17, Yuko Kitagawa18. 1. Department of Medical Oncology, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi, 980-8574, Japan. masanobu.takahashi.a7@tohoku.ac.jp. 2. Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan. 4. Department of Gastroenterological Chemotherapy, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. 5. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. 6. Keio Cancer Center, Keio University School of Medicine, Tokyo, Japan. 7. Department of Surgery, Osaka University Hospital, Osaka, Japan. 8. Department of Medicine, Division of Medical Oncology, Showa University School of Medicine, Tokyo, Japan. 9. Department of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, Osaka, Japan. 10. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan. 11. Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan. 12. Department of Clinical Oncology, Kyoto University Hospital, Kyoto, Japan. 13. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 14. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. 15. Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan. 16. Department of Thoracic Surgery, Akita University Graduate School of Medicine, Akita, Japan. 17. Department of Oncology, Ono Pharmaceutical Co., Ltd., Osaka, Japan. 18. Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: The efficacy and safety of nivolumab versus chemotherapy was evaluated in the Japanese subpopulation from the overall intent-to-treat (ITT) population of the ATTRACTION-3 trial conducted in patients with advanced esophageal squamous cell carcinoma (ESCC) as second-line treatment. METHODS: Data from Japanese patients enrolled in the multicenter, randomized, open-label, phase 3 ATTRACTION-3 trial were analyzed. The primary endpoint was overall survival (OS). Secondary endpoints included duration of response (DOR), objective response rate (ORR), disease control rate (DCR), and safety. Exploratory subgroup analyses evaluated the association between OS and stratification factors/baseline variables. RESULTS: Overall, 274 (nivolumab, 136; chemotherapy, 138) of the 419 patients in ATTRACTION-3 were enrolled from Japan: response-evaluable population (107; 108) and safety population (135; 138). OS tended to be longer in the nivolumab group versus the chemotherapy group (median: 13.4 months vs. 9.4 months; HR, 0.77; 95% CI 0.59-1.01). Median DOR was longer in the nivolumab group (7.6 months) versus the chemotherapy group (3.6 months). ORRs were similar between the nivolumab [22.4% of patients (24/107)] and chemotherapy groups [22.2% (24/108); odds ratio, 0.98; 95% CI 0.52-1.87]. DCR was lower in the nivolumab group [41.1% (44/107)] versus the chemotherapy group [66.7% (72/108)]. OS in the exploratory analysis consistently favored the nivolumab group versus the chemotherapy group. Overall, nivolumab demonstrated favorable efficacy and safety versus chemotherapy in the Japanese subpopulation, and the trend was similar to that observed in the overall ATTRACTION-3 ITT population. CONCLUSION: Nivolumab represents a new standard second-line treatment option for Japanese patients with advanced ESCC.
BACKGROUND: The efficacy and safety of nivolumab versus chemotherapy was evaluated in the Japanese subpopulation from the overall intent-to-treat (ITT) population of the ATTRACTION-3 trial conducted in patients with advanced esophageal squamous cell carcinoma (ESCC) as second-line treatment. METHODS: Data from Japanese patients enrolled in the multicenter, randomized, open-label, phase 3 ATTRACTION-3 trial were analyzed. The primary endpoint was overall survival (OS). Secondary endpoints included duration of response (DOR), objective response rate (ORR), disease control rate (DCR), and safety. Exploratory subgroup analyses evaluated the association between OS and stratification factors/baseline variables. RESULTS: Overall, 274 (nivolumab, 136; chemotherapy, 138) of the 419 patients in ATTRACTION-3 were enrolled from Japan: response-evaluable population (107; 108) and safety population (135; 138). OS tended to be longer in the nivolumab group versus the chemotherapy group (median: 13.4 months vs. 9.4 months; HR, 0.77; 95% CI 0.59-1.01). Median DOR was longer in the nivolumab group (7.6 months) versus the chemotherapy group (3.6 months). ORRs were similar between the nivolumab [22.4% of patients (24/107)] and chemotherapy groups [22.2% (24/108); odds ratio, 0.98; 95% CI 0.52-1.87]. DCR was lower in the nivolumab group [41.1% (44/107)] versus the chemotherapy group [66.7% (72/108)]. OS in the exploratory analysis consistently favored the nivolumab group versus the chemotherapy group. Overall, nivolumab demonstrated favorable efficacy and safety versus chemotherapy in the Japanese subpopulation, and the trend was similar to that observed in the overall ATTRACTION-3 ITT population. CONCLUSION: Nivolumab represents a new standard second-line treatment option for Japanese patients with advanced ESCC.
Entities:
Keywords:
ATTRACTION-3; Esophageal squamous cell carcinoma; Japanese population; Nivolumab
Authors: K Muro; F Lordick; T Tsushima; G Pentheroudakis; E Baba; Z Lu; B C Cho; I M Nor; M Ng; L-T Chen; K Kato; J Li; M-H Ryu; W I Wan Zamaniah; W-P Yong; K-H Yeh; T E Nakajima; K Shitara; H Kawakami; Y Narita; T Yoshino; E Van Cutsem; E Martinelli; E C Smyth; D Arnold; H Minami; J Tabernero; J-Y Douillard Journal: Ann Oncol Date: 2019-01-01 Impact factor: 32.976
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