TY - JOUR
T1 - Japanese subgroup analysis of a phase III study of S-1 versus docetaxel in non-small cell lung cancer patients after platinum-based treatment
T2 - EAST-LC
AU - Sugawara, Shunichi
AU - Nakagawa, Kazuhiko
AU - Yamamoto, Nobuyuki
AU - Nokihara, Hiroshi
AU - Ohe, Yuichiro
AU - Nishio, Makoto
AU - Takahashi, Toshiaki
AU - Goto, Koichi
AU - Maemondo, Makoto
AU - Ichinose, Yukito
AU - Seto, Takashi
AU - Sakai, Hiroshi
AU - Gemma, Akihiko
AU - Imamura, Fumio
AU - Shingyoji, Masato
AU - Saka, Hideo
AU - Inoue, Akira
AU - Takeda, Koji
AU - Okamoto, Isamu
AU - Kiura, Katsuyuki
AU - Morita, Satoshi
AU - Tamura, Tomohide
N1 - Funding Information:
Hematologic toxicities Leucopenia Neutropenia Febrile neutropenia Anemia Thrombocytopenia Non-hematologic toxicities Stomatitis Nausea Vomiting Decreased appetite Diarrhea Constipation Maculopapular rash Skin hyperpigmentation Peripheral edema Pyrexia Weight loss Peripheral sensory neuropathy Cough Dyspnea Alopecia Acknowledgements This study was sponsored by Taiho Pharmaceutical Co., Ltd. We thank all the patients, their families, the clinicians at the medical centers named in Appendix A and the investigators who participated in this study. In addition, we would like to thank Ms Hikari Chiba and Ms Nicola Ryan from Edanz Medical Writing for providing medical writing services, which were funded by Taiho Pharmaceutical Co., Ltd.
Funding Information:
Conflict of interest Shunichi Sugawara: Taiho (Grant, Honoraria for lecture), Chugai, Pfizer, Nippon Boehringer Ingelheim, AstraZen-eca, Eli Lilly, Novartis, Kyowa Hakko Kirin, Bristol-Myers Squibb, Ono, MSD K.K (Honoraria for lecture); Kazuhiko Nakagawa: Taiho, Novartis, Nippon Boehringer Ingelheim, Takeda, Eli Lilly Japan, Ei-sai, MSD, Ono, Daiichi Sankyo, Chugai, AstraZeneca, Astellas (Grant, Personal fees), Oncotherapy Science, EPS Associates, Quintiles, Japan Clinical Research Operations (Grant); Nobuyuki Yamamoto: Taiho (Grant, Personal fees); Hiroshi Nokihara: Taiho (Grant/Research funding, Honoraria), Boehringer Ingelheim, AstraZeneca, Ono, Eli Lilly, Chugai (Research funding, Honoraria), Merck Serono, Pfizer, Eisai, Novartis, Daiichi Sankyo, GlaxoSmithKline, Yakult, Quintiles, As-tellas (Research funding), Sanofi, Bristol-Myers Squibb (Honoraria); Yuichiro Ohe: Taiho, Pfizer, MSD, Novartis (Grant, Honoraria for lecture), AstraZeneca, Chugai, Eli Lilly (Grant, Honoraria for consulting and lecture), Kyorin, Sumitomo Dainippon, Ignita (Grant), Daiichi Sankyo, Nippon Kayaku, Boehringer Ingelheim, Bayer (Honoraria for lecture); Makoto Nishio: Ono, Chugai, Bristol-Myers Squibb, Taiho, Eli Lilly, Pfizer, AstraZeneca (Research funding, Honoraria), Novartis, Astellas (Research funding); Toshiaki Takahashi: Taiho, Takeda, MSD (Grant), AstraZeneca, Eli Lilly Japan, Chugai, Ono (Grant, Person-
Funding Information:
al fees), Boehringer Ingelheim Japan (Personal fees); Koichi Goto: Taiho, Ono, Chugai, Bristol-Myers Squibb, Nippon Boehringer Ingel-heim, Pfizer, Kyowa Hakko Kirin, Eli Lilly Japan, Novartis, Daiichi Sankyo, AstraZeneca (Grant, Personal fees), MSD, Quintiles, Glaxo-SmithKline, OxOnc, Sumitomo Dainippon, Takeda, Astellas, Eisai, Amgen Astellas BioPharma, Merck Serono, AbbVie Stemcentrx, Riken Genesis (Grant), Yakult, Abbott Japan (Personal fees); Makoto Maemondo: Taiho (Grant); Takashi Seto: Astellas, AstraZeneca, Chu-gai, Daiichi Sankyo, Eli Lilly Japan, MSD, Nippon Boehringer Ingel-heim, Pfizer Japan, Yakult (Grant, Honoraria), Eisai, Merck Serono, Novartis, Verastem (Grant), Bristol-Myers Squibb, Kissei, Kyowa Hakko Kirin, Mochida, Nippon Kayaku, Ono, Roche Singapore, Sa-nofi, Showa Yakuhin Kako, Taiho, Takeda (Honoraria); Hiroshi Sakai: Bristol-Myers Squibb, Ono, Chugai (Grant); Akihiko Gemma: Taiho (Honoraria for lecture); Fumio Imamura: Taiho, AstraZeneca, Chugai, Ono, MSD, Eli Lilly, Pfizer, Boehringer Ingelheim (Grant, Personal fees); Hideo Saka: Taiho (Grant), AstraZeneca (Research funding, Honoraria), MSD, Eli Lilly Japan, Bristol-Myers Squibb, Sanofi, Chu-gai, Ono, Bayer (Research funding); Akira Inoue: Taiho (Honoraria for lecture); Koji Takeda: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Eli Lilly, Ono, Taiho, Pfizer (Grant, Personal fees), Merck Serono, Astellas, AbbVie, MSD (Grant), Daiichi Sankyo, Kyowa Hakko Kirin, Novartis (Personal fees); Isamu Okamoto: As-traZeneca, Taiho, Boehringer Ingelheim, Ono, MSD, Eli Lilly, Bristol-Myers Squibb, Chugai (Grant, Personal fees), Astellas, Novartis (Grant), Pfizer (Personal fees); Katsuyuki Kiura: Taiho, Chugai, Astra-Zeneca (Honoraria, Scholarship donation), Ono, Nippon Boehringer Ingelheim (Research funding, Honoraria, Scholarship donation), Pfizer Japan, Bristol-Myers Squibb, Eli Lilly Japan, Novartis, MSD (Honoraria), Shionogi, Daiichi Sankyo, Nippon Kayaku (Scholarship donation), Roch/Genentech/Chugai (Drug-supply); Satoshi Morita: Taiho (Personal fees); Tomohide Tamura: Taiho, Chugai, Eisai, Yakult, Eli
PY - 2019/5/15
Y1 - 2019/5/15
N2 - Introduction: The East Asia S-1 Trial in Lung Cancer (EAST-LC) was a randomized phase III study conducted in East Asia that demonstrated the non-inferiority of S-1 to docetaxel in previously treated patients with advanced non-small cell lung cancer (NSCLC). Here, we reported the results of the Japanese subgroup treated with docetaxel 60 mg/m 2 , the standard dosage in Japan. Patients and methods: Patients were randomized 1:1 to receive either S-1 or docetaxel. The primary endpoint was overall survival (OS); the secondary endpoints included progression-free survival (PFS), response rate (RR), quality of life (QOL), and safety. Results: Patient characteristics in the Japanese subgroup (n = 724) were similar to those in the overall EAST-LC population. Median OS was 13.4 months in the S-1 group and 12.6 months in the docetaxel group. In pemetrexed-pretreated patients, OS with S-1 was similar to that with docetaxel. Median PFS was 2.9 and 3.0 months in the S-1 and docetaxel groups, respectively. RR was 9.4% and 10.3% in the S-1 and docetaxel groups, respectively. The QOL of patients treated with S-1 was better compared with that of patients treated with docetaxel. Decreased appetite and diarrhea were more common in the S-1 group, whereas the frequency of neutropenia and febrile neutropenia was markedly higher in the docetaxel group. Conclusions: This Japanese subgroup analysis showed that S-1 had similar efficacy to docetaxel in patients with previously treated advanced NSCLC. These results are similar to those of the overall EAST-LC population.
AB - Introduction: The East Asia S-1 Trial in Lung Cancer (EAST-LC) was a randomized phase III study conducted in East Asia that demonstrated the non-inferiority of S-1 to docetaxel in previously treated patients with advanced non-small cell lung cancer (NSCLC). Here, we reported the results of the Japanese subgroup treated with docetaxel 60 mg/m 2 , the standard dosage in Japan. Patients and methods: Patients were randomized 1:1 to receive either S-1 or docetaxel. The primary endpoint was overall survival (OS); the secondary endpoints included progression-free survival (PFS), response rate (RR), quality of life (QOL), and safety. Results: Patient characteristics in the Japanese subgroup (n = 724) were similar to those in the overall EAST-LC population. Median OS was 13.4 months in the S-1 group and 12.6 months in the docetaxel group. In pemetrexed-pretreated patients, OS with S-1 was similar to that with docetaxel. Median PFS was 2.9 and 3.0 months in the S-1 and docetaxel groups, respectively. RR was 9.4% and 10.3% in the S-1 and docetaxel groups, respectively. The QOL of patients treated with S-1 was better compared with that of patients treated with docetaxel. Decreased appetite and diarrhea were more common in the S-1 group, whereas the frequency of neutropenia and febrile neutropenia was markedly higher in the docetaxel group. Conclusions: This Japanese subgroup analysis showed that S-1 had similar efficacy to docetaxel in patients with previously treated advanced NSCLC. These results are similar to those of the overall EAST-LC population.
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UR - http://www.scopus.com/inward/citedby.url?scp=85062699644&partnerID=8YFLogxK
U2 - 10.1007/s10147-019-01396-z
DO - 10.1007/s10147-019-01396-z
M3 - Article
C2 - 30830659
AN - SCOPUS:85062699644
VL - 24
SP - 485
EP - 493
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
IS - 5
ER -