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A randomized phase 3 study of maintenance therapy with S‐1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S‐1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L)
Author(s) -
Tanaka Kaoru,
Morita Satoshi,
Ando Masahiko,
Yokoyama Takuma,
Nakamura Atsushi,
Yoshioka Hiroshige,
Ishiguro Takashi,
Miura Satoru,
Toyozawa Ryo,
Oguri Tetsuya,
Daga Haruko,
Ko Ryo,
Bessho Akihiro,
Tachihara Motoko,
Iwamoto Yasuo,
Hirano Katsuya,
Nakanishi Yoichi,
Nakagawa Kazuhiko,
Yamamoto Nobuyuki,
Okamoto Isamu
Publication year - 2020
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.32987
Subject(s) - medicine , carboplatin , hazard ratio , randomized controlled trial , maintenance therapy , induction chemotherapy , confidence interval , lung cancer , performance status , anemia , oncology , chemotherapy , surgery , cisplatin
Background A randomized phase 3 study was performed to investigate the efficacy and safety of maintenance therapy with S‐1 after induction therapy with carboplatin plus S‐1 in patients with advanced squamous non–small cell lung cancer (NSCLC). Methods Chemotherapy‐naive patients with advanced or relapsed squamous NSCLC were treated with carboplatin (area under the curve of 5 on day 1 every 3 weeks) plus S‐1 (40 mg/m 2 twice per day on days 1‐14 every 3 weeks) as induction therapy. Patients who did not progress after 4 cycles of induction therapy were randomized to receive either S‐1 plus best supportive care (BSC) or BSC alone. The primary objective of the study was to confirm the superiority of S‐1 plus BSC in comparison with BSC alone with respect to progression‐free survival. Results Of the 365 patients enrolled in the study, 347 participated in the induction phase, and 131 of these individuals were randomized to receive S‐1 plus BSC (n = 67) or BSC alone (n = 64). The risk of disease progression was significantly lower for patients in the S‐1 plus BSC arm than those in the BSC‐alone arm (hazard ratio, 0.548; 95% confidence interval, 0.374‐0.802; P = .0019). The most common toxicities during maintenance therapy with S‐1 included anorexia, anemia, and fatigue, but most cases were not severe. Conclusions Continued maintenance with S‐1 plus BSC is an effective and well‐tolerated treatment option for patients with advanced squamous NSCLC previously treated with carboplatin plus S‐1.