Randomized controlled trial of S-1 versus docetaxel in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy (East Asia S-1 Trial in Lung Cancer)
Journal
Annals of Oncology
Journal Volume
28
Journal Issue
11
Pages
2698-2706
Date Issued
2017
Author(s)
Nokihara H
Lu S
Mok T.S.K
Nakagawa K
Yamamoto N
Shi Y.K
Zhang L
Soo R.A
Sugawara S
Nishio M
Takahashi T
Goto K
Chang J
Maemondo M
Ichinose Y
Cheng Y
Lim W.T
Morita S
Tamura T.
Abstract
Background: Chemotherapy remains a viable option for the management of advanced non-small-cell lung cancer (NSCLC) despite recent advances in molecular targeted therapy and immunotherapy. We evaluated the efficacy of oral 5-fluorouracilbased S-1 as second- or third-line therapy compared with standard docetaxel therapy in patients with advanced NSCLC. Patients and methods: Patients with advanced NSCLC previously treated with?1 platinum-based therapy were randomized 1: 1 to docetaxel (60 mg/m2 in Japan, 75 mg/m2 at all other study sites; day 1 in a 3-week cycle) or S-1 (80-120 mg/day, depending on body surface area; days 1-28 in a 6-week cycle). The primary endpoint was overall survival. The non-inferiority margin was a hazard ratio (HR) of 1.2. Results: A total of 1154 patients (577 in each arm) were enrolled, with balanced patient characteristics between the two arms. Median overall survival was 12.75 and 12.52 months in the S-1 and docetaxel arms, respectively [HR 0.945; 95% confidence interval (CI) 0.833-1.073; P=0.3818]. The upper limit of 95% CI of HR fell below 1.2, confirming non-inferiority of S-1 to docetaxel. Difference in progression-free survival between treatments was not significant (HR 1.033; 95% CI 0.913-1.168; P=0.6080). Response rate was 8.3% and 9.9% in the S-1 and docetaxel arms, respectively. Significant improvement was observed in the EORTC QLQ-C30 global health status over time points in the S-1 arm. The most common adverse drug reactions were decreased appetite (50.4%), nausea (36.4%), and diarrhea (35.9%) in the S-1 arm, and neutropenia (54.8%), leukocytopenia (43.9%), and alopecia (46.6%) in the docetaxel arm. Conclusion: S-1 is equally as efficacious as docetaxel and offers a treatment option for patients with previously treated advanced NSCLC. ? The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Subjects
Docetaxel; Non-inferiority; Phase 3 study; Previously treated NSCLC; S-1
SDGs
Other Subjects
docetaxel; erlotinib; fluorouracil; gefitinib; gimeracil plus oteracil potassium plus tegafur; antineoplastic agent; docetaxel; oteracil; S 1 (combination); taxoid; tegafur; adult; advanced cancer; adverse drug reaction; aged; alopecia; Article; controlled study; decreased appetite; diarrhea; drug efficacy; drug safety; female; human; leukopenia; major clinical study; male; multiple cycle treatment; nausea; neutropenia; non small cell lung cancer; overall survival; phase 3 clinical trial; priority journal; progression free survival; randomized controlled trial; treatment duration; treatment response; adenocarcinoma; clinical trial; drug combination; drug effects; drug resistance; follow up; large cell carcinoma; lung tumor; middle aged; multicenter study; non small cell lung cancer; pathology; prognosis; salvage therapy; squamous cell carcinoma; survival rate; very elderly; young adult; Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Drug Combinations; Drug Resistance, Neoplasm; Female; Follow-Up Studies; Humans; Lung Neoplasms; Male; Middle Aged; Oxonic Acid; Prognosis; Salvage Therapy; Survival Rate; Taxoids; Tegafur; Young Adult
Publisher
Oxford University Press
Type
journal article