A randomized phase III study of docetaxel alone versus docetaxel plus S‐1 in patients with previously treated non‐small cell lung cancer: JMTO LC09‐01

Autor: Shinji Atagi, Takashi Daimon, Kyoichi Okishio, Kiyoshi Komuta, Yoshio Okano, Koichi Minato, Young Hak Kim, Ryo Usui, Chiharu Tabata, Atsuhisa Tamura, Masaaki Kawahara
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Thoracic Cancer, Vol 14, Iss 29, Pp 2941-2949 (2023)
Druh dokumentu: article
ISSN: 1759-7714
1759-7706
DOI: 10.1111/1759-7714.15080
Popis: Abstract Background This study evaluated the efficacy and safety of the combination chemotherapy of docetaxel plus S‐1 in patients with previously treated non‐small cell lung cancer (NSCLC) compared to docetaxel alone. Methods Patients with previously treated NSCLC were randomly assigned to docetaxel alone (arm A) or a combination of docetaxel and S‐1 (arm B) for a maximum of four cycles. The primary endpoint was overall survival (OS). Results The study was terminated early because of poor accrual. The number of patients evaluated were 74 and 77 in arm A and arm B, respectively. The median OS was 9.8 months (95% confidence interval [CI]: 6.8–15.2) and 12.3 months (95% CI: 9.2–14.5) in arms A and B, respectively. In arms A and B, the median progression‐free survival was 3.5 months (95% CI: 2.7–4.0) and 4.1 months (95% CI: 3.2–4.7), respectively. No statistically significant difference was observed in OS (hazard ratio [HR]: 0.984, 95% CI: 0.682–1.419, p = 0.4569) or progression‐free survival (HR: 0.823, 95% CI: 0.528–1.282, p = 0.0953). The major toxicity was myelosuppression. The incidence of grade 3 or more neutropenia was higher in arm A than in arm B (44.6% vs. 35.1%). However, the incidence of grade 3 or more febrile neutropenia and infection with neutropenia (12.2% vs. 22.1%) was more frequently observed in arm B. Conclusions The prematurely terminated study did not show the benefit of two cytotoxic agents over single‐agent therapy for previously treated NSCLC patients.
Databáze: Directory of Open Access Journals
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