Affiliation:
1. Tetsuya Abe and Akira Yokoyama, Niigata Cancer Center Hospital, Niigata; Koji Takeda, Osaka City General Hospital; Shinzoh Kudoh, Osaka City University; Shinichiro Nakamura, West Japan Oncology Group Data Center; Kazuhiko Nakagawa, Kinki University, Osaka; Yuichiro Ohe, National Cancer Center Hospital East, Chiba; Yukito Ichinose, National Kyushu Cancer Center, Fukuoka; Hiroaki Okamoto, Yokohama Municipal Citizens Hospital, Kanagawa; Nobuyuki Yamamoto, Wakayama Medical University School of Medicine,...
Abstract
Purpose This phase III trial aimed to confirm the superiority of weekly docetaxel and cisplatin over docetaxel monotherapy in elderly patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods Chemotherapy-naïve patients with stage III, stage IV, or recurrent NSCLC age ≥ 70 years with a performance status of 0 or 1 who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15, every 4 weeks. The primary end point was overall survival (OS). Results In the first interim analysis, OS of the doublet arm was inferior to that of the monotherapy arm (hazard ratio [HR], 1.56; 95% CI, 0.98 to 2.49), and the predictive probability that the doublet arm would be statistically superior to the monotherapy arm on final analysis was 0.996%, which led to early study termination. In total, 276 patients with a median age of 76 years (range, 70 to 87 years) were enrolled. At the updated analysis, the median survival time was 14.8 months for the monotherapy arm and 13.3 months for the doublet arm (HR, 1.18; 95% CI, 0.83 to 1.69). The rates of grade ≥ 3 neutropenia and febrile neutropenia were higher in the monotherapy arm, and those of anorexia and hyponatremia were higher in the doublet arm. Conclusion This study failed to demonstrate any survival advantage of weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for advanced NSCLC in elderly patients.
Publisher
American Society of Clinical Oncology (ASCO)
Cited by
96 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献