Abstract | BACKGROUND: METHODS: Patients were assigned into groups (3:1 ratio) to receive either chemotherapy + CAI or chemotherapy alone. Cisplatin (25 mg/m2) was administered by intravenous infusion on days 1, 2, and 3, and vinorelbine (25 mg/m2) on days 1 and 8 of each 3-week cycle for four cycles. CAI was administered at 100 mg daily with concomitant chemotherapy; this treatment was continued after chemotherapy was ceased until serious toxicity or disease progression had occurred. PFS was the primary endpoint, and the secondary endpoints were objective response rate (ORR), disease control rate, overall survival (OS), and quality of life. RESULTS: In total, 495 patients were enrolled in the trial: 378 in the chemotherapy + CAI group and 117 in the chemotherapy + placebo group. PFS was significantly greater in the chemotherapy + CAI [median, 134 days; 95% confidence interval (CI) 127-139] than in the chemotherapy + placebo (median, 98 days; 95% CI: 88-125) group, with a hazard ratio of 0.690 (95% CI: 0.539-0.883; p = 0.003). There was no difference in the OS rates of both groups. The ORR was greater in the chemotherapy + CAI group than in the chemotherapy + placebo group (34.6% versus 25.0%, p = 0.042). Adverse events of ⩾grade 3 occurred more frequently in the CAI group [256 (68.1%) versus 64 (55.2%); p = 0.014]. CONCLUSION: CAI + platinum-based chemotherapy prolonged PFS and could be a useful therapeutic option to treat NSCLC. CLINICAL TRIAL REGISTRATION: chinadrugtrials.org.cn identifier: CTR20160395.
|
Authors | Xiaoyan Si, Jinwan Wang, Ying Cheng, Jianhua Shi, Liying Cui, Helong Zhang, Yunchao Huang, Wei Liu, Lei Chen, Jiang Zhu, Shucai Zhang, Wei Li, Yan Sun, Hanping Wang, Xiaotong Zhang, Mengzhao Wang, Lin Yang, Li Zhang |
Journal | Therapeutic advances in medical oncology
(Ther Adv Med Oncol)
Vol. 12
Pg. 1758835920965849
( 2020)
ISSN: 1758-8340 [Print] England |
PMID | 33281949
(Publication Type: Journal Article)
|
Copyright | © The Author(s), 2020. |
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|