Evaluation of Safety and Efficacy of Salvage Therapy With Sunitinib, Docetaxel (Tyxane) and Cisplatinum Followed by Maintenance Vinorelbine for Unresectable/Metastatic Nonsmall Cell Lung Cancer: Stage 1 of a Simon 2 Stage Clinical Trial. Issue 52 (December 2015)

• Record Type: Journal Article
• Authors: Tai, Cheng-Jeng; Wang, Chien-Kai; Tai, Chen-Jei; Tzao, Ching; Lien, Yung-Chang; Hsieh, Chih-Cheng; Hsieh, Cheng-I; Wu, Hong-Cheng; Wu, Chih-Hsiung; Chang, Chun-Chao; Chen, Ray-Jade; Chiou, Hung-Yi
• Editors: Yang., Chengwu
• Is Part Of: Medicine. Volume 94:Issue 52(2015)
• Page Start: e2303
• Publication Date: 2015-12
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Médecine -- Périodiques; Geneeskunde; Medicine; Periodicals; Periodicals; 610.5
• DOI: 10.1097/MD.0000000000002303
• Languages: English
• ISSNs: 0025-7974

Abstract

Abstract : Abstract: Current chemotherapeutic regimens for nonsmall cell lung cancer (NSCLC) have reached a plateau over the last few years. Targeted therapy makes use of tyrosine kinase inhibitors (TKIs) to suppress a number of signaling pathways including epidermal growth factor receptor and vascular endothelial growth factor which are active in NSCLC biology. In this study, we used sunitinib, a multi-target receptor TKI, combined with chemotherapy for unresectable/metastatic NSCLC. This open label Simon's 2 stage clinical trial enrolled a total of 6 NSCLC patients who received docetaxel (40 mg) and cisplatin (50 mg) on day 1 of each cycle (14 day interval between cycles) and sunitinib (25 mg qd for 10 days between cycles) for a total of 12 cycles (24 weeks), after which patients received maintenance therapy with vinorelbine (30 mg TIW) until disease progression. The sample size was based on a Simon's Optimal Two-Stage Designs for Phase II clinical trials. The expected response rate was set as 35% for P0 and as 60% for P1. The study was designed for a minimum of 6 patients for first stage and 15 patients until second stage with a significance level alpha = 0.10 and power = 70%. Diagnosis of a poor response in the second of 6 patients in Stage I or seventh of the 15 patients in Stage II would lead to early termination of the trial. The overall response rate was 66.7%. Four patients had an overall survival >60 months. The time to PFS ranged from 3 to 42 months. The combination therapy was well-tolerated. Sunitinib combined with chemotherapy shows promise and warrants further investigation.