1. A double-blind, randomized phase II study of dicycloplatin plus paclitaxel versus carboplatin plus paclitaxel as first-line therapy for patients with advanced non-small-cell lung cancers
- Author
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Hai Ying Wu, Shi Ying Yu, Chang Ping Wu, Xiao A. Hu, He Huang, Ying Liang, Cai Cun Zhou, Jian Ping Xiong, Qing Xiang Shao, Zhong Zhen Guan, Shunchang Jiao, Yang Zhang, Xu Qing Yang, Ke Jun Liu, Jie Wang, Yun Zhong Zhu, Shaobin Wang, Jin Peng, Yu Xian Bai, Shi Xiu Wu, Mengzhao Wang, and Ji Feng
- Subjects
medicine.medical_specialty ,business.industry ,non-small cell lung cancer (NSCLC) ,Phases of clinical research ,non-small-cell lung cancer (NSCLC) ,General Medicine ,Pharmacology ,medicine.disease ,Gastroenterology ,platinum derivative ,Carboplatin ,dicycloplatin ,chemistry.chemical_compound ,chemistry ,Paclitaxel ,Clinical Research ,Internal medicine ,first-line therapy ,Toxicity ,medicine ,business ,Adverse effect ,Lung cancer ,phase II study ,Dicycloplatin - Abstract
Introduction The aim of this study was to compare the efficacy and toxicity of dicycloplatin plus paclitaxel with those of carboplatin plus paclitaxel as first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC). Material and methods In this study, 240 NSCLC patients with stage IIIB (with pleural effusion) and stage IV disease were randomly assigned (1: 1) to receive dicycloplatin 450 mg/m(2) or carboplatin AUC = 5, in combination with paclitaxel 175 mg/m(2) (D + P or C + P) every 3 weeks for up to 4 to 6 cycles. The primary endpoint was response rate. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and adverse events. Results The response rates for the D + P and C + P arm were 36.44% and 30.51%, respectively (p = 0.33). The median PFS was 5.6 months in the D + P arm and 4.7 months in the C + P arm (p = 0.31). The median OS was 14.9 months for D + P and 12.9 months for C + P (p = 0.37). Adverse events in the two arms were well balanced. The most common grade 3/4 adverse event was hematologic toxicity. Conclusions Patients treated with D + P had similar response and survival rates to those treated with C + P, and toxicities of both treatments were generally tolerable.
- Published
- 2014