title: 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.
abstract: BACKGROUND
  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).
  
  
  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.
authors.affiliation: State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China ; Department of Medical Oncology, Dongguan People's Hospital, Dongguan, China.
authors.forename: Ke-Jun
authors.initials: KJ
authors.lastname: Liu
authors.affiliation: State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Zhong-Zhen
authors.initials: ZZ
authors.lastname: Guan
authors.affiliation: State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Liang
authors.affiliation: College of Chemistry and Molecular Engineering, Peking University, Beijing, China.
authors.forename: Xu-Qing
authors.initials: XQ
authors.lastname: Yang
authors.affiliation: State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Peng
authors.affiliation: State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: He
authors.initials: H
authors.lastname: Huang
authors.affiliation: Institute of Materia Medica, Zhejiang Academy of Medical Science, Hangzhou, China.
authors.forename: Qing-Xiang
authors.initials: QX
authors.lastname: Shao
authors.affiliation: Department of Respiratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Meng-Zhao
authors.initials: MZ
authors.lastname: Wang
authors.affiliation: Department of Oncology, Beijing Chest Hospital, Capital Medical University, Beijing, China.
authors.forename: Yun-Zhong
authors.initials: YZ
authors.lastname: Zhu
authors.affiliation: Department of Oncology, Third Affiliated Hospital of Soochow University, Changzhou, China.
authors.forename: Chang-Ping
authors.initials: CP
authors.lastname: Wu
authors.affiliation: Department of Internal Medicine, First Affiliated Hospital of Shantou University, Shantou, China.
authors.forename: Shao-Bin
authors.initials: SB
authors.lastname: Wang
authors.affiliation: Department of Oncology, First Affiliated Hospital of Nanchang University, Nanchang, China.
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Xiong
authors.affiliation: Department of Medical Oncology, Affiliated Tumor Hospital of Harbin Medical University, Harbin, China.
authors.forename: Yu-Xian
authors.initials: YX
authors.lastname: Bai
authors.affiliation: Tongji Cancer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Shi-Ying
authors.initials: SY
authors.lastname: Yu
authors.affiliation: Department of Medical Oncology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Oncology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China.
authors.forename: Xiao-Hua
authors.initials: XH
authors.lastname: Hu
authors.affiliation: Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
authors.forename: Ji-Feng
authors.initials: JF
authors.lastname: Feng
authors.affiliation: Department of Radiation Oncology, First Hospital, Wenzhou Medical College, Wenzhou, China.
authors.forename: Shi-Xiu
authors.initials: SX
authors.lastname: Wu
authors.affiliation: Department of Medical Oncology, Cancer Center, Chinese PLA General Hospital, Beijing, China.
authors.forename: Shun-Chang
authors.initials: SC
authors.lastname: Jiao
authors.affiliation: Department of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China.
authors.forename: Cai-Cun
authors.initials: CC
authors.lastname: Zhou
authors.affiliation: Department of Medical Oncology, Beijing Institute for Cancer Research, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Wang
authors.affiliation: State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Hai-Ying
authors.initials: HY
authors.lastname: Wu
keywords: dicycloplatin; first-line therapy; non-small-cell lung cancer (NSCLC); phase II study; platinum derivative