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Arch Med Sci. 2014 Aug 29;10(4):717-24. doi: 10.5114/aoms.2014.44862.

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 information

1
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.
2
State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China.
3
College of Chemistry and Molecular Engineering, Peking University, Beijing, China.
4
Institute of Materia Medica, Zhejiang Academy of Medical Science, Hangzhou, China.
5
Department of Respiratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
6
Department of Oncology, Beijing Chest Hospital, Capital Medical University, Beijing, China.
7
Department of Oncology, Third Affiliated Hospital of Soochow University, Changzhou, China.
8
Department of Internal Medicine, First Affiliated Hospital of Shantou University, Shantou, China.
9
Department of Oncology, First Affiliated Hospital of Nanchang University, Nanchang, China.
10
Department of Medical Oncology, Affiliated Tumor Hospital of Harbin Medical University, Harbin, China.
11
Tongji Cancer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
12
Department of Medical Oncology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.
13
Department of Oncology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China.
14
Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
15
Department of Radiation Oncology, First Hospital, Wenzhou Medical College, Wenzhou, China.
16
Department of Medical Oncology, Cancer Center, Chinese PLA General Hospital, Beijing, China.
17
Department of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China.
18
Department of Medical Oncology, Beijing Institute for Cancer Research, Beijing, China.

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.

KEYWORDS:

dicycloplatin; first-line therapy; non-small-cell lung cancer (NSCLC); phase II study; platinum derivative

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