A randomized, prospective, multi-centre clinical trial of NP regimen (vinorelbine+cisplatin) plus Gensing Rg3 in the treatment of advanced non-small cell lung cancer patients

Yan Sun, Hongsheng Zhu, Yunzhong Zhu, Jifeng Feng, Zhengtang Chen, Gongshu Li, Xiangru Zhang, Zongqi Zhang, Junfang Tang, Meiqi Shi, Xuezhi Hao, Hui Han

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37 Scopus citations

Abstract

Background and objective: Gensing Rg3 is an active component from ginseng. The aim of this study is to observe the clinical anticancer effect of Rg3 in combination with chemotherapy regimen NP (vinorelbine+cisplatin) in advanced non-small cell lung cancer (NSCLC). Methods: Stage III-IV NSCLC patients confirmed by pathology or cytology all received vinorelbine plus cisplatin for at least two cycles, and were randomized into two groups: patients in arm A also received placebo twice a day, while patients in arm B received two tablets of Rg3 twice a day for at least two months. The endpoints of the study were the efficacy, survival and tolerance of patients. Results: From July 2000 to May 2002, 115 patients were enrolled into the trial. The patients' characteristics were well balanced in the two groups. Sex of patients: male, 79; female 36. Types of pathology: adenocarcinoma, 71; squamous cell carcinoma, 29; adenosquamous carcinoma, 8; others, 7. TNM stage: stage III, 45; stage IV, 70. Prior chemotherapy: with, 17; without, 98. Prior radiotherapy: with, 15; without, 100. Prior surgical treatment: with. 23; without, 92. Nine patients discontinued from the trial due to severe adverse effects (5) and other reasons (4), so there were 106 patients evaluable for clinical efficacy. The response rate was 14.5% (8/55) in arm A, and 33.3% (17/51) in arm B (P = 0.011). The survival time in arm A was 9.7 months (mean) and 8.0 months (median), and 15.3 months (mean) and 10.0 months (median) in arm B (P = 0.0088). Conclusion: Preliminary results show improvements in response rate and survival time (median and mean) in Rg3 arm compared with placebo arm. It is worthy to confirm the results in further clinical trials.

Original languageEnglish
Pages (from-to)254-258
Number of pages5
JournalChinese Journal of Lung Cancer
Volume9
Issue number3
StatePublished - Jun 20 2006

Keywords

  • Advanced non-small cell lung cancer
  • Double-blind trial
  • Mean survivaltime
  • Median survival time
  • NP regimen Rg3 of Gensing
  • Response rate

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