title: [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].
abstract: BACKGROUND
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medical Oncology, Cancer Hospital/Institute, Chinese Academy of Medical Sciences & PUMC, Beijing 100021, P.R.China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
authors.forename: Hongsheng
authors.initials: H
authors.lastname: Lin
authors.forename: Yunzhong
authors.initials: Y
authors.lastname: Zhu
authors.forename: Jifeng
authors.initials: J
authors.lastname: Feng
authors.forename: Zhengtang
authors.initials: Z
authors.lastname: Chen
authors.forename: Gongshu
authors.initials: G
authors.lastname: Li
authors.forename: Xiangru
authors.initials: X
authors.lastname: Zhang
authors.forename: Zongqi
authors.initials: Z
authors.lastname: Zhang
authors.forename: Junfang
authors.initials: J
authors.lastname: Tang
authors.forename: Meiqi
authors.initials: M
authors.lastname: Shi
authors.forename: Xuezhi
authors.initials: X
authors.lastname: Hao
authors.forename: Hui
authors.initials: H
authors.lastname: Han