title: Yiqi zhuyu decoction combined with FOLFOX-4 as first-line therapy in metastatic colorectal cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of yiqi zhuyu decoction (YZD) combined with oxaliplatin plus 5-flurouracil/leucovorin (FOLFOX-4) in the patients with metastatic colorectal cancer (MCRC).
  
  
  METHODS
  A total of 120 patients with MCRC were randomly divided into the experimental group (FOLFOX-4 plus YZD, 60 cases) and the control group (FOLFOX-4 plus placebo, 60 cases), according to the sequence of hospitalization from January 2005 to December 2007. The treatment was supposed to be continued until disease progression (PD) or for 48 weeks (i.e., up to 24 cycles of FOLFOX-4). Response rate (RR), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were observed.
  
  
  RESULTS
  RR was 41.5% in the experimental group and 34.0% in the control group [odds ratio (OR): 1.18, 95% CI: 0.77 to 1.82, P=0.432]. Median PFS were 9.0 months and 8.0 months, respectively [hazard ratio (HR): 0.78, 95% CI: 0.53 to 1.15, P=0.215]. Median OS were 21.0 months and 18.0 months (HR: 0.65, 95% CI: 0.43 to 0.99, P=0.043) and grade 3/4 AEs were 56.6% and 76.7% (OR: 0.61, 95% CI: 0.18 to 0.87, P=0.020), respectively.
  
  
  CONCLUSIONS
  YZD combined with FOLFOX-4 chemotherapy significantly improved OS in this first-line trial in the patients with MCRC and significantly decreased grade 3/4 AEs. However, RR was not improved, and PFS did not reach statistical significance by the addition of YZD. The treatment of YZD combined with FOLFOX-4 may be necessary in order to optimize efficacy and safety.
authors.affiliation: Department of Colorectal and Anal Surgery, First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine, Guiyang, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Cao
authors.forename: Shao-tang
authors.initials: ST
authors.lastname: Li
authors.forename: Zhi
authors.initials: Z
authors.lastname: Li
authors.forename: Wen-ling
authors.initials: WL
authors.lastname: Deng
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D057194:Intention to Treat Analysis; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D010352:Patient Dropouts; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004365:Drugs, Chinese Herbal; D009944:Organoplatinum Compounds; C568851:yiqi zhuyu; D002955:Leucovorin; D005472:Fluorouracil