PMID- 21826593
OWN - NLM
STAT- MEDLINE
DCOM- 20111227
LR  - 20211020
IS  - 1993-0402 (Electronic)
IS  - 1672-0415 (Linking)
VI  - 17
IP  - 8
DP  - 2011 Aug
TI  - Yiqi zhuyu decoction combined with FOLFOX-4 as first-line therapy in metastatic 
      colorectal cancer.
PG  - 593-9
LID - 10.1007/s11655-011-0822-z [doi]
AB  - 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.
FAU - Cao, Bo
AU  - Cao B
AD  - Department of Colorectal and Anal Surgery, First Affiliated Hospital of Guiyang 
      College of Traditional Chinese Medicine, Guiyang, China.
FAU - Li, Shao-tang
AU  - Li ST
FAU - Li, Zhi
AU  - Li Z
FAU - Deng, Wen-ling
AU  - Deng WL
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20110809
PL  - China
TA  - Chin J Integr Med
JT  - Chinese journal of integrative medicine
JID - 101181180
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (yiqi zhuyu)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
RN  - Folfox protocol
SB  - IM
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Colorectal Neoplasms/*drug therapy/*pathology
MH  - Disease-Free Survival
MH  - Drugs, Chinese Herbal/adverse effects/*therapeutic use
MH  - Female
MH  - Fluorouracil/adverse effects/therapeutic use
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Leucovorin/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Organoplatinum Compounds/adverse effects/therapeutic use
MH  - Patient Dropouts
MH  - Treatment Outcome
EDAT- 2011/08/10 06:00
MHDA- 2011/12/28 06:00
CRDT- 2011/08/10 06:00
PHST- 2010/11/22 00:00 [received]
PHST- 2011/08/10 06:00 [entrez]
PHST- 2011/08/10 06:00 [pubmed]
PHST- 2011/12/28 06:00 [medline]
AID - 10.1007/s11655-011-0822-z [doi]
PST - ppublish
SO  - Chin J Integr Med. 2011 Aug;17(8):593-9. doi: 10.1007/s11655-011-0822-z. Epub 
      2011 Aug 9.