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Yiqi Zhuyu Decoction (益气逐瘀汤) Combined with FOLFOX-4 as first-line therapy in metastatic colorectal cancer

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Abstract

Objective

To evaluate the efficacy and safety of Yiqi Zhuyu Decoction (益气逐瘀汤, 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.

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Authors and Affiliations

  1. Department of Colorectal and Anal Surgery, the First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine, Guiyang, 550001, China

    Bo Cao  (曹 波), Zhi Li  (李 志) & Wen-ling Deng  (邓文玲)

  2. Department of Colorectal Surgery, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Colorectal Cancer Center of Shanghai Jiaotong University, Shanghai, 200092, China

    Shao-tang Li  (李绍堂)

Authors
  1. Bo Cao  (曹 波)
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  2. Shao-tang Li  (李绍堂)
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  3. Zhi Li  (李 志)
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  4. Wen-ling Deng  (邓文玲)
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Correspondence to Shao-tang Li  (李绍堂).

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Cao, B., Li, St., Li, Z. et al. Yiqi Zhuyu Decoction (益气逐瘀汤) Combined with FOLFOX-4 as first-line therapy in metastatic colorectal cancer. Chin. J. Integr. Med. 17, 593–599 (2011). https://doi.org/10.1007/s11655-011-0822-z

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  • DOI: https://doi.org/10.1007/s11655-011-0822-z

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