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Phase I/II study of PHY906/capecitabine in advanced hepatocellular carcinoma

Medical Oncology, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA 91010-3000, USA.
Anticancer research (Impact Factor: 1.87). 10/2009; 29(10):4083-92.
Source: PubMed

ABSTRACT PHY906 is a Chinese medicine formula with claims for the treatment of severe gastrointestinal distress. PHY906 enhanced the therapeutic index of various chemotherapeutic agents in human hepatocellular carcinoma xenografts. Accordingly, here a phase I/II clinical study was conducted with the combination of capecitabine in patients with advanced, unresectable hepatocellular carcinoma. More than 60% of patients had either stable disease or better after two treatment cycles. Median overall survival was 9.2 months. Asian patients had a higher median overall survival (16.5 months) than non-Asian patients (6.2 months, p=0.03). Patients' quality of life did not deteriorate significantly during treatment. This finding supported further investigation of PHY906 as an adjuvant therapy of capecitabine in a larger hepatocellular cancer population.

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    • "In the United States, a Phase I study of PHY906 in combination with capecitabine was conducted in patients with advanced pancreatic cancer [8] and a similar Phase I/II study of PHY906 in combination with capecitabine in advanced hepatocellular carcinoma (HCC) were conducted [9]. Phytomics quality control is a characteristic methodology adopted, which combines chemical analysis, bioresponse analysis, and animal pharmacology to determine batch-to-batch reproducibility [9]. Formula is the major method and final carrier for TCM pricription. "
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