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.

  • Source
    • "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. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Translational Chinese medicine is one of the latest developing fields in traditional Chinese medicine. In this paper, we discuss the "3 w" namely, "what is", "why to advance", "how to carry out" and the significance of translational Chinese medicine. To overcome the innate drawbacks of traditional Chinese medicine (TCM), the basic theory of TCM had better be refreshed. The safety and efficacy of classic formulae and therapy ex-perience of TCM should be evaluated based on strict quality control and reaffirmed with evidence based medicine. The significance of translational Chinese medicine is to transform Chinese medicine into a balan-ced, personalized medicine with sound safety, good efficacy and strict quality control.
    Chinese Medicine 01/2011; 02(04). DOI:10.4236/cm.2011.24029
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The use of complementary and alternative medicine (CAM) has become a core component of the daily challenges faced when treating cancer patients. PHY906 is a formulation of four herbal compounds traditionally used to treat nausea, vomiting, cramping, and diarrhea. Diarrhea is one of the major side effects of the cancer drug irinotecan. In this issue of Science Translational Medicine, Lam and colleagues report that administration of PHY906 with irinotecan in a mouse model of colon cancer resulted in a synergistic reduction in tumor burden, maintenance of body weight, and stem cell regeneration in the intestinal mucosa. Yet when considering CAM use in the treatment of cancer patients, one must take into account reproducibility of preclinical findings in clinical practice, quality assurance of herbal products, and potential toxicities associated with alternative therapies.
    Science translational medicine 08/2010; 2(45):45ps41. DOI:10.1126/scitranslmed.3001517 · 14.41 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Establishing botanical extracts as globally-accepted polychemical medicines and a new paradigm for disease treatment, requires the development of high-level quality control metrics. Based on comprehensive chemical and biological fingerprints correlated with pharmacology, we propose a general approach called PhytomicsQC to botanical quality control. Incorporating the state-of-the-art analytical methodologies, PhytomicsQC was employed in this study and included the use of liquid chromatography/mass spectrometry (LC/MS) for chemical characterization and chemical fingerprinting, differential cellular gene expression for bioresponse fingerprinting and animal pharmacology for in vivo validation. A statistical pattern comparison method, Phytomics Similarity Index (PSI), based on intensities and intensity ratios, was used to determine the similarity of the chemical and bioresponse fingerprints among different manufactured batches. Eighteen batch samples of Huangqin Tang (HQT) and its pharmaceutical grade version (PHY906) were analyzed using the PhytomicsQC platform analysis. Comparative analysis of the batch samples with a clinically tested standardized batch obtained values of PSI similarity between 0.67 and 0.99. With rigorous quality control using analytically sensitive and comprehensive chemical and biological fingerprinting, botanical formulations manufactured under standardized manufacturing protocols can produce highly consistent batches of products.
    Chinese Medicine 08/2010; 5:30. DOI:10.1186/1749-8546-5-30 · 2.34 Impact Factor
Show more