A Phase II Clinical Trial on the Combination Therapy of PHY906 Plus Capecitabine in Hepatocellular Carcinoma

The oncologist

article

Chun A. Changou¹  Her-Shyong Shiah¹  Li-Tzong Chen⁴  Servina Liu⁵  Frank Luh⁵  Shwu-Huey Liu⁶  Yung-Chi Cheng⁷  Yun Yen¹ 

[1] College of Medical Science and Technology, Taipei Medical University and Academia Sinica;The PhD program for Translational Medicine, College of Medical Science and Technology, Taipei Medical University;The Core Facility Center, Office of Research and Development, Taipei Medical University;National Health Research Institutes;Sino-American Cancer Foundation;Yiviva Inc.;Yale University School of Medicine

关键词: PHY906;    Capecitabine;    Hepatocellular carcinoma;    Chinese herbal medicine;   

DOI  :  10.1002/onco.13582

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

Background. This study aimed to evaluate efficacy and safety of capecitabine combined with a PHY906 (a pharmaceuticalgrade formulation of four traditional Chinese herbs) in the treatment of advanced hepatocellular carcinoma (HCC) in Asian patients who were positive for hepatitis B virus (HBV). Methods. This study was an open-label, phase II safety and efficacy clinical trial of PHY906 and capecitabine in patients with advanced HCC. Patients received 750 mg/m2 capecitabine b.i.d. 14 days plus 800 mg of PHY906 b.i.d. on days 1–4 and days 8–11 every 21-day cycle. The primary endpoint was 6-month survival rate, and secondary endpoints were progression-free survival, overall survival, disease control rate, and safety. Results. Thirty-nine subjects completed the study with a 46.2% stable disease rate. The median progression-free survival was 1.5 months, and median overall survival (mOS) was 6 months with a 51.3% 6-month survival rate. The most common adverse events included lower hemoglobin, diarrhea, pain, abdomen (not otherwise specified), fatigue, increased aspartate aminotransferase, and bilirubin. Patients who (a) had not received previous chemotherapies or targeted therapy or (b) had lower starting alpha-fetoprotein (AFP) levels or (c) had HBV infection showed better clinical outcome. Conclusion. Our data showed that PHY906 increases the therapeutic index of capecitabine by enhancing its antitumor activity and reduces its toxicity profile in advanced HCC.

【 授权许可】

CC BY|CC BY-NC