Phase I/II study of PHY906/capecitabine in advanced hepatocellular carcinoma.
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.
Medical Oncology, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA 91010-3000, USA. yyen@coh.org
Yun
Y
Yen
Samuel
S
So
Michal
M
Rose
M Wasif
MW
Saif
Edward
E
Chu
Shwu-Huey
SH
Liu
Angeline
A
Foo
Zaoli
Z
Jiang
Tahmun
T
Su
Yung-Chi
YC
Cheng
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D015996:Survival Rate
D004365:Drugs, Chinese Herbal; C476037:PHY 906; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil