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Pegylated liposomal doxorubicin and gemcitabine in patients with advanced hepatocellular carcinoma
Author(s) -
Lombardi Giuseppe,
Zustovich Fable,
Farinati Fabio,
Cillo Umberto,
Vitale Alessandro,
Zanus Giacomo,
Donach Martin,
Farina Miriam,
Zovato Stefania,
Pastorelli Davide
Publication year - 2010
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.25578
Subject(s) - medicine , gemcitabine , neutropenia , doxorubicin , hepatocellular carcinoma , toxicity , gastroenterology , clinical endpoint , surgery , chemotherapy , phases of clinical research , oncology , clinical trial
Abstract BACKGROUND: Over the years, doxorubicin and gemcitabine have been among the most widely used drugs for hepatocellular carcinoma (HCC), with relative efficacy. The authors report the results of a phase 2 study of the combination of gemcitabine plus pegylated liposomal doxorubicin. METHODS: Patients with advanced HCC received combination chemotherapy with gemcitabine 1000 mg/m 2 on Days 1 and 8, followed by pegylated liposomal doxorubicin 30 mg/m 2 on Day 1. Treatment was repeated every 4 weeks to a maximum of 8 cycles. Primary endpoint was overall response rate, and secondary endpoints were time to disease progression (TTP), overall survival (OS), and toxicity. RESULTS: Forty‐one patients were enrolled and were evaluable for response, toxicity, and survival. A total of 194 cycles of treatment were administered. Three (7%) patients had a complete response, and 1 of these patients underwent liver transplantation. Seven (17%) patients had a partial response and, among these patients, 1 patient underwent surgical resection. Among the 31 patients who had initial alpha‐fetoprotein levels >400 ng/mL, 20 (64.5%) had a >20% decrease after 2 cycles of treatment. The median TTP and OS were 5.8 and 22.5 months, respectively. Hematologic toxicity was the most common side effect, including neutropenia (17%) and anemia (7%). CONCLUSIONS: The combination of gemcitabine plus pegylated liposomal doxorubicin was active and safe in advanced HCC. Moreover, this treatment induced some complete responses and converted some untreatable HCCs into lesions eligible for resection or transplantation. Cancer 2011. © 2010 American Cancer Society.