Premium
Gemcitabine plus oxaliplatin for patients with advanced hepatocellular carcinoma using two different schedules
Author(s) -
Taïeb Julien,
Bonyhay Luminita,
Golli Lamia,
Ducreux Michel,
Boleslawski Emmanuel,
Tigaud JeanMarie,
de Baere Thierry,
Mansourbakht Touraj,
Delgado Marie Anna,
Hannoun Laureut,
Poynard Thierry,
Boige Valerie
Publication year - 2003
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.11869
Subject(s) - medicine , oxaliplatin , gemcitabine , neutropenia , toxicity , hepatocellular carcinoma , gastroenterology , performance status , adverse effect , chemotherapy , surgery , cancer , colorectal cancer
BACKGROUND New therapies are needed to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Various gemcitabine‐oxaliplatin combinations have been tested recently in patients with ovarian and pancreatic carcinoma, yielding interesting results with little toxicity. Therefore, the authors evaluated the activity and toxicity of two such combinations in patients with HCC. METHODS Twenty‐one patients were enrolled prospectively in the study. Eleven patients received gemcitabine 1000 mg/m 2 on Day 1 and oxaliplatin 100 mg/m 2 on Day 2 (GEMOX‐1), and 10 patients received gemcitabine 1500 mg/m 2 on Day 1 followed by oxaliplatin 85 mg/m 2 on Day 1 (GEMOX‐2). Treatment was repeated every 2 weeks until disease progression developed or until unacceptable adverse effects occurred. RESULTS All patients were assessable for response and toxicity. Four patients (19%) achieved objective responses (95% confidence interval, 13–26%), including 3 patients in the GEMOX‐1 group and 1 patient in the GEMOX‐2 group. Ten patients (48%) had stable disease, and 7 patients (33%) experienced disease progression. The median progression‐free survival was 5 months, and the median overall survival was 12 months. Fifty‐four percent of patients in the GEMOX‐1 group and 50% of patients in the GEMOX‐2 group had received previous systemic chemotherapy or cisplatin‐based chemoembolization. Grade 3–4 hematologic toxicity, according to National Cancer Institute Common Toxicity Criteria, consisted of thrombocytopenia (GEMOX‐1 vs. GEMOX‐2, 18% vs. 40%) and neutropenia (0% vs. 30%). No Grade 3–4 nonhematologic toxicity was observed, except for 1 episode of Grade 3 diarrhea. Grade 1 neurotoxicity and Grade 2 neurotoxicity (specific scale), respectively, were observed in 4 patients and 7 patients receiving GEMOX‐1 and in 7 patients and 1 patient receiving GEMOX‐2. CONCLUSIONS Gemcitabine‐oxaliplatin combination therapy is feasible in patients with advanced HCC. The GEMOX‐1 regimen was tolerated better than the GEMOX‐2 regimen. Currently, the GEMOX‐1 regimen is being evaluated in a Phase II study in previously untreated patients with HCC. Cancer 2003;98:2664–70. © 2003 American Cancer Society.