Gemcitabine Plus Oxaliplatin (GEMOX) 'Effective' in Advanced Hepatocellular Carcinoma
“Tumor responses permitted potentially curative treatment that was not initially feasible in a significant proportion of patients,” reported Julien Taïeb, MD, PhD, of the Georges Pompidou European Hospital in Paris, France, and coauthors.
The study team analyzed data from medical records for 204 consecutively-treated patients administered GEMOX between 2001 and 2010; 8.5% of patients were subsequently eligible for curative-intent therapies after downstaging, the authors reported.
Median age was 60 years and men represented 86% of study participants. “All patients received gemcitabine 1,000 mg/m2 on Day 1 followed by oxaliplatin 100 mg/m2 as a 2-hour infusion on Day 2,” the authors reported. Grade 3-4 non-neurosensory toxicities resulted in delayed, 20% reduced-dose subsequent cycle (administered after recovery).
Overall response and disease control rates were 22% and 66%, respectively. Median progression-free survival (PFS) time for GEMOX patients was 4.5 months (95% CI:4-6) and median overall survival (OS) was 11 months (95% CI:9-14). (Two previously published large, randomized trials of sorafenib reported median OS of 6.5 and 10.7 months, the authors noted.)
Grade 3-4 toxicity occurred in 44% of the patients, and led to a halt in GEMOX therapy in 16% of patients in the study. Grade 3-4 thrombocytopenia was seen in 24% of patients; grade 3-4 neutropenia and diarrhea was present in 18% and 14% of patients, respectively, and grade 3-4 neurotoxicity was recorded in 12% of patients.
Underlying cirrhosis was present in 76% of the study participants. Multivariate analyses identified independent associations with OS for GEMOX response (P<0.0001) and underlying cirrhosis (P=0.01).
The authors reported that they have no funding or other conflicts of interest. No financial support was reported for the study.