Friday, September 21, 2012

Gemcitabine/oxaliplatin treatment effective in patients with advanced HCC

Gemcitabine/oxaliplatin treatment effective in patients with advanced HCC

Zaanan A. J Hepatol. 2012;doi:10.1016/j.jhep.2012.09.006.

September 21, 2012
Patients with hepatocellular carcinoma were responsive to therapy with gemcitabine and oxaliplatin, with some able to undergo previously unfeasible curative treatments, in a recent study.

In a retrospective multicenter study, researchers evaluated 204 patients with advanced hepatocellular carcinoma who received treatment with gemcitabine and oxaliplatin (GEMOX) between 2001 and 2010. Survival and response rates were determined along with predictive factors and incidence of toxicity and disease progression for a median follow-up of 15 months.

Disease control, defined as response with disease stabilization, occurred in 66% of patients, and disease response occurred in 22%. Patients who experienced response were subsequently eligible for secondary surgical resection of residual tumors, including 10 patients who received orthotopic liver transplantation, three who received transarterial chemoembolization, two who underwent radioembolization and one each who received radiofrequency ablation and cyberknife treatment.

Investigators did not observe associations between response and any clinical or biological factors.

Disease progression occurred in 106 participants during follow-up, with a median time to progression of 8 months. No independent associations were observed between time to progression and any evaluated variables. Tumor progression or death occurred in 156 patients; 122 participants died upon conclusion of follow-up.

The median length of progression-free survival was 4.5 months, with an overall median survival length of 11 months. Overall survival was associated with GEMOX response (HR=0.38, 0.23-0.63), along with gender (HR=0.48, 0.24-0.94 for women compared with men), cancer of the liver Italian program (CLIP) score (HR=2.30, 1.11-4.80 for scores greater than 3 compared with 0-1) and the presence of underlying cirrhosis (HR=2.32, 1.17-4.60). Progression-free survival was associated with CLIP score (HR=1.99, 1.16-3.42) and baseline AFP levels (HR=1.49, 1.003-2.21 for levels greater than 15 ng/mL compared with 15 ng/mL or less) (95% CI for all).

Toxicity of grades 3-4 occurred in 44% of participants, including occurrences of thrombocytopenia (24% of toxicity cases), neutropenia (18.1%), diarrhea (13.7%) and neurotoxicity (11.7%). Treatment was discontinued in 32 cases, and three deaths occurred that were related to adverse effects from GEMOX.

“The results of this large, multicenter study suggest that GEMOX is effective with an acceptable profile of safety,” the researchers wrote. “Pending the results of ongoing randomized trials comparing sorafenib plus GEMOX vs. sorafenib alone, GEMOX may also be a therapeutic option after sorafenib discontinuation in the absence of validated second-line treatment.”

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