November 10, 2014
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FIRGEM regimen effective in metastatic pancreatic cancer

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Patients with metastatic pancreatic adenocarcinoma who received FOLFIRI.3 chemotherapy alternating with fixed-dose rate gemcitabine demonstrated improved response and longer survival than those treated with fixed-dose rate gemcitabine alone, according to results of a randomized phase 2 study.

Fluorouracil- and irinotecan-based regimens, as well as gemcitabine-based regimens, are standards of care for first-line therapy for patients with metastatic pancreatic cancer. However, poor outcomes in this patient population demonstrate the need for new, effective treatment options to extend survival and improve quality of life.

Researchers in France conducted an open-label, multicenter study, to determine the safety and efficacy of the FIRGEM regimen, which entails alternating FOLFIRI.3 — which consists of irinotecan, leucovorin and fluorouracil — with gemcitabine.

The analysis included 98 patients with WHO performance status of 0-1 and bilirubin levels <1.5 upper limit of normal values.

Researchers assigned half of the patients to first-line treatment with FIRGEM, which consisted of FOLFIRI.3 alternating with fixed-dose rate gemcitabine in 2-month intervals. The other half of patients received fixed-dose rate gemcitabine alone.

The crude PFS rate at 6 months served as the primary outcome measure. Treatment continued until disease progression or limiting toxicity.

Researchers reported higher rates of objective response (37% vs. 10%) and 6-month PFS (43.5% vs. 26.1%) among patients assigned the FIRGEM regimen.

Results showed longer median PFS (5 months vs. 3.4 months; HR=0.59; 95% CI, 0.38-0.9) and OS (11 months vs. 8.2 months; HR=0.71; 95% CI, 0.46-1.1) in the FIRGEM arm.

Common grade 3 to grade 4 toxicities — all of which were more common in the FIRGEM arm — included neutropenia (49% vs. 24%), febrile neutropenia (4% vs. 0%), diarrhea (12% vs. 0%) and nausea/vomiting (8% vs. 4%). No toxicity-related deaths occurred.

Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.