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Gemcitabine chemotherapy slightly improves survival in pancreatic cancer

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In patients with resected pancreatic cancer, gemcitabine plus adjuvant fluorouracil-based chemotherapy has survival benefits, although the improvement is not significant.

Researchers from various institutions across the nation enrolled 451 patients with gross total resection of pancreatic adenocarcinoma without prior radiation or chemotherapy treatment in a randomized, controlled, phase-3 trial between July 1998 and July 2002. Patients were treated at 164 U.S. and Canadian institutions.

All patients underwent chemoradiation with a continuous infusion of fluorouracil (250 mg/m² per day). For three weeks prior and 12 weeks following chemoradiation therapy, patients were randomly assigned chemotherapy with either fluorouracil (continuous infusion 250 mg/m² per day; n=230) or gemcitabine (Gemzar, Eli Lilly) (30-minute infusion 1,000 mg/m² once per week; n=221).

Patients with pancreatic head tumors (n=388) had a median survival of 16.9 months and three-year survival of 22% in the fluorouracil group, compared with a median survival of 20.5 months and a three-year survival of 31% in the gemcitabine cohort (P=.09). Grade 4 hematologic toxicity was higher in the gemcitabine group (14%) than in the fluorouracil group (1%) (P<.001). – by Stacey L. Adams

JAMA. 2008;299:1019-1026.

This Radiation Therapy Oncology Group trial reinforces the superiority and recommended use of gemcitabine in both the advanced disease setting, and now in the adjuvant setting in pancreatic cancer. In patients treated with cancer of the head of the pancreas receiving postoperative chemoradiation, this trial demonstrated that survival was improved when patients received systemic chemotherapy with gemcitabine, as compared to conventional fluorouracil. What the trial does not address is whether or not radiation is required or beneficial, given recent data from Europe indicating a survival benefit for either fluorouracil/leucovorin or more recently adjuvant gemcitabine without radiation.

– David H. Ilson, MD

HemOnc Today Editorial Board member