One of the deadliest malignancies, only 5% of patients with pancreatic cancer are expected to survive for five years. In a cancer in which a few extra months may make a difference, oncologists from the University of Maryland Medical Center, Baltimore, have found that gemcitabine added to an adjuvant chemotherapy and radiation after surgery can extend survival.

The randomized, controlled study took place at 164 United States and Canadian institutions. Two hundred thirty patients with pancreatic cancer received chemotherapy with fluorouracil (continuous infusion of 250 mg/m²/day) and 221 individuals were treated with chemotherapy plus gemcitabine (30-minute infusion of 1,000 mg/m² once weekly) for three weeks before starting chemoradiation therapy and for 12 weeks after the therapy. All of the subjects received radiation (50.4 Gy) as well as a continuous infusion of fluorouracil (250 mg/m²/day).

Tumors in the pancreatic head were found in 388 out of 451 patients. In these specific patients, the addition of gemcitabine was associated with a five-month gain in median survival and a 40% improved three-year survival rate. However, owing to how the study was powered statistically, this outcome indicated a positive trend but one that was not significantly different (hazard ratio, 0.82; P = .09). No survival benefit was revealed for the other patients receiving gemcitabine who had tumors in other areas of the pancreas.

The principal toxicity that was associated with gemcitabine was hematologic, as 14% of those receiving the intervention experienced grade 4 toxicity compared with only 1% of patients who received fluorouracil in the control group (P < .001). The use of gemcitabine did not affect the ability of the patient to complete the chemotherapy or radiation therapy regimen; the rate was more than 85% in both groups. Adding gemcitabine to adjuvant fluorouracilbased chemoradiation was related to survival benefits for patients with resected pancreatic cancer, the researchers stated, although it was a statistically insignificant trend.

Regine WF, Winter KA, Abrams RA, et al: Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: A randomized controlled trial. JAMA 2008;299:1019-1026.