Adjuvant gemcitabine delays recurrence of resected pancreatic cancer

Adjuvant chemotherapy with gemcitabine, which is routinely given to patients with inoperable pancreatic cancer, can also benefit pancreatic cancer patients undergoing surgery by significantly delaying disease recurrence, according to preliminary findings from an ongoing European study.

In the study, presented as a late-breaker Saturday at the 41st annual meeting of the American Society of Clinical Oncology, researchers randomized 356 patients with resected pancreatic cancer to gemcitabine or observation only following surgery. Gemcitabine was administered beginning within 6 weeks of surgery at a dose of 1 gram per meter squared on days 1, 8 and 15 every 4 weeks for 6 months. Presenting investigator Dr. Peter Neuhaus, from Charite University Medical School in Berlin, reported that, to date, disease-free survival is nearly twice as long in the gemcitabine arm as in the observation arm -- 14.2 months versus 7.5 months, "which is significant." Median disease-free survival in patients with nodal involvement is 13.1 months in the gemcitabine arm and 7 months in the observation arm. Very preliminary data also hint that gemcitabine improves overall survival, but "the number of patients who have been censored is still small," Dr. Neuhaus said adding that full results will be reported later this year.To date, 53% of gemcitabine-treated patients and 45% of control patients have completed treatment and been followed for 3 to 5 years. "The data are preliminary but already we see a significant benefit" favoring adjuvant gemcitabine for 6 months after resection of pancreatic cancer, Dr. Neuhaus said."It's still too soon to recommend this treatment to patients," co-investigator Dr. Hanno Riess from Charite University added in a statement from ASCO.Side effects associated with gemcitabine in this patient population were generally mild to moderate and included neutropenia, diarrhea, and nausea.(Source: American Society of Clinical Oncology: Reuters Health: Oncolink: June 2005.)