Gemcitabine Plus 5-FU Promising in Advanced Pancreatic Cancer

Laurie Barclay, MD

May 02, 2003

May 2, 2003 — The combination of gemcitabine and 5-fluorouracil (5-FU) has promising activity for advanced pancreatic cancer and biliary tract cancer, according to the results of a phase II trial published in the April issue of the American Journal of Clinical Oncology.

"The median overall survival was 9 months (range, 6-38), and the 1-year survival rate was 30%," write Andre M. Murad, MD, PhD, and colleagues from the Universidade Federal de Minas Gerais in Brazil. "The regimen was very well tolerated."

Of 26 patients enrolled in this trial, 17 (65%) had advanced pancreatic adenocarcinoma and 9 patients (35%) had advanced biliary tract adenocarcinoma. Ten had locally advanced and 16 had metastatic cancer. Median age was 58 years (range, 39-68 years), median World Health Organization (WHO) performance status was 2 (range, 1-3), and median number of gemcitabine-5-FU cycles was four per patient.

There were eight objective responses, plus one complete response not confirmed by second-look laparotomy, yielding an overall objective response rate of 30.7% (95% confidence interval 12% - 47%). Six patients (23%) had stable disease. All eight responders and three of the patients with stable disease experienced clinical benefit (42%). Among the patients with biliary tract carcinoma, 3 (33%) of 9 had partial response.

Adverse events included reversible WHO grade IV febrile neutropenia in one patient, grade III neutropenia in 11 cycles (11%); grade III thrombocytopenia in seven cycles (7%); grade III mucositis in seven cycles (7%); grade III diarrhea in 10 cycles (10%); asthenia grades I and II in 30% of cycles and grade II flu-like syndrome in 11 cycles (11%).

"The combination of gemcitabine and 5-FU in patients with advanced pancreatic or biliary tract cancer produces promising activity and tolerability with the added potential for clinical benefit, and thus warrants further investigation," the authors write.

Am J Clin Oncol. 2003;26:151-154

Reviewed by Gary D. Vogin, MD

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