Adjuvant 5-FU comparable to gemcitabine in pancreatic cancer

NEW YORK (Reuters Health) - The results of an international multicenter study indicate that adjuvant chemotherapy with 5-fluorouracil/folinic acid (5-FU/FA) or gemcitabine are both equally effective when given following surgical resection of pancreatic cancer. Gemcitabine (Gemzar), however, is associated with fewer side effects.

Dr. John P. Neoptolemos, of University of Liverpool, who led the study, reported his group's findings over the weekend at the American Society of Clinical Oncology's annual meeting in Orlando.

Adjuvant 5-FU/FA and gemcitabine improved survival of patients with resected pancreatic cancer compared with patients who had no chemotherapy. Until now, it had not been clear whether one was superior.

The current study, Dr. Neoptolemos said, shows "absolutely no difference between the two regimens (in prolonging survival); this actually is extremely important because there had been a tendency to reject 5-FU in pancreas cancer and now it is very much back on the stage."

In the study, a total of 1,088 patients with resected pancreatic ductal adenocarcinoma were randomized to gemcitabine or 5-FU/FA. After a median follow-up of 34 months, the median overall survival was 23 months in patients treated with 5-FU/FA and 23.6 months in patients treated with gemcitabine.

"On the basis of the safety profile, however, this trial shows that gemcitabine is likely to be the preferred adjuvant therapy," Dr. Neoptolemos noted in an ASCO statement.

Patients who received 5-FU/FA reported more toxicities compared with those treated with gemcitabine, including grade 3/4 stomatitis (10% with 5-FU/FA versus 0% with gemcitabine); diarrhea (13% versus 2%, respectively); and treatment-related hospitalizations (10% vs 3.5%), respectively.

"We are now also looking at combining the two treatments to see if we get a better response, because the drugs have different mechanisms of action," Dr. Neoptolemos added.

Copyright © 2009 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.