Gemcitabine compare with 5FU-article dated 10-22-2011
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Hi,everyone,
Below is the article by Neoptolemos JP,cited as reference by the above studyand dated as May 31,2009.
http://www.hemonctoday.com/article.aspx?rid=40436No survival difference between adjuvant 5-FU, gemcitabine in pancreatic cancer
2009 ASCO Annual Meeting
Results of the international ESPAC-3 trial indicated that there was no survival difference between adjuvant treatment of pancreatic ductal adenocarcinoma with the European standard of care, 5-FU/folinic acid, and the U.S. standard gemcitabine.
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“There was absolutely no difference between the two regimens,” John P. Neoptolemos, MD, head of division of surgery and oncology at the University of Liverpool, said at the 2009 ASCO Annual Meeting. “This is extremely important because there has been a tendency to reject 5-FU in pancreatic cancer and now it is very much back on the stage.”
In the phase-3 ESPAC-3 trial 1,088 patients were randomly assigned within eight weeks of surgery to either 5-FU/folinic acid or gemcitabine for six months. The primary endpoint was OS. Median follow-up was 34 months.
Median OS was not significantly difference between the two arms (23 months vs. 23.6 months). However, patients assigned 5-FU/folinic acid reported more toxicities compared to patients assigned gemcitabine. The increase toxicities included grade-3/4 stomatitis (10% vs. 0), diarrhea (13% vs. 2%) and treatment-related hospitalizations (10% vs. 3.5%).
Given this safety profile, Neoptolemos said that gemcitabine is likely to be the preferred adjuvant therapy. – by Leah Lawrence
PERSPECTIVE
This trial suggests that there is no difference between 5-FU and gemcitabine if you give it after surgery alone, but it conflicts with other data suggesting a survival benefit with gemcitabine compared to 5-FU, as demonstrated in the RTOG 97-04. It is a negative trial. Their previous study, ESPAC-2, did suggest that adjuvant chemotherapy was beneficial with 5-FU. It doesn’t invalidate that adjuvant chemotherapy improves survival in pancreatic cancer it just suggests that there may not be as clear a difference between gemcitabine vs. 5-FU in the adjuvant setting as was seen in the ESPAC-2 trial.
– David Ilson, MD
Hi, everyone,
Single agent comparison of Gemzar and 5Fu including capecitabine.,the oral form of 5FU.In short,not much difference between the two agents in survival benefits but less side effects on patients taking gemcitabine.
Gemzar Versus 5-FU for Adjuvant Treatment of Pancreatic Cancer
A large randomized study demonstrated no significant improvement in survival with Gemzar® (gemcitabine) versus 5-fluorouracil (5-FU) for the adjuvant (post-surgery) treatment of pancreatic cancer. These findings were recently published in the Journal of the American Medical Association.[1]
Pancreatic cancer is the fourth leading cause of cancer death in this country. Treatment for early pancreatic cancer may involve surgery to remove as much of the cancer as possible followed by chemotherapy.
In this current European study, researchers conducted a randomized controlled Phase III trial to evaluate chemotherapy with 5-FU and folinic acid versus Gemzar among 1,088 patients with early-stage pancreatic cancer. All patients on this study had their cancer surgically removed prior to being randomized to adjuvant chemotherapy and were followed for at least two years.
Median survival was 23.0 months for patients on the 5-FU/folinic acid arm versus 23.6 months on the Gemzar arm (P=.39).
14% of patients on the 5-FU/folinic acid arm experienced treatment-related serious side effects compared with 7.5% on the Gemzar arm.
Progression-free survival was not significantly different between the two arms.**The researchers concluded that Gemzar did not significantly improve overall survival in patients with resected pancreatic cancer compared with 5-FU/folinic acid. Significantly, fewer patients experienced treatment-related side effects on the Gemzar arm.**
http://news.cancerconnect.com/gemzar-versus-5-fu-for-adjuvant-treatment-of-pancreatic-cancer/
References:
[1] Neoptolemos JP, Stocken DD, Bassi C, et al. Adjuvant chemotherapy with Fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection. Journal of the American Medical Association. 2010;304:1073-1081.
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