(RxWiki News) Pancreatic cancer is one of the most difficult to treat cancers. It usually doesnâ€™t give the patient any clues, so itâ€™s generally found later â€” often when the cancer has spread beyond the pancreas. But results from a recent clinical trial may offer positive news.
Gemzar is the standard of care for advanced pancreatic cancer that has spread from its original site. This study looked specifically at the drug's impact on pancreatic patient lifespan following surgery.
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Helmut Oettle, MD, PhD, of the CharitĂ©-UniversitĂ¤tsmedizin in Berlin, Germany, and colleagues conducted this follow-up study of the CONKO-OO1 trial that showed Gemzar improved disease-free survival (period during which the cancer is not evident) in patients whoâ€™d had surgery.
This study was looking at overall survival in the same patients.
Participants included 368 patients who entered the CONKO-OO1 trial between July 1998 and December 2004. The researchers followed the patients until September 2012.
These patients were randomly assigned to receive either six months of Gemzar following surgery or to be observed with no treatment.
The researchers found that the median disease-free survival was 13.4 months in the group who had received Gemzar and 6.2 months for the observed patients.
By the end of the follow-up period, which was a median of 11.3 years, only 23 in the treated group and 15 in the observation group were still alive.
The five-year disease-free survival rate for the treated group was 16.6 percent and the ten-year survival rate in this group was 14.3 percent.
Overall survival was improved in the treated group â€” a median of 22.8 months in the Gemzar group, compared with 20.2 months in the observation group.
â€śThe main result of this trial is that treatment with adjuvant [after surgery] gemcitabine for 6 months leads to a 24 percent improvement in overall survival, with a statistically significant absolute 10.3 percent improvement in the 5-year overall survival rate (20.7 percent vs 10.4 percent) and a 4.5 percent improvement in the 10-year survival rate (12.2 percent vs 7.7 percent), compared with observation alone,â€ť the authors wrote.
dailyRx News spoke with pancreatic cancer expert, James Farrell, MD, director of Interventional Endoscopy and Pancreatic Diseases at the Yale University School of Medicine in New Haven, CT.
"This updated set of results from the CONKO-OO1 trial confirm the benefits of adjuvant chemotherapy with gemcitabine over doing nothing after surgical resection for pancreatic cancer,â€ť Dr. Farrell said.
â€śHowever, the persistent poor 5- and 10-year survival numbers, even after surgery and chemotherapy, favor pursuing ongoing efforts to see if the addition of other agents such as erlotinib [Tarceva] or nab-paclitaxel [Abraxane] to gemcitabine or the use of non-gemcitabine based treatments altogether such as FOLFIRONOX [a combination of chemotherapy agents] will further improve these dismal statistics after surgical resection of pancreas cancer,â€ť said Dr. Farrell, an Associate Professor of Medicine at Yale, who was not involved in the study.
These findings were published October 8 in the Journal of the American Medical Association (JAMA).
This trial was supported in part by a grant from Lilly Germany. The study was further supported by the German Cancer Society
Two of the authors disclosed financial relationships with a number of pharmaceutical firms, including Eli Lilly, the manufacturer of Gemzar. One of the authors was a former Lilly employee and owns stock in the company.