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Adjuvant gemcitabine extended OS after pancreatic cancer surgery
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Adjuvant chemotherapy with gemcitabine for 6 months extended OS compared with observation in a cohort of patients who had undergone macroscopic complete removal of pancreatic cancer, according to results of a multicenter, open-label, phase 3 study.
Prior studies showed adjuvant gemcitabine (Gemzar, Eli Lilly) extended DFS. Helmut Oettle, MD, PhD, of the department of medical oncology and hematology at Charite-Universitatsmedizin in Berlin, Germany, and colleagues conducted the current study to determine whether the improved DFS translated to extended OS.
The analysis included 354 patients recruited between 1998 and 2004 at 88 hospitals in Germany and Austria. Follow-up continued through September 2012.
All patients had undergone surgery for pancreatic surgery.
Oettle and colleagues assigned half of the patients to 1g/m2 adjuvant gemcitabine on days 1, 8 and 15 every 4 weeks for 6 months. The other half of patients underwent observation.
At median follow-up of 11.3 years, 87% of patients had relapsed and 89.3% had died.
Median DFS was 13.4 months in the gemcitabine arm compared with 6.7 months in the observation arm (HR=.55; 95% CI, 0.44-0.69).
Patients assigned to gemcitabine also demonstrated longer OS (HR=0.76; 95% CI, 0.61-0.95). Researchers reported higher rates of 5-year OS (20.7% vs. 10.4%) and 10-year OS (12.2% vs. 7.7%) in the gemcitabine arm.
Disclosure: The researchers report honoraria from Bayer, Bristol-Myers Squibb, Celgene, Eli Lilly, Fresenius, GlaxoSmithKline, Novartis, Pfizer, Roche and Sanofi-Aventis. They also report stock ownership in and former employment with Eli Lilly.
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