Gemcitabine Improves Overall Survival Following Surgery for Pancreatic Cancer
Among patients with pancreatic cancer who had surgery for removal of the cancer, treatment with the drug gemcitabine for 6 months resulted in increased overall survival as well as disease-free survival, compared with observation alone, according to a study in published in the October 9 issue of JAMA.
Patients with pancreatic cancer have a poor prognosis, largely because of the inability to detect the cancer at an early stage, the disease’s high potential for early dissemination, and its poor sensitivity to therapy. The ratio of overall mortality to incidence is almost 98%, and even after complete removal of the tumor, the vast majority of patients relapse within 2 years. No consensus has been reached on a standard treatment approach for additional therapy. Gemcitabine-based chemotherapy is standard treatment for advanced pancreatic cancer, but its effect on survival after surgery has not previously been demonstrated.
Study Details
Helmut Oettle, MD, PhD, of the Charité-Universitätsmedizin Berlin, Germany, and colleagues conducted follow-up of the phase III randomized CONKO-001 trial that previously reported an improvement in disease-free survival with adjuvant gemcitabine therapy to determine if this treatment improved overall survival. The study enrolled patients with macroscopically completely removed pancreatic cancer between July 1998 and December 2004 in 88 hospitals in Germany and Austria; follow-up ended in September 2012. Patients were randomly assigned to either adjuvant gemcitabine treatment for 6 months or to observation alone. The primary endpoint was disease-free survival, and the secondary endpoints included overall survival and treatment safety.
A total of 368 patients were randomized, and 354 were eligible for intention-to-treat-analysis. By September 2012, 308 patients (87.0%) had relapsed. The median follow-up time was 136 months (11.3 years). The median disease-free survival was 13.4 months in the treatment group vs 6.7 months in the observation group.
Overall Survival Outcomes
By the end of the follow-up period, 316 patients (89.3%) had died and 38 patients were still alive, with 23 patients in the treatment group and 15 in the observation group. The researchers found a statistically significant difference in overall survival between the study groups, with a median of 22.8 months in the gemcitabine group compared with 20.2 months in the observation group (hazard ratio [HR] = 0.76, 95% confidence interval [CI] = 0.61–0.95, P = .01). There was also a statistically significant absolute 10.3% improvement in the 5-year overall survival rate (20.7% vs 10.4%) and a 4.5% improvement in the 10-year survival rate (12.2% vs 7.7%), compared with observation alone.
“[These] data show that among patients with macroscopic complete removal of pancreatic cancer, the use of adjuvant gemcitabine for 6 months compared with observation resulted in increased overall survival as well as disease-free survival. These findings support the use of gemcitabine in this setting,” the authors concluded.
This trial was supported in part by a grant from Lilly Germany. The study was further supported by the German Cancer Society and promoted by a research grant from the Charite-Universitatsmedizin Berlin.
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