Among patients with pancreatic cancer who have undergone surgery for the removal of the tumor, treatment with gemcitabine for six months resulted in an increase in overall survival and disease-free survival compared with observation alone, according to a study is published in the Wednesday edition of the journal JAMA.
“Pancreatic cancer is a disease with a poor prognosis, mainly due to the inability to detect the tumor at an early stage, high potential early disseminated and relatively low sensitivity to chemotherapy or radiation therapy,” according to information the article.
Even after complete removal of the tumor, the majority of patients relapse within two years, resulting in a survival rate after five years of less than 25 percent. Not reached a consensus on an additional approach to the standard treatment.
Gemcitabine-based chemotherapy is the standard treatment for advanced pancreatic cancer, but its effect on survival after surgery has not been shown previously. Helmut Oettle, ‘The Charité – Universitätsmedizin Berlin’, in Germany, and colleagues conducted a randomized trial to determine whether gemcitabine therapy improves overall survival.
Patients with pancreatic cancer completely removed macroscopically (naked eye observation) entered the study between July 1998 and December 2004 in 88 hospitals in Germany and Austria, whose follow-up ended in September 2012. Patients were randomized to adjuvant gemcitabine therapy for six months or observation.
A total of 368 patients were randomized and 354 were eligible for the purpose of analysis. In September last year, 308 patients (87 percent) had relapsed.
The mean follow-up time was 136 months (11.3 years), with the average disease-free survival of 13.4 months in the treatment group compared with 6.7 months in the observation.
At the end of the follow-up period, 316 patients (89.3 percent) had died and 38 patients were alive, 23 in the treatment group and 15 in the observation.
The researchers found a statistically significant difference in overall survival between the study groups, with a mean of 22.8 months in the gemcitabine group compared with 20.2 months in the observation.
There was also a statistically significant absolute improvement of 10.3 percent overall survival rate at five years (20.7 percent vs. 10.4 percent) and a 4.5 percent improvement in the rate of Ten-year survival (12.2 percent vs. 7.7 percent) compared with observation alone.
“These data show that among patients with macroscopic complete elimination of pancreatic cancer, the use of adjuvant gemcitabine for six months as compared to observation led to an increase in overall survival and disease-free survival for which support the use of gemcitabine in this way, “conclude the authors.