The drug gemcitabine, when taken for 6 months after surgery for pancreatic cancer, was found to increase overall survival as well as disease-free survival when compared with observation, according to researchers from Germany and Austria.
The authors of the study, published in JAMA, note that even after complete removal of the tumor, the vast majority of patients develop disease recurrence within 2 years, resulting in a 5-year survival rate of less than 25%. No consensus has been reached regarding standard treatment for additional therapy beyond surgery, although gemcitabine-based chemotherapy is standard for patients with advanced prostate cancer.
The researchers conducted a follow-up study of a randomized trial that previously demonstrated improved disease-free survival with adjuvant gemcitabine to determine whether the treatment improved overall survival. Participants entered the study between July 1998 and December 2004 in 88 hospitals throughout Germany and Austria. The patients had their pancreatic tumors completely removed macroscopically and were randomly assigned to receive either adjuvant gemcitabine therapy for 6 months or observation. A total of 368 patients were randomized, and 354 were eligible for intention-to-treat analysis.
By September 2012, 308 patients (87%) had developed disease recurrence. The median disease-free survival was 13.4 months in the treatment group compared with 6.7 months in the observation group. In addition, 316 patients (89.3%) had died and 38 patients were still alive. The statistically significant difference in overall survival was a median of 22.8 months for the patients treated with gemcitabine and 20.2 months for those in the observation group.