The role of adjuvant therapy in resectable pancreatic cancer is still uncertain, and no recommended standard exists.
Dr Helmut Oettle and colleagues from Germany evaluated whether adjuvant chemotherapy with gemcitabine after resection of pancreatic cancer improves disease-free survival by 6 months or more.
The research team conducted an open, multicenter, randomized controlled phase 3 trial with stratification for resection, tumor, and node status.
The study was conducted from 1998 to 2004 in outpatient settings at 88 academic and community-based oncology centers in Germany and Austria.
A total of 368 patients with gross complete resection of pancreatic cancer, and no prior radiation or chemotherapy were enrolled into 2 groups.
The team randomized 179 patients received adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks, or 175 controls.
The researchers' primary end point was disease-free survival.
|Disease-free survival at 3 years was 24% with gemcitabine|
|Journal of the American Medical Association|
Secondary end points were overall survival, toxicity, and quality of life.
The research team's survival analysis was based on all eligible patients.
More than 80% of patients had complete resection.
The researchers found that the median number of chemotherapy cycles in the gemcitabine group was 6.
The team noted grade 3 or 4 toxicities rarely occurred with no difference in quality of life between groups.
During median follow-up of 53 months, 74% of patients in the gemcitabine group, and 92% of patients in the control group developed recurrent disease.
The team identified that the median disease-free survival was 13 months in the gemcitabine group, and 7 months in the control group.
Estimated disease-free survival at 3 and 5 years was 24% and 17% in the gemcitabine group, respectively.
The researchers found that disease-free survival at 3 and 5 years in the control group was 8% and 6%, respectively.
Subgroup analyses showed that the effect of gemcitabine on disease-free survival was significant in patients with either gross complete resection.
The team noted no difference in overall survival between the gemcitabine groups, and the control group.
The research team observed that the estimated survival was 34% at 3 years, and 23% at 5 years in the gemcitabine group.
The researchers noted that the estimated survival was 21% at 3 years, and 12% at 5 years.
Dr Oettle's concludes, “Postoperative gemcitabine significantly delayed the development of recurrent disease after complete resection of pancreatic cancer compared with observation alone.”
“These results support the use of gemcitabine as adjuvant chemotherapy in resectable carcinoma of the pancreas.”