Adjuvant Chemotherapy With Gemcitabine and Long-term Outcomes Among Patients With Resected Pancreatic Cancer

SUMMARY: Curative surgical resection has been shown to significantly improve Overall Survival (OS) when compared to Chemoradiation, for resectable Pancreatic Cancer. The standard surgical procedure for tumors of the Pancreatic head is the Pancreaticoduodenectomy (Whipple procedure), whereas distal Pancreatectomy is performed for tumors of the body or tail of the Pancreas. The role of adjuvant chemotherapy following surgery has however remained unclear. In this community based, phase III trial, 368 patients were randomly assigned to receive either adjuvant chemotherapy with GEMZAR® (Gemcitabine) (N=186) or Observation (N=182), following curative resection of the pancreas (Macroscopic complete removal of Pancreatic cancer). Chemotherapy consisted of 6 cycles of GEMZAR® with each cycle consisting of GEMZAR® 1000mg/m2, given weekly, 3 out of 4 weeks. Patients were stratified based on tumor stage (T), nodal status (N) and resection (R) status. The primary endpoint was Disease Free Survival (DFS). Secondary endpoints included OS and safety. With a median follow up of 136 months, the median DFS was 13.4 months in the treatment group vs 6.7 months in the observation group (HR=0.55; P<0.001). The OS in the treatment group was significantly prolonged (HR=0.76; P=0.01), with a 5 year survival of 21% and 10 year survival of 12% compared to 10% and 8% respectively, in the Observation group. The authors concluded that 6 months of GEMZAR® based adjuvant therapy improves Overall Survival for patients with resectable Pancreatic Cancer. There may be added benefit with regimens associated with higher remission rates such as FOLFIRINOX or weekly ABRAXANE® (Paclitaxel albumin-bound particles) and GEMZAR®. Oettle H, Neuhaus P, Hochhaus A, et al. JAMA. 2013;310:1473-1481.