Gemcitabine Alone vs Gemcitabine Plus Radiotherapy in Patients with Locally Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial

Kanani, Samir P. MD

Associate Clinical Professor of Neurosurgery and Radiation Oncology, George Washington University; Radiation Oncology, Inova Fairfax Hospital

Dr. Kanani reports no financial relationships relevant to this field of study.

SOURCE: Loehrer P, et al. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: An Eastern Cooperative Group Trial. J Clin Oncol 2011;29:4105-4112.

Clinical Oncology Alert 28(1):p 3-4, January 2012.

SYNOPSIS:

In a muti-institutional prospective trial conducted from 2003-2005, 74 patients with unresectable pancreatic adenocarcinoma were randomly assigned to receive GEM alone (at 1,000 mg/m/wk for weeks 1-6, followed by I week rest, then for 3 of 4 weeks) or GEM (600 mg/m/wk for weeks 1-5, then 4 weeks later 1,000 mg/m/wk for 3 of 4 weeks) plus radiotherapy for a total of 50.4 Gy. Measurement of quality of life also was performed. Patients enrolled in Arm B (GEM plus radiation) had a higher incidence of grades 4 and 5 toxicities (41% vs 9%), but grades 3 and 4 toxicities combined were similar in both arms. No statistical difference was noted in quality of life. The primary endpoint of survival was improved with the addition of radiotherapy with I I. I months for Arm B and 9.2 months for Arm A.