GEMCITABINE AND RADIOTHERAPY FOR LOCALLY ADVANCED PANCREATIC CANCER

J Clin Oncol. 2011 Oct 3. [Epub ahead of print]

Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally
Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial.

Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P,
Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd.

Patrick J. Loehrer Sr and Higinia Cardenes, Melvin and Bren Simon Cancer Center, 
Indiana University, Indian-apolis, IN; Yang Feng, Dana Farber Cancer Institute,
Boston, MA; Lynne Wagner, David Cella, and Al B. Benson III, Northwestern
University School of Medicine, Chicago, IL; Joanna M. Brell, Ireland Cancer
Center, Case Western Reserve University, Cleveland, OH; Patrick Flynn,
Minneapolis Hematology/Oncology, Minneapolis; Steven R. Alberts, Mayo Clinic,
Rochester, MN; Ramesh K. Ramanathan, University of Pittsburgh Cancer Institute,
Pittsburgh, PA; and Christopher H. Crane, MD Anderson Cancer Center, Houston, TX.

PURPOSEThe purpose of this trial was to evaluate the role of radiation therapy
with concurrent gemcitabine (GEM) compared with GEM alone in patients with
localized unresectable pancreatic cancer. PATIENTS AND METHODSPatients with
localized unresectable adenocarcinoma of the pancreas were randomly assigned to
receive GEM alone (at 1,000 mg/m(2)/wk for weeks 1 to 6, followed by 1 week rest,
then for 3 of 4 weeks) or GEM (600 mg/m(2)/wk for weeks 1 to 5, then 4 weeks
later 1,000 mg/m(2) for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8
Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional 
Assessment of Cancer Therapy-Hepatobiliary questionnaire was also
performed.ResultsOf 74 patients entered on trial and randomly assigned to receive
GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm 
B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and
4 toxicities combined were similar (77% in A v 79% in B). No statistical
differences were seen in quality of life measurements at 6, 15 to 16, and 36
weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to
11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B,
respectively (one-sided P = .017 by stratified log-rank test). CONCLUSIONThis
trial demonstrates improved overall survival with the addition of radiation
therapy to GEM in patients with localized unresectable pancreatic cancer, with
acceptable toxicity.