Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)
Patients with stage III pancreatic cancer have tumors that are technically unresectable because of local vessel impingement or invasion by tumor. These patients may benefit from palliation of biliary obstruction by endoscopic, surgical, or radiological means.
The pancreas is an organ located behind your stomach next to the top of the small intestine. It is about six inches long but is less than 2 inches wide and functions as two separate organs. It has two big manufacturing jobs in the body:
It makes digestive juices that help the intestines break down food.
It produces hormones -- including insulin -- that regulate the body's use of sugars and starches.
The pancreas is divided into three sections: the head, the body, and the tail.
Three trials attempted to look at issues of combined modality therapy versus radiation therapy alone (the Gastrointestinal Tumor Study Group's GITSG-9173 trial, the Eastern Cooperative Oncology Group's EST-8282 trial, and the Federation Francophone de Cancerologie Digestive-Société Française de Radiothérapie Oncologie group's FFCD-2000-01 trial).[2,3,4] The three trials had substantial deficiencies in design or analysis. Until recently, the standard of practice has been to give chemoradiation therapy, and that was based on the first two studies; however, with the preliminary publication of the third study, standard practice has changed.
Prior to the use of gemcitabine for patients with locally advanced or metastatic pancreatic cancer, investigators from the GITSG randomly assigned 106 patients with locally advanced pancreatic adenocarcinoma to receive external beam radiation therapy (EBRT) (60 Gy) alone or to receive concurrent EBRT (either 40 Gy or 60 Gy) plus bolus fluorouracil (5-FU).[Level of evidence: 1iiA] The study was stopped early when the chemoradiation therapy arms were found to have better efficacy. The 1-year survival was 11% for patients who received EBRT alone compared with 38% for patients who received chemoradiation with 40 Gy and 36% for patients who received chemoradiation with 60 Gy. After an additional 88 patients were enrolled in the combined modality arms, there was a trend toward improved survival with 60 Gy EBRT plus 5-FU, but the difference in time-to-progression and overall survival (OS) was not statistically significant when compared to the 40 Gy arm.
In contrast, investigators from the ECOG randomly assigned 114 patients to radiation therapy (59.4 Gy) alone or with concurrent infusional 5-FU (1,000 mg/m2 daily on days 2 through 5 and days 28 through 31) plus mitomycin (10 mg/m2 on day 2) and found no difference in OS between the two groups.
Whether chemoradiation therapy should be considered for patients with stage III pancreatic cancer is controversial. Preliminary results from a study of the FFCD-SFRO were presented in abstract form at the 2006 American Society of Clinical Oncology meeting. Patients with locally advanced pancreatic cancer were randomly assigned to receive either concurrent chemoradiation therapy followed by gemcitabine or gemcitabine alone. The trial was halted because of poor accrual after 109 of the planned 176 patients were enrolled. In a preliminary report with a median 16-month follow-up, patients who received chemoradiation followed by gemcitabine had a median survival of 8.4 months versus 14.3 months for the group who received gemcitabine alone (stratified log-rank, P = .014).