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Regine WF , Winter KA , Abrams R , Safran H , Hoffman JP , Konski A , Benson AB , Macdonald JS , Rich TA , Willett CG
Fluorouracil-based Chemoradiation with Either Gemcitabine or Fluorouracil Chemotherapy after Resection of Pancreatic Adenocarcinoma: 5-Year Analysis of the US Intergroup/RTOG 9704 Phase III Trial
Annals of Surgical Oncology. 2011 May;18(5) :1319-1326
PMID: ISI:000289564600019   
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Abstract
The impact of the addition of gemcitabine to 5-fluorouracil (5-FU) chemoradiation (CRT) on 5-year overall survival (OS) in resected pancreatic adenocarcinoma are presented with updated results of a phase III trial. After resection of pancreatic adenocarcinoma, patients were randomized to pre- and post-CRT 5-FU versus pre- and post-CRT gemcitabine. 5-FU was provided continuously at 250 mg/m(2)/day, and gemcitabine was provided at 1000 mg/m(2) weekly. Both were provided over 3 weeks before and 12 weeks after CRT. CRT was provided at 50.4 Gy with continuously provided 5-FU. The primary end point was survival for all patients and for patients with tumor of the pancreatic head. Four hundred fifty-one patients were eligible. Univariate analysis showed no difference in OS. Pancreatic head tumor patients (n = 388) had a median survival and 5-year OS of 20.5 months and 22% with gemcitabine versus 17.1 months and 18% with 5-FU. On multivariate analysis, patients on the gemcitabine arm with pancreatic head tumors experienced a trend toward improved OS (P = 0.08). First site of relapse local recurrence in 28% of patients versus distant relapse in 73%. The sequencing of 5-FU CRT with gemcitabine as done in this trial is not associated with a statistically significant improvement in OS. Despite local recurrence being approximately half of that reported in previous adjuvant trials, distant disease relapse still occurs in a parts per thousand yen70% of patients. These findings serve as the basis for the recently activated EORTC/U.S. Intergroup RTOG 0848 phase III adjuvant trial evaluating the impact of CRT after completion of a full course of gemcitabine.
Notes
Regine, William F. Winter, Kathryn A. Abrams, Ross Safran, Howard Hoffman, John P. Konski, Andre Benson, Al B. Macdonald, John S. Rich, Tyvin A. Willett, Christopher G. Nci [rtog u10 ca21661, ccop u10 ca37422] Supported by RTOG U10 CA21661 and CCOP U10 CA37422 grants from the NCI. 24 Springer; 233 spring st, new york, ny 10013 usa 750rb