caa a22 4500 445336919 CHVBK 20180317142759.0 cr unu---uuuuu 170323e20110501xx s 000 0 eng 10.1245/s10434-011-1630-6 doi (NATIONALLICENCE)springer-10.1245/s10434-011-1630-6 Fluorouracil-based Chemoradiation with Either Gemcitabine or Fluorouracil Chemotherapy after Resection of Pancreatic Adenocarcinoma: 5-Year Analysis of the U.S. Intergroup/RTOG 9704 Phase III Trial [Elektronische Daten] [William Regine, Kathryn Winter, Ross Abrams, Howard Safran, John Hoffman, Andre Konski, Al Benson, John Macdonald, Tyvin Rich, Christopher Willett] Background: 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. Methods: 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 250mg/m2/day, and gemcitabine was provided at 1000mg/m2 weekly. Both were provided over 3weeks before and 12weeks after CRT. CRT was provided at 50.4Gy with continuously provided 5-FU. The primary end point was survival for all patients and for patients with tumor of the pancreatic head. Results: 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 20.5months and 22% with gemcitabine versus 17.1months 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%. Conclusions: 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 ≥70% 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. Society of Surgical Oncology, 2011 Regine William Department of Radiation Oncology, University of Maryland, Baltimore, MD, USA aut Winter Kathryn Department of Radiation Oncology, Therapy Group Statistical Center, Philadelphia, PA, USA aut Abrams Ross Radiation Oncology, Rush University Medical Center, Chicago, IL, USA aut Safran Howard Hematology Oncology, Miriam Hospital, Providence, RI, USA aut Hoffman John Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA aut Konski Andre Radiation Oncology, Wayne State University, Detroit, MI, USA aut Benson Al Hematology Oncology, Northwestern University, Chicago, IL, USA aut Macdonald John GI Oncology, Aptium Oncology, Los Angeles, CA, USA aut Rich Tyvin Radiation Oncology, University of Virginia, Charlottesville, VA, USA aut Willett Christopher Radiation Oncology, Duke University, Durham, NC, USA aut Annals of Surgical Oncology Springer-Verlag 18/5(2011-05-01), 1319-1326 1068-9265 18:5<1319 2011 18 10434 https://doi.org/10.1245/s10434-011-1630-6 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1245/s10434-011-1630-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Regine William Department of Radiation Oncology, University of Maryland, Baltimore, MD, USA aut NATIONALLICENCE 700 1- Winter Kathryn Department of Radiation Oncology, Therapy Group Statistical Center, Philadelphia, PA, USA aut NATIONALLICENCE 700 1- Abrams Ross Radiation Oncology, Rush University Medical Center, Chicago, IL, USA aut NATIONALLICENCE 700 1- Safran Howard Hematology Oncology, Miriam Hospital, Providence, RI, USA aut NATIONALLICENCE 700 1- Hoffman John Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA aut NATIONALLICENCE 700 1- Konski Andre Radiation Oncology, Wayne State University, Detroit, MI, USA aut NATIONALLICENCE 700 1- Benson Al Hematology Oncology, Northwestern University, Chicago, IL, USA aut NATIONALLICENCE 700 1- Macdonald John GI Oncology, Aptium Oncology, Los Angeles, CA, USA aut NATIONALLICENCE 700 1- Rich Tyvin Radiation Oncology, University of Virginia, Charlottesville, VA, USA aut NATIONALLICENCE 700 1- Willett Christopher Radiation Oncology, Duke University, Durham, NC, USA aut NATIONALLICENCE 773 0- Annals of Surgical Oncology Springer-Verlag 18/5(2011-05-01), 1319-1326 1068-9265 18:5<1319 2011 18 10434 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer