A phase 2 trial of gemcitabine, 5-fluorouracil, and radiation therapy in locally advanced nonmetastatic pancreatic adenocarcinoma

Cancer and Leukemia Group B (CALGB) 80003

Authors


  • We thank Margaret Hall for expert assistance with data analysis.

  • The following institutions participated in this study: Christiana Care Health Services, Inc. CCOP, Wilmington, Delaware (Stephen Grubbs, MD, supported by CA45418); Dana-Farber Cancer Institute, Boston, Massachusetts (Harold J. Burstein, MD, PhD, supported by CA32291); Dartmouth Medical School-Norris Cotton Cancer Center, Lebanon, New Hampshire (Konstantin Dragnev, MD, supported by CA04326); Georgetown University Medical Center, Washington, DC (Minetta C. Liu, MD, supported by CA77597); Hematology-Oncology Associates of Central New York CCOP, Syracuse, New York (Jeffrey Kirshner, MD, supported by CA45389); Kansas City Community Clinical Oncology Program CCOP, Kansas City, Missouri (Rakesh Gaur, MD); Long Island Jewish Medical Center, Lake Success, New York (Kanti R. Rai, MD, supported by CA35279); Massachusetts General Hospital, Boston, Massachusetts (Jeffrey W. Clark, MD, supported by CA32291); Mount Sinai Medical Center, Miami, Florida (Rogerio C. Lilenbaum, MD, supported by CA45564); New Hampshire Oncology-Hematology PA, Concord, New Hampshire (Douglas J. Weckstein); NorthShore University HealthSystem CCOP, Evanston, Illinois (David L Grinblatt, MD); Roswell Park Cancer Institute, Buffalo, New York (Ellis Levine, MD, supported by CA59518); Southeast Cancer Control Consortium Inc. CCOP, Goldsboro, North Carolina (James N. Atkins, MD, supported by CA45808); The Ohio State University Medical Center, Columbus, Ohio (Clara D. Bloomfield, MD, supported by CA77658); University of California at San Diego, San Diego, California (Barbara A. Parker, MD, supported by CA11789); University of Iowa, Iowa City, Iowa (Daniel A. Vaena, MD, supported by CA47642); University of Minnesota, Minneapolis, Minnesota (Bruce A Peterson, MD, supported by CA16450); University of Missouri/Ellis Fischel Cancer Center, Columbia, Missouri (Michael C Perry, MD, supported by CA12046); University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (Thomas C. Shea, MD, supported by CA47559); University of Vermont, Burlington, Vermont (Steven M Grunberg, MD, supported by CA77406); Wake Forest University School of Medicine, Winston-Salem, North Carolina (David D Hurd, MD, supported by CA03927); Washington University School of Medicine, St. Louis, Missouri (Nancy Bartlett, MD, supported by CA77440); and Weill Medical College of Cornell University, New York, New York (John Leonard, MD, supported by CA07968).

Abstract

BACKGROUND:

The purpose of this study was to assess the efficacy and safety of 5-fluorouracil (5FU) and gemcitabine administered concurrently with radiation in patients with locally advanced, nonmetastatic pancreatic cancer.

METHODS:

Eligible patients had histologically confirmed pancreatic adenocarcinoma deemed locally unresectable without evidence of metastatic disease. In addition, all patients underwent laparoscopy or laparotomy before study entry to rule out peritoneal carcinomatosis. Patients received radiation therapy (50.4 Gy) with concurrent infusional 5FU (200 mg/m2 5 days/week) and weekly gemcitabine (200 mg/m2). After a 3-week break, patients received weekly gemcitabine at 1000 mg/m2 for 3 of 4 weeks, for 4 cycles. The primary endpoint of the trial was the proportion of patients surviving 9 months from study entry. Secondary endpoints included objective tumor response, CA19-9 response, overall survival (OS) time to progression (TTP), and toxicity.

RESULTS:

Between November 2001 and October 2004, 81 patients were enrolled, 78 of whom were eligible for analysis. With a median follow-up of 55.2 months, the median OS was 12.2 months (95% confidence interval [CI], 10.9-14.9) and the median TTP was 10 months (95% CI, 6.4-12.0). An objective tumor response was seen in 19 patients (25%), and among 56 patients with an elevated CA19-9 at baseline, 29 (52%) had a sustained CA19-9 response. Overall, 41% of patients had grade 3 or greater treatment-related gastrointestinal adverse events.

CONCLUSIONS:

The combination of 5FU, gemcitabine, and radiation is well tolerated. Survival is comparable with the best results of other recent studies of 5FU and radiation or gemcitabine and radiation. Cancer 2011;. © 2010 American Cancer Society.

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