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[Abstract]

PURPOSE:

The role of postoperative therapy in extrahepatic cholangiocarcinoma (EHCC) or gallbladder carcinoma (GBCA) is unknown. S0809 was designed to estimate 2-year survival (overall and after R0 or R1 resection), pattern of relapse, and toxicity in patients treated with this adjuvant regimen.

PATIENTS AND METHODS:

Eligibility criteria included diagnosis of EHCC or GBCA after radical resection, stage pT2-4 or N+ or positive resection margins, M0, and performance status 0 to 1. Patients received four cycles of gemcitabine (1,000 mg/m(2) intravenously on days 1 and 8) and capecitabine (1,500 mg/m(2) per day on days 1 to 14) every 21 days followed by concurrent capecitabine (1,330 mg/m(2) per day) and radiotherapy (45 Gy to regional lymphatics; 54 to 59.4 Gy to tumor bed). With 80 evaluable patients, results would be promising if 2-year survival 95% CI were > 45% and R0 and R1 survival estimates were ≥ 65% and 45%, respectively.

RESULTS:

A total of 79 eligible patients (R0, n = 54; R1, n = 25; EHCC, 68%; GBCA, 32%) were treated (86% completed). For all patients, 2-year survival was 65% (95% CI, 53% to 74%); it was 67% and 60% in R0 and R1 patients, respectively. Median overall survival was 35 months (R0, 34 months; R1, 35 months). Local, distant, and combined relapse occurred in 14, 24, and nine patients. Grade 3 and 4 adverse effects were observed in 52% and 11% of patients, respectively. The most common grade 3 to 4 adverse effects were neutropenia (44%), hand-foot syndrome (11%), diarrhea (8%), lymphopenia (8%), and leukopenia (6%). There was one death resulting from GI hemorrhage.

CONCLUSION:

This combination was well tolerated, has promising efficacy, and provides clinicians with a well-supported regimen. Our trial establishes the feasibility of conducting national adjuvant trials in EHCC and GBCA and provides baseline data for planning future phase III trials.

© 2014 by American Society of Clinical Oncology.

[Author information]

Ben-Josef E1, Guthrie KA2, El-Khoueiry AB2, Corless CL2, Zalupski MM2, Lowy AM2, Thomas CR Jr2, Alberts SR2, Dawson LA2, Micetich KC2, Thomas MB2, Siegel AB2, Blanke CD2.

1Edgar Ben-Josef, University of Pennsylvania, Philadelphia, PA; Katherine A. Guthrie, Fred Hutchinson Cancer Research Center, Seattle, WA; Anthony B. El-Khoueiry, University of Southern California Norris Comprehensive Cancer Center, Los Angeles; Andrew M. Lowy, University of California San Diego Moores Cancer Center, La Jolla, CA; Christopher L. Corless, Oregon Health and Science University Knight Diagnostic Laboratories; Charles R. Thomas Jr and Charles D. Blanke, Oregon Health and Science University Knight Cancer Institute, Portland, OR; Mark M. Zalupski, University of Michigan, Ann Arbor, MI; Steven R. Alberts, Mayo Clinic, Rochester, MN; Laura A. Dawson, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada; Kenneth C. Micetich, Loyola University Medical Center, Maywood, IL; Melanie B. Thomas, Medical University of South Carolina, Charleston, SC; and Abby B. Siegel, Columbia University, New York, NY. edgar.ben-josef@uphs.upenn.edu.

2Edgar Ben-Josef, University of Pennsylvania, Philadelphia, PA; Katherine A. Guthrie, Fred Hutchinson Cancer Research Center, Seattle, WA; Anthony B. El-Khoueiry, University of Southern California Norris Comprehensive Cancer Center, Los Angeles; Andrew M. Lowy, University of California San Diego Moores Cancer Center, La Jolla, CA; Christopher L. Corless, Oregon Health and Science University Knight Diagnostic Laboratories; Charles R. Thomas Jr and Charles D. Blanke, Oregon Health and Science University Knight Cancer Institute, Portland, OR; Mark M. Zalupski, University of Michigan, Ann Arbor, MI; Steven R. Alberts, Mayo Clinic, Rochester, MN; Laura A. Dawson, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada; Kenneth C. Micetich, Loyola University Medical Center, Maywood, IL; Melanie B. Thomas, Medical University of South Carolina, Charleston, SC; and Abby B. Siegel, Columbia University, New York, NY.