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Clinical Trial
. 2015 Aug 20;33(24):2617-22.
doi: 10.1200/JCO.2014.60.2219. Epub 2015 May 11.

SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Edgar Ben-Josef  1 , Katherine A Guthrie  2 , Anthony B El-Khoueiry  2 , Christopher L Corless  2 , Mark M Zalupski  2 , Andrew M Lowy  2 , Charles R Thomas Jr  2 , Steven R Alberts  2 , Laura A Dawson  2 , Kenneth C Micetich  2 , Melanie B Thomas  2 , Abby B Siegel  2 , Charles D Blanke  2
Affiliations
Clinical Trial

SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Edgar Ben-Josef et al. J Clin Oncol. .

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.

Trial registration: ClinicalTrials.gov NCT00789958.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
Overall survival (A) in all patients and (B) by resection margin; 2-year estimate was 65% for all, 67% for R0, and 60% for R1 patients (not significantly different).
Fig 2.
Fig 2.
Disease-free survival (A) in all patients and (B) by resection margin; 2-year estimate was 52% for all, 54% for R0, and 48% for R1 patients (not significantly different).
Fig 3.
Fig 3.
(A) Overall and (B) disease-free survival by primary site (no statistically significant differences between extrahepatic cholangiocarcinoma and gallbladder carcinoma).
See this image and copyright information in PMC

Comment in

References

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