Adjuvant Regimen Produces Good Survival Results in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
In a phase II Intergroup study (SWOG S0809) reported in the Journal of Clinical Oncology, Ben-Josef et al found that adjuvant capecitabine and gemcitabine followed by concurrent radiotherapy and capecitabine produced good survival results in patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma.
Study Details
The study included 79 patients who had undergone radical resection and had stage pT2–4 or N+ or positive resection margins, M0, and a Zubrod performance status of 0 to 1. Patients received four cycles of gemcitabine 1,000 mg/m2 on days 1 and 8 and capecitabine 1,500 mg/m2/d on days 1 to 14 every 21 days followed by concurrent capecitabine 1,330 mg/m2/d and radiotherapy consisting of 45 Gy to regional lymphatics and 54 to 59.4 Gy to the tumor bed. The study was designed to estimate 2-year survival overall after R0 or R1 resection.
Of the 79 patients, 68% had extrahepatic cholangiocarcinoma, and 32% had gallbladder carcinoma; 68% had R0 resection, and 32% had R1 resection.
Survival
In total, treatment was completed in 86% of patients. Among all patients, 2-year overall survival was 65% (95% confidence interval [CI] = 53%–74%), including 67% in R0 patients and 60% in R1 patients. Median overall survival was 35 months, including 34 months in R0 patients and 35 months in R1 patients. Local relapse occurred in 18% of patients, distant relapse occurred in 30%, and combined relapse occurred in 11%.
Adverse Events
The most common grade 3 (52% of patients) or grade 4 (11%) adverse events were neutropenia (44%), hand-foot syndrome (11%), diarrhea (8%), lymphopenia (8%), and leukopenia (6%). One death, due to duodenal hemorrhage, was considered possibly related to treatment.
The investigators concluded: “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 [extrahepatic cholangiocarcinoma] and [gallbladder carcinoma] and provides baseline data for planning future phase III trials.”
Edgar Ben-Josef, MD, of University of Pennsylvania, is the corresponding author of the Journal of Clinical Oncology article.
The study was supported by the National Institutes of Health, National Cancer Institute, and National Clinical Trials Network grants and Community Oncology Research Program grants. For full disclosures of the study authors, visit jco.ascopubs.org.
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