Adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine is well tolerated and shows promising efficacy in patients with extrahepatic cholangiocarcinoma (EHCC) or gallbladder carcinoma (GBCA). These findings were published online ahead of print in the Journal of Clinical Oncology.
Edgar Ben-Josef, MD, of the University of Pennsylvania and fellow researchers looked at 79 patients diagnosed with EHCC or GBCA who were given four cycles of gemcitabine as well as capecitabine followed by concurrent capecitabine and radiotherapy.
They found that two-year survival in all patients was 65 percent. With patients who underwent R0 or R1 resection, two-year survival was 67 percent and 60 percent, respectively. Median overall survival was 35 months.
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Grade 3 and 4 adverse events were found in 52 percent and 11 percent of patients, respectively. In addition, local, distant and combined relapses was observed in 14, 24 and nine patients, respectively.
“Our trial establishes the feasibility of conducting national adjuvant trials in EHCC and GBCA and provides baseline data for planning future phase III trials,” the authors concluded. “This combination was well tolerated, has promising efficacy, and provides clinicians with a well-supported regimen.”
- Ben-Josef, Edgar, et al. “SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma.” Journal of Clinical Oncology. doi: 10.1200/JCO.2014.60.2219. [epub ahead of print]. May 11, 2015.