Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 4123
© 2005 American Society of Clinical Oncology

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Abstract

A phase II study of oxaliplatin and capecitabine (XELOX) in patients with unresectable cholangiocarcinoma, including carcinoma of the gallbladder and biliary tract

UT MD Anderson Cancer Ctr, Houston, TX

4123

Background: Malignancies of the gallbladder and biliary tract are uncommon in the United States, but are common in certain Japanese, Chilean, and Native American populations. Most patients present with advanced disease and are not candidates for potentially curative resection. Response rates range from 10–20% for patients receiving palliative chemotherapy, indicating the need for new therapeutic regimens. Patients and Methods: We prospectively studied capecitabine (Xeloda) 750mg/m2 twice daily on days 1–14 in combination with oxaliplatin 130mg/m2 on day 1 every 21 days in patients (pts) with unresectable or recurrent cholangiocarcinoma, to determine the response rate (RR), safety, and survival of pts treated with XELOX. Twenty-six pts were enrolled; 8 men and 18 women with a median age of 63(range 46–77). Pathologically 96% were adenocarcinoma and 4% were squamous carcinoma. Pts were stratified into 2 arms according to prior chemotherapy (8 pts) versus no prior chemotherapy (18 pts). Results: Twenty-one pts were evaluable for response and 26 pts were evaluable for toxicity. The overall RR was 19% (4/21). RR with and without prior therapy were 0%(0/6) and 26.6%(4/15), respectively. Following 3 courses of therapy 38% had stable disease and 43% had disease progression. Grade 1 neurotoxicity, diarrhea, anorexia, and nausea, were common. Grade 3 fatigue and diarrhea occurred in 23% and 8% of the pts respectively. Following treatment of 12 pts the starting dose of oxaliplatin was reduced to 100mg/m2 after prolonged myelosuppression, fatigue, and decreased PS were observed at the 130mg/m2 dose. Conclusions: With careful attention to dose XELOX is well tolerated. A RR of 26.6% in previously untreated pts is encouraging. XELOX should be considered an active regimen in the treatment of unresectable gallbladder cancer and cholangiocarcinoma. Accrual will continue to 50 pts and survival data analyzed. The toxicity profile is similar to that seen in other malignancies.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting