Phase II trial of capecitabine and oxaliplatin in patients with advanced or metastatic pancreatic adenocarcinoma

Autor: Anna Berkenblit, P. Forino, Keith Stuart, Michael Goldstein, L. C. Garrot, J. Underhill, E. Florendo
Rok vydání: 2006
Předmět:
Zdroj: Journal of Clinical Oncology. 24:14103-14103
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2006.24.18_suppl.14103
Popis: 14103 Background: Advanced pancreatic adenocarcinoma (PCa) portends a poor prognosis. Both capecitabine (CAP) and oxaliplatin (OX) have demonstrated activity in pancreas cancer, may be synergistic, and are well tolerated. We report the outcomes and toxicities of patients (pts) with PCa treated with CAP and OX in combination. Methods: Entry criteria: ECOG PS ≥ 2, adequate renal, hepatic and bone marrow function and at least one measurable lesion. Pts were allowed to have received one prior chemotherapy for advanced disease, or adjuvant therapy if completed more than 12 months prior. Pts received CAP 2000 mg/m2 po taken in two divided doses for 14 days starting on day one and OX 130 mg/m2 IV on day 1 of each 21 day cycle. Response was recorded per RECIST criteria. Results: Sixteen pts have been enrolled, 14 have been treated (2 pts suffered rapid decline prior to start) thus far. The average number of cycles was 2.7, and 3 pts received 4 or more cycles. Of 10 evaluable pts, 6 had stable disease, 1 had a partial response and 3 had progressive disease. Of the 5 pts who had received prior chemotherapy with progression, 3 had stable disease, and one had a partial response, and 1 had progressive disease. Of the 5 pts who had not recieved prior chemotherapy, 3 had stable disease and 2 had progressive disease. Median time to progression was 7 weeks. Four pts are still undergoing treatment. Toxicity was acceptable in the12 pts evaluated. Three grade 4 events occurred and were unrelated to therapy (venous thromboembolism, stroke, hyperbilirubinemia). Grade 3 toxicity was noted in 5 pts (fatigue, nausea, vomiting and diarrhea). Grade 1/2 toxicity was minimal, predominated by neurosensory deficits in 7 pts, hand foot syndrome (HFS) in four pts, and nausea in 4 pts. Two pts stopped therapy due to toxicity, one for HFS (grade 2) after 1 cycle, and one for diarrhea (grade 3) after two cycles. Four pts required dose reduction. Conclusion: The combination of CAP and OX is reasonable and tolerable treatment of pancreas cancer with activity even in pts receiving second line chemotherapy. Accrual is ongoing. No significant financial relationships to disclose.
Databáze: OpenAIRE
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