Efficacy of the FOLFOX/CAPOX regimen for advanced small bowel adenocarcinoma: a three-center study from China.

Purpose: Small bowel adenocarcinoma (SBA) is a rare Malignancy, and most patients present with unresectable or metastatic disease. Thus far, no standard chemotherapeutic regimen has been established and related data are scarce, especially in Eastern countries. The purpose of this multicenter study was to evaluate the efficacy and toxicity of oxaliplatin combined with fluoropyrimidines in Chinese patients with advanced SBA. Methods: Advanced SBA patients who received FOLFOX (5-fluorouracil/5-FU plus leucovorin and oxaliplatin)/CAPOX (capecitabine plus oxaliplatin) as first-line chemotherapy between February, 2004 and October, 2010 were identified from 3 large medical centers in China. The response rate (RR), progression-free survival (PFS), overall survival (OS), and chemotherapy-associated toxicity were evaluated. Cox models were applied for multivariate analyses. Results: Of 34 patients, with SBA 28 received FOLFOX and 6 CAPOX The objective response (OR) and disease control (DC) rates were 32.3% and 61.7%, respectively. The median PFS and OS were 6.3 and 14.2 months, respectively. The toxicity was tolerable, grade 3-4 toxicity was rare. In multivariate analysis, only multi-organ metastasis reached borderline significance for shorter PFS (p=0.059), but the variables of age (>65 years; p=0.001), and multi-organ metastasis (p=0.001) were significantly associated with poor OS. Conclusion: To our knowledge, this multicenter retrospective study is the first and largest one among Asian studies at present estimating oxaliplatin combined with fluoropyrimidines as first-line chemotherapy for advanced SBA. FOLFOX/CAPOX is proved effective for advanced SBA in this study, but the results do not absolutely agree with previous studies from Western countries, showing that further studies are still needed.