Emory University, Winship Cancer Institute, Atlanta, GA
Jerome Carl Landry , Yang Feng , Roshan Sudhir Prabhu , Steven J. Cohen , Charles A. Staley , Richard M. Whittington , Elin R. Sigurdson , Halla Sayed Nimeiri , Udit N. Verma , Al Bowen Benson III
Background: As previously reported, the regimen of preoperative capecitabine, oxaliplatin, and bevacizumab with radiation therapy (RT) followed by surgery and postoperative 5-FU, leucovorin, oxaliplatin (FOLFOX) andbevacizumabfor locally advanced rectal cancer did not improve pathologic complete response (path CR) rates. However, the effect of an intensified adjuvant regimen is not reflected in path CR. The purpose of this report is to describe the 5-year oncologic outcomes of this regimen. Methods: Fifty-seven patients (pts) with resectable T3/T4 rectal adenocarcinoma were enrolled. Preoperative treatment: capecitabine (825 mg/m² bid M-F), oxaliplatin (50 mg/m² weekly), bevacizumab (5 mg/kg D1,15,29), and RT (50.4 Gy). Surgery was performed by 8 weeks after neoadjuvant therapy. Beginning 8 – 12 weeks after surgery, patients received FOLFOX plus bevacizumab (5 mg/kg) Q2 weeks for 12 cycles. Results: Fifty-three of 57 enrolled pts were eligible and included in the analysis. Most patients were clinical (c)T3 (92%) and cN positive (64%). Of the 48 patients who underwent curative surgery, 26 (54%) began adjuvant chemotherapy. After a median follow-up period of 41 months, the 5-year overall survival (OS) rate for all patients was 80% (90% confidence interval (CI) [67%, 92%]). Only 2 patients experienced cancer recurrence, 1 distant and 1 loco-regional, respectively. The 5-year recurrence free survival rate (RFS) was 81% (90% CI [68%, 94%]). Conclusions: Despite the path CR primary endpoint of this trial not being reached, the 5-year OS and RFS rates were excellent. However, as previously reported, the neoadjuvant and surgical toxicity of this regimen was significant and was the primary reason for the low compliance with adjuvant systemic therapy. Due to the lack of an improvement in the path CR rate, the substantial associated toxicity, and negative phase III trials of adjuvant bevacizumab in colon cancer, this regimen cannot be recommended for further study. Clinical trial information: NCT00321685
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Abstract Disclosures
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