• Eur. J. Cancer · Jan 2012

    Multicenter Study

    Pre-operative bevacizumab, capecitabine, oxaliplatin and radiation among patients with locally advanced or low rectal cancer: a phase II trial.

    • Hagen Kennecke, Scott Berry, Ralph Wong, Chen Zhou, Keith Tankel, Jacob Easaw, Sanjay Rao, Jacqueline Post, and John Hay.
    • BC Cancer Agency, 600 West 10th Avenue, Vancouver, BC, Canada V5Z 4E6. hkennecke@bccancer.bc.ca
    • Eur. J. Cancer. 2012 Jan 1; 48 (1): 37-45.

    BackgroundTo evaluate the safety and efficacy of pre-operative chemoradiation, using capecitabine, oxaliplatin and bevacizumab with standard doses of radiation, in patients with high-risk rectal cancer.MethodsPatients with locally advanced or low rectal cancer were treated with capecitabine 825 mg/m(2) twice daily on days 1-14 and 22-35, oxaliplatin 50mg/m(2) on days 1, 8, 22 and 29, bevacizumab 5mg/kg on days 14, 1, 15 and 29, and radiation 50.4 Gy in 28 fractions including boost. Total mesorectal excision was performed 7-9 weeks after chemoradiation. The primary end-point was complete tumour regression (ypT0NX) by central review.FindingsForty-two evaluable patients were enrolled, and 38 proceeded to definitive surgery. Eighteen patients (43%) had clinical T4 tumours and/or N2 tumours. Mean relative dose intensity was >90% for all systemic agents, and 97% for radiation. Grade 3/4 diarrhoea occurred in 10 patients (24%) and pain in 4 patients (10%) pre-operatively, while grade 3/4 pain, fatigue and infection were each reported among 5 patients (13%) post-operatively. Re-operation due to complications occurred in 4 patients (11%). Complete tumour regression (ypT0) was seen in 9 patients (23.7%) of which two had N1 disease and the pathological complete response (pCR) rate (ypT0N0) was 18.4%. Central review changed pathologic stage in six cases (16%).InterpretationIn this study, pre-operative bevacizumab added to oxaliplatin, capecitabine and radiation was safe and resulted in a promising tumour regression rate. Surgical complications were closely monitored and occurred with the expected frequency. Central pathology review should be considered for trials with pathologic response as the primary end-point.FundingBritish Columbia Cancer Agency, Hoffmann-La Roche Canada and Sanofi-Aventis.Copyright © 2011 Elsevier Ltd. All rights reserved.

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