Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 15068
© 2008 American Society of Clinical Oncology

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Abstract

Bevacizumab-based conformal radio-chemotherapy for locally advanced inoperable colorectal cancer

Tumour and Angiogenesis Rsrch, Alexandroupolis, Greece; Democritus University of Thrace, Alexandroupolis, Greece

15068

Background: Anti-VEGF therapy enhances the activity of radiotherapy in experimental models and has shown important activity in patients with metastatic colorectal cancer (CRC). We report our experience in the treatment of locally advanced inoperable CRC (LA/I-CRC) with accelerated high dose radiotherapy, capecitabine and bevacizumab anti-VEGF monocolonal antibody. Methods: Eligible patients had an adenocarcinoma histology, LA/I-CRC and a median performance status of 1 (0–2). Eleven patients with LA/I-CRC were treated with conformal hypofractionated accelerated radiotherapy (3.4 Gy x 15 fractions within 4 weeks, biological equivalent dose of 70 Gy), capecitabine (600 mg/m² daily, 5-days per week) and bevacizumab (5 mg/kgr every 2 weeks). Capecitabine and bevacizumab were continued thereafter for 3 months (same schedule). Amifostine (1,000 mg/day) was administered subcutaneously before each radiotherapy fraction. Primary endpoints were toxicities assessed by common toxicity criteria, delay in radiotherapy administration, response and progression-free survival. Results: The regimen showed increased but acceptable early toxicity. Diarrhea grade 3/4 appeared in 3/11 (27 %) and proctitis grade 3 in 2/11 (18 %) patients. One patient died from intercurrent disease and another 1 died from Fournier's gangrene syndrome after the 2nd week of therapy. Out of 9 evaluable patients, 7 (78 %) had a complete response, and 2 (22 %) a partial response. Within a median of 12 months of follow-up (range 6–24 months), 9/11 patients are alive with no evidence of local or distant disease progression and without severe late sequelae. Conclusions: These preliminary data show an impressive rate of long lasting complete responses obtained by this regimen in LA/I-CRC. Early toxicity was, however, high and the radiotherapy schedule has thereafter been modified to deliver the same dose within 5 weeks instead of 4 in a new prospective study.

No significant financial relationships to disclose.