Bevacizumab, Capecitabine, Amifostine, and Preoperative Hypofractionated Accelerated Radiotherapy (HypoArc) for Rectal Cancer: A Phase II Study
- Department of Pathology, Democritus University of Thrace, Alexandroupolis (Greece)
- Department of Radiotherapy/Oncology, Democritus University of Thrace, Alexandroupolis (Greece)
- Department of Surgery, Democritus University of Thrace, Alexandroupolis (Greece)
- Department of Anesthesiology, Democritus University of Thrace, Alexandroupolis (Greece)
Purpose: Bevacizumab has established therapeutic activity in patients with metastatic colorectal cancer, and anti-vascular endothelial growth factor therapy enhances the activity of radiotherapy in experimental models. We assessed the feasibility and efficacy of preoperative radiochemotherapy combined with bevacizumab in patients with rectal cancer. Methods and Materials: Nineteen patients with radiologic T3 and/or N+ rectal carcinoma were treated with preoperative conformal hypofractionated accelerated radiotherapy (3.4 Gy in 10 consecutive fractions) supported with amifostine (500-1,000 mg daily), capecitabine (600 mg/m{sup 2} twice daily, 5 days per week), and bevacizumab (5 mg/kg every 2 weeks for 2 cycles). Surgery followed 6 weeks after the end of radiotherapy. A cohort of 14 sequential patients treated with the same regimen without bevacizumab was available for comparison. Results: Grade 2 or 3 diarrhea was noted in 7 of 19 patients (36.8%), which was statistically worse than patients receiving the same regimen without bevacizumab (p = 0.01). A higher incidence of Grade 2 or 3 proctalgia was also noted (21.1%) (p = 0.03). Bladder and skin toxicity was negligible. All toxicities regressed completely within 2 weeks after the end of therapy. Pathologic complete and partial response was noted in 7 of 19 cases (36.8%) and 8 of 19 cases (42.1%). Within a median follow-up of 21 months, none of the patients has had late complications develop and only 1 of 18 evaluable cases (5.5%) has had locoregional relapse. Conclusions: Bevacizumab can be safely combined with hypofractionated radiotherapy and capecitabine as a preoperative radiochemotherapy regimen for patients with rectal cancer. The high pathologic complete response rates urges the testing of bevacizumab in randomized studies.
- OSTI ID:
- 21491779
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 80, Issue 2; Other Information: DOI: 10.1016/j.ijrobp.2010.02.037; PII: S0360-3016(10)00329-9; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
Similar Records
Phase II Trial of Neoadjuvant Bevacizumab, Capecitabine, and Radiotherapy for Locally Advanced Rectal Cancer
Phase I Trial of Preoperative Hypofractionated Intensity-Modulated Radiotherapy with Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer
Related Subjects
ANTINEOPLASTIC DRUGS
CARCINOMAS
CHEMOTHERAPY
DIARRHEA
FRACTIONATED IRRADIATION
RADIOTHERAPY
RECTUM
BODY
DIGESTIVE SYSTEM
DISEASES
DRUGS
GASTROINTESTINAL TRACT
INTESTINES
IRRADIATION
LARGE INTESTINE
MEDICINE
NEOPLASMS
NUCLEAR MEDICINE
ORGANS
RADIOLOGY
SYMPTOMS
THERAPY