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Title: Bevacizumab, Capecitabine, Amifostine, and Preoperative Hypofractionated Accelerated Radiotherapy (HypoArc) for Rectal Cancer: A Phase II Study

Abstract

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 ofmore » 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.« less

Authors:
 [1];  [2]; ; ;  [3];  [4];  [3];  [1]
  1. Department of Pathology, Democritus University of Thrace, Alexandroupolis (Greece)
  2. Department of Radiotherapy/Oncology, Democritus University of Thrace, Alexandroupolis (Greece)
  3. Department of Surgery, Democritus University of Thrace, Alexandroupolis (Greece)
  4. Department of Anesthesiology, Democritus University of Thrace, Alexandroupolis (Greece)
Publication Date:
OSTI Identifier:
21491779
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 80; Journal 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.; Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; 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

Citation Formats

Koukourakis, Michael I., E-mail: targ@her.forthnet.g, Giatromanolaki, Alexandra, Tsoutsou, Pelagia, Lyratzopoulos, Nikolaos, Pitiakoudis, Michael, Kouklakis, George, Chloropoulou, Pelagia A, Manolas, Kostantinos, and Sivridis, Efthimios. Bevacizumab, Capecitabine, Amifostine, and Preoperative Hypofractionated Accelerated Radiotherapy (HypoArc) for Rectal Cancer: A Phase II Study. United States: N. p., 2011. Web. doi:10.1016/j.ijrobp.2010.02.037.
Koukourakis, Michael I., E-mail: targ@her.forthnet.g, Giatromanolaki, Alexandra, Tsoutsou, Pelagia, Lyratzopoulos, Nikolaos, Pitiakoudis, Michael, Kouklakis, George, Chloropoulou, Pelagia A, Manolas, Kostantinos, & Sivridis, Efthimios. Bevacizumab, Capecitabine, Amifostine, and Preoperative Hypofractionated Accelerated Radiotherapy (HypoArc) for Rectal Cancer: A Phase II Study. United States. https://doi.org/10.1016/j.ijrobp.2010.02.037
Koukourakis, Michael I., E-mail: targ@her.forthnet.g, Giatromanolaki, Alexandra, Tsoutsou, Pelagia, Lyratzopoulos, Nikolaos, Pitiakoudis, Michael, Kouklakis, George, Chloropoulou, Pelagia A, Manolas, Kostantinos, and Sivridis, Efthimios. 2011. "Bevacizumab, Capecitabine, Amifostine, and Preoperative Hypofractionated Accelerated Radiotherapy (HypoArc) for Rectal Cancer: A Phase II Study". United States. https://doi.org/10.1016/j.ijrobp.2010.02.037.
@article{osti_21491779,
title = {Bevacizumab, Capecitabine, Amifostine, and Preoperative Hypofractionated Accelerated Radiotherapy (HypoArc) for Rectal Cancer: A Phase II Study},
author = {Koukourakis, Michael I., E-mail: targ@her.forthnet.g and Giatromanolaki, Alexandra and Tsoutsou, Pelagia and Lyratzopoulos, Nikolaos and Pitiakoudis, Michael and Kouklakis, George and Chloropoulou, Pelagia A and Manolas, Kostantinos and Sivridis, Efthimios},
abstractNote = {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.},
doi = {10.1016/j.ijrobp.2010.02.037},
url = {https://www.osti.gov/biblio/21491779}, journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 2,
volume = 80,
place = {United States},
year = {Wed Jun 01 00:00:00 EDT 2011},
month = {Wed Jun 01 00:00:00 EDT 2011}
}