Neoadjuvant Radiotherapy with Capecitabine Plus Bevacizumab for Locally Advanced Lower Rectal Cancer: Results of a Single-institute Phase II Study

• Published in: Anticancer research Vol. 38; no. 7; pp. 4193 - 4197
• Main Authors: Maeda, Kiyoshi, Shibutani, Masatsune, Otani, Hiroshi, Fukuoka, Tatsunari, Iseki, Yasuhito, Matsutani, Shinji, Nagahara, Hisashi, Inoue, Toru, Tachimori, Akiko, Nishii, Takafumi, Miki, Yoshitaka, Hosono, Masako, Ohira, Masaichi
• Format: Journal Article
• Language: English
• Published: Greece International Institute of Anticancer Research 01.07.2018
• Subjects: Acute toxicity; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Bevacizumab; Bevacizumab - administration & dosage; Bevacizumab - adverse effects; Cancer; Capecitabine - administration & dosage; Capecitabine - adverse effects; Capecitabine - therapeutic use; Chemoradiotherapy; Chemoradiotherapy, Adjuvant - methods; Colorectal cancer; Complications; Female; Humans; Immunotherapy; Male; Middle Aged; Monoclonal antibodies; Neoadjuvant Therapy - methods; Patients; Radiation therapy; Rectal Neoplasms - drug therapy; Rectal Neoplasms - radiotherapy; Rectum; Surgery; Targeted cancer therapy; Toxicity; radiotherapy; capecitabine; lower rectal cancer; Bevacizumab
• ISSN: 0250-7005; 1791-7530
• DOI: 10.21873/anticanres.12713

A single-arm phase II clinical trial was conducted to evaluate the safety and efficacy of adding bevacizumab to standard capecitabine-based neoadjuvant chemoradiotherapy (CRT) for the treatment of locally advanced rectal cancer (LARC). Twenty-five patients were enrolled. Patients received capecitabine-based CRT for 5 weeks and 3 days. Bevacizumab was administered every 2 weeks during CRT. Within 6-10 weeks after completion of CRT, surgery was performed. With regard to CRT-related acute toxicities, most of the adverse events were limited to grade 1. A pathological complete response was obtained in four (16%) patients. In total, six patients (24%) developed postoperative complications. Six out of five (83%) patients healed without the need for surgical intervention. Although acute toxicity during CRT with bevacizumab was minimal and postoperative complications do not seem to increase, the addition of bevacizumab apparently offers no clinically-significant benefit for patients with LARC.