ORIGINAL ARTICLE A observational study of the efficacy and safety of capecitabine versus bolus infusional 5-fluorouracil in pre-operative chemoradiotherapy for locally advanced rectal cancer Chin-Fan Chen & Ming-Yii Huang & Chih-Jen Huang & Chan-Han Wu & Yung-Sung Yeh & Hsiang-Lin Tsai & Cheng-Jen Ma & Chien-Yu Lu & Shun-Jen Chang & Ming-Jenn Chen & Jaw-Yuan Wang Accepted: 24 November 2011 / Published online: 19 January 2012 # Springer-Verlag 2012 Abstract Background and objectives This study is to evaluate the safety and efficacy of preoperative radiotherapy (RT) combined with bolus infusional 5-fluorouracil (5-FU) or oral capecitabine in patients with locally advanced rectal cancer (LARC). Materials and methods Seventy-four patients were retro- spectively analyzed. Twenty-seven patients were treated with 5-FU (350 mg/m 2 IV bolus) and leucovorin (20 mg/ m 2 IV bolus) for 5 days/week during week 1 and 5 of RT. Forty-seven patients were treated with capecitabine (850 mg/m 2 , twice daily for 5 days/week). Both groups received the same RT course (45–50.4 Gy/25 fractions, 5 days/week, for 5 weeks). Patients underwent surgery in 6 weeks after completion of the chemoradiotherapy. Data of the observational study were collected. Results Grade 3 or 4 toxicities occurred in 40.7% (5-FU) and 19.1% (capecitabine) of the patients (P 0 0.044). Six patients in the 5-FU group (22.2%) and six patients in the capecitabine group (14%) achieved complete response. Pri- mary tumor (T) downstaging were achieved in 51.9% (5- C.-F. Chen : Y.-S. Yeh Department of Emergency Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan M.-Y. Huang : C.-J. Huang Department of Radiation Oncology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan M.-Y. Huang : C.-J. Huang Department of Radiation Oncology, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan C.-H. Wu Department of Medical Research, Fooyin University Hospital, Pingtung, Taiwan H.-L. Tsai Division of General Surgery Medicine, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan H.-L. Tsai School of Medical and Health Sciences, Fooyin University, Kaohsiung, Taiwan C.-J. Ma : J.-Y. Wang (*) Division of Gastrointestinal and General Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100 Tzyou 1st Road, Kaohsiung 807, Taiwan e-mail: cy614112@ms14.hinet.net J.-Y. Wang e-mail: jayuwa@cc.kmu.edu.tw C.-Y. Lu Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan C.-Y. Lu Department of Internal Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan Int J Colorectal Dis (2012) 27:727–736 DOI 10.1007/s00384-011-1377-3