ORIGINAL ARTICLE Neoadjuvant chemoradiation with concomitant boost radiotherapy associated to capecitabine in rectal cancer patients Mattia F. Osti & Linda Agolli & Stefano Bracci & Luigi Masoni & Maurizio Valeriani & Teresa Falco & Vitaliana De Sanctis & Riccardo Maurizi Enrici Accepted: 18 April 2014 /Published online: 14 May 2014 # Springer-Verlag Berlin Heidelberg 2014 Abstract Purpose The primary end-points were complete pathological response and local control. Secondary end-points were sur- vivals, anal sphincter preservation, and toxicity profile. Methods Patients with T3/T4 and or N+ rectal cancer (n =65) were treated with preoperative concomitant boost radiothera- py (55 Gy/25 fractions) associated to concurrent chemothera- py with oral capecitabine. Results All patients completed the programmed treatment. The complete pathological response was achieved by 17 % of the patients. Anal sphincter preservation surgery was pos- sible for 86 % of the patients with low rectal cancer (≤5 cm from the anal verge). The T-stage and N-stage downstaging were achieved by 40 and 58 % of the patients, respectively. Circumferential radial margin was involved (close/positive) in eight patients. After a median follow-up of 26 months, local and distant recurrence occurred in two and 11 patients, respec- tively. The 3-year overall survival and disease-free survival were 86.8 and 81 %, respectively. Non-hematological ≥ grade 3 toxicities were observed in 15 % of the patients. On univar- iate analysis N-downstaging and positive circumferential ra- dial margin were significantly associated with worse overall survival (p =0.003 and p =0.023, respectively), disease-free survival ( p =0.001 and p =0.036, respectively), and metastasis-free survival (MFS) (p =0.001 and p =0.038, respectively).On multivariate analysis, the N-downstaging were significantly associated with better overall survival (OS) (p =0.022). Conclusions Our data support the efficacy of preoperative treatment for rectal cancer in terms of local outcomes. Radi- ation treatment intensification may have a biological rationale; longer follow-up is needed. Keywords Rectal cancer . Concomitant boost . Radiotherapy . Capecitabine Introduction Colorectal cancer is one of the most common malignancies in European countries either in women or in men [1]. Preoperative radiotherapy shows a survival benefit and bet- ter local control in locally advanced rectal cancer (LARC) patients when compared with surgery alone as proven by randomized trials [2, 3]. Preoperative treatment is carried out in LARC (T3/T4 and/or N+) to increase disease control and probabilities for sphincter-saving surgery. Nowadays, total mesorectal excision (TME) is the gold standard of surgical management of the middle and distal thirds of rectal cancer [4] and is performed after 6–8 weeks from neoadjuvant therapy completion [5]. Therefore, several studies have demonstrated that the ad- dition of chemotherapy to neoadjuvant radiotherapy improves tumor response (downstaging/downsizing) and sphincter preservation [ 6, 7]. The concurrent administration of fluorouracil-based chemotherapy is able to reduce recurrence and increase complete pathological response rates, although, no advantage in survival advantage was observed. Continuous intravenous infusion of 5-fluorouracil (5-FU) is superior to 5- FU bolus in terms of downstaging and overall survival (OS), even though the continuous modality leads to higher rates of severe hematological toxicity [8]. The capacity of 5-FU is to M. F. Osti : L. Agolli (*) : S. Bracci : M. Valeriani : T. Falco : V. De Sanctis : R. Maurizi Enrici Institute of Radiation Oncology, Sant’Andrea Hospital Sapienza Rome University, Via di Grottarossa, 1035-1039, Rome 00189, Italy e-mail: linda.agolli@gmail.com L. Masoni Department of Medical and Surgical Sciences and Translational Medicine, Sant’Andrea Hospital, Sapienza Rome University, Rome, Italy Int J Colorectal Dis (2014) 29:835–842 DOI 10.1007/s00384-014-1879-x