Author/Editor		Valk, Maxime J. M. van der; Marijnen, Corrie A. M.; Etten, Boudewijn van; Dijkstra, Esmée A.; Hilling, Denise E.; Putter, Hein; Roodvoets, Annet G. H.; Bahadoer, Renu R.; Fokstuen, Tone; Edhemović, Ibrahim
Title		Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer
Type		članek
Vol. and No.		Letnik 38, št. 147
Publication year		2020
Volume		str. 75-83
ISSN		0167-8140 - Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
Language		eng
Abstract		Background: Preoperative chemoradiotherapy (CRT) followed by total mesorectal excision is widely accepted as the standard of care for high-risk rectal cancer. Adjuvant chemotherapy is advised in several international guidelines, although the survival benefit remains unclear and compliance is poor. The current multidisciplinary approach has led to major improvements in local control, yet the occurrence of distant metastases has not decreased accordingly. The combination of short-course radiotherapy (SCRT) and chemotherapy in the waiting period before surgery might have several benefits, including higher compliance, downstaging and better effect of systemic therapy. Methods: This is an investigator-initiated, international multicentre randomized phase III trial. High-risk rectal cancer patients were randomized to SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy (25%28 % 2%1.8 Gy) with concomitant capecitabine followed by surgery and optional postoperative chemotherapy (8 cycles CAPOX or 12 cycles FOLFOX4) according to local institutions% policy. The primary endpoint is time to diseaserelated treatment failure. Here, we report the compliance, toxicity and postoperative complications in both study groups. Findings: Between June 2011 and June 2016, 920 patients were enrolled. Of these, 901 were evaluable (460 in the experimental arm and 441 in the standard arm). All patients in the experimental arm received 5 % 5 Gy radiotherapy, and 84% of all patients received at least 75% of the prescribed chemotherapy. In the standard arm, the compliance for CRT was 94% and 57% for postoperative chemotherapy. Toxicity grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy. No statistically significant differences in surgical procedures or postoperative complications were observed.
Keywords		rektalni rak predoperativna radioterapija kemoterapija multimodalno zdravljenje rectal cancer preoperative radiotherapy chemotherapy multimodal treatment