Randomized clinical trial of short or long interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer

Abstract

Disease regression and pCR rate are increased with an interval between CRT and surgery exceeding 8 weeks. Registration number: NCT03287843 (http://www.clinicaltrials.gov).

Meta-analysis of the effect of extending the interval after long-course chemoradiotherapy before surgery in locally advanced rectal cancer

“…). A total of 26 publications, including four RCTs and 25 445 patients with rectal cancer were eligible for inclusion ( Table ). Twenty‐four of the 26 studies (22 650 patients) reported the primary endpoint of pCR based on the predefined wait interval and were included in the qualitative and quantitative analysis for this outcome variable; 15·9 per cent (1522 of 9551) and 11·3 per cent (1481 of 13 099) had achieved pCR in the extended and classical intervals respectively.…”

“…All patients underwent neoadjuvant 5FU‐based (5FU–capecitabine–folinic acid) nCRT, except in seven trials that included some patients treated with concomitant oxaliplatin (5 trials) or irinotecan (2) in addition to 5FU or had a proportion of patients who had nSCRT (1 trial). The number of participants in the included trials ranged from 31 to 16 915; apart from the RCTs and one phase II non‐randomized trial, all were retrospective or prospective observational series. Median follow‐up ranged from 14·25 months to 5 years.…”

“…GRECCAR‐6 compared intervals of 11 and 7 weeks and found no significant difference in pCR rates; however, a significant increase in morbidity and decrease in TME quality was observed in patients who had an 11‐week interval. Conversely, a more recent RCT found that the pCR rate was significantly higher in patients whose surgery was performed after 8 weeks compared with that in the group that had TME with a shorter interval after chemoradiotherapy, with no differences identified in postoperative morbidity or surgical quality.…”

“…Thirty-day mortality and local recurrence, distant metastasis, RFS and overall survival (OS) rates were also evaluated. Stein et al 21 Tran et al 22 Tulchinsky et al 23 De Campos-Lobato et al 24 Evans et al 32 Garcia-Aguilar et al 31 Wolthuis et al 25 Saglam et al 33 Jeong et al 43 You et al 44 Zeng et al 46 Sirohi et al 45 Probst et al 47 Mihmanlı et al 49 Timudom et al 48 Akbar et al 26 Lefevre et al 35 Kwak et al 51 Foster et al 34 Garrer et al 50 Lee et al 52 Kuan et al 53 Akgun et al 36 Kim et al 54…”

“…Since then, a number of studies, including four RCTs, have been published; only two of the RCTs had pCR as a primary endpoint. GRECCAR‐6 compared intervals of 11 and 7 weeks and found no significant difference in pCR rates; however, a significant increase in morbidity and decrease in TME quality was observed in patients who had an 11‐week interval.…”