Randomized controlled trial of 8 weeks' vs 12 weeks' interval between neoadjuvant chemoradiotherapy and surgery for locally advanced rectal cancer

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dc.authorid0000-0002-2282-7207
dc.contributor.authorTerzi, Cem
dc.contributor.authorBingül, Meryem
dc.contributor.authorArslan, Naciye Çi?dem
dc.contributor.authorÖztürk, Ersin
dc.contributor.authorCanda, Aras Emre
dc.contributor.authorIşık, Özgen
dc.contributor.authorYılmazlar, Tuncay
dc.contributor.authorObuz, Funda
dc.contributor.authorGörken, İlknur Bilkay
dc.contributor.authorKurt, Meral A.
dc.contributor.authorÜnlü, Mehtat Ş.
dc.contributor.authorU?raş, Nesrin
dc.contributor.authorKanat, Özkan
dc.contributor.authorÖztop, İlhan
dc.date.accessioned2019-12-23T12:41:18Z
dc.date.available2019-12-23T12:41:18Z
dc.date.issued2020
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Cerrahi Tıp Bilimleri Bölümü, Genel Cerrahi Ana Bilim Dalı
dc.description.abstractAim The aim was to compare the pathological complete response (pCR) rate at 8 compared to 12 weeks' interval between completion of neoadjuvant chemoradiotherapy (CRT) and surgery in patients with locally advanced rectal cancer. Method This was a randomized trial which included a total of 330 patients from two institutions. Patients with locally advanced (T3-4N0M0, TxN+M0) rectal cancer were randomized into 8- and 12-week interval groups. All the patients received long-course CRT (45 Gy in 1.8 Gy fractions and concomitant oral capecitabine or 5-fluorouracil infusion). Surgery was performed at either 8 or 12 weeks after CRT. The primary end-point was pCR. Secondary end-points were sphincter preservation, postoperative morbidity and mortality. Results Two-hundred and fifty-two patients (n = 125 in the 8-week group, n = 127 in the 12-week group) were included. Demographic and clinical characteristics were similar between groups. The overall pCR rate was 17.9% (n = 45): 12% (n = 15) in the 8-week group and 23.6% (n = 30) in the 12-week group (P = 0.021). Sphincter-preserving surgery was performed in 107 (85.6%) patients which was significantly higher than the 94 (74%) patients in the 12-week group (P = 0.016). Postoperative mortality was seen in three (1.2%) patients overall and was not different between groups (1.6% in 8 weeks vs 0.8% in 12 weeks, P = 0.494). Groups were similar in anastomotic leak (10.8% in 8 weeks vs 4.5% in 12 weeks, P = 0.088) and morbidity (30.4% in 8 weeks and 20.1% in 12 weeks, P = 0.083). Conclusion Extending the interval between CRT and surgery from 8 to 12 weeks resulted in a 2-fold increase in pCR rate without any difference in mortality and morbidity.
dc.identifier.citationTerzi, C., Bingül, M., Arslan, N. Ç., Öztürk, E., Canda, A. E., Işık, Ö. ... Öztop, İ. (2020). Randomized controlled trial of 8 weeks' vs 12 weeks' interval between neoadjuvant chemoradiotherapy and surgery for locally advanced rectal cancer. Colorectal Disease, 22(3), 279-288. https://doi.org/10.1111/codi.14867
dc.identifier.doi10.1111/codi.14867
dc.identifier.endpage288
dc.identifier.issue3
dc.identifier.scopusqualityQ2
dc.identifier.startpage279
dc.identifier.urihttps://doi.org/10.1111/codi.14867
dc.identifier.urihttps://hdl.handle.net/20.500.12511/4614
dc.identifier.volume22
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherWiley
dc.relation.ispartofColorectal Diseaseen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/embargoedAccess
dc.subjectRectal Cancer
dc.subjectNeoadjuvant Chemoradiotherapy
dc.subjectInterval
dc.subjectComplete Response
dc.titleRandomized controlled trial of 8 weeks' vs 12 weeks' interval between neoadjuvant chemoradiotherapy and surgery for locally advanced rectal cancer
dc.typeArticle

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