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Open Access 01-12-2016 | Research article

Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial

Authors: Tadas Latkauskas, Henrikas Pauzas, Laura Kairevice, Aleksandras Petrauskas, Zilvinas Saladzinskas, Rasa Janciauskiene, Jurate Gudaityte, Paulius Lizdenis, Saulius Svagzdys, Algimantas Tamelis, Dainius Pavalkis

Published in: BMC Cancer | Issue 1/2016

Abstract

Background

There still is no evidence which neoadjuvant therapy regimen for stage II–III rectal cancer is superior. The aim of this study was to compare results achieved after long-course chemoradiotherapy (CRT) with short-term radiotherapy (RT) followed by delayed surgery.

Methods

A randomized trial was carried out between 2007–2013. One hundred fifty patients diagnosed with stage II–III rectal cancer were randomized into one of two neoadjuvant treatment arms: conventional chemoradiotherapy (CRT) and short-term radiotherapy (RT) followed by surgery after 6–8 weeks. Primary endpoints of this trial were downstaging and pathological complete response rate. Secondary endpoints were local recurrence rate and overall survival.

Results

The pathological complete response was found in 3 (4.4%) cases after RT and 8 (11.1%) after CRT (P = 0.112). Downstaging (stage 0 and I) was observed in 21 (30.9%) cases in RT group vs. 27 (37.5%) cases in CRT group (P = 0.409). Median follow-up time was 39.7 (range 4.9–79.7) months. 3-years overall survival (OS) was 78% in RT group vs. 82.4% in CRT group (P = 0.145), while disease-free survival (DFS) differed significantly – 59% in RT group vs. 75.1% in CRT group (P = 0,022). Hazard ratio of cancer progression for RT patients was 1.93 (95% CI: 1.08–3.43) compared to CRT patients.

Conclusion

Three-years disease-free survival was better in CRT group comparing with RT group with no difference in overall survival.

Trial registration

http://clinicaltrials.gov identifier NCT00597311. January 2008.

Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012;30(16):1926-33.

Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, et al. The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma. Ann Surg. 2007;246(5):693–701.CrossRefPubMed

Cedermark B, Johansson H, Rutqvist LE, Wilking N. The Stockholm I trial of preoperative short term radiotherapy in operable rectal carcinoma. A prospective randomized trial. Stockholm Colorectal Cancer Study Group. Cancer. 1995;75(9):2269–75.CrossRefPubMed

Martling A, Holm T, Johansson H, Rutqvist LE, Cedermark B. The Stockholm II trial on preoperative radiotherapy in rectal carcinoma: long-term follow-up of a population-based study. Cancer. 2001;92(4):896–902.CrossRefPubMed

Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, et al. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006;355(11):1114–23.CrossRefPubMed

Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Michalski W, Bebenek M, Kryj M. Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer. Br J Surg. 2006;93(10):1215–23.CrossRefPubMed

Gerard JP, Conroy T, Bonnetain F, Bouche O, Chapet O, Closon-Dejardin MT, et al. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006;24(28):4620–5.CrossRefPubMed

Latkauskas T, Paskauskas S, Dambrauskas Z, Gudaityte J, Saladzinskas S, Tamelis A, et al. Preoperative chemoradiation vs radiation alone for stage II and III resectable rectal cancer: a meta-analysis. Colorectal Dis. 2010;12(11):1075–83.CrossRefPubMed

Ceelen W, Fierens K, Van Nieuwenhove Y, Pattyn P. Preoperative chemoradiation versus radiation alone for stage II and III resectable rectal cancer: a systematic review and meta-analysis. Int J Cancer. 2009;124(12):2966–72.CrossRefPubMed

10.

De Caluwe L, Van Nieuwenhove Y, Ceelen WP. Preoperative chemoradiation versus radiation alone for stage II and III resectable rectal cancer. Cochrane Database Syst Rev. 2013;2:CD006041.

11.

Radu C, Berglund A, Pahlman L, Glimelius B. Short-course preoperative radiotherapy with delayed surgery in rectal cancer - a retrospective study. Radiother Oncol. 2008;87(3):343–9.CrossRefPubMed

12.

Pettersson D, Cedermark B, Holm T, Radu C, Pahlman L, Glimelius B, et al. Interim analysis of the Stockholm III trial of preoperative radiotherapy regimens for rectal cancer. Br J Surg. 2010;97(4):580–7.CrossRefPubMed

13.

Latkauskas T, Pauzas H, Gineikiene I, Janciauskiene R, Juozaityte E, Saladzinskas Z, et al. Initial results of a randomized controlled trial comparing clinical and pathological downstaging of rectal cancer after preoperative short-course radiotherapy or long-term chemoradiotherapy, both with delayed surgery. Colorectal Dis. 2012;14(3):294–8.CrossRefPubMed

14.

Glimelius B, Tiret E, Cervantes A, Arnold D. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24 Suppl 6:vi81–8.CrossRefPubMed

15.

Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986;1(8496):1479–82.CrossRefPubMed

16.

Schrag D, Weiser MR, Goodman KA, Gonen M, Hollywood E, Cercek A, et al. Neoadjuvant Chemotherapy Without Routine Use of Radiation Therapy for Patients With Locally Advanced Rectal Cancer: A Pilot Trial. J Clin Oncol. 2014;13.

Title: Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial
Authors: Tadas Latkauskas
Henrikas Pauzas
Laura Kairevice
Aleksandras Petrauskas
Zilvinas Saladzinskas
Rasa Janciauskiene
Jurate Gudaityte
Paulius Lizdenis
Saulius Svagzdys
Algimantas Tamelis
Dainius Pavalkis
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: BMC Cancer / Issue 1/2016
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-016-2959-9

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Abstract

Background

Methods

Results

Conclusion

Trial registration

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