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Original Article |
1 Department of Colorectal Cancer, The Maria Sklodowska-Curie Memorial Cancer Centre, W. K. Roentgena 5, 02 781 Warsaw, Poland
2 Department of Radiotherapy, The Maria Sklodowska-Curie Memorial Cancer Centre, W. K. Roentgena 5, 02 781 Warsaw, Poland
3 Department of Pathology, The Maria Sklodowska-Curie Memorial Cancer Centre, Gliwice, Poland
4 Department of Pathology, The Maria Sklodowska-Curie Memorial Cancer Centre, W. K. Roentgena 5, 02 781 Warsaw, Poland
5 Department of Pathology, Silesian Oncological Centre, Wroclaw, Poland
Correspondence: Address correspondence and reprint requests to: Krzysztof Bujko, MD, PhD; E-mail: bujko{at}coi.waw.pl
Background: The primary end-point of our randomized trial was sphincter preservation. The secondary aim was to evaluate whether distal bowel clearance
1 cm is safe after radiation.
Methods: The study randomized 312 patients with cT3-4 resectable low-lying and mid-rectal cancer to receive either preoperative irradiation (5 x 5 Gy) with immediate total mesorectal excision (TME) or chemoradiation (50.4 Gy, bolus 5-fluorouracil and leucovorin) with delayed TME. After anterior resection, pathologists prospectively measured macroscopic and microscopic distal bowel clearance.
Results: Macroscopic and microscopic distal bowel clearance, distal intramural spread, sphincter preservation, local control, disease-free survival, and overall survival did not differ in the two randomized groups. Pooled analysis of the two groups showed that the incidence of local recurrence at 4 years (median follow-up) for patients with macroscopic clearance
1 cm (n = 42) and >1 cm (n = 124) was 11.3% and 15.4%, respectively (P = 0.514); the hazard ratio (HR) was 0.70, and the 95% confidence interval (CI) was 0.23–2.07. The corresponding values for patients with microscopic clearance
1 cm (n = 51) and >1 cm (n = 101) were 9.6% and 17.6% (P = 0.220; HR 0.51; 95% CI 0.17–1.53).
Conclusion: After preoperative radiotherapy, distal bowel clearance
1 cm did not compromise local control.
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