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International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 8/2018

Open Access 01-08-2018 | Original Article

The gentamicin-collagen implant and the risk of distant metastases of rectal cancer following short-course radiotherapy and curative resection: the long-term outcomes of a randomized study

Authors: Andrzej Rutkowski, Lucyna Pietrzak, Jacek Kryński, Leszek Zając, Mariusz Bednarczyk, Tomasz Olesiński, Marek Szpakowski, Piotr Saramak, Ireneusz Pierzankowski, Piotr Hevelke, Piotr Surowski, Krzysztof Bujko

Published in: International Journal of Colorectal Disease | Issue 8/2018

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Abstract

Purpose

A previous randomized study conducted by our group showed that application of gentamicin-collagen implant (GCI) into the pelvic cavity after total mesorectal excision (TME) reduced the incidence of distant metastases. Therefore, we decided to conduct a confirmatory study.

Methods

Patients with rectal cancer were included in the study if they met the following criteria: adenocarcinoma of the rectum, preoperative short-term radiotherapy (5 × 5 Gy), and WHO performance score 0–1.

Results

One hundred seventy-six patients were randomly assigned either to an experimental group in which GCI was applied (n = 81) or to a control group without GCI (n = 81). Median follow-up was 80 months. Cumulative incidence of distant metastases at 5 years was higher in the control group compared to the experimental group: 23.5 vs 8.6% (HR 2.4 [95% CI 1.1–5.5], P = 0.005). Overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) did not differ between the experimental group and the control group: HR 0.95 [95% CI 0.55–1.70], P = 0.864; HR 0.85 [95% CI 0.50–1.45], P = 0.548, and HR 0.5 [95%CI 0.22–1.22], P = 0.093, respectively. The predefined by the protocol subgroup analysis for yp stage III disease showed better DFS in the experimental group compared to the control group; HR 0.47 [95%CI 0.23–0.97], P = 0.042).

Conclusions

The results confirmed our previous finding that GCI applied in the pelvis significantly reduced the rate of distant metastases in patients after radical rectal cancer resection.
Appendix
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Metadata
Title
The gentamicin-collagen implant and the risk of distant metastases of rectal cancer following short-course radiotherapy and curative resection: the long-term outcomes of a randomized study
Authors
Andrzej Rutkowski
Lucyna Pietrzak
Jacek Kryński
Leszek Zając
Mariusz Bednarczyk
Tomasz Olesiński
Marek Szpakowski
Piotr Saramak
Ireneusz Pierzankowski
Piotr Hevelke
Piotr Surowski
Krzysztof Bujko
Publication date
01-08-2018
Publisher
Springer Berlin Heidelberg
Published in
International Journal of Colorectal Disease / Issue 8/2018
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-018-3045-3

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