Abstract
PurposeA 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.MethodsPatients 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.ResultsOne 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).ConclusionsThe 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.
Highlights
The use of neoadjuvant radiotherapy in rectal cancer reduces the rate of local recurrence but does not improve overall survival [1, 2]
The study was designed to detect clinically relevant benefit associated with intraoperative implantation of gentamicin-collagen implant (GCI) in order to reduce distant recurrence in a patient after short-term radiotherapy and R0 resection
The results showed that GCI applied in the pelvis significantly reduced the rate of distant metastases (P = 0.005)
Summary
The use of neoadjuvant radiotherapy in rectal cancer reduces the rate of local recurrence but does not improve overall survival [1, 2]. Our previous study randomly allocated 229 of 245 consecutive patients scheduled for rectal cancer resection either to local application of gentamicin-collagen implant (GCI) into the pelvic cavity after total mesorectal excision (TME) or to the control group without GCI [4]. The primary endpoint of the study was the rate of postoperative complications. Preoperative short-course radiotherapy or chemoradiation was used in 51% of patients. Application of GCI was associated with reduced postoperative morbidity and, unexpectedly, with the improvement of overall survival (P = 0.004) and disease-free survival (P = 0.007) in patients after R0 resection, mainly by reducing the
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
