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

Rutkowski, A.; Pietrzak, L.; Kryński, J; Zajâc, Leszek; Bednarczyk, M.; Olesiński, Tomasz; Szpakowski, Marek; Saramak, Piotr; Pierzankowski, Ireneusz; Hevelke, Piotr; Surowski, Piotr; Bujko, Krzysztof

doi:10.1007/s00384-018-3045-3

Cited by 3 publications

(9 citation statements)

References 19 publications

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“…observed in a randomised trial a significantly reduced rate of distant metastases in patients with GCS after TME with preoperative radiotherapy compared to a control group without GCS 21. These surprising findings were also demonstrated in a confirmatory study from the same institution with the median follow-up of 80 months 36. These results are difficult to explain, in particular, the fact that there were no significant differences in overall and disease-free survival rates.…”

Section: Discussionmentioning

confidence: 89%

“… 21 These surprising findings were also demonstrated in a confirmatory study from the same institution with the median follow-up of 80 months. 36 These results are difficult to explain, in particular, the fact that there were no significant differences in overall and disease-free survival rates. Apart from the assessment of oncological outcomes, a detailed cost-effectiveness analysis as well as a long-term evaluation of conceivable late side effects (anastomosis stricture, persistent anterior resection syndrome) are other interesting topics worth to be explored in the future.…”

Section: Discussionmentioning

confidence: 94%

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Ultralow anterior resection with implantation of gentamicin-collagen sponge and no defunctioning stoma: anastomotic leakage and local cancer relapse

Michalik¹,

Matkowski

Biecek

et al. 2019

Radiology and Oncology

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Background Anterior resection with total mesorectal excision (TME) of ultralow rectal cancer may result in the increased risk of the anastomotic leakage (AL). The aim of this study was to evaluate the usefulness of the gentamicin-collagen sponge (GCS) for the protection against symptomatic AL and investigate association between AL and local relapse (LR). Patients and methods A series of 158 patients with ultralow rectal cancer was studied. All the patients underwent R0 sphincter-saving TME with anastomosis wrapping using GCS. In none of the cases a temporary protective stoma was constructed. Results AL rate was 3.2% (5/158) while median time to AL diagnosis was 5 days following surgery (range 3-15). There was no postoperative and leakage-related mortality. Patient age > 75 years and smoking were independent risk factors related to significantly increased AL rate: 12.5% vs. 0.8% (P = 0.0004) and 5.7% vs. 0% P = 0.043), respectively. LR was observed in 12% of cases. It was highly significantly more common and developed earlier in patients who have had AL when compared with non-AL group: 80% vs. 9% (P = 0.00001) and 8.5 vs. 17 months (P = 0.014), respectively. Conclusions Anastomosis wrapping with GCS after anterior resection with TME is a safe procedure resulting in the low incidence of anastomotic leakage which may be also associated with decreased risk of local relapse.

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Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 94%

Ultralow anterior resection with implantation of gentamicin-collagen sponge and no defunctioning stoma: anastomotic leakage and local cancer relapse

Michalik¹,

Matkowski

Biecek

et al. 2019

Radiology and Oncology

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“…The objective of the first study (Nowacki et al) [1] was to determine the effect of GRM on the risk of post-operative complications and oncological results. The surprising results of the 3-year long-term follow-up, showed a significantly lower rate of distant metastases in the group of patients operated on with the use of GRM inspired another study with the objective to confirm the previous results (Rutkowski et al) [2]. This time, the main objective of the project was to confirm the anti-cancer properties of GRM with regards to a reduction of generalized relapse.…”

Section: Introductionmentioning

confidence: 76%

“…The analysis concerned the data of the patients who participated in two randomized studies, completed and published. The criteria of participation were described before [1,2]. Both studies concerned patients with rectal primary adenocarcinoma.…”

Section: Methodsmentioning

confidence: 99%

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Long-term results of randomized studies on the use of a gentamicin-collagen sponge in rectal cancer – depending on the length of time between the completion of radiotherapy and the surgery

Dmitruk¹,

Olesiński²,

Hevelke³

et al. 2021

Nowotwory. Journal of Oncology

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Introduction. Two randomized studies on the use of a gentamicin-collagen sponge (GRM01/1997 and GRM02/2007) in rectal cancer surgery showed a statistically significant decrease in the rate of distant metastases in the experimental group and a similar rate of local recurrences. The objective of the presented study was a retrospective evaluation of the effect of the GRM use on the observed rate of generalized recurrences, disease-free survival (DFS), overall survival (OS) and cancer-specific survival (CSS) -depending on the length of the interval between radiotherapy and surgery. Materials and methods. The study comprised 239 patients, included previously into randomized studies, in whom the 5 x 5 Gy radiotherapy was used. In 204 people, the surgery was made within 7 days of the completion of radiotherapy (group A). The remaining group of 35 patients were operated on after 4-8 weeks (group B). The follow-up period was 5 years. The statistical analysis was made with the Kaplan-Meier test. The value of α = 0.05 was degfined as the threshold of statistical significance. Results. In both groups, there were no statistical differences between the patients operated on with the use of GRM and those operated on without the use of GRM. The analysis took into consideration the most significant parameters, which could affect the oncological results, (ypTNM, lympho-vascular invasion (LVI), blood vessel invasion (BVI). In group A, the use of GRM was connected with a lower rate of metachronic distant metastases (p = 0.002; RR 0.41; 95% CI [0.24-0.72]), the prolongation of DFS (p = 0.008; HR 2.16; 95% ) and of CSS (p = 0.010; HR 2.37; 95% ). No such relationships were observed in group B. Conclusions. The use of GRM decreases the risk of distant metastases and has an influence on the prolongation of recurrence free survival, but only when surgery is carried out within 7 days of the completion of irradiation.

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Quality of Surgical Outcome Reporting in Randomised Clinical Trials of Multimodal Rectal Cancer Treatment: A Systematic Review

Janczak,

Ukegjini,

Bischofberger

et al. 2023

Cancers

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Introduction: Randomised controlled trials (RCTs) continue to provide the best evidence for treatment options, but the quality of reporting in RCTs and the completeness rate of reporting of surgical outcomes and complication data vary widely. The aim of this study was to measure the quality of reporting of the surgical outcome and complication data in RCTs of rectal cancer treatment and whether this quality has changed over time. Methods: Eligible articles with the keywords (“rectal cancer” OR “rectal carcinoma”) AND (“radiation” OR “radiotherapy”) that were RCTs and published in the English, German, Polish, or Italian language were identified by reviewing all abstracts published from 1982 through 2022. Two authors independently screened and analysed all studies. The quality of the surgical outcome and complication data was assessed based on fourteen criteria, and the quality of RCTs was evaluated based on a modified Jadad scale. The primary outcome was the quality of reporting in RCTs and the completeness rate of reporting of surgical results and complication data. Results: A total of 340 articles reporting multimodal therapy outcomes for 143,576 rectal cancer patients were analysed. A total of 7 articles (2%) met all 14 reporting criteria, 13 met 13 criteria, 27 met from 11 to 12 criteria, 36 met from 9 to 10 criteria, 76 met from 7 to 8 criteria, and most articles met fewer than 7 criteria (mean 5.5 criteria). Commonly underreported criteria included complication severity (15% of articles), macroscopic integrity of mesorectal excision (17% of articles), length of stay (18% of articles), number of lymph nodes (21% of articles), distance between the tumour and circumferential resection margin (CRM) (26% of articles), surgical radicality according to the site of the primary tumour (R0 vs. R1 + R2) (29% of articles), and CRM status (38% of articles). Conclusion: Inconsistent surgical outcome and complication data reporting in multimodal rectal cancer treatment RCTs is standard. Standardised reporting of clinical and oncological outcomes should be established to facilitate comparing studies and results of related research topics.

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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

Cited by 3 publications

References 19 publications

Ultralow anterior resection with implantation of gentamicin-collagen sponge and no defunctioning stoma: anastomotic leakage and local cancer relapse

Ultralow anterior resection with implantation of gentamicin-collagen sponge and no defunctioning stoma: anastomotic leakage and local cancer relapse

Long-term results of randomized studies on the use of a gentamicin-collagen sponge in rectal cancer – depending on the length of time between the completion of radiotherapy and the surgery

Quality of Surgical Outcome Reporting in Randomised Clinical Trials of Multimodal Rectal Cancer Treatment: A Systematic Review

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