[Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial]. / Instillation préopératoire immédiate (IPOI) de mitomycine C comparée à l'instillation postopératoire précoce (IPOP) dans les tumeurs de la vessie. Étude de phase II randomisée.
Prog Urol
; 31(2): 63-70, 2021 Feb.
Article
em Fr
| MEDLINE
| ID: mdl-32891506
ABSTRACT
OBJECTIVE:
A single immediate instillation of mitomycin C is recommended after a complete transurethral resection of the bladder (TURB) in low- and intermediate-risk patients with NMIBC. Actually, post-TURB instillation is seldom used due to logistical difficulties and surgical contraindications. Our aim was to compare patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of mitomycin C.METHODS:
We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score.RESULTS:
Among 35 eligible participants, 20 were randomly assigned in the pre-TURB instillation group and 15 in the post-TURB instillation group. Follow-up was comparable 12,3±1,6 months in the SI group and 10,2±4,5 months in the pre-TURB instillation group. In the post-TURB instillation group, 2 patients didn't have any instillation. We did not identify significant differences in disease-free interval. Tolerance at 1 month after TURB was similar in both groups.CONCLUSION:
Tolerance and efficacy were not significantly different. As expected, logisitics were easier for the health providers in the pre-TURB group where all patients had their instillation conversely to the post-TURB group. These results suggest that the advantages of a single immediate pre-TURB instillation warrant further evaluation of this strategy in a phase III randomized trial.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Cuidados Pós-Operatórios
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Neoplasias da Bexiga Urinária
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Cuidados Pré-Operatórios
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Mitomicina
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Antibióticos Antineoplásicos
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Female
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Humans
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Male
Idioma:
Fr
Ano de publicação:
2021
Tipo de documento:
Article