Recommandations en onco-urologie 2013 du CCAFU : Tumeurs de la vessie

Rouprêt, Morgan; Neuzillet, Y.; Masson-Lecomte, A.; Colin, Philippe; Comperat, E.; Dubosq, Francis; Houédé, Nadine; Larré, S.; Pignot, G.; Puech, P; Roumiguié, M.; Xylinas, Évanguelos; Méjean, Arnaud

doi:10.1016/s1166-7087(13)70049-6

Cited by 39 publications

(23 citation statements)

References 87 publications

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“…There was more frequent use of hexaminolevulinate in the HOPE study than expected (49.8% compared with the predicted 20%). The estimated frequency was based upon the previous Association Française d'Urologie guidelines indicating the use of hexaminolevulinate when a high-risk lesion was suspected [2] , but the European registration of the product provides a broader indication ("in patients with known or high suspicion of bladder cancer"). The more frequent use of hexaminolevulinate in the HOPE study may reflect the recent update of the French guidelines, which recommend the use of hexaminolevulinate for diagnosis at every TURB [22] .…”

Section: Discussionmentioning

confidence: 99%

“…It was estimated that 600 patients would be needed to obtain a CI of 95% with a precision of 3.5%. The estimation that 20% of patients would be diagnosed using hexaminolevulinate was based upon the Association Française d'Urologie guidelines, which state that the preferential indications of hexaminolevulinate are suspected of high-grade bladder lesions (isolated high-grade cytology without cystoscopic visible lesions) and previous history of high-risk tumours (T1-G3 and/or carcinoma in situ) [2] .…”

Section: Statistics and Sample Size Calculationmentioning

confidence: 99%

“…for approximately 75% of newly diagnosed bladder cancers, and 60-70% of NMIBC patients are expected to experience a relapse of the cancers [2] . Outcomes of NMIBC can be optimised with precise risk-stratification of recurrence and progression, adapted adjuvant intravesical treatments and follow-up, but the duration and intensity of follow-up in NMIBC entail high cost-ratios per patient [3,4] .…”

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confidence: 99%

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Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect

Jacqmin

Jichlinski²,

Molinier³

et al. 2017

Urol Int

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Objective: The Hexvix® Observational Patients Evaluation (HOPE) study was designed to determine the extent of distribution of the use of hexaminolevulinate in the diagnosis of non-muscle invasive bladder cancer (NMIBC) and assess patient and treatment characteristics associated with different endoscopic modalities and to address the French authorities' request for information on routine practices for NMIBC diagnosis and surveillance. Patients and Methods: A prospective, observational study in 30 centres in France with fluorescence endoscopy equipment available. All candidates for endoscopy with transurethral resection who gave their consent were eligible. The primary endpoint was the proportion of patients with an NMIBC diagnosis performed with hexaminolevulinate. Results: 506 patients were included: 252 (49.8%) diagnosed with hexaminolevulinate and 254 (50.2%) with white-light endoscopy alone. There were more patients with tumour recurrence, multiple lesions, lesions with a diameter <3 cm, stage Ta disease, and grade 1 lesions in the hexaminolevulinate group. The first quartile median recurrence-free survival time was 310 days in the hexaminolevulinate group and 144 days in the standard-endoscopy group (p = 0.0015). Conclusion: Hexaminolevulinate was in frequent use in France with specific patient and disease characteristics associated with its use. HOPE illustrates the type of data that can be gained in post-authorisation studies to address requests from European health authorities.

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Section: Discussionmentioning

confidence: 99%

Section: Statistics and Sample Size Calculationmentioning

confidence: 99%

mentioning

confidence: 99%

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Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect

Jacqmin

Jichlinski²,

Molinier³

et al. 2017

Urol Int

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“…Ainsi, s'il n'existe aucun essai randomisé comparant la chimioradiothérapie concomitante au traitement standard, qui demeure la cystectomie radicale, leur comparaison indirecte semble indiquer que la chimioradiothérapie concomitante est au moins aussi efficace que la cystectomie radicale tout en permettant un maintien de la qualité de vie. De ce fait, elle est actuellement une option pouvant être proposée chez certains patients sélectionnés [9][10][11][12].…”

Section: Rationnel De La Chimioradiothérapie Des Tumeurs Infiltrantesunclassified

“…La chimioradiothérapie concomitante est l'option la plus étudiée, et si elle était initialement réservée aux patients non candidats à la chirurgie, elle peut être désormais proposée à certains patients sélectionnés dans le cadre d'un protocole trimodal associant une résection transurétrale de la vessie, une radiothérapie et une chimiothérapie [9][10][11][12]. Le bénéfice de contrôle local de la radiothérapie potentialisée par rapport à la radiothérapie exclusive a été démontré dans trois essais randomisés [13][14][15].…”

Section: Introductionunclassified