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Clements, Matthew; Beech, Benjamin; Atkinson, Thomas M.; Dalbagni, Guido; Li, Yuelin; Herr, Harry W.; Donat, S. Machele; Sjoberg, Daniel D.; Tin, Amy; Coleman, Jonathan; Rapkin, Bruce D.; Laudone, Vincent P.; Bochner, Bernard H.

doi:10.1097/ju.0000000000003201.02

Cited by 1 publication

(1 citation statement)

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“…Data regarding HR-QoL upon treatment for MIBC are scarce, in particular due to short follow-up periods and the lack of sufficient prospective studies. Nevertheless, results of two prospective trials demonstrate that radical cystectomy can result in long-term effects on HR-QoL, with sexual dysfunction being a main domain compromised by surgery (48,49). Bladder-sparing treatment on the other hand resulted in a short-term drop directly after chemoradiation, followed by a long-term HR-QoL comparable to baseline levels (50).…”

Section: Health-related Quality Of Lifementioning

confidence: 99%

Induction therapy with ipilimumab and nivolumab followed by consolidative chemoradiation as organ-sparing treatment in urothelial bladder cancer: study protocol of the INDIBLADE trial

Stockem,

Mellema,

van Rhijn

et al. 2023

Front. Oncol.

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IntroductionStudies that assessed the efficacy of pre-operative immune checkpoint blockade (ICB) in locally advanced urothelial cancer of the bladder showed encouraging pathological complete response rates, suggesting that a bladder-sparing approach may be a viable option in a subset of patients. Chemoradiation is an alternative for radical cystectomy with similar oncological outcomes, but is still mainly used in selected patients with organ-confined tumors or patients ineligible to undergo radical cystectomy. We propose to sequentially administer ICB and chemoradiation to patients with (locally advanced) muscle-invasive bladder cancer.MethodsThe INDIBLADE trial is an investigator-initiated, single-arm, multicenter phase 2 trial. Fifty patients with cT2-4aN0-2M0 urothelial bladder cancer will be treated with ipilimumab 3 mg/kg on day 1, ipilimumab 3 mg/kg plus nivolumab 1 mg/kg on day 22, and nivolumab 3 mg/kg on day 43 followed by chemoradiation. The primary endpoint is the bladder-intact event-free survival (BI-EFS). Events include: local or distant recurrence, salvage cystectomy, death and switch to platinum-based chemotherapy. We will also evaluate the potential of multiparametric magnetic resonance imaging of the bladder to identify non-responders, and we will assess the clearance of circulating tumor DNA as a biomarker for ICB treatment response.DiscussionThis is the first trial in which the efficacy of induction combination ICB followed by chemoradiation is being evaluated to provide bladder-preservation in patients with (locally advanced) urothelial bladder cancer.Clinical Trial RegistrationThe INDIBLADE trial was registered on clinicaltrials.gov on January 21, 2022 (NCT05200988).

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Section: Health-related Quality Of Lifementioning

confidence: 99%