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Systematic Review of the Therapeutic Efficacy of Bladder-preserving Treatments for Non–muscle-invasive Bladder Cancer Following Intravesical Bacillus Calmette-Guérin
- Source :
- Eur Urol
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Context There is a critical need for effective bladder-sparing therapies for bacillus Calmette-Guerin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC). Owing to the current lack of effective agents that can be used as a control, the US Food and Drug Administration began to accept single-arm trials for patients with carcinoma in situ (CIS), using complete response rate (CRR) and duration of response as the primary endpoints to support marketing applications. Despite the ensuing growth of clinical trials in this space, no consensus exists on a clinically relevant benchmark for CRR. Objective To elucidate the CRR and recurrence-free rate (RFR) using bladder-sparing agents after BCG failure in order to provide a frame of reference for future clinical trial results. Evidence acquisition We performed a systematic review of clinical trials utilizing bladder-sparing therapeutics for NMIBC recurring after intravesical BCG (PROSPERO CRD42019130553). The search was performed in MEDLINE, EMBASE, and Cochrane Library. Relevant studies identified from bibliography search and conference abstracts were searched to complement the systematic review. A total of 42 studies utilizing 24 treatment options and consisting of 2254 patients were included for final analysis. Evidence synthesis Median CRRs in the treatment of CIS-containing tumors were 26% at 6 mo, 17% at 12 mo, and 8% at 24 mo after treatment. In comparison, median RFRs in the papillary-only studies were 67% at 6 mo, 44% at 12 mo, and 10% at 24 mo. Specifically in the BCG-unresponsive population, 6- and 12-mo CRRs in CIS-containing patients treated with Mycobacterium phlei cell wall–nucleic acid complex were 45% and 27%, respectively, and the median 6-, 12-, and 24-mo disease-free rates in the other studies were 43%, 35%, and 18%, respectively. The median progression-free rate was 91%: 95% in the CIS-containing studies and 89% in studies restricted to papillary-only recurrences. Toxicities of intravesical agents were generally mild, with very few dose limiting toxicities. Conclusions We demonstrate that, to date, bladder-sparing therapies achieved modest efficacy in patients with NMIBC after BCG. Results from the current study will serve as a frame of reference for emerging trial results in the BCG-unresponsive space. Patient summary In this study, we found that bladder-sparing therapies achieved modest efficacy in patients with non–muscle-invasive bladder cancer after bacillus Calmette-Guerin (BCG). These results will serve to inform future clinical trial results for salvage agents used to treat BCG-unresponsive bladder cancer.
- Subjects :
- Oncology
medicine.medical_specialty
Urology
Population
030232 urology & nephrology
MEDLINE
Antineoplastic Agents
Context (language use)
Cochrane Library
Article
03 medical and health sciences
0302 clinical medicine
Adjuvants, Immunologic
Internal medicine
medicine
Humans
Neoplasm Invasiveness
education
education.field_of_study
Bladder cancer
business.industry
Carcinoma in situ
medicine.disease
Clinical trial
Treatment Outcome
Administration, Intravesical
Urinary Bladder Neoplasms
030220 oncology & carcinogenesis
BCG Vaccine
Neoplasm Recurrence, Local
business
Non muscle invasive
Organ Sparing Treatments
Carcinoma in Situ
Subjects
Details
- ISSN :
- 03022838
- Volume :
- 78
- Database :
- OpenAIRE
- Journal :
- European Urology
- Accession number :
- edsair.doi.dedup.....27200d70d0c3913e6e51bc9b8e6cb5da