A prospective descriptive 1-year study in France of all BCG therapy dispensations for non-muscle-invasive bladder cancer.
Humans
Non-Muscle Invasive Bladder Neoplasms
Administration, Intravesical
Urinary Bladder Neoplasms
/ drug therapy
Urinary Bladder
/ pathology
Adjuvants, Immunologic
/ therapeutic use
France
/ epidemiology
BCG Vaccine
/ therapeutic use
Neoplasm Invasiveness
/ pathology
Neoplasm Recurrence, Local
/ pathology
adjuvant treatment
bladder cancer
carcinoma in situ
induction therapy
intravesical BCG
maintenance therapy
non-muscle-invasive bladder cancer
prescriptions
recurrence
risk
Journal
BJU international
ISSN: 1464-410X
Titre abrégé: BJU Int
Pays: England
ID NLM: 100886721
Informations de publication
Date de publication:
05 2023
05 2023
Historique:
medline:
25
4
2023
pubmed:
4
12
2022
entrez:
3
12
2022
Statut:
ppublish
Résumé
To describe the clinico-pathological characteristics of non-muscle-invasive bladder cancer (NMIBC) treated in metropolitan France over 1 year when bacille Calmette-Guérin (BCG) was subject to a national quota, and to document, in the context of recurrent shortages of intravesical BCG for NMIBC, the real-life indications for adjuvant treatment. Between February 2021 and February 2022, the French National Agency for the Safety of Medicines (ANSM) asked the French Association of Urology to propose a science-based quota solution for BCG using a clinical score. The ANSM then asked the distributor of the drug, MEDAC, to collect the scores for all patients for whom BCG was requested by healthcare institutions and to prioritize the requests for patients with the highest scores. Tumour stage, grade, size, number, time to recurrence, carcinoma in situ, age, accessibility of alternative treatments (total cystectomy, radio-chemotherapy, thermo-chemotherapy) and BCG treatment progress (initiation or maintenance) were documented for each intravesical BCG prescription. A descriptive analysis of the data collected during the quota year was performed. During the 1-year quota, 25 878 requests for BCG were made for 19 024 patients, 60.5% of whom were aged ≥70 years. Requests for induction and maintenance treatment accounted for 12 704 (49.1%) and 13 174 prescriptions (50.9%), respectively. NMIBC treated with BCG maintenance therapy was more frequently high-risk NMIBC (91.7% vs 90.2%; P < 0.0001) than NMIBC for which induction therapy was requested. The number of cases of NMIBC leading to BCG adjuvant treatment was estimated at 12 704 cases/66 062 188 inhabitants over 1 year in metropolitan France. Our data suggest that the incidence of NMIBC at high risk of recurrence and progression is underestimated in reference epidemiological studies. These results should help to better define future care needs.
Substances chimiques
Adjuvants, Immunologic
0
BCG Vaccine
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
611-616Informations de copyright
© 2022 BJU International.
Références
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