A Prospective descriptive one-year study in France of all BCG therapy dispensations for NMIBC.

OBJECTIVE
To describe the clinico-pathological characteristics of NMIBC treated in metropolitan France over one year when BCG was subject to a national quota. In the context of recurrent shortages of intravesical BCG for non-muscle-invasive bladder cancer (NMIBC), it is interesting to document the real-life indications for adjuvant treatment.


MATERIAL AND METHODS
Between February 2021 and February 2022, the French National Agency for the Safety of Medicines (ANSM) asked the French Association of Urology (AFU) 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 prioritise 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.


RESULTS
During the 1-year quota, 25 878 requests for BCG were made for 19 024 patients, 60.5% of whom were ≥70-years-old. Requests for induction and maintenance treatment accounted for 12 704 (49.1%) and 13 174 (50.9%) of prescriptions, respectively. NMIBCs treated with BCG maintenance therapy were more frequently high-risk NMIBCs (91.7% vs. 90.2%, p<0.0001) than NMIBCs 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.


CONCLUSIONS
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.