BCG strain shortage from 2012 to 2014: evaluation of its impact on the management of patients with high-risk NMIBC
Phase observational
- Population
- Patients with newly diagnosed high-risk NMIBC followed at one French centre, May 2005 to May 2015.
- Design
- Retrospective single-centre study of patients followed from May 2005 to May 2015 with newly diagnosed high-risk NMIBC, split into patients not impacted by the 2012-2014 Connaught-strain shortage in France and patients impacted by it. The abstract is in English; the article is in French.
- Arms
- Not impacted by the shortage (control, n = 56): Patients not impacted by the BCG shortage (NISG)
- Impacted by the shortage (experimental, n = 53): Patients impacted by the BCG shortage (ISG)
- People
- Surlemont L
Δ Incomplete BCG induction+15.5 pointsΔ Incomplete BCG maintenance+19.1 points
Show the numbers
| Endpoint | Analysis | Impacted by the shortage | Not impacted by the shortage | Effect |
|---|---|---|---|---|
| Incomplete BCG inductionSingle-centre retrospective cohort; comparison of impacted versus not-impacted groups | finalSurlemont 2021 | 20.8% | 5.3% | P=0.02 |
| Incomplete BCG maintenanceSingle-centre retrospective cohort; comparison of impacted versus not-impacted groups | finalSurlemont 2021 | 56.6% | 37.5% | P=0.047The abstract reports no significant difference between groups in recurrence-free, progression-free, overall or specific survival, and a higher cystectomy rate in the impacted group (no figure given). |
| Endpoint | Analysis | Impacted by the shortage | Not impacted by the shortage | Effect |
|---|---|---|---|---|
| Incomplete BCG inductionSingle-centre retrospective cohort; comparison of impacted versus not-impacted groups | finalSurlemont 2021 | 20.8% | 5.3% | P=0.02 |
| Incomplete BCG maintenanceSingle-centre retrospective cohort; comparison of impacted versus not-impacted groups | finalSurlemont 2021 | 56.6% | 37.5% | P=0.047The abstract reports no significant difference between groups in recurrence-free, progression-free, overall or specific survival, and a higher cystectomy rate in the impacted group (no figure given). |