Quantifying patient preferences for bacillus Calmette-Guérin (BCG) and PD-(L)1 inhibitors in high-risk non-muscle invasive bladder cancer (NMIBC): A discrete choice experiment.

Abstract

4579 Background: Intravesical Bacillus Calmette-Guerin (BCG) induction + maintenance (I+M) is the standard of care for high-risk NMIBC. Disease recurrence and progression is common. The studies investigating programmed cell death-1/programmed death-ligand 1 (PD-[L]1) inhibitors + BCG aim to enhance treatment outcomes and reduce burden in BCG naïve high-risk NMIBC. There is limited evidence on patient preferences for these combination regimens. Methods: A discrete choice experiment quantified preferences for attribute levels related to BCG and PD-(L)1 inhibitors. Attributes and levels were informed by a literature review, patient interviews, regulatory scientific advice, clinical experts and a patient advocate. Patients completed hypothetical choice tasks describing administration mode and frequency for PD-(L)1 inhibitors and BCG (induction [I]; I+M), median event-free survival (EFS) and adverse events (AEs: bladder AEs; chronic endocrine conditions; serious immune AEs). Hierarchical Bayesian modelling estimated preference weights (PWs) for attribute levels. PWs identified level combinations with the lowest choice probability. Relative importance (RI) was calculated by systematically varying attribute levels and capturing the gain in choice probability. Results: 150 patients (77 BCG-naïve; 73 BCG-experienced) in the United States completed the survey. Clinician-confirmed diagnosis (17%) and/or self-reported ongoing or planned BCG I+M (99%) was obtained. The sample was 51% male, had a median age of 63 years (49-74) and diverse by race (Caucasian 46%; African American/Black 27%; Other 27%) and ethnicity (Hispanic/Latino/Spanish 21%). EFS was the most important attributes to patients (RI 17.2), followed by bladder AEs (RI 16.4) and serious immune AEs (RI 14.0). Administration attributes were important (RI 9-9.9), but less important than other attributes. PWs show that short duration ( < 1 minute) subcutaneous (SC) injections was the most preferred PD-(L)1 route and shorter BCG schedule was preferred. Conclusions: Findings highlight the value of prolonging EFS, effective clinical management of BCG AEs and reducing administration burden in future BCG + PD(L)1 regimens. Attribute Level Mean PW 95% CI (±) RI*(%) EFS (months) 362722 3.46-1.03-2.43 0.280.110.22 17.2 Bladder AEs (%) 03575 2.98-0.10-2.88 0.290.120.26 16.4 Serious immune AEs (%) 01020 1.40-0.09-1.31 0.220.090.18 14.0 Chronic endocrine conditions (%) 0510 0.99-0.08-0.91 0.150.080.16 12.6 PD-(L)1 frequency (weeks) 643 0.45-0.10-0.35 0.100.100.06 9.9 PD-(L)1 administration route and time SC <1 minuteSC 7-10 minutesIV 30-60 minutes 0.150.06-0.21 0.090.100.08 9.5 BCG schedule II+M 0.25-0.25 0.140.14 9.0 *Sums to 88.7. The remaining 11.3 corresponds to an attribute used for analysis only. CI: confidence interval; IV: intravenous infusion.