Quality of life and cost-effectiveness of intravesical gemcitabine/docetaxel vs BCG in BCG-naïve non-muscle-invasive bladder cancer.

Abstract

To compare intravesical gemcitabine/docetaxel (Gem/Doce) vs standard-of-care bacillus Calmette-Guérin (BCG) in intermediate-/high-risk non-muscle-invasive bladder cancer (NMIBC), as patient-reported physical-psychological quality of life (QoL) and cost-effectiveness estimation are pivotal to evaluate adjuvant intravesical treatments yet are rarely evaluated head-on. In a prospective per-protocol analysis (Gem/Doce 39 patients; BCG 44 patients), survival endpoints (recurrence-free survival [RFS], progression-free survival [PFS]) and National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)-graded adverse events (AEs) were recorded. QoL was assessed at baseline, post-induction, and at 6 and 12 months using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-30-item core (EORTC QLQ-C30) and 24-item QLQ-NMIBC (QLQ-NMIBC24) and mapped to the EuroQoL five Dimensions five Levels (EQ-5D-5L) using an Indian tariff to estimate quality-adjusted life years (QALYs). Direct medical costs were recorded, and incremental cost-effectiveness ratios (ICERs) were calculated per QALY and recurrence/progression outcomes. Patients receiving Gem/Doce achieved higher 1-year RFS (94.74% vs 75%, hazard ratio 0.44; P = 0.02) and PFS (100.00% vs 93.19%, P = 0.09). The AEs were fewer with Gem/Doce (12.82% vs 34.10%, P = 0.028); Grade 3 events occurred only with BCG (4.65%). Gem/Doce showed significantly higher global health, physical/role/emotional functioning and sexual health scores at 6-12 months, with reduced fatigue, urinary symptoms and intravesical-treatment problems. Mean QALYs improved with Gem/Doce (0.8807 vs 0.7198), and with an ICER of ₹504 000 Indian Rupees ($6072 United States Dollars) per QALY - well within India's willingness-to-pay threshold and far below international benchmarks. Additional gains included +1.38 recurrence-free months overall and +2.82 in high-risk patients, achieved at acceptable incremental cost, indicating pragmatic cost profile against avoided recurrences and QoL gains. Sequential Gem/Doce delivered optimal short-term survival outcomes, favourable patient-reported QoL and safety profile, and attractive cost per avoided recurrence/progression compared with BCG, supporting its adoption as a clinically and economically viable alternative in resource-constrained NMIBC care.