Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial

• Published in: European urology 2020-02, Vol.77 (2), p.260-268
• Main Authors: Huddart, Robert A., Hall, Emma, Lewis, Rebecca, Porta, Nuria, Crundwell, Malcolm, Jenkins, Peter J., Rawlings, Christine, Tremlett, Jean, Campani, Leila, Hendron, Carey, Hussain, Syed A., James, Nicholas D.
• Format: Article
• Language: English
• Subjects: BC2001; Carcinoma, Transitional Cell - drug therapy; Carcinoma, Transitional Cell - pathology; Carcinoma, Transitional Cell - radiotherapy; Chemoradiotherapy; Female; Health-related quality of life; Humans; Male; Muscle-invasive bladder cancer; Neoplasm Invasiveness; Patient Reported Outcome Measures; Patient-reported outcomes; Prospective Studies; Quality of Life; Randomised controlled trial; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Urinary Bladder Neoplasms - radiotherapy
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2019.11.001

BC2001, the largest randomised trial of bladder-sparing treatment for muscle-invasive bladder cancer, demonstrated improvement of local control and bladder cancer–specific survival from the addition of concomitant 5-fluorouracil and mitomycin C to radiotherapy. To determine the impact of treatment on the health-related quality of life (HRQoL) of BC2001 participants. 458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder. Patients were randomised to the chemotherapy comparison (radiotherapy, 178, or chemoradiotherapy, 182); and/or to the radiotherapy comparison (standard, 108, or reduced high-dose volume radiotherapy, 111). Patients completed Functional Assessment of Cancer Therapy—Bladder (FACT-BL) questionnaires at baseline, end of treatment (EoT), and 6, 12, 24, 36, 48, and 60 months after radiotherapy. The primary endpoint was change from baseline in the bladder cancer subscale (BLCS) at 12 months. Data were available for 331 (92%) and 204 (93%) participants at baseline and for 192 (54%) and 114 (52%) at 12 months for the chemotherapy and radiotherapy comparisons, respectively. HRQoL declined at EoT (BLCS –5.06 [99% confidence interval: –6.12 to –4.00, p< 0.001]; overall FACT-B TOTAL score –8.22 [–10.76 to –5.68, p< 0.01]), recovering to baseline at 6 months and remaining similar to baseline subsequently. There was no significant difference between randomised groups at any time point. Immediately following (chemo)radiotherapy, a significant proportion of patients report declines in HRQoL, which improve to baseline after 6 months. Two-thirds of patients report stable or improved HRQoL on long-term follow-up. There is no evidence of impairment in HRQoL resulting from the addition of chemotherapy. Quality of life of bladder cancer patients treated with radiotherapy±chemotherapy deteriorates during treatment, but improves to at least pretreatment levels within 6 months. Addition of chemotherapy to radiotherapy does not affect patient-reported quality of life. Bladder cancer patients receiving radical radiotherapy frequently experience a health-related quality of life (HRQoL) decline during treatment, which recovers within 6 mo such that, on average, subsequent HRQoL is maintained at or above baseline. Adding concomitant 5-fluorouracil/mitomycin C has no significant impact on HRQoL.