Chemoradiotherapy impairs health-related quality of life (HRQoL) after the initiation of treatment in patients with muscle-invasive bladder cancer, according to an exploratory analysis of trial data.
However, HRQoL scores improved to pretreatment levels within 6 months, and improvements were maintained at 5-year follow up.
“[We] planned a prospective assessment of patient-reported outcomes within BC2001, using the Functional Assessment of Cancer Therapy–Bladder (FACT-BL) questionnaire,” wrote Robert A. Huddart, MBBS, MRCP, FRCR, PhD, of the Institute of Cancer Research, England, and colleagues. Their report is in European Urology.
The exploratory analyses of HRQoL data included 452 patients from the phase 3 BC2001 trial. The objective of the analysis was to evaluate the impact of chemoradiotherapy on HRQoL in trial participants.
The BC2001 trial randomized patients to either radiotherapy (standard or reduced high-dose volume radiotherapy) and/or chemotherapy (radiotherapy or chemoradiotherapy) comparison groups. The primary outcome was the change in bladder cancer subscale (BLCS) scores from baseline to 12 months.
At trial baseline, study subjects were enrolled into the optional substudy, which involved completion of the FACT-BL questionnaire. Follow-up assessment was conducted at various time points after the start of radiotherapy.
After analysis, the researchers found that HRQoL scores deteriorated at end of treatment (BLCS: –5.06; 99% confidence interval, –6.12 to –4.00; overall FACT-BL: –8.22; 99% CI, –10.76 to –5.68), but improved to baseline levels at 6 months, and were maintained thereafter.
“Two-thirds of patients report stable or improved HRQoL on long-term follow-up,” they reported. “There [was] no evidence of impairment in HRQoL resulting from the addition of chemotherapy,” the researchers said.
In addition, the team found that pretrial administration of neoadjuvant chemotherapy had no significant impact on HRQoL outcomes.
One key limitation of the analysis was incomplete follow-up with HRQoL questionnaires. Over time, response rates declined, with a 60% expected response rate at 5 years.
“Addition of concomitant chemotherapy or use of neoadjuvant chemotherapy has no significant impact on HRQoL, further supporting the routine use of 5-FU and mitomycin C in this setting,” Dr. Huddart and coauthors concluded.
Cancer Research UK funded the study. The authors reported having no conflicts of interest.
SOURCE: Huddart RA et al. Eur Urol. 2019 Dec 13. doi: 10.1016/j.eururo.2019.11.001.