Adding chemotherapy to radiation treatment for muscle-invasive bladder cancer (MIBC) does not worsen health-related quality of life (HRQoL), a finding that supports the routine use of 5-fluorouracil and mitomycin C, according to investigators.

Although a significant proportion of patients report declines in HRQoL immediately following either radiotherapy or chemoradiotherapy, HRQoL returns to baseline after 6 months. In addition, two-thirds of patients report stable or improved HRQoL on long-term follow-up.

“This study shows that overall, after an initial fall immediately after treatment, HRQoL recovers to baseline levels and is maintained at this level to 5 years,” Robert A. Huddart, MBBS, PhD, of the Institute of Cancer Research in London, and colleagues reported in European Urology.

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Dr Huddart and his collaborators analyzed patient-reported HRQoL outcomes among participants in the phase 3 BC2001 trial of bladder-sparing treatment for MIBC. The study included 458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder. Investigators randomly assigned patients to a chemotherapy comparison group (radiotherapy or chemoradiotherapy), and/or a radiotherapy comparison group (standard or reduced high-dose volume radiotherapy). Patients completed Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires at baseline, end of treatment, and 6, 12, 24, 36, 48, and 60 months after radiotherapy. The primary end point was change from baseline in the bladder cancer subscale (BLCS) at 12 months.

For the overall study population, the mean BLCS score decreased by 5.06 immediately following radiotherapy. By 1 year, BLCS score had recovered to at least baseline or improved on subsequent follow-up, the investigators reported.

At the end of treatment, 59% of patients reported worsening of symptoms according to BLCS score, whereas 49% reported worsening symptoms according to FACT-BL total score.

By 6 months, the proportions of patients reporting worsening symptoms had decreased to 35% and 29% according to BLCS and FACT-BL total scores, respectively, with improvement reported in 29% and 33%, respectively, Dr Huddart’s team noted. At 12 months and beyond, these relative proportions remained fairly constant, with 32% to 36% of patients reporting worsening based on BLCS score and 25% to 30% reporting worsening based on FACT-BL total score, according to the investigators.

Dr Huddart and his colleagues found no significant difference between randomized groups within each comparison in the proportions of patients reporting clinically relevant worsening or improvement on any scale or at any time point, the investigators stated.

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“We report the largest study of patient-reported outcomes after bladder-preserving treatment for MIBC,” the authors wrote. “A key strength is that these are, to our knowledge, the only such data prospectively collected within a randomised controlled trial. A drawback, however, is that not all patients returned HRQoL questionnaires at the key defined time point, most frequently due to prior recurrence or cystectomy, so it is likely that the impact of recurrence is not fully captured in these data.”


Huddart RA, Hall E, Lewis R, et al. 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 online December 13, 2019]. Eur Urol. 2019.

doi: 10.1016/j.eururo.2019.11.001