Evidence map›Paper›PMID 31843338›Full record

Trial reportEuropean urology2020

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.

Robert A Huddart, Emma Hall, Rebecca Lewis, Nuria Porta, Malcolm Crundwell, Peter J Jenkins, Christine Rawlings, Jean Tremlett, Leila Campani, Carey Hendron and 3 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. Recent Advances and Future Directions in Bladder Preservation Therapy for Muscle-Invasive Bladder Cancer.International journal of urology : official journal of the Japanese Urological Association · 2025
    Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Bladder cancer.Nature reviews. Disease primers · 2023
    Review
  15. Article
  16. [Radical cystectomy versus trimodality therapy for muscle-invasive bladder cancer].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Article
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Robert A HuddartThe Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK. Electronic address: Robert.Huddart@icr.ac.uk.
Emma HallThe Institute of Cancer Research, London, UK.
Rebecca LewisThe Institute of Cancer Research, London, UK.
Nuria PortaThe Institute of Cancer Research, London, UK.
Malcolm CrundwellRoyal Devon & Exeter NHS Foundation Trust, Exeter, UK.
Peter J JenkinsGloucestershire Oncology Centre, Cheltenham General Hospital, Cheltenham, UK.
Christine RawlingsTorbay and South Devon NHS Foundation Trust, Torquay, UK.
Jean TremlettBrighton & Sussex University Hospitals NHS Trust, Brighton, UK.
Leila CampaniUniversity of Birmingham, Birmingham, UK.
Carey HendronUniversity of Birmingham, Birmingham, UK.
Syed A HussainAcademic unit of Oncology, Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.
Nicholas D JamesUniversity of Birmingham, Birmingham, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
BC2001 Investigators

Funding

Cancer Research UK 15955Cancer Research UK 25351Cancer Research UK C1491/A15955Cancer Research UK C1491/A9895Cancer Research UK C547/A2606Cancer Research UK C547/A6845Cancer Research UK C9764/A9904Cancer Research UK CRUK/01/004
6 · The paper itself

Abstract

backgroundBC2001, 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.

objectiveTo determine the impact of treatment on the health-related quality of life (HRQoL) of BC2001 participants. DESIGN, SETTING, AND

participants458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder.

interventionPatients 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). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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. RESULTS AND LIMITATIONS: 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.

conclusionsImmediately 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. PATIENT SUMMARY: 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.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeCarcinoma, Transitional CellChemoradiotherapyFemaleHumansMaleNeoplasm InvasivenessProspective StudiesUrinary Bladder NeoplasmsBC2001ChemoradiotherapyHealth-related quality of lifeMuscle-invasive bladder cancerPatient-reported outcomesRandomised controlled trial

Identifiers

PMID31843338
PMCPMC6983941

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.