BC2001 long-term outcomes: A phase III randomized trial of chemoradiotherapy versus radiotherapy (RT) alone and standard RT versus reduced high-dose volume RT in muscle-invasive bladder cancer.

Authors

null

Emma Hall

Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom

Emma Hall , Syed A. Hussain , Nuria Porta , Malcolm Crundwell , Peter Jenkins , Christine Lisa Rawlings , Jean Tremlett , Charlotte Friend , Clive Stubbs , Rebecca Lewis , Nicholas D. James , Robert Anthony Huddart

Organizations

Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom, University of Liverpool, Liverpool, United Kingdom, Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, United Kingdom, Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom, Cheltenham General Hospital, Cheltenham, United Kingdom, South Devon Healthcare NHS Foundation, Torbay, United Kingdom, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom, Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom, University of Birmingham and Queen Elizabeth Hospital, Brimingham, United Kingdom, Institute of Cancer Research, Sutton, United Kingdom

Research Funding

Other

Background: BC2001 showed that adding chemotherapy (5FU+MMC) to radiotherapy significantly improved rates of muscle invasive bladder cancer (MIBC) locoregional control (LRC) [James 2012] but that reduced high dose volume RT rather than standard RT did not significantly reduce late side effects [Huddart 2013]. Here we present an update of the time to event outcomes after a median 10 years follow up. Methods: Under the 2x2 partial factorial design, 458 pts were randomised to RT (178) or cRT (182) (CT comparison) and/or to stRT (108) or RHDVRT (111) (RT comparison). Primary endpoint was LRC, secondary endpoints included overall survival (OS), bladder-cancer specific survival (BCSS), metastasis free survival (MFS) and salvage cystectomy rates. Results: Median follow up was 118 months (95%CI: 112-122). LRC and invasive LRC (ILRC) were improved with cRT (Table 1). Though no statistically significant differences between groups were found in OS, cRT exhibited a trend towards improvement in BCSS, significant when adjusted by known prognostic factors. Similar trend was found for MFS. Salvage cystectomy rate was lower for cRT (2-year rate, cRT:11% vs RT:17%, p=0.03). No differences between stRT and RHDVRT were found for any trial endpoint. Conclusions: With extended follow-up, an improvement in LRC and a reduced salvage cystectomy rate is confirmed with cRT. After adjustment for known prognostic factors this results in an improvement in BCSS. This updated data supports the use of cRT with 5FU/MMC and confirms this should be a standard of care for this patient population. Clinical trial information: ISRCTN68324339.

Results for the trial endpoints (cRT vs RT).

Unadjusted1
Adjusted2
HR1CI95%p-value*HR2CI95%p-value**
LRC0.610.43-0.860.0040.590.41-0.830.003
ILRC0.550.36-0.840.0060.520.33-0.810.004
MFS0.780.58-1.050.0890.740.54-1.000.051
OS0.880.69-1.130.310.810.62-1.040.10
BCSS0.790.59-1.060.110.730.54-0.990.043

*Log rank test, stratified by RT treatment; **Adjusted Cox p-value.1 Cox hazard ratio (HR) adjusted by RT group; 2 HR adjusted by RT group and dose, neoadjuvant CT, age, stage, grade, multiple tumours and WHO status.

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Abstract Details

Meeting

2017 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer and Urothelial Carcinoma

Track

Prostate Cancer,Urothelial Carcinoma,Prostate Cancer

Sub Track

Urothelial Carcinoma

Clinical Trial Registration Number

ISRCTN68324339

Citation

J Clin Oncol 35, 2017 (suppl 6S; abstract 280)

DOI

10.1200/JCO.2017.35.6_suppl.280

Abstract #

280

Poster Bd #

A2

Abstract Disclosures