dc.contributor.author | Hussain, SA | |
dc.contributor.author | Porta, N | |
dc.contributor.author | Hall, E | |
dc.contributor.author | Salawu, A | |
dc.contributor.author | Lewis, R | |
dc.contributor.author | Sreenivasan, T | |
dc.contributor.author | Wallace, J | |
dc.contributor.author | Crundwell, M | |
dc.contributor.author | Jenkins, P | |
dc.contributor.author | Tremlett, J | |
dc.contributor.author | Huddart, R | |
dc.contributor.author | James, ND | |
dc.contributor.author | BC2001 Investigators, | |
dc.date.accessioned | 2021-01-08T16:20:53Z | |
dc.date.issued | 2021-02-01 | |
dc.identifier.citation | European urology, 2021, 79 (2), pp. 307 - 315 | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4270 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2020.11.036 | |
dc.description.abstract | BACKGROUND: BC2001 demonstrated improved local control with the addition of chemotherapy to radiotherapy in 360 patients with muscle-invasive bladder cancer. OBJECTIVE: To establish whether such benefit remained in BC2001 patients who received prior neoadjuvant chemotherapy. DESIGN, SETTING, AND PARTICIPANTS: A total of 117 patients (33%) received neoadjuvant chemotherapy and were randomised to radiotherapy with (48%) or without (52%) concomitant chemotherapy. Patients were recruited between August 2001 and April 2008 from 28 UK centres. INTERVENTION: Platinum-based neoadjuvant chemotherapy, followed by radiotherapy with (cRT) or without (RT) synchronous 5-fluorouracil and mitomycin-C. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Toxicity, locoregional control (LRC), overall survival (OS), and quality of life (QoL) were measured. RESULTS AND LIMITATIONS: Of the patients, 74% received gemcitabine plus cisplatin or carboplatin. Compliance rates with full-dose radiotherapy were cRT 93% and RT 92%. An excess of grade ≥3 toxicities while on (chemo)radiation occurred for cRT 33% versus RT 22%, although nonstatistically significant (p = 0.16). With 110 mo median follow-up for survival (interquartile range 96-123), cRT showed improved LRC though not statistically significant (adjusted hazard ratio [aHR] = 0.64, 95% confidence interval [CI] 0.33-1.23, p = 0.18). No differences in OS (aHR = 0.95, 95% CI 0.57-1.57, p = 0.8) were observed. No significant detriment in QoL was observed between cRT and RT in this subgroup of patients. CONCLUSIONS: Neoadjuvant chemotherapy does not compromise the delivery of radical curative treatment. Although underpowered due to a small sample size, the benefit of chemoradiotherapy to improve local control in this group of patients receiving neoadjuvant chemotherapy is consistent with that observed in the main trial. Although a nonsignificant excess of toxicity was observed, there was no evidence of impaired QoL. PATIENT SUMMARY: Chemotherapy before radical chemo(radiotherapy) is feasible and well tolerated. | |
dc.format | Print-Electronic | |
dc.format.extent | 307 - 315 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.subject | BC2001 Investigators | |
dc.title | Outcomes in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Chemotherapy Followed by (Chemo)radiotherapy in the BC2001 Trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2020-11-19 | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2020.11.036 | |
rioxxterms.licenseref.startdate | 2021-02 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European urology | |
pubs.issue | 2 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research | |
pubs.publication-status | Accepted | |
pubs.volume | 79 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | |
icr.researchteam | ICR-CTSU Urology and Head and Neck Trials Team | |
icr.researchteam | Clinical Academic Radiotherapy (Huddart) | |
icr.researchteam | Prostate and Bladder Cancer Research | |
dc.contributor.icrauthor | Porta, Nuria | |
dc.contributor.icrauthor | Hall, Emma | |
dc.contributor.icrauthor | Lewis, Rebecca | |
dc.contributor.icrauthor | Huddart, Robert | |
dc.contributor.icrauthor | James, Nicholas | |