dc.contributor.author | Jones, R | |
dc.contributor.author | Crabb, S | |
dc.contributor.author | Chester, J | |
dc.contributor.author | Elliott, T | |
dc.contributor.author | Huddart, R | |
dc.contributor.author | Birtle, A | |
dc.contributor.author | Evans, L | |
dc.contributor.author | Lester, J | |
dc.contributor.author | Jagdev, S | |
dc.contributor.author | Casbard, A | |
dc.contributor.author | Huang, C | |
dc.contributor.author | Madden, T-A | |
dc.contributor.author | Griffiths, G | |
dc.date.accessioned | 2020-07-08T10:47:27Z | |
dc.date.issued | 2020-05-19 | |
dc.identifier.citation | BJU international, 2020, 126 (2), pp. 292 - 299 | |
dc.identifier.issn | 1464-4096 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3826 | |
dc.identifier.eissn | 1464-410X | |
dc.identifier.doi | 10.1111/bju.15096 | |
dc.description.abstract | OBJECTIVES: To assess the efficacy and tolerability of the dual epidermal growth factor receptor/vascular endothelial growth factor receptor inhibitor, vandetanib, in combination with carboplatin and gemcitabine in the first-line treatment of patients with advanced transitional cell carcinoma urothelial cancer (UC) who were unsuitable for cisplatin. PATIENTS AND METHODS: From 2011 to 2014, 82 patients were randomised from 16 hospitals across the UK into the TOUCAN double-blind, placebo-controlled randomised Phase II trial, receiving six 21-day cycles of intravenous carboplatin (target area under the concentration versus time curve 4.5, day 1) and gemcitabine (1000 mg/m2 days 1 and 8) combined with either oral vandetanib 100 mg or placebo (once daily). Progression-free survival (PFS; primary endpoint), adverse events, tolerability and feasibility of use, objective response rate and overall survival (OS) were evaluated. Intention-to-treat and per-protocol analyses were used to analyse the primary endpoint. RESULTS: The 82 patients were randomised 1:1 to vandetanib (n = 40) or placebo (n = 42), and 25 patients (30%) completed six cycles of all allocated treatment. Toxicity Grade ≥3 was experienced in 80% (n = 32) and 76% (n = 32) of patients in the vandetanib and placebo arms, respectively. The median PFS was 6.8 and 8.8 months for the vandetanib and placebo arms, respectively (hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.65-1.76; P = 0.71); the median OS was 10.8 vs 13.8 months (HR 1.41, 95% CI 0.79-2.52; P = 0.88); and radiological response rates were 50% and 55%. CONCLUSION: There is no evidence that vandetanib improves clinical outcome in this setting. Our present data do not support its adoption as the regimen of choice for first-line treatment in patients with UC who were unfit for cisplatin. | |
dc.format | Print-Electronic | |
dc.format.extent | 292 - 299 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | WILEY | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Carcinoma, Transitional Cell | |
dc.subject | Cisplatin | |
dc.subject | Carboplatin | |
dc.subject | Piperidines | |
dc.subject | Quinazolines | |
dc.subject | Deoxycytidine | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Drug Combinations | |
dc.subject | Neoplasm Staging | |
dc.subject | Treatment Outcome | |
dc.subject | Double-Blind Method | |
dc.subject | Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.title | A randomised Phase II trial of carboplatin and gemcitabine ± vandetanib in first-line treatment of patients with advanced urothelial cell cancer not suitable to receive cisplatin. | |
dc.type | Journal Article | |
rioxxterms.versionofrecord | 10.1111/bju.15096 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2020-08 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | BJU international | |
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/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
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/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
pubs.publication-status | Published | |
pubs.volume | 126 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Academic Radiotherapy (Huddart) | |
dc.contributor.icrauthor | Huddart, Robert | |