dc.contributor.author | Powles, T | |
dc.contributor.author | Huddart, RA | |
dc.contributor.author | Elliott, T | |
dc.contributor.author | Sarker, S-J | |
dc.contributor.author | Ackerman, C | |
dc.contributor.author | Jones, R | |
dc.contributor.author | Hussain, S | |
dc.contributor.author | Crabb, S | |
dc.contributor.author | Jagdev, S | |
dc.contributor.author | Chester, J | |
dc.contributor.author | Hilman, S | |
dc.contributor.author | Beresford, M | |
dc.contributor.author | Macdonald, G | |
dc.contributor.author | Santhanam, S | |
dc.contributor.author | Frew, JA | |
dc.contributor.author | Stockdale, A | |
dc.contributor.author | Hughes, S | |
dc.contributor.author | Berney, D | |
dc.contributor.author | Chowdhury, S | |
dc.date.accessioned | 2017-01-04T13:18:03Z | |
dc.date.issued | 2017-01-01 | |
dc.identifier.citation | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017, 35 (1), pp. 48 - 55 | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/361 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/jco.2015.66.3468 | |
dc.description.abstract | Purpose To establish whether maintenance lapatinib after first-line chemotherapy is beneficial in human epidermal growth factor receptor (HER) 1/HER2-positive metastatic urothelial bladder cancer (UBC). Methods Patients with metastatic UBC were screened centrally for HER1/HER2 overexpression. Patients who screened positive for HER1/2 and who did not have progressive disease during chemotherapy (four to eight cycles) were randomly assigned one to one to lapatinib or placebo after completion of first-line/initial chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS). Results Between 2007 and 2013, 446 patients with UBC were screened, and 232 with HER1- or HER2-positive disease were randomly assigned. The median PFS for lapatinib and placebo was 4.5 (95% CI, 2.8 to 5.4) and 5.1 (95% CI, 3.0 to 5.8) months, respectively (hazard ratio, 1.07; 95% CI, 0.81 to 1.43; P = .63). The overall survival for lapatinib and placebo was 12.6 (95% CI, 9.0 to 16.2) and 12.0 (95% CI, 10.5 to 14.9) months, respectively (hazard ratio, 0.96; 95% CI, 0.70 to 1.31; P = .80). Discontinuation due to adverse events were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3 to 4 adverse events for lapatinib and placebo was 8.6% versus 8.1% ( P = .82). Preplanned subset analysis of patients strongly positive for HER1/HER2 (3+ on immunohistochemistry; n = 111), patients positive for only HER1 (n = 102), and patients positive for only HER2 (n = 42) showed no significant benefit with lapatinib in terms of PFS and overall survival ( P > .05 for each). Conclusion This trial did not find significant improvements in outcome by the addition of maintenance lapatinib to standard of care. | |
dc.format | Print-Electronic | |
dc.format.extent | 48 - 55 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | AMER SOC CLINICAL ONCOLOGY | |
dc.subject | Humans | |
dc.subject | Carcinoma, Transitional Cell | |
dc.subject | Cisplatin | |
dc.subject | Quinazolines | |
dc.subject | Receptor, erbB-2 | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Disease-Free Survival | |
dc.subject | Double-Blind Method | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Urinary Bladder Neoplasms | |
dc.subject | Maintenance Chemotherapy | |
dc.subject | Response Evaluation Criteria in Solid Tumors | |
dc.subject | ErbB Receptors | |
dc.subject | Lapatinib | |
dc.title | Phase III, Double-Blind, Randomized Trial That Compared Maintenance Lapatinib Versus Placebo After First-Line Chemotherapy in Patients With Human Epidermal Growth Factor Receptor 1/2-Positive Metastatic Bladder Cancer. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2016-10-31 | |
rioxxterms.versionofrecord | 10.1200/jco.2015.66.3468 | |
rioxxterms.licenseref.startdate | 2017-01 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | |
pubs.issue | 1 | |
pubs.notes | 6 months | |
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 | 35 | |
pubs.embargo.terms | 6 months | |
icr.researchteam | Clinical Academic Radiotherapy (Huddart) | |
dc.contributor.icrauthor | Huddart, Robert | |