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dc.contributor.authorSherwood Forest Hospitals NHS Foundation Trust
dc.date.accessioned2019-02-25T16:27:15Z
dc.date.available2019-02-25T16:27:15Z
dc.date.issued2017-01
dc.identifier.citationPowles, T. et al. (2017) ‘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’, Journal Of Clinical Oncology: Official Journal Of The American Society Of Clinical Oncology, 35(1), pp. 48–55.en
dc.identifier.issnNCT00949455
dc.identifier.urihttp://hdl.handle.net/20.500.12904/1439
dc.descriptionOpen Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 3.0)en
dc.description.abstractPurpose 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.en
dc.language.isoenen
dc.subjectClinical Trialen
dc.subjectPhase III Clinical Trialen
dc.subjectLAMBen
dc.subjectBladder Canceren
dc.titlePhase 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.en
dc.typeArticleen
refterms.dateFOA2021-06-03T11:50:10Z


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