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

Author:

Powles Thomas1,Huddart Robert A.1,Elliott Tony1,Sarker Shah-Jalal1,Ackerman Charlotte1,Jones Robert1,Hussain Syed1,Crabb Simon1,Jagdev Satinder1,Chester John1,Hilman Serena1,Beresford Mark1,Macdonald Graham1,Santhanam Sundar1,Frew John A.1,Stockdale Andrew1,Hughes Simon1,Berney Daniel1,Chowdhury Simon1

Affiliation:

1. Thomas Powles, Shah-Jalal Sarker, Charlotte Ackerman, and Daniel Berney, Queen Mary University of London; Simon Hughes and Simon Chowdhury, Guy’s and St Thomas’ National Health Service (NHS) Foundation Trust, London; Robert A. Huddart, Institute of Cancer Research, Sutton; Tony Elliott, Christie Hospital NHS Foundation Trust, Manchester; Robert Jones, University of Glasgow, Glasgow; Syed Hussain, University of Liverpool, Liverpool; Simon Crabb, University of Southampton, Southampton; Satinder Jagdev, St...

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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