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An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer

2009; Elsevier BV; Volume: 21; Issue: 3 Linguagem: Inglês

10.1093/annonc/mdp373

1569-8041

Giuseppe Capri, José Chang, S.-C. Chen, Pierfranco Conté, Karel Cwiertka, Guy Jérusalem, Zefei Jiang, Stephen Johnston, Bella Kaufman, John S. Link, Jungsil Ro, J. Schütte, Cristina Oliva, Roma Parikh, A. Preston, J. Rosenlund, ME Selzer, Denise Zembryki, Sabino De Placido,

Chronic Lymphocytic Leukemia Research

BackgroundThe Lapatinib Expanded Access Program (LEAP) was designed to provide access to lapatinib plus capecitabine for HER2-positive metastatic breast cancer patients who previously received an anthracycline, a taxane, and a trastuzumab and had no other treatment options.Patients and methodsLEAP opened globally and enrollment continued until lapatinib received regulatory approval in each participating country. Patients were assessed for progression-free survival (PFS) and overall survival (OS) and monitored for serious adverse events (SAEs).ResultsAs of 30 September 2008, 4283 patients from 45 countries enrolled in LEAP. The median treatment duration was 24.7 weeks. The most common drug-related SAEs were diarrhea (9.7%), vomiting (4.3%), and nausea (2.4%) and were mainly grade 3 or higher. The incidences of special interest SAEs were decreased left ventricle ejection fraction (0.5%), interstitial lung disease/pneumonitis (0.2%), and serious hepatobiliary events (0.4%). This safety profile is consistent with the overall lapatinib program. The median PFS and OS were 21.1 [95% confidence interval (CI) = 20.1–22.3] and 39.6 (95% CI = 37.7–40.7) weeks, respectively (n = 4006). Subgroup analysis showed longer PFS and OS in patients who had not received prior capecitabine.ConclusionsThese results demonstrate the safety and efficacy of lapatinib in a broader patient population compared with a clinical trial.