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

G. Capri*, J. Chang, S. C. Chen, P. Conte, K. Cwiertka, G. Jerusalem, Z. Jiang, S. Johnston, B. Kaufman, J. Link, J. Ro, J. Schütte, C. Oliva, R. Parikh, A. Preston, J. Rosenlund, M. Selzer, D. Zembryki, S. De Placido

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

75 Scopus citations

Abstract

Background: The 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 methods: LEAP 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). Results: As 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. Conclusions: These results demonstrate the safety and efficacy of lapatinib in a broader patient population compared with a clinical trial.

Original languageEnglish
Pages (from-to)474-480
Number of pages7
JournalAnnals of Oncology
Volume21
Issue number3
DOIs
StatePublished - 08 10 2009
Externally publishedYes

Keywords

  • Capecitabine
  • EGFR
  • Expanded access
  • HER2
  • Lapatinib
  • Metastatic breast cancer

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