Article (Scientific journals)
An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer.
Capri, G.; Chang, J.; Chen, S. C. et al.
2010In Annals of Oncology, 21 (3), p. 474-80
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Abstract :
[en] 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.
Disciplines :
Oncology
Author, co-author :
Capri, G.
Chang, J.
Chen, S. C.
Conte, P.
Cwiertka, K.
Jerusalem, Guy  ;  Centre Hospitalier Universitaire de Liège - CHU > Oncologie médicale
Jiang, Z.
Johnston, S.
Kaufman, B.
Link, J.
Ro, J.
Schutte, J.
Oliva, C.
Parikh, R.
Preston, A.
Rosenlund, J.
Selzer, M.
Zembryki, D.
De Placido, S.
More authors (9 more) Less
Language :
English
Title :
An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer.
Publication date :
2010
Journal title :
Annals of Oncology
ISSN :
0923-7534
eISSN :
1569-8041
Publisher :
Oxford University Press, London, United Kingdom
Volume :
21
Issue :
3
Pages :
474-80
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 19 September 2010

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