| アブストラクト | 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. |
|---|
| 投稿者 | Capri, G; Chang, J; Chen, S-C; Conte, P; Cwiertka, K; Jerusalem, G; 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 |
|---|
| 組織名 | Department of Medical Oncology, Fondazione IRCCS Istituto Tumori, Milano, Italy.;Electronic address: giuseppe.capri@istitutotumori.mi.it.;Medical Oncology Program, RS McLaughlin Durham Regional Cancer Centre, Oshawa,;Ontario, Canada.;Department of General Surgery, Chang Gung Memorial Hospital, Taipei, Taiwan.;Department of Oncology and Hematology, Universita degli Studi di Modena e Reggio;Emilia, Modena, Italy.;Department of Oncology, Hospital Olomouc, Olomouc, Czech Republic.;Department of Medical Oncology, CHU Liege Hospital du Sart-Tilman, Liege,;Belgium.;Breast Cancer Department, The Hospital Associated With Military Medical Science,;Beijing, China.;Department of Medical Oncology, Royal Marsden NHS Foundation Trust & Institute of;Cancer Research, London, UK.;Breast Cancer Unit, Sheba Medical Center, Ramat Gan, Israel.;Breast Link Medical Group, Inc., Long Beach, CA, USA.;Breast and Endocrine Cancer Branch, National Cancer Center, Kyunggi-do, South;Korea.;Department of Hematology and Oncology, Marien Hospital Dusseldorf, Dusseldorf,;Germany.;Oncology Medicine Development Center, GlaxoSmithKline, Uxbridge, Middlesex, UK.;Oncology Medicine Development Center, GlaxoSmithKline, Collegeville, PA, USA.;Oncology, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline,;Collegeville, PA, USA.;Department of Molecular and Clinical Oncology, Universita degli Studi di Napoli;Federico II, Napoli, Italy. |
|---|
