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Description
  • Background: The Lapatinib Expanded Access Program (LEAP) was initiated in 45 countries to provide lapatinib in combination with capecitabine to patients with ErbB2 (HER2)-positive breast cancer already treated with anthracyclines, taxanes and trastuzumab. We report the results from 12 Central and Eastern European countries. Patients and Methods: By 30 September 2008, 293 patients were enrolled. Patients were monitored for serious adverse events (SAEs) and for any decrease in left ventricular ejection fraction (LVEF). Overall survival and progression-free survival were also assessed. Results: Mean treatment duration was 30 weeks; 107 patients (36.5%) discontinued therapy during the study, mainly due to disease progression (n = 86; 29.4%). A total of 78 SAEs were reported from 47 patients; the most frequently reported was diarrhoea (13 reports). Treatment had a relatively small effect on LVEF. Decreases were minor (0 to < 20%) in 61% of patients at the end of the study. During the study, 3 patients had decreased LVEF meeting the definition of an SAE; these events all resolved. Median overall and median progression-free survival were 37.6 and 21.1 weeks, respectively. Conclusions: Heavily pretreated patients with ErbB2-positive locally advanced or metastatic breast cancer may benefit from treatment with lapatinib and capecitabine, with a low risk of cardiac toxicity.
  • Background: The Lapatinib Expanded Access Program (LEAP) was initiated in 45 countries to provide lapatinib in combination with capecitabine to patients with ErbB2 (HER2)-positive breast cancer already treated with anthracyclines, taxanes and trastuzumab. We report the results from 12 Central and Eastern European countries. Patients and Methods: By 30 September 2008, 293 patients were enrolled. Patients were monitored for serious adverse events (SAEs) and for any decrease in left ventricular ejection fraction (LVEF). Overall survival and progression-free survival were also assessed. Results: Mean treatment duration was 30 weeks; 107 patients (36.5%) discontinued therapy during the study, mainly due to disease progression (n = 86; 29.4%). A total of 78 SAEs were reported from 47 patients; the most frequently reported was diarrhoea (13 reports). Treatment had a relatively small effect on LVEF. Decreases were minor (0 to < 20%) in 61% of patients at the end of the study. During the study, 3 patients had decreased LVEF meeting the definition of an SAE; these events all resolved. Median overall and median progression-free survival were 37.6 and 21.1 weeks, respectively. Conclusions: Heavily pretreated patients with ErbB2-positive locally advanced or metastatic breast cancer may benefit from treatment with lapatinib and capecitabine, with a low risk of cardiac toxicity. (en)
Title
  • Combination therapy of Lapatinib and Capecitabine for ErbB2-positive metastatic or locally advanced breast cancer: results from the Lapatinib Expanded Access Program (LEAP) in Central and Eastern Europe
  • Combination therapy of Lapatinib and Capecitabine for ErbB2-positive metastatic or locally advanced breast cancer: results from the Lapatinib Expanded Access Program (LEAP) in Central and Eastern Europe (en)
skos:prefLabel
  • Combination therapy of Lapatinib and Capecitabine for ErbB2-positive metastatic or locally advanced breast cancer: results from the Lapatinib Expanded Access Program (LEAP) in Central and Eastern Europe
  • Combination therapy of Lapatinib and Capecitabine for ErbB2-positive metastatic or locally advanced breast cancer: results from the Lapatinib Expanded Access Program (LEAP) in Central and Eastern Europe (en)
skos:notation
  • RIV/00209805:_____/11:#0000180!RIV12-MZ0-00209805
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • I
http://linked.open...iv/cisloPeriodika
  • 5
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 190870
http://linked.open...ai/riv/idVysledku
  • RIV/00209805:_____/11:#0000180
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • Lapatinib; ErbB2; HER-2; breast cancer; cardiac safety; left ventricular ejection fraction (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • CH - Švýcarská konfederace
http://linked.open...ontrolniKodProRIV
  • [FB584002FFE5]
http://linked.open...i/riv/nazevZdroje
  • Onkologie
http://linked.open...in/vavai/riv/obor
http://linked.open...ichTvurcuVysledku
http://linked.open...cetTvurcuVysledku
http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 34
http://linked.open...iv/tvurceVysledku
  • Greil, Richard
  • Petráková, Katarína
http://linked.open...ain/vavai/riv/wos
  • 000290560200003
issn
  • 0378-584X
number of pages
http://bibframe.org/vocab/doi
  • 10.1159/000327710
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