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

Research output: Contribution to journalArticle

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
Article numbermdp373
Pages (from-to)474-480
Number of pages7
JournalAnnals of Oncology
Volume21
Issue number3
DOIs
Publication statusPublished - Oct 8 2009

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Breast Neoplasms
Disease-Free Survival
Survival
Confidence Intervals
Safety
Anthracyclines
Interstitial Lung Diseases
lapatinib
Capecitabine
Nausea
Heart Ventricles
Vomiting
Diarrhea
Pneumonia
Clinical Trials
Incidence
Therapeutics
Pharmaceutical Preparations
Population

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

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

In: Annals of Oncology, Vol. 21, No. 3, mdp373, 08.10.2009, p. 474-480.

Research output: Contribution to journalArticle

Capri, G, Chang, J, Chen, SC, Conte, P, Cwiertka, K, Jerusalem, G, Jiang, Z, Johnston, S, Kaufman, B, Link, J, Ro, J, Schütte, J, Oliva, C, Parikh, R, Preston, A, Rosenlund, J, Selzer, M, Zembryki, D & De Placido, S 2009, 'An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer', Annals of Oncology, vol. 21, no. 3, mdp373, pp. 474-480. https://doi.org/10.1093/annonc/mdp373
Capri, G. ; Chang, J. ; Chen, S. C. ; Conte, P. ; Cwiertka, K. ; Jerusalem, G. ; Jiang, Z. ; Johnston, S. ; Kaufman, B. ; Link, J. ; Ro, J. ; Schütte, J. ; Oliva, C. ; Parikh, R. ; Preston, A. ; Rosenlund, J. ; Selzer, M. ; Zembryki, D. ; De Placido, S. / An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer. In: Annals of Oncology. 2009 ; Vol. 21, No. 3. pp. 474-480.
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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.",
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AU - Capri, G.

AU - Chang, J.

AU - Chen, S. C.

AU - Conte, P.

AU - Cwiertka, K.

AU - Jerusalem, G.

AU - Jiang, Z.

AU - Johnston, S.

AU - Kaufman, B.

AU - Link, J.

AU - Ro, J.

AU - Schütte, J.

AU - Oliva, C.

AU - Parikh, R.

AU - Preston, A.

AU - Rosenlund, J.

AU - Selzer, M.

AU - Zembryki, D.

AU - De Placido, S.

PY - 2009/10/8

Y1 - 2009/10/8

N2 - 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.

AB - 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.

KW - Capecitabine

KW - EGFR

KW - Expanded access

KW - HER2

KW - Lapatinib

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