Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine: an open-label expanded access study in Korea

Jungsil Ro, Sohee Park, Sung B. Kim, Tae Y. Kim, Young H. Im, Sun Y. Rha, Joo S. Chung, Hanlim Moon, Sergio Santillana

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background: To evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP).Methods: LEAP is a worldwide, single-arm, open-label study. HER2-positive, locally-advanced or metastatic breast cancer patients with progression after an anthracycline, taxane, and trastuzumab were eligible. Patients received capecitabine 2000 mg/m2 daily in two divided doses, days 1-14, every 21 days and lapatinib 1250 mg once daily.Results: Among 186 patients enrolled in 6 Korean centers, 58 had BM. Progression-free survival (PFS) was 18.7 weeks in patients with BM and 19.4 weeks without BM (P = 0.88). In patients with BM, brain response was synchronized with systemic responses (P = 0.0001). Overall survival (OS) was 48.9 weeks in patients with BM and 64.6 weeks without BM (P = 0.23). Multivariable analysis found hormone receptor positivity (P = 0.003) and clinical benefit rate (CBR) of combined systemic and brain disease (P < 0.0001) significantly associated with prolonged brain PFS, and CBR of combined systemic and brain disease (P = 0.03) and longer trastuzumab use (P = 0.047) associated with prolonged OS in patients with BM; prior capecitabine did not affect PFS or OS in patients with BM.Conclusion: Lapatinib plus capecitabine is equally effective in patients with or without BM.Trial registration: ClinicalTrials.gov (NCT00338247).

Original languageEnglish
Article number322
JournalBMC cancer
Volume12
DOIs
Publication statusPublished - 2012 Jul 28

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Korea
Breast Neoplasms
Neoplasm Metastasis
Brain
Disease-Free Survival
Brain Diseases
Survival
Capecitabine
lapatinib
Anthracyclines
Hormones

All Science Journal Classification (ASJC) codes

  • Genetics
  • Oncology
  • Cancer Research

Cite this

Ro, Jungsil ; Park, Sohee ; Kim, Sung B. ; Kim, Tae Y. ; Im, Young H. ; Rha, Sun Y. ; Chung, Joo S. ; Moon, Hanlim ; Santillana, Sergio. / Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine : an open-label expanded access study in Korea. In: BMC cancer. 2012 ; Vol. 12.
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abstract = "Background: To evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP).Methods: LEAP is a worldwide, single-arm, open-label study. HER2-positive, locally-advanced or metastatic breast cancer patients with progression after an anthracycline, taxane, and trastuzumab were eligible. Patients received capecitabine 2000 mg/m2 daily in two divided doses, days 1-14, every 21 days and lapatinib 1250 mg once daily.Results: Among 186 patients enrolled in 6 Korean centers, 58 had BM. Progression-free survival (PFS) was 18.7 weeks in patients with BM and 19.4 weeks without BM (P = 0.88). In patients with BM, brain response was synchronized with systemic responses (P = 0.0001). Overall survival (OS) was 48.9 weeks in patients with BM and 64.6 weeks without BM (P = 0.23). Multivariable analysis found hormone receptor positivity (P = 0.003) and clinical benefit rate (CBR) of combined systemic and brain disease (P < 0.0001) significantly associated with prolonged brain PFS, and CBR of combined systemic and brain disease (P = 0.03) and longer trastuzumab use (P = 0.047) associated with prolonged OS in patients with BM; prior capecitabine did not affect PFS or OS in patients with BM.Conclusion: Lapatinib plus capecitabine is equally effective in patients with or without BM.Trial registration: ClinicalTrials.gov (NCT00338247).",
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Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine : an open-label expanded access study in Korea. / Ro, Jungsil; Park, Sohee; Kim, Sung B.; Kim, Tae Y.; Im, Young H.; Rha, Sun Y.; Chung, Joo S.; Moon, Hanlim; Santillana, Sergio.

In: BMC cancer, Vol. 12, 322, 28.07.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine

T2 - an open-label expanded access study in Korea

AU - Ro, Jungsil

AU - Park, Sohee

AU - Kim, Sung B.

AU - Kim, Tae Y.

AU - Im, Young H.

AU - Rha, Sun Y.

AU - Chung, Joo S.

AU - Moon, Hanlim

AU - Santillana, Sergio

PY - 2012/7/28

Y1 - 2012/7/28

N2 - Background: To evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP).Methods: LEAP is a worldwide, single-arm, open-label study. HER2-positive, locally-advanced or metastatic breast cancer patients with progression after an anthracycline, taxane, and trastuzumab were eligible. Patients received capecitabine 2000 mg/m2 daily in two divided doses, days 1-14, every 21 days and lapatinib 1250 mg once daily.Results: Among 186 patients enrolled in 6 Korean centers, 58 had BM. Progression-free survival (PFS) was 18.7 weeks in patients with BM and 19.4 weeks without BM (P = 0.88). In patients with BM, brain response was synchronized with systemic responses (P = 0.0001). Overall survival (OS) was 48.9 weeks in patients with BM and 64.6 weeks without BM (P = 0.23). Multivariable analysis found hormone receptor positivity (P = 0.003) and clinical benefit rate (CBR) of combined systemic and brain disease (P < 0.0001) significantly associated with prolonged brain PFS, and CBR of combined systemic and brain disease (P = 0.03) and longer trastuzumab use (P = 0.047) associated with prolonged OS in patients with BM; prior capecitabine did not affect PFS or OS in patients with BM.Conclusion: Lapatinib plus capecitabine is equally effective in patients with or without BM.Trial registration: ClinicalTrials.gov (NCT00338247).

AB - Background: To evaluate efficacy in patients with brain metastasis (BM) on entry into the lapatinib expanded access program (LEAP).Methods: LEAP is a worldwide, single-arm, open-label study. HER2-positive, locally-advanced or metastatic breast cancer patients with progression after an anthracycline, taxane, and trastuzumab were eligible. Patients received capecitabine 2000 mg/m2 daily in two divided doses, days 1-14, every 21 days and lapatinib 1250 mg once daily.Results: Among 186 patients enrolled in 6 Korean centers, 58 had BM. Progression-free survival (PFS) was 18.7 weeks in patients with BM and 19.4 weeks without BM (P = 0.88). In patients with BM, brain response was synchronized with systemic responses (P = 0.0001). Overall survival (OS) was 48.9 weeks in patients with BM and 64.6 weeks without BM (P = 0.23). Multivariable analysis found hormone receptor positivity (P = 0.003) and clinical benefit rate (CBR) of combined systemic and brain disease (P < 0.0001) significantly associated with prolonged brain PFS, and CBR of combined systemic and brain disease (P = 0.03) and longer trastuzumab use (P = 0.047) associated with prolonged OS in patients with BM; prior capecitabine did not affect PFS or OS in patients with BM.Conclusion: Lapatinib plus capecitabine is equally effective in patients with or without BM.Trial registration: ClinicalTrials.gov (NCT00338247).

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