Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer

Cross-talk between human epidermal growth factor receptors and hormone receptor pathways may cause endocrine resistance in breast cancer. This trial evaluated the effect of adding lapatinib, a dual tyrosine kinase inhibitor blocking epidermal growth factor receptor and human epidermal growth factor...

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Vydané v:	Journal of clinical oncology Ročník 27; číslo 33; s. 5538
Hlavní autori:	Johnston, Stephen, Pippen, Jr, John, Pivot, Xavier, Lichinitser, Mikhail, Sadeghi, Saeed, Dieras, Veronique, Gomez, Henry Leonidas, Romieu, Gilles, Manikhas, Alexey, Kennedy, M John, Press, Michael F, Maltzman, Julie, Florance, Allison, O'Rourke, Lisa, Oliva, Cristina, Stein, Steven, Pegram, Mark
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 20.11.2009
Predmet:	Adult Aged Aged, 80 and over Antineoplastic Agents, Hormonal - administration & dosage Antineoplastic Agents, Hormonal - adverse effects Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Biomarkers, Tumor - analysis Biomarkers, Tumor - genetics Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - mortality Breast Neoplasms - pathology Carcinoma - drug therapy Carcinoma - metabolism Carcinoma - mortality Carcinoma - pathology Carcinoma - secondary Disease-Free Survival Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Humans Kaplan-Meier Estimate Maximum Tolerated Dose Middle Aged Neoplasm Invasiveness - pathology Neoplasm Staging Nitriles - administration & dosage Nitriles - adverse effects Postmenopause - drug effects Prognosis Proportional Hazards Models Quinazolines - administration & dosage Quinazolines - adverse effects Receptor, ErbB-2 - genetics Receptor, ErbB-2 - metabolism Receptors, Estrogen - genetics Receptors, Estrogen - metabolism Receptors, Progesterone - genetics Receptors, Progesterone - metabolism Risk Assessment Survival Analysis Treatment Outcome Triazoles - administration & dosage Triazoles - adverse effects
ISSN:	1527-7755, 1527-7755
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Abstract	Cross-talk between human epidermal growth factor receptors and hormone receptor pathways may cause endocrine resistance in breast cancer. This trial evaluated the effect of adding lapatinib, a dual tyrosine kinase inhibitor blocking epidermal growth factor receptor and human epidermal growth factor receptor 2 (HER2), to the aromatase inhibitor letrozole as first-line treatment of hormone receptor (HR) -positive metastatic breast cancer (MBC). Postmenopausal women with HR-positive MBC were randomly assigned to daily letrozole (2.5 mg orally) plus lapatinib (1,500 mg orally) or letrozole and placebo. The primary end point was progression-free survival (PFS) in the HER2-positive population. Results In HR-positive, HER2-positive patients (n = 219), addition of lapatinib to letrozole significantly reduced the risk of disease progression versus letrozole-placebo (hazard ratio [HR] = 0.71; 95% CI, 0.53 to 0.96; P = .019); median PFS was 8.2 v 3.0 months, respectively. Clinical benefit (responsive or stable disease >or= 6 months) was significantly greater for lapatinib-letrozole versus letrozole-placebo (48% v 29%, respectively; odds ratio [OR] = 0.4; 95% CI, 0.2 to 0.8; P = .003). Patients with centrally confirmed HR-positive, HER2-negative tumors (n = 952) had no improvement in PFS. A preplanned Cox regression analysis identified prior antiestrogen therapy as a significant factor in the HER2-negative population; a nonsignificant trend toward prolonged PFS for lapatinib-letrozole was seen in patients who experienced relapse less than 6 months since prior tamoxifen discontinuation (HR = 0.78; 95% CI, 0.57 to 1.07; P = .117). Grade 3 or 4 adverse events were more common in the lapatinib-letrozole arm versus letrozole-placebo arm (diarrhea, 10% v 1%; rash, 1% v 0%, respectively), but they were manageable. This trial demonstrated that a combined targeted strategy with letrozole and lapatinib significantly enhances PFS and clinical benefit rates in patients with MBC that coexpresses HR and HER2.
AbstractList	Cross-talk between human epidermal growth factor receptors and hormone receptor pathways may cause endocrine resistance in breast cancer. This trial evaluated the effect of adding lapatinib, a dual tyrosine kinase inhibitor blocking epidermal growth factor receptor and human epidermal growth factor receptor 2 (HER2), to the aromatase inhibitor letrozole as first-line treatment of hormone receptor (HR) -positive metastatic breast cancer (MBC).PURPOSECross-talk between human epidermal growth factor receptors and hormone receptor pathways may cause endocrine resistance in breast cancer. This trial evaluated the effect of adding lapatinib, a dual tyrosine kinase inhibitor blocking epidermal growth factor receptor and human epidermal growth factor receptor 2 (HER2), to the aromatase inhibitor letrozole as first-line treatment of hormone receptor (HR) -positive metastatic breast cancer (MBC).Postmenopausal women with HR-positive MBC were randomly assigned to daily letrozole (2.5 mg orally) plus lapatinib (1,500 mg orally) or letrozole and placebo. The primary end point was progression-free survival (PFS) in the HER2-positive population. Results In HR-positive, HER2-positive patients (n = 219), addition of lapatinib to letrozole significantly reduced the risk of disease progression versus letrozole-placebo (hazard ratio [HR] = 0.71; 95% CI, 0.53 to 0.96; P = .019); median PFS was 8.2 v 3.0 months, respectively. Clinical benefit (responsive or stable disease >or= 6 months) was significantly greater for lapatinib-letrozole versus letrozole-placebo (48% v 29%, respectively; odds ratio [OR] = 0.4; 95% CI, 0.2 to 0.8; P = .003). Patients with centrally confirmed HR-positive, HER2-negative tumors (n = 952) had no improvement in PFS. A preplanned Cox regression analysis identified prior antiestrogen therapy as a significant factor in the HER2-negative population; a nonsignificant trend toward prolonged PFS for lapatinib-letrozole was seen in patients who experienced relapse less than 6 months since prior tamoxifen discontinuation (HR = 0.78; 95% CI, 0.57 to 1.07; P = .117). Grade 3 or 4 adverse events were more common in the lapatinib-letrozole arm versus letrozole-placebo arm (diarrhea, 10% v 1%; rash, 1% v 0%, respectively), but they were manageable.PATIENTS AND METHODSPostmenopausal women with HR-positive MBC were randomly assigned to daily letrozole (2.5 mg orally) plus lapatinib (1,500 mg orally) or letrozole and placebo. The primary end point was progression-free survival (PFS) in the HER2-positive population. Results In HR-positive, HER2-positive patients (n = 219), addition of lapatinib to letrozole significantly reduced the risk of disease progression versus letrozole-placebo (hazard ratio [HR] = 0.71; 95% CI, 0.53 to 0.96; P = .019); median PFS was 8.2 v 3.0 months, respectively. Clinical benefit (responsive or stable disease >or= 6 months) was significantly greater for lapatinib-letrozole versus letrozole-placebo (48% v 29%, respectively; odds ratio [OR] = 0.4; 95% CI, 0.2 to 0.8; P = .003). Patients with centrally confirmed HR-positive, HER2-negative tumors (n = 952) had no improvement in PFS. A preplanned Cox regression analysis identified prior antiestrogen therapy as a significant factor in the HER2-negative population; a nonsignificant trend toward prolonged PFS for lapatinib-letrozole was seen in patients who experienced relapse less than 6 months since prior tamoxifen discontinuation (HR = 0.78; 95% CI, 0.57 to 1.07; P = .117). Grade 3 or 4 adverse events were more common in the lapatinib-letrozole arm versus letrozole-placebo arm (diarrhea, 10% v 1%; rash, 1% v 0%, respectively), but they were manageable.This trial demonstrated that a combined targeted strategy with letrozole and lapatinib significantly enhances PFS and clinical benefit rates in patients with MBC that coexpresses HR and HER2.CONCLUSIONThis trial demonstrated that a combined targeted strategy with letrozole and lapatinib significantly enhances PFS and clinical benefit rates in patients with MBC that coexpresses HR and HER2. Cross-talk between human epidermal growth factor receptors and hormone receptor pathways may cause endocrine resistance in breast cancer. This trial evaluated the effect of adding lapatinib, a dual tyrosine kinase inhibitor blocking epidermal growth factor receptor and human epidermal growth factor receptor 2 (HER2), to the aromatase inhibitor letrozole as first-line treatment of hormone receptor (HR) -positive metastatic breast cancer (MBC). Postmenopausal women with HR-positive MBC were randomly assigned to daily letrozole (2.5 mg orally) plus lapatinib (1,500 mg orally) or letrozole and placebo. The primary end point was progression-free survival (PFS) in the HER2-positive population. Results In HR-positive, HER2-positive patients (n = 219), addition of lapatinib to letrozole significantly reduced the risk of disease progression versus letrozole-placebo (hazard ratio [HR] = 0.71; 95% CI, 0.53 to 0.96; P = .019); median PFS was 8.2 v 3.0 months, respectively. Clinical benefit (responsive or stable disease >or= 6 months) was significantly greater for lapatinib-letrozole versus letrozole-placebo (48% v 29%, respectively; odds ratio [OR] = 0.4; 95% CI, 0.2 to 0.8; P = .003). Patients with centrally confirmed HR-positive, HER2-negative tumors (n = 952) had no improvement in PFS. A preplanned Cox regression analysis identified prior antiestrogen therapy as a significant factor in the HER2-negative population; a nonsignificant trend toward prolonged PFS for lapatinib-letrozole was seen in patients who experienced relapse less than 6 months since prior tamoxifen discontinuation (HR = 0.78; 95% CI, 0.57 to 1.07; P = .117). Grade 3 or 4 adverse events were more common in the lapatinib-letrozole arm versus letrozole-placebo arm (diarrhea, 10% v 1%; rash, 1% v 0%, respectively), but they were manageable. This trial demonstrated that a combined targeted strategy with letrozole and lapatinib significantly enhances PFS and clinical benefit rates in patients with MBC that coexpresses HR and HER2.
Author	Romieu, Gilles Oliva, Cristina Kennedy, M John Sadeghi, Saeed Florance, Allison Manikhas, Alexey Pippen, Jr, John Stein, Steven Pegram, Mark Pivot, Xavier Johnston, Stephen Dieras, Veronique O'Rourke, Lisa Lichinitser, Mikhail Gomez, Henry Leonidas Maltzman, Julie Press, Michael F
Author_xml	– sequence: 1 givenname: Stephen surname: Johnston fullname: Johnston, Stephen email: stephen.johnston@rmh.nhs.uk organization: Royal Marsden Hospital, London, United Kingdom. stephen.johnston@rmh.nhs.uk – sequence: 2 givenname: John surname: Pippen, Jr fullname: Pippen, Jr, John – sequence: 3 givenname: Xavier surname: Pivot fullname: Pivot, Xavier – sequence: 4 givenname: Mikhail surname: Lichinitser fullname: Lichinitser, Mikhail – sequence: 5 givenname: Saeed surname: Sadeghi fullname: Sadeghi, Saeed – sequence: 6 givenname: Veronique surname: Dieras fullname: Dieras, Veronique – sequence: 7 givenname: Henry Leonidas surname: Gomez fullname: Gomez, Henry Leonidas – sequence: 8 givenname: Gilles surname: Romieu fullname: Romieu, Gilles – sequence: 9 givenname: Alexey surname: Manikhas fullname: Manikhas, Alexey – sequence: 10 givenname: M John surname: Kennedy fullname: Kennedy, M John – sequence: 11 givenname: Michael F surname: Press fullname: Press, Michael F – sequence: 12 givenname: Julie surname: Maltzman fullname: Maltzman, Julie – sequence: 13 givenname: Allison surname: Florance fullname: Florance, Allison – sequence: 14 givenname: Lisa surname: O'Rourke fullname: O'Rourke, Lisa – sequence: 15 givenname: Cristina surname: Oliva fullname: Oliva, Cristina – sequence: 16 givenname: Steven surname: Stein fullname: Stein, Steven – sequence: 17 givenname: Mark surname: Pegram fullname: Pegram, Mark
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/19786658$$D View this record in MEDLINE/PubMed
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Title	Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer
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