Identification of early breast cancer patient cohorts who may benefit from lapatinib therapy.
Identifieur interne : 002171 ( PubMed/Curation ); précédent : 002170; suivant : 002172Identification of early breast cancer patient cohorts who may benefit from lapatinib therapy.
Auteurs : Kathrin Strasser-Weippl [Autriche] ; Nora Horick [États-Unis] ; Ian E. Smith [Royaume-Uni] ; Joyce O'Shaughnessy [États-Unis] ; Bent Ejlertsen [Danemark] ; Frances Boyle [Australie] ; Aman U. Buzdar [États-Unis] ; Pierre Fumoleau [France] ; William Gradishar [États-Unis] ; Miguel Martin [Espagne] ; Beverly Moy [États-Unis] ; Martine Piccart-Gebhart [Belgique] ; Kathleen I. Pritchard [Canada] ; Deborah Lindquist [États-Unis] ; Erica Rappold [États-Unis] ; Dianne M. Finkelstein [États-Unis] ; Paul E. Goss [États-Unis]Source :
- European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antinéoplasiques (effets indésirables), Antinéoplasiques (usage thérapeutique), Estimation de Kaplan-Meier, Facteurs temps, Femelle, Humains, Inhibiteurs de protéines kinases (effets indésirables), Inhibiteurs de protéines kinases (usage thérapeutique), Modèles de hasards proportionnels, Médecine individualisée, Quinazolines (effets indésirables), Quinazolines (usage thérapeutique), Récepteur ErbB-2 (antagonistes et inhibiteurs), Récepteur ErbB-2 (génétique), Récepteur ErbB-2 (métabolisme), Récidive tumorale locale, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Sélection de patients, Technique FISH, Traitement médicamenteux adjuvant, Transduction du signal (), Tumeurs du sein (anatomopathologie), Tumeurs du sein (enzymologie), Tumeurs du sein (génétique), Tumeurs du sein (mortalité), Tumeurs du sein (traitement médicamenteux).
- MESH :
- anatomopathologie : Tumeurs du sein.
- antagonistes et inhibiteurs : Récepteur ErbB-2.
- effets indésirables : Antinéoplasiques, Inhibiteurs de protéines kinases, Quinazolines.
- enzymologie : Tumeurs du sein.
- génétique : Récepteur ErbB-2, Tumeurs du sein.
- mortalité : Tumeurs du sein.
- métabolisme : Récepteur ErbB-2.
- traitement médicamenteux : Tumeurs du sein.
- usage thérapeutique : Antinéoplasiques, Inhibiteurs de protéines kinases, Quinazolines.
- Adulte, Adulte d'âge moyen, Estimation de Kaplan-Meier, Facteurs temps, Femelle, Humains, Modèles de hasards proportionnels, Médecine individualisée, Récidive tumorale locale, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Sélection de patients, Technique FISH, Traitement médicamenteux adjuvant, Transduction du signal.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Agents (adverse effects), Antineoplastic Agents (therapeutic use), Breast Neoplasms (drug therapy), Breast Neoplasms (enzymology), Breast Neoplasms (genetics), Breast Neoplasms (mortality), Breast Neoplasms (pathology), Chemotherapy, Adjuvant, Disease-Free Survival, Female, Humans, In Situ Hybridization, Fluorescence, Kaplan-Meier Estimate, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Patient Selection, Precision Medicine, Proportional Hazards Models, Protein Kinase Inhibitors (adverse effects), Protein Kinase Inhibitors (therapeutic use), Quinazolines (adverse effects), Quinazolines (therapeutic use), Receptor, ErbB-2 (antagonists & inhibitors), Receptor, ErbB-2 (genetics), Receptor, ErbB-2 (metabolism), Signal Transduction (drug effects), Time Factors, Treatment Outcome.
- MESH :
- chemical , adverse effects : Antineoplastic Agents, Protein Kinase Inhibitors, Quinazolines.
- chemical , antagonists & inhibitors : Receptor, ErbB-2.
- chemical , genetics : Receptor, ErbB-2.
- chemical , metabolism : Receptor, ErbB-2.
- chemical , therapeutic use : Antineoplastic Agents, Protein Kinase Inhibitors, Quinazolines.
- drug effects : Signal Transduction.
- drug therapy : Breast Neoplasms.
- enzymology : Breast Neoplasms.
- genetics : Breast Neoplasms.
- mortality : Breast Neoplasms.
- pathology : Breast Neoplasms.
- Adult, Aged, Aged, 80 and over, Chemotherapy, Adjuvant, Disease-Free Survival, Female, Humans, In Situ Hybridization, Fluorescence, Kaplan-Meier Estimate, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Patient Selection, Precision Medicine, Proportional Hazards Models, Time Factors, Treatment Outcome.
Abstract
In resource-constrained environments many patients with human epidermal growth factor receptor 2 (HER2)+ early breast cancer are currently not offered adjuvant anti-HER2 therapy. For patients who might be able to receive the tyrosine kinase inhibitor (TKI) lapatinib (e.g. after patent expiration), it is important to identify subgroups of patients for whom anti-HER2 TKI therapy could be beneficial. To do this, we used data from 2489 patients with centrally confirmed HER2+ disease enrolled in the adjuvant Tykerb Evaluation After Chemotherapy (TEACH) trial, investigating the effect of lapatinib in patients with HER2+ early breast cancer not treated with trastuzumab. We performed subgroup analyses and number-needed-to-treat (NNT) calculations using patient and tumour associated predictors. Hormone receptor negative (HR-) patients on lapatinib had a significantly prolonged disease-free survival (DFS) compared to HR- patients on placebo (hazard ratio 0.64, P=0.003). For patients with HR- disease, starting treatment with lapatinib ≤1 year from diagnosis improved DFS by 12.1% [2.1-22.1] at 2 years and 15.7% [4.1-27.2] at 5 years. Depending on lymph node status and time since diagnosis the NNT for recurrence (at 5 years) was between 5.9 (node positive patients <1 year from diagnosis) and 15.9. These numbers are in range with numbers reported for up-front adjuvant trastuzumab for HR unselected patients (e.g. 15.6 for DFS at 4 years in HERA). In a subgroup analysis of the adjuvant TEACH trial, we show that anti-HER2 monotherapy with a TKI is beneficial as adjuvant therapy in a subgroup of patients. NNT in HER2+ HR- patients are in range with those reported from up-front adjuvant trastuzumab trials.
DOI: 10.1016/j.ejca.2015.12.024
PubMed: 26829011
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Electronic address: kathrin.strasserweippl@gmail.com.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Center for Oncology and Hematology, Wilhelminen Hospital, Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Horick, Nora" sort="Horick, Nora" uniqKey="Horick N" first="Nora" last="Horick">Nora Horick</name><affiliation wicri:level="1"><nlm:affiliation>Massachusetts General Hospital Biostatistics Center, Boston, MA, USA. Electronic address: nhorick@partners.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Massachusetts General Hospital Biostatistics Center, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Smith, Ian E" sort="Smith, Ian E" uniqKey="Smith I" first="Ian E" last="Smith">Ian E. Smith</name><affiliation wicri:level="1"><nlm:affiliation>Royal Marsden Hospital, London, UK. Electronic address: ian.smith@rmh.nhs.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Marsden Hospital, London</wicri:regionArea></affiliation></author><author><name sortKey="O Shaughnessy, Joyce" sort="O Shaughnessy, Joyce" uniqKey="O Shaughnessy J" first="Joyce" last="O'Shaughnessy">Joyce O'Shaughnessy</name><affiliation wicri:level="1"><nlm:affiliation>Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX, USA. Electronic address: Joyce.OShaughnessy@usoncology.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX</wicri:regionArea></affiliation></author><author><name sortKey="Ejlertsen, Bent" sort="Ejlertsen, Bent" uniqKey="Ejlertsen B" first="Bent" last="Ejlertsen">Bent Ejlertsen</name><affiliation wicri:level="1"><nlm:affiliation>Rigshospitalet, DBCG Secretariat, Copenhagen, Denmark. Electronic address: ejlertsen@dadlnet.dk.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Rigshospitalet, DBCG Secretariat, Copenhagen</wicri:regionArea></affiliation></author><author><name sortKey="Boyle, Frances" sort="Boyle, Frances" uniqKey="Boyle F" first="Frances" last="Boyle">Frances Boyle</name><affiliation wicri:level="1"><nlm:affiliation>Mater Hospital, North Sydney, NSW, Australia. Electronic address: franb@bigpond.net.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Mater Hospital, North Sydney, NSW</wicri:regionArea></affiliation></author><author><name sortKey="Buzdar, Aman U" sort="Buzdar, Aman U" uniqKey="Buzdar A" first="Aman U" last="Buzdar">Aman U. Buzdar</name><affiliation wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: abuzdar@mdanderson.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea></affiliation></author><author><name sortKey="Fumoleau, Pierre" sort="Fumoleau, Pierre" uniqKey="Fumoleau P" first="Pierre" last="Fumoleau">Pierre Fumoleau</name><affiliation wicri:level="1"><nlm:affiliation>Centre GF Leclerc, Dijon, France. Electronic address: pfumoleau@cgfl.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre GF Leclerc, Dijon</wicri:regionArea></affiliation></author><author><name sortKey="Gradishar, William" sort="Gradishar, William" uniqKey="Gradishar W" first="William" last="Gradishar">William Gradishar</name><affiliation wicri:level="1"><nlm:affiliation>Northwestern University, Chicago, IL, USA. Electronic address: WGradishar@nmff.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Northwestern University, Chicago, IL</wicri:regionArea></affiliation></author><author><name sortKey="Martin, Miguel" sort="Martin, Miguel" uniqKey="Martin M" first="Miguel" last="Martin">Miguel Martin</name><affiliation wicri:level="1"><nlm:affiliation>Hospital Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain. Electronic address: mmartin@geicam.org.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario Gregorio Marañón, Universidad Complutense, Madrid</wicri:regionArea></affiliation></author><author><name sortKey="Moy, Beverly" sort="Moy, Beverly" uniqKey="Moy B" first="Beverly" last="Moy">Beverly Moy</name><affiliation wicri:level="1"><nlm:affiliation>Massachusetts General Hospital, Boston, MA, USA. Electronic address: bmoy@partners.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Massachusetts General Hospital, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Piccart Gebhart, Martine" sort="Piccart Gebhart, Martine" uniqKey="Piccart Gebhart M" first="Martine" last="Piccart-Gebhart">Martine Piccart-Gebhart</name><affiliation wicri:level="1"><nlm:affiliation>Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: martine.piccart@bordet.be.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Institut Jules Bordet, Université Libre de Bruxelles, Brussels</wicri:regionArea></affiliation></author><author><name sortKey="Pritchard, Kathleen I" sort="Pritchard, Kathleen I" uniqKey="Pritchard K" first="Kathleen I" last="Pritchard">Kathleen I. Pritchard</name><affiliation wicri:level="1"><nlm:affiliation>Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. Electronic address: kathy.pritchard@sunnybrook.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Lindquist, Deborah" sort="Lindquist, Deborah" uniqKey="Lindquist D" first="Deborah" last="Lindquist">Deborah Lindquist</name><affiliation wicri:level="1"><nlm:affiliation>Arizona Oncology, US Oncology, Sedona, AZ, USA. Electronic address: deborah.lindquist@usoncology.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Arizona Oncology, US Oncology, Sedona, AZ</wicri:regionArea></affiliation></author><author><name sortKey="Rappold, Erica" sort="Rappold, Erica" uniqKey="Rappold E" first="Erica" last="Rappold">Erica Rappold</name><affiliation wicri:level="1"><nlm:affiliation>GlaxoSmithKline, Collegeville, PA, USA. Electronic address: mprcer@gmail.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>GlaxoSmithKline, Collegeville, PA</wicri:regionArea></affiliation></author><author><name sortKey="Finkelstein, Dianne M" sort="Finkelstein, Dianne M" uniqKey="Finkelstein D" first="Dianne M" last="Finkelstein">Dianne M. Finkelstein</name><affiliation wicri:level="1"><nlm:affiliation>Massachusetts General Hospital Biostatistics Center, Boston, MA, USA. Electronic address: dfinkelstein@partners.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Massachusetts General Hospital Biostatistics Center, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Goss, Paul E" sort="Goss, Paul E" uniqKey="Goss P" first="Paul E" last="Goss">Paul E. Goss</name><affiliation wicri:level="1"><nlm:affiliation>Massachusetts General Hospital, Boston, MA, USA. Electronic address: pgoss@partners.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Massachusetts General Hospital, Boston, MA</wicri:regionArea></affiliation></author></analytic><series><title level="j">European journal of cancer (Oxford, England : 1990)</title><idno type="eISSN">1879-0852</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Agents (adverse effects)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Breast Neoplasms (drug therapy)</term><term>Breast Neoplasms (enzymology)</term><term>Breast Neoplasms (genetics)</term><term>Breast Neoplasms (mortality)</term><term>Breast Neoplasms (pathology)</term><term>Chemotherapy, Adjuvant</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>In Situ Hybridization, Fluorescence</term><term>Kaplan-Meier Estimate</term><term>Middle Aged</term><term>Neoplasm Recurrence, Local</term><term>Neoplasm Staging</term><term>Patient Selection</term><term>Precision Medicine</term><term>Proportional Hazards Models</term><term>Protein Kinase Inhibitors (adverse effects)</term><term>Protein Kinase Inhibitors (therapeutic use)</term><term>Quinazolines (adverse effects)</term><term>Quinazolines (therapeutic use)</term><term>Receptor, ErbB-2 (antagonists & inhibitors)</term><term>Receptor, ErbB-2 (genetics)</term><term>Receptor, ErbB-2 (metabolism)</term><term>Signal Transduction (drug effects)</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Antinéoplasiques (effets indésirables)</term><term>Antinéoplasiques (usage thérapeutique)</term><term>Estimation de Kaplan-Meier</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Inhibiteurs de protéines kinases (effets indésirables)</term><term>Inhibiteurs de protéines kinases (usage thérapeutique)</term><term>Modèles de hasards proportionnels</term><term>Médecine individualisée</term><term>Quinazolines (effets indésirables)</term><term>Quinazolines (usage thérapeutique)</term><term>Récepteur ErbB-2 (antagonistes et inhibiteurs)</term><term>Récepteur ErbB-2 (génétique)</term><term>Récepteur ErbB-2 (métabolisme)</term><term>Récidive tumorale locale</term><term>Résultat thérapeutique</term><term>Stade de la tumeur</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Sélection de patients</term><term>Technique FISH</term><term>Traitement médicamenteux adjuvant</term><term>Transduction du signal ()</term><term>Tumeurs du sein (anatomopathologie)</term><term>Tumeurs du sein (enzymologie)</term><term>Tumeurs du sein (génétique)</term><term>Tumeurs du sein (mortalité)</term><term>Tumeurs du sein (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Agents</term><term>Protein Kinase Inhibitors</term><term>Quinazolines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Receptor, ErbB-2</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Receptor, ErbB-2</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Receptor, ErbB-2</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents</term><term>Protein Kinase Inhibitors</term><term>Quinazolines</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Récepteur ErbB-2</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Signal Transduction</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antinéoplasiques</term><term>Inhibiteurs de protéines kinases</term><term>Quinazolines</term></keywords><keywords scheme="MESH" qualifier="enzymologie" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="enzymology" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Récepteur ErbB-2</term><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Récepteur ErbB-2</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antinéoplasiques</term><term>Inhibiteurs de protéines kinases</term><term>Quinazolines</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Chemotherapy, Adjuvant</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>In Situ Hybridization, Fluorescence</term><term>Kaplan-Meier Estimate</term><term>Middle Aged</term><term>Neoplasm Recurrence, Local</term><term>Neoplasm Staging</term><term>Patient Selection</term><term>Precision Medicine</term><term>Proportional Hazards Models</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Estimation de Kaplan-Meier</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Modèles de hasards proportionnels</term><term>Médecine individualisée</term><term>Récidive tumorale locale</term><term>Résultat thérapeutique</term><term>Stade de la tumeur</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Sélection de patients</term><term>Technique FISH</term><term>Traitement médicamenteux adjuvant</term><term>Transduction du signal</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In resource-constrained environments many patients with human epidermal growth factor receptor 2 (HER2)+ early breast cancer are currently not offered adjuvant anti-HER2 therapy. For patients who might be able to receive the tyrosine kinase inhibitor (TKI) lapatinib (e.g. after patent expiration), it is important to identify subgroups of patients for whom anti-HER2 TKI therapy could be beneficial. To do this, we used data from 2489 patients with centrally confirmed HER2+ disease enrolled in the adjuvant Tykerb Evaluation After Chemotherapy (TEACH) trial, investigating the effect of lapatinib in patients with HER2+ early breast cancer not treated with trastuzumab. We performed subgroup analyses and number-needed-to-treat (NNT) calculations using patient and tumour associated predictors. Hormone receptor negative (HR-) patients on lapatinib had a significantly prolonged disease-free survival (DFS) compared to HR- patients on placebo (hazard ratio 0.64, P=0.003). For patients with HR- disease, starting treatment with lapatinib ≤1 year from diagnosis improved DFS by 12.1% [2.1-22.1] at 2 years and 15.7% [4.1-27.2] at 5 years. Depending on lymph node status and time since diagnosis the NNT for recurrence (at 5 years) was between 5.9 (node positive patients <1 year from diagnosis) and 15.9. These numbers are in range with numbers reported for up-front adjuvant trastuzumab for HR unselected patients (e.g. 15.6 for DFS at 4 years in HERA). In a subgroup analysis of the adjuvant TEACH trial, we show that anti-HER2 monotherapy with a TKI is beneficial as adjuvant therapy in a subgroup of patients. NNT in HER2+ HR- patients are in range with those reported from up-front adjuvant trastuzumab trials.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26829011</PMID><DateCreated><Year>2016</Year><Month>02</Month><Day>27</Day></DateCreated><DateCompleted><Year>2016</Year><Month>07</Month><Day>12</Day></DateCompleted><DateRevised><Year>2016</Year><Month>02</Month><Day>27</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-0852</ISSN><JournalIssue CitedMedium="Internet"><Volume>56</Volume><PubDate><Year>2016</Year><Month>Mar</Month></PubDate></JournalIssue><Title>European journal of cancer (Oxford, England : 1990)</Title><ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation></Journal><ArticleTitle>Identification of early breast cancer patient cohorts who may benefit from lapatinib therapy.</ArticleTitle><Pagination><MedlinePgn>85-92</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2015.12.024</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0959-8049(15)01180-6</ELocationID><Abstract><AbstractText>In resource-constrained environments many patients with human epidermal growth factor receptor 2 (HER2)+ early breast cancer are currently not offered adjuvant anti-HER2 therapy. For patients who might be able to receive the tyrosine kinase inhibitor (TKI) lapatinib (e.g. after patent expiration), it is important to identify subgroups of patients for whom anti-HER2 TKI therapy could be beneficial. To do this, we used data from 2489 patients with centrally confirmed HER2+ disease enrolled in the adjuvant Tykerb Evaluation After Chemotherapy (TEACH) trial, investigating the effect of lapatinib in patients with HER2+ early breast cancer not treated with trastuzumab. We performed subgroup analyses and number-needed-to-treat (NNT) calculations using patient and tumour associated predictors. Hormone receptor negative (HR-) patients on lapatinib had a significantly prolonged disease-free survival (DFS) compared to HR- patients on placebo (hazard ratio 0.64, P=0.003). For patients with HR- disease, starting treatment with lapatinib ≤1 year from diagnosis improved DFS by 12.1% [2.1-22.1] at 2 years and 15.7% [4.1-27.2] at 5 years. Depending on lymph node status and time since diagnosis the NNT for recurrence (at 5 years) was between 5.9 (node positive patients <1 year from diagnosis) and 15.9. These numbers are in range with numbers reported for up-front adjuvant trastuzumab for HR unselected patients (e.g. 15.6 for DFS at 4 years in HERA). In a subgroup analysis of the adjuvant TEACH trial, we show that anti-HER2 monotherapy with a TKI is beneficial as adjuvant therapy in a subgroup of patients. NNT in HER2+ HR- patients are in range with those reported from up-front adjuvant trastuzumab trials.</AbstractText><CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Strasser-Weippl</LastName><ForeName>Kathrin</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Center for Oncology and Hematology, Wilhelminen Hospital, Vienna, Austria. Electronic address: kathrin.strasserweippl@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Horick</LastName><ForeName>Nora</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Massachusetts General Hospital Biostatistics Center, Boston, MA, USA. Electronic address: nhorick@partners.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Ian E</ForeName><Initials>IE</Initials><AffiliationInfo><Affiliation>Royal Marsden Hospital, London, UK. Electronic address: ian.smith@rmh.nhs.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>O'Shaughnessy</LastName><ForeName>Joyce</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX, USA. Electronic address: Joyce.OShaughnessy@usoncology.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ejlertsen</LastName><ForeName>Bent</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Rigshospitalet, DBCG Secretariat, Copenhagen, Denmark. Electronic address: ejlertsen@dadlnet.dk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boyle</LastName><ForeName>Frances</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Mater Hospital, North Sydney, NSW, Australia. Electronic address: franb@bigpond.net.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Buzdar</LastName><ForeName>Aman U</ForeName><Initials>AU</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: abuzdar@mdanderson.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fumoleau</LastName><ForeName>Pierre</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Centre GF Leclerc, Dijon, France. Electronic address: pfumoleau@cgfl.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gradishar</LastName><ForeName>William</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Northwestern University, Chicago, IL, USA. Electronic address: WGradishar@nmff.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Martin</LastName><ForeName>Miguel</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Hospital Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain. Electronic address: mmartin@geicam.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moy</LastName><ForeName>Beverly</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Massachusetts General Hospital, Boston, MA, USA. Electronic address: bmoy@partners.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Piccart-Gebhart</LastName><ForeName>Martine</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: martine.piccart@bordet.be.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pritchard</LastName><ForeName>Kathleen I</ForeName><Initials>KI</Initials><AffiliationInfo><Affiliation>Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. Electronic address: kathy.pritchard@sunnybrook.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lindquist</LastName><ForeName>Deborah</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Arizona Oncology, US Oncology, Sedona, AZ, USA. Electronic address: deborah.lindquist@usoncology.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rappold</LastName><ForeName>Erica</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>GlaxoSmithKline, Collegeville, PA, USA. Electronic address: mprcer@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Finkelstein</LastName><ForeName>Dianne M</ForeName><Initials>DM</Initials><AffiliationInfo><Affiliation>Massachusetts General Hospital Biostatistics Center, Boston, MA, USA. Electronic address: dfinkelstein@partners.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goss</LastName><ForeName>Paul E</ForeName><Initials>PE</Initials><AffiliationInfo><Affiliation>Massachusetts General Hospital, Boston, MA, USA. Electronic address: pgoss@partners.org.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>01</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Eur J Cancer</MedlineTA><NlmUniqueID>9005373</NlmUniqueID><ISSNLinking>0959-8049</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D047428">Protein Kinase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011799">Quinazolines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0VUA21238F</RegistryNumber><NameOfSubstance UI="C490728">lapatinib</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance UI="C508053">ERBB2 protein, human</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance UI="D018719">Receptor, ErbB-2</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001943" MajorTopicYN="N">Breast Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000201" MajorTopicYN="N">enzymology</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017024" MajorTopicYN="N">Chemotherapy, Adjuvant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017404" MajorTopicYN="N">In Situ Hybridization, Fluorescence</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009364" MajorTopicYN="N">Neoplasm Recurrence, Local</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009367" MajorTopicYN="N">Neoplasm Staging</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018579" MajorTopicYN="N">Patient Selection</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D057285" MajorTopicYN="N">Precision Medicine</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D047428" MajorTopicYN="N">Protein Kinase Inhibitors</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011799" MajorTopicYN="N">Quinazolines</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018719" MajorTopicYN="N">Receptor, ErbB-2</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="N">antagonists & inhibitors</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015398" MajorTopicYN="N">Signal Transduction</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Adjuvant</Keyword><Keyword MajorTopicYN="N">Early breast cancer</Keyword><Keyword MajorTopicYN="N">Hormone receptor</Keyword><Keyword MajorTopicYN="N">Lapatinib</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>08</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>12</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>12</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>2</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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