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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): An open-label, randomised, phase 3 trial
The Lancet Oncology, Volume 17, No. 3, Year 2016
Notification
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Description
Background: Trastuzumab resistance is a key therapeutic challenge in metastatic breast cancer. We postulated that broader inhibition of ErbB receptors with afatinib would improve clinical outcomes compared with HER2 inhibition alone in patients who had progressed on previous trastuzumab treatment. LUX-Breast 1 compared afatinib plus vinorelbine with trastuzumab plus vinorelbine for such patients with HER2-positive metastatic breast cancer. Methods: We did this open-label trial at 350 hospitals in 41 countries worldwide. We enrolled female patients with HER2-overexpressing metastatic breast cancer who had progressed on or following adjuvant trastuzumab or first-line treatment of metastatic disease with trastuzumab. Participants were randomly assigned (2:1) to receive oral afatinib (40 mg/day) plus intravenous vinorelbine (25 mg/m 2 per week) or intravenous trastuzumab (2 mg/kg per week after 4 mg/kg loading dose) plus vinorelbine. Randomisation was done centrally and stratified by previous trastuzumab treatment (adjuvant vs first-line treatment), hormone receptor status (oestrogen receptor and progesterone receptor positive vs others), and region. The primary endpoint was progression-free survival, assessed in the intention-to-treat population. This trial is closed to enrolment and is registered with ClinicalTrials.gov, NCT01125566. Findings: Between Aug 26, 2010, and April 26, 2013, we enrolled 508 patients: 339 assigned to the afatinib group and 169 assigned to the trastuzumab group. Recruitment was stopped on April 26, 2013, after a benefit-risk assessment by the independent data monitoring committee was unfavourable for the afatinib group. Patients on afatinib plus vinorelbine had to switch to trastuzumab plus vinorelbine, afatinib monotherapy, vinorelbine monotherapy, or receive treatment outside of the trial. Median follow-up was 9·3 months (IQR 3·7-16·0). Median progression-free survival was 5·5 months (95% CI 5·4-5·6) in the afatinib group and 5·6 months (5·3-7·3) in the trastuzumab group (hazard ratio 1·10 95% CI 0·86-1·41; p=0·43). The most common drug-related adverse events of grade 3 or higher were neutropenia (190 [56%] of 337 patients in the afatinib group vs 102 [60%] of 169 patients in the trastuzumab group), leucopenia (64 [19%] vs 34 [20%]), and diarrhoea (60 [18%] vs none). Interpretation: Trastuzumab-based therapy remains the treatment of choice for patients with HER2-positive metastatic breast cancer who had progressed on trastuzumab. Funding: Boehringer Ingelheim. © 2016 Elsevier Ltd.
Authors & Co-Authors
Harbeck, Nadia
Germany, Munich
Ludwig-maximilians-universität München
Huang, Chiun Sheng
Taiwan, Taipei
National Taiwan University College of Medicine
Taiwan, Taipei
National Taiwan University Hospital
Hurvitz, Sara Alsterlind
United States, Los Angeles
University of California, Los Angeles
Yeh, Darh Cherng
Taiwan, Taichung
Veterans General Hospital-taichung Taiwan
Zhimin Shao, Zhiming
China, Shanghai
Fudan University Shanghai Cancer Center
Im, Seock Ah
South Korea, Seoul
Seoul National University College of Medicine
South Korea, Seoul
Seoul National University Hospital
Jung, Kyung-hae
South Korea, Seoul
Asan Medical Center
Shen, Kunwei
China, Shanghai
Ruijin Hospital
Rø, Jungsil
South Korea, Goyang
National Cancer Center, Gyeonggi
Jassem, Jacek
Poland, Gdansk
Gdanski Uniwersytet Medyczny
Zhang, Qingyuan
China, Harbin
Harbin Medical University
Im, Young-hyuck
South Korea, Seoul
Samsung Medical Center, Sungkyunkwan University
Wojtukiewicz, Marek Z.
Poland, Bialystok
Uniwersytet Medyczny w Bialymstoku
Sun, Qiang
China, Beijing
Peking Union Medical College Hospital
Chen, Shin Cheh
Taiwan, Taipei
Chang Gung Memorial Hospital
Goeldner, Rainer G.
Germany, Ingelheim am Rhein
Boehringer Ingelheim International Gmbh
Uttenreuther-Fischer, Martina M.
Germany, Ingelheim am Rhein
Boehringer Ingelheim International Gmbh
Xu, Binghe
China, Beijing
Cancer Institute & hospital, Chinese academy of Medical Sciences & Peking Union Medical College
China, Beijing
Chinese Academy of Medical Sciences & Peking Union Medical College
Piccart-Gebhart, Martine J.
Belgium, Brussels
Institut Jules Bordet
Krasnozhon, Dmitriy
Unknown Affiliation
Tong, Zhongsheng
Unknown Affiliation
Arora, Rajender Singh
Unknown Affiliation
Jacob, Linu Abraham
India, Bengaluru
Kidwai Memorial Institute of Oncology India
StarosŁawska, Ełzbieta
Poland, Lublin
Centrum Onkologii Ziemi Lubelskiej
Wang, Xiaojia
Unknown Affiliation
Satya Suresh Attili, V.
Unknown Affiliation
Mehta, Ajay Omprakash
Unknown Affiliation
Lee, Soohyeon
South Korea, Seoul
Severance Hospital
Tseng, Mingling
Taiwan, Taipei
Taipei Veterans General Hospital
Perera, N. A.Mahendra
Sri Lanka, Maharagama
National Cancer Institute Sri Lanka
Huizing, Manon T.
Belgium, Antwerpen
Universiteit Antwerpen
Melichar, Bohuslav
Czech Republic, Olomouc
Fakultní Nemocnice Olomouc
Grigiene, Ruta
Unknown Affiliation
Bharwani, Lavina D.
Singapore, Singapore City
Johns Hopkins Singapore International Medical Centre
Corteś, Javier O.
Spain, Barcelona
Hospital Universitari Vall D'hebron
García, Mirta
Spain, Las Palmas de Gran Canaria
Complejo Hospitalario Universitario Insular Materno-infantil
Chirgwin, Jacquie H.
Australia, Ringwood East
Maroondah Hospital
Baranau, Yauheni V.
Unknown Affiliation
Ermakov, Nikolai
Unknown Affiliation
Li, Wei
China, Changchun
The First Bethune Hospital of Jilin University
Lin, Tong Yu
China, Guangzhou
Sun Yat-sen University Cancer Center
Qin, Shukui
Unknown Affiliation
Shen, Peng
China, Hangzhou
Zhejiang University
Yang, Junlan
China, Beijing
China Pla General Hospital
Dohollou, Nadine
Unknown Affiliation
Kerbrat, Pierre
France, Rennes
Centre Eugène Marquis Rennes
Uleer, Christoph
Unknown Affiliation
Kristeleit, Harmut
United Kingdom, Hill
Queen Elizabeth Hospital
Nagarkar, Rajnish Vasant
Unknown Affiliation
Crown, John P.A.
Ireland, Dublin
St Vincent's University Hospital
Kelly, Catherine Margaret A.
Ireland, Dublin
Mater Misericordiae University Hospital
Ireland, Cork
Mater Private Hospital
Kaufman, Bella
Israel, Tel Hashomer Tel Aviv
Chaim Sheba Medical Center Israel
Ionta, Maria Teresa
Unknown Affiliation
Park, Kyong Hwa
South Korea, Seoul
Korea University Anam Hospital
Farhat, Fadi Sami
Lebanon, Saida
Hammoud Hospital
Chin, Lee Soo
Singapore, Singapore City
National University Hospital
Ŝufliarsky, Jozef
Unknown Affiliation
Sáenz, José Ángel García
Spain, Madrid
Hospital Clínico San Carlos
Begbie, Stephen D.
Unknown Affiliation
Dittrich, Christian
Austria, Vienna
Kaiser Franz Josef Hospital
Karchmit, Yauheniya
Unknown Affiliation
Awada, Ahmad Hussein
Unknown Affiliation
Bines, José
Brazil, Rio de Janeiro
Instituto Nacional de Cancer
Rigo, Rodrigo
Unknown Affiliation
Califaretti, Nadia
Canada, Kitchener
Grand River Regional Cancer Centre
Sridhar, Srikala S.
Canada, Toronto
Princess Margaret Cancer Centre
Villa, Diego R.
Canada, Vancouver
British Columbia Cancer Agency
Jiang, Zefei
China, Beijing
307 Hospital of Pla
Wang, Xiuwen
China, Jinan
Shandong University
Wu, Gang
China, Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wang, Shu
China, Beijing
Peking University People's Hospital
Zheng, Hong
China, Chengdu
West China School of Medicine/west China Hospital of Sichuan University
Delva, Rémy G.
France, Angers
Centre Paul Papin
Pivot, Xavier B.
France, Besancon
Hopital Jean Minjoz
Beckmann, Matthias Wilhelm
Germany, Erlangen
Friedrich-alexander-universität Erlangen-nürnberg
Bischoff, Joachim
Germany, Magdeburg
Medizinische Fakultät Und Uniklinikum Magdeburg
Gerber, Bernd
Unknown Affiliation
Maass, Nicolaì
Germany, Aachen
Uniklinik Rwth Aachen
Richters, Lisa K.
Germany, Koln
Uniklinik Köln
Schumacher, Claudia
Unknown Affiliation
Jain, Minish Mahendra
India, Pune
Kem Hospital
Indelli, Monica
Unknown Affiliation
Purkalne, Gunta
Latvia, Riga
Paula Stradina Clinical University Hospital
Juozaitytė, Elona
Lithuania, Kaunas
Lietuvos Sveikatos Mokslų Universitetas
Erdkamp, Frans L.G.
Unknown Affiliation
Sanchez, Fernando Salas
Unknown Affiliation
Susko-Kazamowicz, Magorzata
Unknown Affiliation
Sousa, Susana
Portugal, Porto
Epe
Mukhametshina, Guzel Z.
Unknown Affiliation
Shomova, Marina V.
Unknown Affiliation
Yap, Yoon Sim
Singapore, Singapore City
National Cancer Centre, Singapore
Beniak, Juraj
Unknown Affiliation
Grasic, Cvetka
Slovenia, Ljubljana
Onkološki Inštitut Ljubljana
Demetriou, Georgia Savva
South Africa, Johannesburg
Wits Donald Gordon Medical Centre
Maart, Keith
Unknown Affiliation
Pienaar, Rika
Unknown Affiliation
Rapoport, Bernardo L.
South Africa, Johannesburg
Medical Oncology Centre of Rosebank
Chacón, José Ignacio
Spain, Toledo
Complejo Hospitalario de Toledo
González-Cao, María
Spain, Barcelona
Hospital Universitari Dexeus
Chen, Shon Tung
Taiwan, Changhua
Changhua Christian Hospital
Lawler, William Eyre
Unknown Affiliation
Lerzo, Guillermo L.
Unknown Affiliation
Chan, Arlene
Australia, Perth
Mount Medical Centre
Snyder, Raymond D.
Australia, Fitzroy
St. Vincent's Hospital Melbourne
Graas, Marie Pascale L.
Belgium, Gilly
Hopital St. Joseph
Caleffi, Maira
Unknown Affiliation
Hegg, Robberto
Unknown Affiliation
Santi, Patrícia Xavier
Brazil, Santo Andre
Centro Universitário Fmabc
Vinholes, Jefferson J.F.
Unknown Affiliation
Yelle, Louise
Canada, Montreal
Hôpital Notre-dame
Yañez Ruiz, Eduardo Patricio
Unknown Affiliation
Petruželka, Lubos B.
Czech Republic, Prague
Všeobecná Fakultní Nemocnice V Praze
Azim, Hamdy Abdel
Unknown Affiliation
Shamaa, Sameh
Egypt, Mansoura
Mansoura University
Brain, Étienne G.C.
France, Saint-cloud
Centre René Huguenin
Chauffert, Bruno
Unknown Affiliation
Espié, Marc
France, Paris
Hôpital Saint-louis
Lortholary, Alain H.
Unknown Affiliation
Petit, Thierry
France, Strasbourg
Centre Paul Strauss Centre Régional de Lutte Contre le Cancer de Strasbourg
Hannig, Carla Verena
Unknown Affiliation
Paepke, Stefan
Germany, Munich
Klinikum Rechts Der Isar
O'Brien, Mary E.R.
United Kingdom, Sutton
Royal Marsden Hospital
Bhattacharyya, Gouri Shankar
Unknown Affiliation
Honkoop, Aafke H.
Netherlands, Zwolle
Isala Clinics
Tjan–Heijnen, Vivianne C.G.
Netherlands, Maastricht
Maastricht Universitair Medisch Centrum+
Błasińska-Morawiec, Maria
Unknown Affiliation
Wysocki, Piotr Jan
Unknown Affiliation
Biakhov, Mikhail I.
Unknown Affiliation
Chang, Tsai-Wang
Taiwan, Tainan
National Cheng Kung University Hospital
Altundag, Kadri
Turkey, Ankara
Hacettepe Üniversitesi
Gokmen, Erhan
Turkey, Izmir
Ege Üniversitesi
Statistics
Citations: 120
Authors: 131
Affiliations: 106
Identifiers
Doi:
10.1016/S1470-2045(15)00540-9
ISSN:
14702045
Research Areas
Cancer
Environmental
Health System And Policy
Infectious Diseases
Study Design
Cross Sectional Study
Cohort Study
Participants Gender
Female