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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Pattern of rash, diarrhea, and hepatic toxicities secondary to lapatinib and their association with age and response to neoadjuvant therapy: Analysis from the NeoALTTO trial
Journal of Clinical Oncology, Volume 31, No. 36, Year 2013
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Description
Purpose We investigated the pattern of rash, diarrhea, and hepatic adverse events (AEs) secondary to lapatinib and their association with age and pathologic complete response (pCR) in the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (NeoALLTO) phase III trial. Patients and Methods Patients with HER2-positive early breast cancer were randomly assigned to receive lapatinib (Arm A), trastuzumab (Arm B), or their combination (Arm C) for 6 weeks followed by the addition of paclitaxel for 12 weeks before surgery. We investigated the frequency and time to developing each AE according to age (≤ 50 v > 50 years) and their association with pCR in a logistic regression model adjusted for age, hormone receptors, tumor size, nodal status, planned breast surgery, completion of lapatinib administration, and treatment arm. Results Only patients randomly assigned to arms A and C were eligible (n = 306). Younger patients (≤ 50 years) experienced significantly more rash compared with older patients (74.4% v 47.9%; P < .0001). Diarrhea and hepatic AEs were observed in 78.8% and 41.2% of patients, respectively, with no differences in rate or severity or time of onset according to age. Early rash (ie, before starting paclitaxel) was independently associated with a higher chance of pCR, mainly in patients older than 50 years (odds ratio [OR] = 3.76; 95% CI, 1.69 to 8.34) but not in those ≤ 50 years (OR = 0.92; 95% CI, 0.45 to 1.88; P for interaction = .01). No significant association was observed between pCR and diarrhea or hepatic AEs. Conclusion Our results indicate that the frequency and clinical relevance of lapatinib-related rash is largely dependent on patient age. © 2013 by American Society of Clinical Oncology.
Authors & Co-Authors
Azim, Hatem A.
Belgium, Brussels
Institut Jules Bordet
Agbor-Tarh, Dominique
United Kingdom, Kingussie
Frontier Science Scotland Ltd
Bradbury, Ian
United Kingdom, Kingussie
Frontier Science Scotland Ltd
Dinh, Phuong
Belgium, Brussels
Breast International Group
Baselga, José M.
United States, New York
Memorial Sloan-kettering Cancer Center
Di Cosimo, Serena
Italy, Milan
Fondazione Irccs Istituto Nazionale Dei Tumori, Milan
Spain, Barcelona
Solti Breast Cancer Research Group
Greger, James G.
United States, Philadelphia
Glaxosmithkline, Usa
Smith, Ian E.
United Kingdom, London
The Royal Marsden Hospital
Jackisch, Christian
Germany, Offenbach
Kilinikum Offenbach
Kim, Sung-bae
South Korea, Seoul
University of Ulsan College of Medicine
Aktaş, Bahriye
Germany, Essen
Kliniken Essen-mitte
Huang, Chiun Sheng
Taiwan, Taipei
National Taiwan University Hospital
Vuylsteke, Peter
Belgium, Namur
Sint-elisabeth Hospital
Hsieh, Ruey Kuen
Taiwan, Taipei
Mackay Memorial Hospital Taiwan
Dreosti, Lydia M.
South Africa, Pretoria
University of Pretoria
Eidtmann, Holger
Germany, Kiel
Universitätsklinikum Schleswig-holstein Campus Kiel
Piccart-Gebhart, Martine J.
Belgium, Brussels
Institut Jules Bordet
de Azambuja, Evandro
Belgium, Brussels
Institut Jules Bordet
Statistics
Citations: 55
Authors: 18
Affiliations: 16
Identifiers
Doi:
10.1200/JCO.2013.50.9448
ISSN:
0732183X
e-ISSN:
15277755
Research Areas
Cancer
Health System And Policy
Study Design
Case-Control Study