Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013
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.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 24 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Dual neoadjuvant blockade plus chemotherapy versus monotherapy for the treatment of women with non-metastatic HER2-positive breast cancer: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023Pooled it
- Pooled it
- Systematic Review of the Side Effects Associated With Anti-HER2-Targeted Therapies Used in the Treatment of Breast Cancer, on Behalf of the EORTC Quality of Life Group.Targeted oncology · 2016Pooled it
- DEGRO practical guidelines for radiotherapy of breast cancer V: Therapy for locally advanced and inflammatory breast cancer, as well as local therapy in cases with synchronous distant metastases.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2015Guideline
- Overnight fasting before lapatinib administration to breast cancer patients leads to reduced toxicity compared with nighttime dosing: a retrospective cohort study from a randomized clinical trial.Cancer medicine · 2020Trial
- Lapatinib-Related Rash and Breast Cancer Outcome in the ALTTO Phase III Randomized Trial.Journal of the National Cancer Institute · 2016Trial
- A Pilot Study of Dose-Dense Paclitaxel With Trastuzumab and Lapatinib for Node-negative HER2-Overexpressed Breast Cancer.Clinical breast cancer · 2016Trial
- The involvement of hepatic cytochrome P450s in the cytotoxicity of lapatinib.Toxicological sciences : an official journal of the Society of Toxicology · 2023Article
- Role of ErbB1 in the Underlying Mechanism of Lapatinib-Induced Diarrhoea: A Review.BioMed research international · 2022Review
- The GLP-2 analogue elsiglutide reduces diarrhoea caused by the tyrosine kinase inhibitor lapatinib in rats.Cancer chemotherapy and pharmacology · 2020Article
- Lapatinib Activates the Kelch-Like ECH-Associated Protein 1-Nuclear Factor Erythroid 2-Related Factor 2 Pathway in HepG2 Cells.Frontiers in pharmacology · 2020Article
- Early Adverse Events predict Survival Outcomes in HER2-positive Advanced Breast Cancer Patients treated with Lapatinib plus Capecitabine.Journal of Cancer · 2020Article
- Interindividual Variation in CYP3A Activity Influences Lapatinib Bioactivation.Drug metabolism and disposition: the biological fate of chemicals · 2019Article
- Prophylaxis and Management of Skin Toxicities.Breast care (Basel, Switzerland) · 2019Review
- Dermatologic events from EGFR inhibitors: the issue of the missing patient voice.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Review
- Cytochrome P450 3A4 and CYP3A5-Catalyzed Bioactivation of Lapatinib.Drug metabolism and disposition: the biological fate of chemicals · 2016Article
- Neratinib in HER-2-positive breast cancer: results to date and clinical usefulness.Therapeutic advances in medical oncology · 2016Review
- Systemic targeted therapy for her2-positive early female breast cancer: a systematic review of the evidence for the 2014 Cancer Care Ontario systemic therapy guideline.Current oncology (Toronto, Ont.) · 2015Review
- Mechanism-based inactivation of CYP450 enzymes: a case study of lapatinib.Drug metabolism reviews · 2015Review
- Efficacy and Safety of HER2-Targeted Agents for Breast Cancer with HER2-Overexpression: A Network Meta-Analysis.PloS one · 2015Article
Corrections and comments
- Commented on by
- Commented on by
- Erratum issuedErrata.2018
- Erratum issued
Authors and funding
18 authors at 1 institution in 4 countries.
Funding
Abstract
purposeWe 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
methodsPatients 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.
resultsOnly 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.
conclusionOur results indicate that the frequency and clinical relevance of lapatinib-related rash is largely dependent on patient age.
Indexed as
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.