Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008
Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. 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 161 papers, 10 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
161 citing papers in PubMed, 10 syntheses or guidelines pooled it, 420 citations in OpenAlex.
- Clinical data mining reveals analgesic effects of lapatinib in cancer patients.Scientific reports · 2021Pooled it
- Quality of adverse event reporting in phase III randomized controlled trials of breast and colorectal cancer: A systematic review.Cancer medicine · 2020Pooled it
- Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology: A Systematic Review and Quantitative Analysis.JAMA internal medicine · 2018Pooled it
- Meta-analysis of cardiovascular toxicity risks in cancer patients on selected targeted agents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Pooled it
- Updated UK Recommendations for HER2 assessment in breast cancer.Journal of clinical pathology · 2015Guideline
- Surrogate endpoints in metastatic breast cancer treated with targeted therapies: an analysis of the first-line phase III trials.Medical oncology (Northwood, London, England) · 2014Pooled it
- Risk of oral and gastrointestinal mucosal injury among patients receiving selected targeted agents: a meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013Pooled it
- A literature-based meta-analysis taxane-based doublet versus single-agent taxane chemotherapy in patients with advanced breast cancer.Journal of cancer research and clinical oncology · 2011Pooled it
- Breast cancer (metastatic).BMJ clinical evidence · 2010Pooled it
- Cost effectiveness of cytotoxic and targeted therapy for metastatic breast cancer: a critical and systematic review.PharmacoEconomics · 2010Pooled it
- Pan-Cancer Landscape and Analysis of ERBB2 Mutations Identifies Poziotinib as a Clinically Active Inhibitor and Enhancer of T-DM1 Activity.Cancer cell · 2019Trial
- A Phase I/IIa Study of DHP107, a Novel Oral Paclitaxel Formulation, in Patients with Advanced Solid Tumors or Gastric Cancer.The oncologist · 2017Trial
- Lapatinib-Related Rash and Breast Cancer Outcome in the ALTTO Phase III Randomized Trial.Journal of the National Cancer Institute · 2016Trial
- Dermatologic Adverse Events Associated With Use of Adjuvant Lapatinib in Combination With Paclitaxel and Trastuzumab for HER2-Positive Breast Cancer: A Case Series Analysis.Clinical breast cancer · 2016Trial
- A Pilot Study of Dose-Dense Paclitaxel With Trastuzumab and Lapatinib for Node-negative HER2-Overexpressed Breast Cancer.Clinical breast cancer · 2016Trial
- Safety, pharmacokinetics and efficacy findings in an open-label, single-arm study of weekly paclitaxel plus lapatinib as first-line therapy for Japanese women with HER2-positive metastatic breast cancer.International journal of clinical oncology · 2015Trial
- The efficacy of Pistacia Terebinthus soap in the treatment of cetuximab-induced skin toxicity.Investigational new drugs · 2014Trial
- Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial.British journal of cancer · 2014Trial
- An open-label safety study of lapatinib plus trastuzumab plus paclitaxel in first-line HER2-positive metastatic breast cancer.The oncologist · 2013Trial
- Combination neratinib (HKI-272) and paclitaxel therapy in patients with HER2-positive metastatic breast cancer.British journal of cancer · 2013Trial
101 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
14 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeLapatinib, a dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR/ErbB1) and human epidermal growth factor receptor 2 (HER-2/ErbB2), is effective against HER-2-positive locally advanced or metastatic breast cancer (MBC). This phase III trial evaluated the efficacy of lapatinib in HER-2-negative and HER-2-uncharacterized MBC. PATIENTS AND
methodsWomen with MBC were randomly assigned to first-line therapy with paclitaxel 175 mg/m(2) every 3 weeks plus lapatinib 1,500 mg/d or placebo. A preplanned retrospective evaluation of HER-2 status was performed using fluorescence in situ hybridization and immunohistochemistry. The primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), clinical benefit rate (CBR), event-free survival (EFS), and overall survival (OS).
resultsIn the intent-to-treat population (n = 579), there were no significant differences in TTP, EFS, or OS between treatment arms, although differences in ORR and CBR were noted. In 86 HER-2-positive patients (15%), treatment with paclitaxel-lapatinib resulted in statistically significant improvements in TTP, EFS, ORR, and CBR compared with paclitaxel-placebo. No differences between treatment groups were observed for any end point in HER-2-negative patients. The most common adverse events were alopecia, rash, and diarrhea. The incidence of diarrhea and rash was significantly higher in the paclitaxel-lapatinib arm. The rate of cardiac events was low, and no difference was observed between treatment arms.
conclusionPatients with HER-2-negative or HER-2-untested MBC did not benefit from the addition of lapatinib to paclitaxel. However, first-line therapy with paclitaxel-lapatinib significantly improved clinical outcomes in HER-2-positive patients. Prospective evaluation of the efficacy and safety of this combination is ongoing in early and metastatic HER-2-positive breast cancer patients.
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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.