Ixabepilone alone or with cetuximab as first-line treatment for advanced/metastatic triple-negative breast cancer
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
25218708
DOI
10.1016/j.clbc.2014.07.007
PII: S1526-8209(14)00162-1
Knihovny.cz E-resources
- Keywords
- Cetuximab, EGFR, Ixabepilone, Metastatic breast cancer, Triple negative,
- MeSH
- Adenocarcinoma drug therapy pathology MeSH
- Cetuximab MeSH
- Adult MeSH
- Epothilones administration & dosage adverse effects MeSH
- Antibodies, Monoclonal, Humanized administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Metastasis MeSH
- Neoadjuvant Therapy MeSH
- Disease-Free Survival MeSH
- Disease Progression MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Aged MeSH
- Triple Negative Breast Neoplasms drug therapy pathology MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Cetuximab MeSH
- Epothilones MeSH
- Antibodies, Monoclonal, Humanized MeSH
- ixabepilone MeSH Browser
BACKGROUND: Despite high initial sensitivity to chemotherapy, TNBC is associated with a poor prognosis, highlighting the need for novel therapeutic strategies. The aim of this multicenter, randomized, open-label phase II trial was to assess the efficacy of ixabepilone as monotherapy, and the combination of ixabepilone with cetuximab, as first-line treatment in patients with triple-negative locally advanced nonresectable and/or metastatic breast cancer. PATIENTS AND METHODS: Women were randomly assigned to receive either ixabepilone (40 mg/m(2)) every 21 days (n = 40), or ixabepilone (40 mg/m(2)) every 21 days with cetuximab (400 mg/m(2) loading dose, followed by 250 mg/m(2)) once weekly (n = 39). The primary end point of the trial was to estimate the response rates of ixabepilone monotherapy and ixabepilone with cetuximab combination therapy. RESULTS: Of 79 randomized patients, 77 were treated. Based on an intent-to-treat analysis, an objective response rate of 30% (95% confidence interval [CI], 16.6-46.5) was observed in the monotherapy arm, and 35.9% (95% CI, 21.2-52.8) in the combination arm. Median progression-free survival was 4.1 months in both treatment groups. Safety findings were consistent with the known individual toxicity profiles of ixabepilone and cetuximab. Skin and subcutaneous tissue disorders were more common with combination therapy, as were discontinuations because of adverse events. CONCLUSION: Ixabepilone monotherapy and the ixabepilone and cetuximab combination demonstrated similar levels of clinical activity in first-line treatment of advanced TNBC, with a predictable safety profile. Further investigation of novel therapies for TNBC is required to improve patient outcomes.
Bristol Myers Squibb Rome Italy
Bristol Myers Squibb Wallingford CT
Centre Léon Bérard Centre de Recherche en Cancérologie de Lyon Lyon France
Clinique Armoricaine de Radiologie Saint Brieuc France
Crlcc G Francois Leclerc Dijon France
Hospital Clinic Barcelona Spain
Institut Claudius Regaud Toulouse France
Institut de Cancerologie de L Ouest Saint Herblain France
Istituto Nazionale Tumori Fondazione Pascale Napoli Italy
Klinika Onkologii 1 Radioterapii Uniwersyteckie Gdansk Poland
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