A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer Journal Article
| Authors: | Tolaney Dr, S. M.; Najita, J.; Sperinde, J.; Huang, W.; Chen, W. Y.; Savoie, J.; Fornier, M.; Winer, E. P.; Bunnell, C.; Krop, I. E. |
| Article Title: | A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer |
| Abstract: | Background: A multicenter NCI-sponsored phase II study was conducted to analyze the safety and efficacy of the combination of ixabepilone with trastuzumab in patients with metastatic HER2-positive breast cancer. Patients and methods: Two cohorts were enrolled: cohort 1 had received no prior chemotherapy or trastuzumab for metastatic disease and cohort 2 had received 1-2 prior trastuzumab-containing regimens for metastatic disease. Patients in both cohorts received ixabepilone 40 mg/m2 as a 3-h infusion and trastuzumab on day 1 of a 21-day cycle. Tumor biomarkers that may predict response to trastuzumab were explored. Results: Thirty-nine women entered the study with 15 patients in cohort 1 and 24 patients in cohort 2. Across both cohorts, the overall RR was 44%, with a clinical benefit rate (CR + PR + SD for at least 24 weeks) of 56%. Treatmentrelated toxic effects included neuropathy (grade >2, 56%), leukopenia (grade >2, 26%), myalgias (grade >2, 21%), neutropenia (grade >2, 23%), and anemia (grade >2, 18%). Conclusions: This represents the first study of the combination of ixabepilone with trastuzumab for the treatment of metastatic HER2-positive breast cancer. These results suggest that the combination has encouraging activity as first and subsequent line therapy for metastatic breast cancer. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. |
| Keywords: | adult; clinical article; controlled study; protein expression; aged; unclassified drug; constipation; drug tolerability; fatigue; neutropenia; cancer growth; diarrhea; drug dose reduction; drug efficacy; drug safety; side effect; cancer staging; anorexia; multiple cycle treatment; pain; phase 2 clinical trial; sensory neuropathy; anemia; breast; bleeding; leukopenia; nausea; stomatitis; thrombocytopenia; vomiting; myalgia; epidermal growth factor receptor 2; cohort analysis; weight reduction; bone pain; continuous infusion; tumor marker; abdominal pain; arthralgia; backache; chill; coughing; dizziness; dyspnea; febrile neutropenia; fever; hyperglycemia; nail disease; rash; hypoalbuminemia; hypokalemia; hyponatremia; insomnia; rigor; multicenter study; cardiotoxicity; drug response; peripheral edema; flu like syndrome; headache; hot flush; taxane derivative; estrogen receptor; progesterone receptor; trastuzumab; breast metastasis; dyspepsia; alopecia; allergic reaction; hematologic disease; her2; ixabepilone; hypernatremia; hypocalcemia; motor neuropathy; protein p95 |
| Journal Title: | Annals of Oncology |
| Volume: | 24 |
| Issue: | 7 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 2013-07-01 |
| Start Page: | 1841 |
| End Page: | 1847 |
| Language: | English |
| DOI: | 10.1093/annonc/mdt121 |
| PROVIDER: | scopus |
| PMCID: | PMC3690910 |
| PUBMED: | 23559151 |
| DOI/URL: | |
| Notes: | --- - Cited By (since 1996):1 - "Export Date: 1 October 2013" - "Art. No.: mdt121" - "CODEN: ANONE" - "Source: Scopus" |
