A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer

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. Two cohorts were enrolled: cohort 1 had received no prior chemotherapy or trastuzumab for metastatic...

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Veröffentlicht in:Annals of oncology 2013-07, Vol.24 (7), p.1841-1847
Hauptverfasser: Tolaney, S.M., Najita, J., Sperinde, J., Huang, W., Chen, W.Y., Savoie, J., Fornier, M., Winer, E.P., Bunnell, C., Krop, I.E.
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Sprache:eng
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Zusammenfassung: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. 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. 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%. Treatment-related toxic effects included neuropathy (grade ≥2, 56%), leukopenia (grade ≥2, 26%), myalgias (grade ≥2, 21%), neutropenia (grade ≥2, 23%), and anemia (grade ≥2, 18%). 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.
ISSN:0923-7534
1569-8041
DOI:10.1093/annonc/mdt121