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Sub-category:
New Systemic Agents---Cytotoxics
Category:
Treatment
Meeting:
2007 Breast Cancer Symposium
Session Type and Session Title:
General Poster Session B
Abstract No:
152
Author(s):
S. L. Moulder, M. Wang, W. Gradishar, E. A. Perez, J. Sparano, M. Pins, G. Sledge, Eastern Cooperative Oncology Group
Abstract:
Background: Ixabepilone (I) binds to beta tubulin and shows activity in paclitaxel resistant cell lines and patients with taxane- refractory MBC. The addition of trastuzumab (T) and carboplatin (C) improves efficacy of paclitaxel in patients with HER2+ MBC. Methods: Patients with HER2+ (3+ by IHC or FISH amplified) MBC, no prior chemotherapy regimens for MBC, ECOG PS of 0-1 and LVEF > 50%, were treated with I (15mg/m2 IV) and C (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. T was administered weekly (4mg/kg loading dose then 2mg/kg IV) during chemotherapy then Q 3 weeks (6mg/kg IV) until disease progression. Response was measured using RECIST criteria every 3 months. Results: 59 eligible patients were enrolled, median age=50 (24-81) and 54% were ER-. Of the 57 patients evaluated for response, 2 had CR (3.5%, 95% CI=0.5-12.1%), 22 had PR (38.6%, 95% CI=26-52.5%) and 13 had stable disease > 6 months (22.8%, 95% CI=12.7-35.8%). Median PFS was 8 months (95% CI=6.0-9.7). Common toxicity (grade 3 or 4) included: anemia (7%, 5%), neutropenia (29%, 19%), thrombocytopenia (12%, 2%), non-neutropenic infection (3%, 0), fatigue (12%, 0), nausea (7%, 0), neuropathy (7%, 0). One patient died of therapy related complications during cycle 1 of treatment (74YO with diarrhea, neutropenia and sepsis). This was the only case of fever/infection with neutropenia reported. The median number of cycles administered was 6 (range 1-22). Common reasons for discontinuation were progression of disease (65%) and toxicity (12%). Conclusions: TIC is an active regimen with an acceptable toxicity profile for the treatment of patients with HER2+ MBC.
 Associated Presentation(s):
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1. A Phase II Trial of Trastuzumab, Weekly Ixabepilone (BMS-247550) and Carboplatin (TIC) in Patients with HER2/Neu-Positive (HER2+) Metastatic Breast Cancer (MBC): A Trial Coordinated by the Eastern Cooperative Oncology Group (E2103)
Meeting:
2007 Breast Cancer Symposium
Presenter:
Stacy L Moulder
Session:
General Poster Session B
(General Poster Session)
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Other Abstracts in this Sub-Category:
Abstracts by S. L. Moulder:
Presentations by S. L. Moulder:
Educational Book Manuscripts by S. L. Moulder:
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