Phase II genomics study in patients receiving ixabepilone as neoadjuvant treatment for breast cancer (BC): Preliminary efficacy and safety data
2005; Lippincott Williams & Wilkins; Volume: 23; Issue: 16_suppl Linguagem: Inglês
10.1200/jco.2005.23.16_suppl.586
ISSN1527-7755
AutoresAntonio Llombart‐Cussac, José Baselga, G. Manikhas, E. Kubista, Guenther G. Steger, Susan Galbraith, M A Sullivan, Kim E. Zerba, H. Lee, Lorenzo Gianni,
Tópico(s)Lung Cancer Treatments and Mutations
Resumo586 Background: Previous studies have confirmed the activity of ixabepilone (BMS-247550, a semi-synthetic analog of epothilone) in metastatic BC. The present study was designed to determine the pathological response obtained with ixabepilone as neoadjuvant therapy for BC and to obtain tumor samples for analysis of gene expression and identification of potential predictors of response to ixabepilone. Methods: Women with invasive stage IIA-IIIB breast cancer with tumors ≥3 cm diameter received 40 mg/m2 ixabepilone as a 3-hour infusion on Day 1 for up to four 21-day cycles, followed by surgery within 3–4 weeks of completion of chemotherapy. Biopsies for analysis of mRNA expression were obtained both pre- and post-therapy. Adjuvant chemotherapy with an anthracycline combination regimen followed by radiotherapy and tamoxifen were administered as indicated. Pathological response was assessed using the Sataloff criteria. Results: A total of 164 patients were enrolled. Data were available for 47 patients for this preliminary report. Median age was 57 years (range 27–77) and 100% were ECOG 0. Median tumor diameter was 4 cm (range 3–10), Grade 1/2/3/unk was 6%/47%/23%/23% and ER status of +/-/unk was 49%/47%/4%. A complete pathological response (pCR) in the breast was achieved in 10 patients (21%), of whom 8 (17%) also had pCR in the axillary lymph nodes. Grade 3/4 neutropenia occurred in 21%/13%. Common grade 2/3 toxicities on-treatment included arthralgia/myalgia (28%/6%), neuropathy (11%/2%), and mucositis (6%/2%). Conclusions: Based on this early analysis, ixabepilone has manageable toxicity and a pCR rate which compares favorably to that reported for studies of single agent taxanes (ranging from 3–20%). This analysis will be updated at the ASCO annual meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb
Referência(s)