TY - JOUR
T1 - Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy
AU - Roché, Henri
AU - Yelle, Louise
AU - Cognetti, Francesco
AU - Mauriac, Louis
AU - Bunnell, Craig
AU - Sparano, Joseph
AU - Kerbrat, Pierre
AU - Delord, Jean Pierre
AU - Vahdat, Linda
AU - Peck, Ronald
AU - Lebwohl, David
AU - Ezzeddine, Rana
AU - Curé, Hervé
PY - 2007/8/10
Y1 - 2007/8/10
N2 - Purpose: There is a need for new agents to treat metastatic breast cancer (MBC) in patients for whom anthracycline therapy has failed or is contraindicated. This study was conducted to assess the efficacy and safety of the novel antineoplastic, the epothilone B analog ixabepilone, in patients with MBC previously treated with an adjuvant anthracycline. Patients and Methods: Patients were age ≥ 18 years and had received a prior anthracycline-based regimen as adjuvant treatment. Ixabepilone as first-line metastatic chemotherapy was administered as a 40 mg/m2 intravenous infusion during 3 hours every 3 weeks. The primary efficacy end point was objective response rate (ORR). Secondary efficacy end points included duration of response, time to response, time to progression, and survival. Results: All 65 patients were assessable for response. Their median age was 52 years (range, 33 to 80 years). ORR was 41.5% (95% CI, 29.4% to 54.4%), median duration of response was 8.2 months (95% CI, 5.7 to 10.2 months), and median time to response was 6 weeks (range, 5 to 17 weeks). Median survival was 22.0 months (95% CI, 15.6 to 27.0 months). Treatment-related adverse events were manageable and mostly grades 1/2: the most common of these (other than alopecia) was mild to moderate neuropathy, which was primarily sensory and mostly reversible in nature. Conclusion: Ixabepilone is efficacious and has a predictable and manageable safety profile in women with MBC previously treated with an adjuvant anthracycline.
AB - Purpose: There is a need for new agents to treat metastatic breast cancer (MBC) in patients for whom anthracycline therapy has failed or is contraindicated. This study was conducted to assess the efficacy and safety of the novel antineoplastic, the epothilone B analog ixabepilone, in patients with MBC previously treated with an adjuvant anthracycline. Patients and Methods: Patients were age ≥ 18 years and had received a prior anthracycline-based regimen as adjuvant treatment. Ixabepilone as first-line metastatic chemotherapy was administered as a 40 mg/m2 intravenous infusion during 3 hours every 3 weeks. The primary efficacy end point was objective response rate (ORR). Secondary efficacy end points included duration of response, time to response, time to progression, and survival. Results: All 65 patients were assessable for response. Their median age was 52 years (range, 33 to 80 years). ORR was 41.5% (95% CI, 29.4% to 54.4%), median duration of response was 8.2 months (95% CI, 5.7 to 10.2 months), and median time to response was 6 weeks (range, 5 to 17 weeks). Median survival was 22.0 months (95% CI, 15.6 to 27.0 months). Treatment-related adverse events were manageable and mostly grades 1/2: the most common of these (other than alopecia) was mild to moderate neuropathy, which was primarily sensory and mostly reversible in nature. Conclusion: Ixabepilone is efficacious and has a predictable and manageable safety profile in women with MBC previously treated with an adjuvant anthracycline.
UR - http://www.scopus.com/inward/record.url?scp=34548179878&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34548179878&partnerID=8YFLogxK
U2 - 10.1200/JCO.2006.09.7535
DO - 10.1200/JCO.2006.09.7535
M3 - Article
C2 - 17606972
AN - SCOPUS:34548179878
SN - 0732-183X
VL - 25
SP - 3415
EP - 3420
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 23
ER -