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

Henri Roché, Louise Yelle, Francesco Cognetti, Louis Mauriac, Craig Bunnell, Joseph A. Sparano, Pierre Kerbrat, Jean Pierre Delord, Linda Vahdat, Ronald Peck, David Lebwohl, Rana Ezzeddine, Hervé Curé

Research output: Contribution to journalArticle

197 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3415-3420
Number of pages6
JournalJournal of Clinical Oncology
Volume25
Issue number23
DOIs
StatePublished - Aug 10 2007
Externally publishedYes

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Phase II Clinical Trials
Anthracyclines
Breast Neoplasms
Drug Therapy
Reaction Time
Therapeutics
Safety
Survival
Alopecia
Intravenous Infusions
Antineoplastic Agents
ixabepilone
epothilone B

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Roché, Henri; Yelle, Louise; Cognetti, Francesco; Mauriac, Louis; Bunnell, Craig; Sparano, Joseph A.; Kerbrat, Pierre; Delord, Jean Pierre; Vahdat, Linda; Peck, Ronald; Lebwohl, David; Ezzeddine, Rana; Curé, Hervé.

In: Journal of Clinical Oncology, Vol. 25, No. 23, 10.08.2007, p. 3415-3420.

Research output: Contribution to journalArticle

Roché, H, Yelle, L, Cognetti, F, Mauriac, L, Bunnell, C, Sparano, JA, Kerbrat, P, Delord, JP, Vahdat, L, Peck, R, Lebwohl, D, Ezzeddine, R & Curé, H 2007, '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', Journal of Clinical Oncology, vol. 25, no. 23, pp. 3415-3420. https://doi.org/10.1200/JCO.2006.09.7535
Roché, Henri ; Yelle, Louise ; Cognetti, Francesco ; Mauriac, Louis ; Bunnell, Craig ; Sparano, Joseph A. ; Kerbrat, Pierre ; Delord, Jean Pierre ; Vahdat, Linda ; Peck, Ronald ; Lebwohl, David ; Ezzeddine, Rana ; Curé, Hervé. / 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. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 23. pp. 3415-3420.
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abstract = "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.",
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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 A.

AU - Kerbrat, Pierre

AU - Delord, Jean Pierre

AU - Vahdat, Linda

AU - Peck, Ronald

AU - Lebwohl, David

AU - Ezzeddine, Rana

AU - Curé, Hervé

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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.

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