Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non-small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy

Johan Vansteenkiste, Primo N. Lara, Thierry Le Chevalier, Jean Luc Breton, Philip Bonomi, Alan B. Sandler, Mark A. Socinski, Catherine Delbaldo, Brent McHenry, David Lebwohl, Ronald Peck, Mark Edelman

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Abstract

Purpose: Ixabepilone is the first in a new class of antineoplastic agents, the epothilones and their analogs. This international, randomized, phase II trial assessed two administration schedules of ixabepilone as second-line therapy in patients with non-small-cell lung cancer (NSCLC). Patients and Methods: Patients had experienced disease progression after one prior cisplatin- or carboplatin-based chemotherapy regimen. Ixabepilone was administered as a single 32 mg/m2 3-hour infusion (77 patients; arm A) or a 6 mg/m 2 1-hour infusion daily for 5 consecutive days (69 patients; arm B) in a 3-week cycle. Results: The intent-to-treat objective response rate was 14.3% in arm A and 11.6% in arm B. Median duration of response was 8.7 months (95% CI, 5.3 to 9.5 months) in arm A and 9.6 months (95% CI, 6.1 to 19.7 months) in arm B. Median time to progression was 2.1 months (95% CI, 1.4 to 2.8 months) for arm A and 1.5 months (95% CI, 1.4 to 2.8 months) for arm B. Median survival was 8.3 months (95% CI, 5.8 to 11.5 months) for arm A, and 7.3 months (95% CI, 5.7 to 11.7 months) for arm B; the 1-year survival rate (both cohorts) was 38%. Responses occurred in patients with taxane-pretreated and platinum-refractory tumors. Both regimens had an acceptable toxicity profile. Myelosuppression was manageable, manifesting primarily as neutropenia and leukopenia. Neuropathy was primarily sensory, generally mild to moderate in severity, and mostly reversible (both regimens). Conclusion: Single-agent ixabepilone had clinically relevant activity and an acceptable safety profile in patients with advanced NSCLC whose tumors had failed one prior platinum-based chemotherapy regimen.

Original languageEnglish (US)
Pages (from-to)3448-3455
Number of pages8
JournalJournal of Clinical Oncology
Volume25
Issue number23
DOIs
StatePublished - Aug 10 2007

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Phase II Clinical Trials
Platinum
Non-Small Cell Lung Carcinoma
Drug Therapy
Neoplasms
Epothilones
Carboplatin
Leukopenia
epothilone B
ixabepilone
Neutropenia
Antineoplastic Agents
Cisplatin
Disease Progression
Appointments and Schedules
Survival Rate
Safety
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non-small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy. / Vansteenkiste, Johan; Lara, Primo N.; Le Chevalier, Thierry; Breton, Jean Luc; Bonomi, Philip; Sandler, Alan B.; Socinski, Mark A.; Delbaldo, Catherine; McHenry, Brent; Lebwohl, David; Peck, Ronald; Edelman, Mark.

In: Journal of Clinical Oncology, Vol. 25, No. 23, 10.08.2007, p. 3448-3455.

Research output: Contribution to journalArticle

Vansteenkiste, J, Lara, PN, Le Chevalier, T, Breton, JL, Bonomi, P, Sandler, AB, Socinski, MA, Delbaldo, C, McHenry, B, Lebwohl, D, Peck, R & Edelman, M 2007, 'Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non-small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy', Journal of Clinical Oncology, vol. 25, no. 23, pp. 3448-3455. https://doi.org/10.1200/JCO.2006.09.7097
Vansteenkiste, Johan ; Lara, Primo N. ; Le Chevalier, Thierry ; Breton, Jean Luc ; Bonomi, Philip ; Sandler, Alan B. ; Socinski, Mark A. ; Delbaldo, Catherine ; McHenry, Brent ; Lebwohl, David ; Peck, Ronald ; Edelman, Mark. / Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non-small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 23. pp. 3448-3455.
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abstract = "Purpose: Ixabepilone is the first in a new class of antineoplastic agents, the epothilones and their analogs. This international, randomized, phase II trial assessed two administration schedules of ixabepilone as second-line therapy in patients with non-small-cell lung cancer (NSCLC). Patients and Methods: Patients had experienced disease progression after one prior cisplatin- or carboplatin-based chemotherapy regimen. Ixabepilone was administered as a single 32 mg/m2 3-hour infusion (77 patients; arm A) or a 6 mg/m 2 1-hour infusion daily for 5 consecutive days (69 patients; arm B) in a 3-week cycle. Results: The intent-to-treat objective response rate was 14.3{\%} in arm A and 11.6{\%} in arm B. Median duration of response was 8.7 months (95{\%} CI, 5.3 to 9.5 months) in arm A and 9.6 months (95{\%} CI, 6.1 to 19.7 months) in arm B. Median time to progression was 2.1 months (95{\%} CI, 1.4 to 2.8 months) for arm A and 1.5 months (95{\%} CI, 1.4 to 2.8 months) for arm B. Median survival was 8.3 months (95{\%} CI, 5.8 to 11.5 months) for arm A, and 7.3 months (95{\%} CI, 5.7 to 11.7 months) for arm B; the 1-year survival rate (both cohorts) was 38{\%}. Responses occurred in patients with taxane-pretreated and platinum-refractory tumors. Both regimens had an acceptable toxicity profile. Myelosuppression was manageable, manifesting primarily as neutropenia and leukopenia. Neuropathy was primarily sensory, generally mild to moderate in severity, and mostly reversible (both regimens). Conclusion: Single-agent ixabepilone had clinically relevant activity and an acceptable safety profile in patients with advanced NSCLC whose tumors had failed one prior platinum-based chemotherapy regimen.",
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T1 - Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non-small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy

AU - Vansteenkiste, Johan

AU - Lara, Primo N.

AU - Le Chevalier, Thierry

AU - Breton, Jean Luc

AU - Bonomi, Philip

AU - Sandler, Alan B.

AU - Socinski, Mark A.

AU - Delbaldo, Catherine

AU - McHenry, Brent

AU - Lebwohl, David

AU - Peck, Ronald

AU - Edelman, Mark

PY - 2007/8/10

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N2 - Purpose: Ixabepilone is the first in a new class of antineoplastic agents, the epothilones and their analogs. This international, randomized, phase II trial assessed two administration schedules of ixabepilone as second-line therapy in patients with non-small-cell lung cancer (NSCLC). Patients and Methods: Patients had experienced disease progression after one prior cisplatin- or carboplatin-based chemotherapy regimen. Ixabepilone was administered as a single 32 mg/m2 3-hour infusion (77 patients; arm A) or a 6 mg/m 2 1-hour infusion daily for 5 consecutive days (69 patients; arm B) in a 3-week cycle. Results: The intent-to-treat objective response rate was 14.3% in arm A and 11.6% in arm B. Median duration of response was 8.7 months (95% CI, 5.3 to 9.5 months) in arm A and 9.6 months (95% CI, 6.1 to 19.7 months) in arm B. Median time to progression was 2.1 months (95% CI, 1.4 to 2.8 months) for arm A and 1.5 months (95% CI, 1.4 to 2.8 months) for arm B. Median survival was 8.3 months (95% CI, 5.8 to 11.5 months) for arm A, and 7.3 months (95% CI, 5.7 to 11.7 months) for arm B; the 1-year survival rate (both cohorts) was 38%. Responses occurred in patients with taxane-pretreated and platinum-refractory tumors. Both regimens had an acceptable toxicity profile. Myelosuppression was manageable, manifesting primarily as neutropenia and leukopenia. Neuropathy was primarily sensory, generally mild to moderate in severity, and mostly reversible (both regimens). Conclusion: Single-agent ixabepilone had clinically relevant activity and an acceptable safety profile in patients with advanced NSCLC whose tumors had failed one prior platinum-based chemotherapy regimen.

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