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 language | English (US) |
|---|---|
| Pages (from-to) | 3448-3455 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 25 |
| Issue number | 23 |
| DOIs | |
| State | Published - Aug 10 2007 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
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 journal › Article
}
TY - JOUR
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
Y1 - 2007/8/10
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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=34548158974&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34548158974&partnerID=8YFLogxK
U2 - 10.1200/JCO.2006.09.7097
DO - 10.1200/JCO.2006.09.7097
M3 - Article
C2 - 17606973
AN - SCOPUS:34548158974
VL - 25
SP - 3448
EP - 3455
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 23
ER -