A phase II study of halichondrin B analog eribulin mesylate (E7389) in patients with advanced non-small cell lung cancer previously treated with a taxane: A California cancer consortium trial

Barbara J. Gitlitz, Denice D. Tsao-Wei, Susan Groshen, Angela Davies, Marianna Koczywas, Chandra P. Belani, Athanassios Argiris, Suresh Ramalingam, Everett E. Vokes, Martin Edelman, Philip Hoffman, Marc S. Ballas, Stephen V. Liu, David R. Gandara

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Abstract

Eribulin mesylate (E7389) is an analog of halichondrin B with a unique mechanism of microtubule binding. The activity and toxicity of eribulin were assessed in patients with advanced non-small cell lung cancer (NSCLC) previously treated with a taxane. Methods: An open-label phase II study included patients with NSCLC previously treated with platinum and taxane-based therapy, with up to two prior cytotoxic regimens, given for metastatic disease or as adjuvant therapy. Patients were stratified by taxane-sensitivity: taxane-sensitive (TS, progression >90 days after taxane) or taxane-resistant (TR, progression ≤90 days after taxane). Patients received an intravenous infusion of eribulin at 1.4 mg/m2 on days 1 and 8 every 21 days. The primary end point was objective response rate and secondary end points included progression-free survival and overall survival. Results: Sixty-six patients were accrued. The objective response rate was 5% with a median duration of response of 7.8 months. In the TS arm, 3 of 45 patients (7%) achieved a partial response and another 11 of 45 (24%) achieved stable disease for at least 3 months, whereas in the TR arm, no patients achieved a partial response and 4 of 21 (19%) achieved stable disease for at least 3 months. Median progression-free survival was 2.9 months in the TS subgroup and 1.2 months in the TR subgroup. The median overall survival was 12.6 months in the TS subgroup and 8.9 months in the TR subgroup. Toxicities were primarily hematologic; only two patients developed grade 3 neuropathy. Conclusions: Eribulin mesylate is well tolerated and demonstrates activity in pretreated, TS NSCLC.

Original languageEnglish (US)
Pages (from-to)574-578
Number of pages5
JournalJournal of Thoracic Oncology
Volume7
Issue number3
DOIs
StatePublished - Mar 2012

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eribulin
Non-Small Cell Lung Carcinoma
Neoplasms
Disease-Free Survival
Survival
taxane
halichondrin B
Platinum
Intravenous Infusions
Microtubules

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Gitlitz, Barbara J. ; Tsao-Wei, Denice D. ; Groshen, Susan ; Davies, Angela ; Koczywas, Marianna ; Belani, Chandra P. ; Argiris, Athanassios ; Ramalingam, Suresh ; Vokes, Everett E. ; Edelman, Martin ; Hoffman, Philip ; Ballas, Marc S. ; Liu, Stephen V. ; Gandara, David R. / A phase II study of halichondrin B analog eribulin mesylate (E7389) in patients with advanced non-small cell lung cancer previously treated with a taxane : A California cancer consortium trial. In: Journal of Thoracic Oncology. 2012 ; Vol. 7, No. 3. pp. 574-578.
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title = "A phase II study of halichondrin B analog eribulin mesylate (E7389) in patients with advanced non-small cell lung cancer previously treated with a taxane: A California cancer consortium trial",
abstract = "Eribulin mesylate (E7389) is an analog of halichondrin B with a unique mechanism of microtubule binding. The activity and toxicity of eribulin were assessed in patients with advanced non-small cell lung cancer (NSCLC) previously treated with a taxane. Methods: An open-label phase II study included patients with NSCLC previously treated with platinum and taxane-based therapy, with up to two prior cytotoxic regimens, given for metastatic disease or as adjuvant therapy. Patients were stratified by taxane-sensitivity: taxane-sensitive (TS, progression >90 days after taxane) or taxane-resistant (TR, progression ≤90 days after taxane). Patients received an intravenous infusion of eribulin at 1.4 mg/m2 on days 1 and 8 every 21 days. The primary end point was objective response rate and secondary end points included progression-free survival and overall survival. Results: Sixty-six patients were accrued. The objective response rate was 5{\%} with a median duration of response of 7.8 months. In the TS arm, 3 of 45 patients (7{\%}) achieved a partial response and another 11 of 45 (24{\%}) achieved stable disease for at least 3 months, whereas in the TR arm, no patients achieved a partial response and 4 of 21 (19{\%}) achieved stable disease for at least 3 months. Median progression-free survival was 2.9 months in the TS subgroup and 1.2 months in the TR subgroup. The median overall survival was 12.6 months in the TS subgroup and 8.9 months in the TR subgroup. Toxicities were primarily hematologic; only two patients developed grade 3 neuropathy. Conclusions: Eribulin mesylate is well tolerated and demonstrates activity in pretreated, TS NSCLC.",
author = "Gitlitz, {Barbara J.} and Tsao-Wei, {Denice D.} and Susan Groshen and Angela Davies and Marianna Koczywas and Belani, {Chandra P.} and Athanassios Argiris and Suresh Ramalingam and Vokes, {Everett E.} and Martin Edelman and Philip Hoffman and Ballas, {Marc S.} and Liu, {Stephen V.} and Gandara, {David R.}",
year = "2012",
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Gitlitz, BJ, Tsao-Wei, DD, Groshen, S, Davies, A, Koczywas, M, Belani, CP, Argiris, A, Ramalingam, S, Vokes, EE, Edelman, M, Hoffman, P, Ballas, MS, Liu, SV & Gandara, DR 2012, 'A phase II study of halichondrin B analog eribulin mesylate (E7389) in patients with advanced non-small cell lung cancer previously treated with a taxane: A California cancer consortium trial', Journal of Thoracic Oncology, vol. 7, no. 3, pp. 574-578. https://doi.org/10.1097/JTO.0b013e31823f43ca

A phase II study of halichondrin B analog eribulin mesylate (E7389) in patients with advanced non-small cell lung cancer previously treated with a taxane : A California cancer consortium trial. / Gitlitz, Barbara J.; Tsao-Wei, Denice D.; Groshen, Susan; Davies, Angela; Koczywas, Marianna; Belani, Chandra P.; Argiris, Athanassios; Ramalingam, Suresh; Vokes, Everett E.; Edelman, Martin; Hoffman, Philip; Ballas, Marc S.; Liu, Stephen V.; Gandara, David R.

In: Journal of Thoracic Oncology, Vol. 7, No. 3, 03.2012, p. 574-578.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase II study of halichondrin B analog eribulin mesylate (E7389) in patients with advanced non-small cell lung cancer previously treated with a taxane

T2 - A California cancer consortium trial

AU - Gitlitz, Barbara J.

AU - Tsao-Wei, Denice D.

AU - Groshen, Susan

AU - Davies, Angela

AU - Koczywas, Marianna

AU - Belani, Chandra P.

AU - Argiris, Athanassios

AU - Ramalingam, Suresh

AU - Vokes, Everett E.

AU - Edelman, Martin

AU - Hoffman, Philip

AU - Ballas, Marc S.

AU - Liu, Stephen V.

AU - Gandara, David R.

PY - 2012/3

Y1 - 2012/3

N2 - Eribulin mesylate (E7389) is an analog of halichondrin B with a unique mechanism of microtubule binding. The activity and toxicity of eribulin were assessed in patients with advanced non-small cell lung cancer (NSCLC) previously treated with a taxane. Methods: An open-label phase II study included patients with NSCLC previously treated with platinum and taxane-based therapy, with up to two prior cytotoxic regimens, given for metastatic disease or as adjuvant therapy. Patients were stratified by taxane-sensitivity: taxane-sensitive (TS, progression >90 days after taxane) or taxane-resistant (TR, progression ≤90 days after taxane). Patients received an intravenous infusion of eribulin at 1.4 mg/m2 on days 1 and 8 every 21 days. The primary end point was objective response rate and secondary end points included progression-free survival and overall survival. Results: Sixty-six patients were accrued. The objective response rate was 5% with a median duration of response of 7.8 months. In the TS arm, 3 of 45 patients (7%) achieved a partial response and another 11 of 45 (24%) achieved stable disease for at least 3 months, whereas in the TR arm, no patients achieved a partial response and 4 of 21 (19%) achieved stable disease for at least 3 months. Median progression-free survival was 2.9 months in the TS subgroup and 1.2 months in the TR subgroup. The median overall survival was 12.6 months in the TS subgroup and 8.9 months in the TR subgroup. Toxicities were primarily hematologic; only two patients developed grade 3 neuropathy. Conclusions: Eribulin mesylate is well tolerated and demonstrates activity in pretreated, TS NSCLC.

AB - Eribulin mesylate (E7389) is an analog of halichondrin B with a unique mechanism of microtubule binding. The activity and toxicity of eribulin were assessed in patients with advanced non-small cell lung cancer (NSCLC) previously treated with a taxane. Methods: An open-label phase II study included patients with NSCLC previously treated with platinum and taxane-based therapy, with up to two prior cytotoxic regimens, given for metastatic disease or as adjuvant therapy. Patients were stratified by taxane-sensitivity: taxane-sensitive (TS, progression >90 days after taxane) or taxane-resistant (TR, progression ≤90 days after taxane). Patients received an intravenous infusion of eribulin at 1.4 mg/m2 on days 1 and 8 every 21 days. The primary end point was objective response rate and secondary end points included progression-free survival and overall survival. Results: Sixty-six patients were accrued. The objective response rate was 5% with a median duration of response of 7.8 months. In the TS arm, 3 of 45 patients (7%) achieved a partial response and another 11 of 45 (24%) achieved stable disease for at least 3 months, whereas in the TR arm, no patients achieved a partial response and 4 of 21 (19%) achieved stable disease for at least 3 months. Median progression-free survival was 2.9 months in the TS subgroup and 1.2 months in the TR subgroup. The median overall survival was 12.6 months in the TS subgroup and 8.9 months in the TR subgroup. Toxicities were primarily hematologic; only two patients developed grade 3 neuropathy. Conclusions: Eribulin mesylate is well tolerated and demonstrates activity in pretreated, TS NSCLC.

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