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A phase II study of eribulin mesylate (E7389) in patients with advanced, previously treated non-small-cell lung
Alexander I Spira1, Nicholas O Iannotti, Michael A Savin
1Virginia Cancer Specialists, INOVA Thoracic Oncology Program, Fairfax, VA 22031, USA. Alexander.Spira@USOncology.com
Introduction:
This open-label phase II study assessed the efficacy and tolerability of eribulin, a non-taxane microtubule dynamics inhibitor with novel mechanism of action, as monotherapy in patients who have advanced non-small-cell lung cancer (NSCLC).
Patients And Methods:
Enrolled patients had progressed during or after platinum-based doublet chemotherapy. Initially, two patient cohorts (taxane-pre-treated and taxane-naïve) received eribulin mesylate (1.4 mg/m(2)) as a 2- to 5-minute intravenous infusion on days 1, 8, and 15 of a 28-day cycle. To assess tolerability of a second dosing schedule, a cohort of taxane-pre-treated patients received eribulin on days 1 and 8 of a 21-day cycle. The primary endpoint was objective response rate (ORR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) by independent radiographic review.
Results:
One hundred three patients received eribulin. The ORR was 9.7% (all partial responses [PR]). Overall disease control rate (PR + stable disease) was 55.3%. Median duration of response, progression-free survival, and overall survival were 5.8, 3.4, and 9.4 months, respectively. The most common drug-related adverse events were neutropenia (54%; 49% grade 3/4); fatigue (49%; 11% grade 3, no grade 4); nausea (38%; 1% grade 3, no grade 4); alopecia (32%); anemia (29%, 4% grade 3/4) and neuropathy (23%; 2% grade 3, no grade 4). The 28-day schedule was associated with many dose delays, interruptions, or omissions due to neutropenia (day 15). The 21-day cycle was well-tolerated.
Conclusions:
Eribulin monotherapy administered on days 1 and 8 of a 21-day cycle is active and tolerated as second- or later-line chemotherapy for NSCLC.
Insights
Eribulin monotherapy shows activity in advanced non-small-cell lung cancer (NSCLC) patients. A 21-day dosing schedule was well-tolerated and effective in this patient population.
Area of Science:
- Oncology
- Pharmacology
Background:
- Eribulin is a non-taxane microtubule inhibitor with a novel mechanism of action.
- This study evaluated eribulin as monotherapy for advanced non-small-cell lung cancer (NSCLC).
Purpose of the Study:
- To assess the efficacy and tolerability of eribulin in patients with advanced NSCLC who progressed on or after platinum-based chemotherapy.
- To compare two different dosing schedules of eribulin mesylate.
Main Methods:
- An open-label phase II study enrolled 103 patients with advanced NSCLC.
- Patients received eribulin mesylate (1.4 mg/m(2)) on either a 28-day cycle (days 1, 8, 15) or a 21-day cycle (days 1, 8).
- Objective response rate (ORR) was the primary endpoint, assessed by RECIST criteria.
Main Results:
- The overall ORR was 9.7% (all partial responses).
- The disease control rate (ORR + stable disease) was 55.3%.
- Common adverse events included neutropenia, fatigue, nausea, alopecia, anemia, and neuropathy. The 21-day cycle was better tolerated.
Conclusions:
- Eribulin monotherapy is active and tolerated in NSCLC patients.
- The 21-day dosing schedule (days 1 and 8) is recommended for second- or later-line treatment of NSCLC.
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