FDA Approves New Indication for Halaven Injection
February 9, 2016
Key clinical point: Eribulin is superior to dacarbazine in improving outcomes in advanced liposarcoma.
Major finding: Overall survival with eribulin was 15.6 months versus 8.4 months with dacarbazine (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P less than .001).
Data source: Phase 3 randomized, prospective clinical trial that included 452 patients with advanced liposarcoma.
Disclosures: The study was supported by Eisai. Dr. Demetri and several of the coauthors report relationships with industry including Eisai.
In patients with advanced liposarcoma, eribulin was superior to dacarbazine in improving both overall and progression-free survival, investigators report.
In a phase 3 trial that included 452 patients with advanced liposarcoma (LPS), those treated with eribulin had an overall survival of 15.6 months, compared with 8.4 months with dacarbazine (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P less than .001).
Longer overall survival was also seen in all histologic subtypes of LPS and in all geographic regions included in the study.
Median progression-free survival was significantly longer among patients in the eribulin arm, compared with those who received dacarbazine, at 2.9 versus 1.7 months (HR, 0.521; 95% CI, 0.35 to 0.78; nominal P = .0015).
“Our findings demonstrate that eribulin is an important treatment option for patients with previously treated LPS, a sarcoma subtype for which limited treatment options are available,” wrote lead author, of the Dana-Farber Cancer Institute and Brigham and Women’s Cancer Center, both in Boston, and his colleagues (J Clin Oncol. 2017 Aug 30. ).
A larger randomized, phase 3 prospective study had found that eribulin significantly improved overall survival versus dacarbazine (13.5 versus 11.5 months, respectively; HR, 0.77; 95% CI, 0.62-0.95; P = .0169) in patients with LPS and leiomyosarcoma. Toxicity was also manageable and similar to that observed when used to treat breast cancer.
However, the survival benefit with eribulin was greater in patients with LPS than those with leiomyosarcoma; on the basis of this trial, eribulin was approved in both the United States and European Union for use in advanced LPS in patients who have received a prior anthracycline-containing regimen.
The current study is a subgroup analysis of 452 patients with advanced or metastatic LPS that is dedifferentiated, myxoid/round cell, or pleomorphic and has been deemed incurable by surgery or radiotherapy; patients were randomized to receive either eribulin mesylate (1.4 mg/m2 intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m2 intravenously on day 1) every 21 days.
The largest difference in overall survival for eribulin versus dacarbazine was observed in patients with pleomorphic LPS (22.2 versus 6.7 months), but there were only 23 patients (16.2%) with this disease subtype included in the study. Thus, the authors caution that this particular finding should be interpreted carefully.
All patients who received eribulin and 95.8% treated with dacarbazine experienced adverse events, with the majority being treatment related (95.7% versus 84.7% in the eribulin and dacarbazine arms, respectively).
“On the basis of its activity in patients with advanced LPS, eribulin merits further exploration in earlier lines of treatment, either alone or in combination with other therapies,” the authors concluded.
February 9, 2016