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Bending the Curve Trial by Trial
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Study 309

Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial

Phase 3N = 452NCT01327885

Population
452 patients aged 18 years or older with intermediate- or high-grade advanced liposarcoma or leiomyosarcoma who had received at least two previous systemic regimens for advanced disease, including an anthracycline
Design
Randomised (1:1), open-label phase 3 trial at 110 sites in 22 countries, 10 March 2011 to 22 May 2013; stratified by disease type, region and number of prior regimens. Dacarbazine given at 850, 1000 or 1200 mg/m2 depending on centre and clinician, every 21 days until progression.
Primary endpoint
OS
Arms
  • Dacarbazine (control, n = 224): Dacarbazine 850, 1000 or 1200 mg/m2 intravenously on day 1 of each 21-day cycle
  • Eribulin (experimental, n = 228): Eribulin mesilate 1.4 mg/m2 intravenously on days 1 and 8 of each 21-day cycle
People
Schöffski P
OSHR 0.77 (95% CI 0.62–0.95)Δ median OS+2 months
Show the numbers
Results reported for Study 309
EndpointAnalysisEribulinDacarbazineEffect
OSprimarySchöffski 2016median 13.5 months (10.9–15.6)median 11.5 months (9.6–13.0)HR 0.77 (95% CI 0.62–0.95)P=0.0169
Results reported for Study 309
EndpointAnalysisEribulinDacarbazineEffect
OSprimarySchöffski 2016median 13.5 months (10.9–15.6)median 11.5 months (9.6–13.0)HR 0.77 (95% CI 0.62–0.95)P=0.0169
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.770.62–0.95
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Eribulin (experimental)
  • Dacarbazine (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsEribulinDacarbazine
0100.0%100.0%
866.3%61.7%
1741.8%35.9%
2527.7%22.2%
3417.5%12.9%
Primary publication: Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016;387(10028):1629-37. PubMedDOI

Appears in

Sources

  1. Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016;387(10028):1629-37.

    PubMedDOI