Abstract
BackgroundEribulin, a nontaxane synthetic inhibitor of microtubule dynamics, is widely used to manage locally advanced or metastatic breast cancer (MBC). Eribulin has demonstrated immunomodulatory activity on the tumour microenvironment. Baseline neutrophil-to-lymphocyte ratio (NLR), a marker of immune status, may predict progression-free survival in eribulin treatment. This post hoc analysis assessed predictors for overall survival (OS).MethodsThe phase 3 open-label study (EMBRACE) of eribulin versus treatment of physician’s choice (TPC) in patients with MBC provided source data. Baseline absolute lymphocyte counts (ALCs) and NLR were evaluable in 751 and 713 patients, respectively.ResultsEribulin prolonged OS versus TPC in patients with baseline ALC ≥ 1500/µl (hazard ratio [HR] 0.586; 95% confidence interval [CI] 0.437–0.784; P < 0.001). There was no significant difference by treatment for ALC < 1500/µl (HR 1.002; 95% CI 0.800–1.253; P = 0.989). Univariate and multivariate analyses were performed and identified baseline ALC as a potential predictor of OS in eribulin-treated patients. Interaction analysis of OS supported 1500/µl as a potentially differential cutoff value. NLR at a cutoff value of 3 was associated with prolonged OS (eribulin group). However, similar results were also observed in the TPC group, without apparent interaction effect, suggesting that NLR may be a general prognostic marker rather than a specific predictor of OS for eribulin.DiscussionThis hypothesis-generating study speculates that baseline ALC may be an independent predictor for longer OS in eribulin-treated MBC patients and could be clinically impactful because it can be evaluated without the need for additional invasive procedures.Trial Registrationwww.ClinicalTrials.gov code: NCT00388726
Highlights
Eribulin, a synthetic inhibitor of microtubule dynamics, is widely used for locally advanced or metastatic breast cancer (MBC) after one or two previous lines of chemotherapy in Europe and the United States, respectively [1, 2]
Baseline characteristics were similar between ≥ 3 and < 3 patients in both the eribulin and treatment of physician’s choice (TPC) groups except for the number of patients with > 2 organs involved, > 3 prior chemotherapy regimens and the number of patients from North America/Western Europe/Australia (Online Resource Table 1)
In this post hoc analysis conducted with data from EMBRACE, a high absolute lymphocyte counts (ALCs) (≥ 1500/μl) was found to be a significant and independent predictor for longer overall survival (OS) in patients treated with eribulin, but not in those treated with TPC
Summary
A synthetic inhibitor of microtubule dynamics, is widely used for locally advanced or metastatic breast cancer (MBC) after one or two previous lines of chemotherapy in Europe and the United States, respectively [1, 2]. Baseline neutrophil-to-lymphocyte ratio (NLR), a marker of immune status, may predict progression-free survival in eribulin treatment. This post hoc analysis assessed predictors for overall survival (OS). Methods The phase 3 open-label study (EMBRACE) of eribulin versus treatment of physician’s choice (TPC) in patients with MBC provided source data. Results Eribulin prolonged OS versus TPC in patients with baseline ALC ≥ 1500/μl (hazard ratio [HR] 0.586; 95% confidence interval [CI] 0.437–0.784; P < 0.001). Discussion This hypothesis-generating study speculates that baseline ALC may be an independent predictor for longer OS in eribulin-treated MBC patients and could be clinically impactful because it can be evaluated without the need for additional invasive procedures.
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