Eribulin Mesylate in Heavily Pretreated Metastatic Breast Cancer Patients: Current Practice in an Italian Community Hospital

Objectives: Predictive factors of response to eribulin are lacking. We aimed to investigate the activity and safety of eribulin in a real-world population of metastatic breast cancer (MBC) patients and to identify possible predictive factors of progression-free survival (PFS) and objective response. Methods: We retrospectively analyzed 71 eribulin-treated MBC patients. Best response rate, PFS, and adverse events (AEs) were evaluated. The impact of different clinical-pathological factors on PFS was evaluated using the Cox proportional hazards model. Predictive factors of response were identified by discriminant function analysis (DFA). Results: Median PFS was 3.75 months (95% CI, 2.39–4.48); 12 patients (16.90%) achieved partial response (PR), 27 (38.03%) stable disease. The most common AEs were fatigue (25.83%), neutropenia (16.56%), and peripheral neuropathy (13.91%). A worse performance status (p = 0.025) and a higher number of metastatic organ sites (p = 0.011) were associated with a worse PFS under eribulin. Overall, in the DFA-predictive model, neutrophil-to-lymphocyte ratio at baseline, estrogen receptor, Ki67, histology, and age were predictive of PR with 100% accuracy. Conclusions: Activity and safety profiles of eribulin were consistent with literature data. Performance status and number of metastatic sites were predictive factors of PFS. DFA could be a promising tool to discriminate responses to eribulin among MBC patients.

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“…The safety profile of eribulin in our cohort was consistent with AEs previously reported [6,[25][26][27].…”

Section: Discussionsupporting

confidence: 90%

Predictive Factors of Eribulin Activity in Metastatic Breast Cancer Patients

et al. 2018

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“…17,18 Aside from anemia, which was more common in the pemetrexed treatment group, adverse event rates were similar between study groups in phase II. The rates of common adverse events with eribulin 0.9 mg/m 2 on day 1 in combination with pemetrexed in this study were lower compared with other studies of eribulin monotherapy in which eribulin was dosed at 1.4 mg/m 2 on days 1 and 8 each cycle in heavily pretreated breast cancer patients [19][20][21][22] and in patients with advanced NSCLC previously treated with a taxane. 17,18 Previous reports of eribulin monotherapy dosed at 1.4 mg/m 2 on days 1 and 8 of a 21-day cycle in NSCLC patients reported the following rates of common adverse events (all Grades): neutropenia, 54% to 62%; anemia, 23% to 65%; peripheral neuropathy, 30% to 31%; and fatigue, 50% to 64%.…”

Section: Discussioncontrasting

confidence: 62%

“…This dosing regimen of eribulin is approximately one-third the dosing intensity compared with the eribulin monotherapy regimen that has been evaluated in NSCLC and breast cancer (eribulin 1.4 mg/m 2 on days 1 and 8 of a 21-day cycle). [17][18][19][20][21][22] The recommended phase 2 dose was generally well tolerated and had an expected toxicity profile.…”

Section: Discussionmentioning

confidence: 99%

An Open-Label, Multicenter, Randomized Phase Ib/II Study of Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second-Line Therapy in Patients With Advanced Nonsquamous Non–Small-Cell Lung Cancer

Waller

Vynnychenko

Bondarenko

et al. 2015

Clinical Lung Cancer

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“…To our knowledge, only two studies with small sample size reported in full text the use of eribulin in real-world population, with similar results 36,37.…”

Section: Discussionmentioning

confidence: 65%

Eribulin Mesylate in Pretreated Breast Cancer Patients: A Multicenter Retrospective Observational Study

Gamucci¹,

Michelotti²,

Pizzuti³

et al. 2014

J. Cancer

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Background: Eribulin was recently approved in patients progressing after being treated with anthracyclines and taxanes and after two or more chemotherapy lines for advanced disease.Objectives: This multicenter observational retrospective study was performed in order to evaluate activity and tolerability of eribulin in real-world patient population.Methods: 133 advanced breast cancer patients pretreated with ≥ 2 chemotherapy lines for metastatic disease were retrospectively enrolled in the observational trial in 11 italian cancer centres.Results: A median of 5 cycles of eribulin (range, 1-15) were administered. Twenty-eight partial responses were observed, for an overall response rate of 21.1% (95%CI,14.1-28.0). A stable disease was recorded in 57 patients (42.8%), and a clinical benefit (response or stable disease lasting ≥ six months) was observed in 51 patients (38.3%, 95%CI, 30.1-46.6). The subgroup analysis showed that a significant improvement in term of partial response and clinical benefit was achieved when eribulin was administered in HER-2 negative tumors (p=0.01 and p=0.004, respectively) and when it is given as third-line (p=0.09 and p=0.02, respectively). Toxicity was manageable; fatigue is the most common side effect observed, usually of low-grade, and clearly cumulative-dose related.Conclusions: In this retrospective, observational analysis eribulin confirmed its efficacy and manageable tolerability even in real-world population and in heavily pretreated patients.

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Eribulin Mesylate in Heavily Pretreated Metastatic Breast Cancer Patients: Current Practice in an Italian Community Hospital

Abstract: Our retrospective analysis of a clinical practice experience supports the evidence that eribulin mesylate has clinical activity and provides acceptable benefit to heavily pretreated MBC.

Cited by 19 publications

References 16 publications

Predictive Factors of Eribulin Activity in Metastatic Breast Cancer Patients

Predictive Factors of Eribulin Activity in Metastatic Breast Cancer Patients

An Open-Label, Multicenter, Randomized Phase Ib/II Study of Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second-Line Therapy in Patients With Advanced Nonsquamous Non–Small-Cell Lung Cancer

Eribulin Mesylate in Pretreated Breast Cancer Patients: A Multicenter Retrospective Observational Study

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