Efficacy and safety of eribulin as first- to third-line treatment in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes

Maeda, Shuichi; Saimura, Michiyo; Minami, Shigeki; Kurashita, Kaname; Nishimura, Reiki; Kai, Yuichiro; Yano, Hiroshi; Mashino, Kohjiro; Mitsuyama, Shoshu; Shimokawa, Mototsugu; Tamura, Kazuo

doi:10.1016/j.breast.2016.12.017

Cited by 30 publications

(28 citation statements)

References 26 publications

(35 reference statements)

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“…The incidence of febrile neutropenia in EMBRACE (5%) was higher than that of the Kaufman study (2%), which was attributed to more prior lines of chemotherapy (up to 5) in EMBRACE. In our study, in which eribulin was exclusively used as third line, the incidence was also 5%, similar to a recent Japanese study, in which eribulin was used as first line treatment in 48.9% of the patients, as second in 29.8% and as third in 21.3% and the incidence of febrile neutropenia was 8.5%; thus, it seems that the line of therapy has little to do with reported febrile neutropenia.…”

Section: Discussionsupporting

confidence: 89%

“…It has been reported that eribulin shows better OS results at third line than at later lines of treatment, and this might also apply when comparing earlier lines of treatment (the Kauffman study, 50.5% in second line), to third line. In the Japanese study, with almost 50% of the patients in first line, the median OS was even larger at 17.4 months, which further suggests that OS gets larger when eribulin is used in earlier lines of treatment. In that study, median OS in patients treated in first line was not reached while it was 11.8 months in second/third line.…”

Section: Discussionmentioning

confidence: 92%

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Safety of eribulin as third-line chemotherapy in HER2-negative, advanced breast cancer pre-treated with taxanes and anthracycline: OnSITE study

et al. 2019

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Eribulin is active and safe in heavily pre‐treated metastatic breast cancer patients. Few safety data have been published in third line. We aimed to report the specific safety profile on third line beyond taxanes and anthracyclines in advanced breast cancer (ABC). A multicenter phase II, prospective study was conducted in anthracyclines and taxanes pre‐treated HER2‐negative ABC, programmed to receive eribulin as third‐line chemotherapy. Adverse events (AEs) were assessed and classified according to CTCAE. In addition, efficacy, in terms of overall survival (OS) and progression‐free survival (PFS), and the dynamics of circulating tumor cells (CTCs) during treatment were assessed. 59 patients fulfilled the criteria. All but one showed AEs with a cumulative number of 598 AEs. The most frequent grade 3/4 drug‐related AEs were neutropenia (1.7%), febrile neutropenia (0.5%), leukopenia (0.5%), alopecia (0.5%), asthenia (0.3%), elevated gamma glutamyl transferase levels (0.2%), and respiratory tract infection (0.2%). Median PFS was 4 months (95% CI 3.1‐5.9) and median OS was 13.6 months (11.8‐not reached). The mean number of CTCs in peripheral blood was significantly reduced from baseline to cycle 2 (16.8 vs 5.4 CTCs; P < 0.001). Median OS was significantly longer in <5 baseline CTC patients compared to ≥5 baseline CTC patients (13.1 months [95% CI: 11.8‐not reached] vs 12.5 months [95% CI: 7.6‐not reached]; P = 0.045). A significant correlation (P = 0.0129) was observed between CTC levels at cycle 2 and death when CTCs were analyzed using cox regression. Eribulin chemotherapy is effective and safe as third line in advanced HER2‐negative breast cancer. CTC levels correlate with overall survival.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 92%

Safety of eribulin as third-line chemotherapy in HER2-negative, advanced breast cancer pre-treated with taxanes and anthracycline: OnSITE study

et al. 2019

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“…We postulate that the risk of FN in Japanese patients may tend to be higher. However, the incidence of FN was 8.5% in a phase II study in Japanese patients who had received from one to three lines of eribulin therapy . With regard to non‐hematological AEs, PN occurred in 21 (72.4%) patients, at grade 3 in only four (13.8%); however, all AEs occurred during pretreatment, not during eribulin therapy.…”

Section: Discussionmentioning

confidence: 99%

Retrospective analysis of the efficacy and safety of eribulin therapy for metastatic breast cancer in daily practice

et al. 2017

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BackgroundEvidence of eribulin therapy for metastatic breast cancer (MBC) in clinical practice is not well documented.MethodsWe retrospectively analyzed the safety and efficacy of eribulin in 29 MBC patients from 2011 to 2016 at Fukuoka University Hospital.ResultsThe median patient age, number of courses, total dose, and relative dose intensity were as follows: 65 years, five courses, 8.6 mg/m2, and 75%, respectively. One patient achieved a complete response, (CR) six a partial response (PR), eight stable disease (SD) and 14 patients exhibited progressive disease. The objective response rate (ORR: CR + PR) was 24.1%, and the clinical benefit rate (CBR: CR + PR + SD) was 51.7%. The median progression‐free survival was 90 days (95% confidence interval [CI] 67–126) and median overall survival was 264 days (95% CI 198–357). In patients who previously received 2–4 regimens, the ORR was 28.5% and the CBR was 57.1%. In patients who received 5–12 regimens, the ORR was 20% and the CBR was 45%. Chemotherapy was administered to 20 patients (69%) after eribulin administration, and the median overall survival rate of cases that achieved greater than a PR was 1088 days. The most frequent treatment‐related grade 3/4 adverse events were neutropenia (55.2%), and febrile neutropenia (20.1%). Grade 3 peripheral neuropathy occurred in 13.8% of patients, but was not exacerbated even if present before treatment.ConclusionEribulin is effective for MBC patients who have received multiple chemotherapies. Neutropenia and febrile neutropenia may develop after heavy prior therapy.

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“…However, the disease often progresses due to primary or acquired resistance to these treatment regimens, and there are few subsequent therapeutic options for patients with refractory disease . Over the past several years, eribulin mesilate, a microtubule inhibitor, has shown reasonable efficacy with acceptable toxicity in patients with RBC/MBC . The phase III EMBRACE trial of eribulin mesilate for women with pretreated metastatic breast cancer showed promising results, showing a significant improvement in median overall survival of 2.5 months compared with the treatment of physician's choice …”

Section: Introductionmentioning

confidence: 99%

Pharmacodynamic analysis of eribulin safety in breast cancer patients using real‐world postmarketing surveillance data

Kawamura

Kasai²,

Fermanelli

et al. 2018

Cancer Science

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Postmarketing surveillance is useful to collect safety data in real‐world clinical settings. In this study, we applied postmarketing real‐world data on a mechanistic model analysis for neutropenic profiles of eribulin in patients with recurrent or metastatic breast cancer. Demographic and safety data were collected using an active surveillance method from eribulin‐treated recurrent or metastatic breast cancer patients. Changes in neutrophil counts over time were analyzed using a mechanistic pharmacodynamic model. Pathophysiological factors that might affect the severity of neutropenia were investigated, and neutropenic patterns were simulated for different treatment schedules. Clinical and laboratory data were collected from 401 patients (5199 neutrophil count measurements) who had not received granulocyte colony‐stimulating factor and were eligible for pharmacodynamic analysis. The estimated mean parameters were as follows: mean transit time = 104.5 h, neutrophil proliferation rate constant = 0.0377 h−1, neutrophil elimination rate constant = 0.0295 h−1, and linear coefficient of drug effect = 0.0413 mL/ng. Low serum albumin levels and low baseline neutrophil counts were associated with severe neutropenia. The probability of grade ≥3 neutropenia was predicted to be 69%, 27%, and 27% for patients on standard, biweekly, and triweekly treatment scenarios, respectively, based on virtual simulations using the developed pharmacodynamic model. In conclusion, this is the first application of postmarketing surveillance data to a model‐based safety analysis. This analysis of safety data reflecting authentic clinical settings will provide useful information on the safe use and potential risk factors of eribulin.

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Efficacy and safety of eribulin as first- to third-line treatment in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes

Abstract: Eribulin exhibited efficacy and manageable tolerability in Japanese women with pretreated MBC in first- to third-line use. (ID: UMIN000007121).

Cited by 30 publications

References 26 publications

Safety of eribulin as third-line chemotherapy in HER2-negative, advanced breast cancer pre-treated with taxanes and anthracycline: OnSITE study

Safety of eribulin as third-line chemotherapy in HER2-negative, advanced breast cancer pre-treated with taxanes and anthracycline: OnSITE study

Retrospective analysis of the efficacy and safety of eribulin therapy for metastatic breast cancer in daily practice

Pharmacodynamic analysis of eribulin safety in breast cancer patients using real‐world postmarketing surveillance data

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