Effect of eribulin on patients with metastatic breast cancer: multicenter retrospective observational study in Taiwan

Rau, Kun Ming; Ouyang, Fusheng; Chao, Ta‐Chung; Kuo, Yiyo; Cheng, Tsui Fen; Chao, Tsu Yi; Chen, Dar Ren; Tzeng, Yen‐Dun Tony; Wang, Being Whey; Liu, Chun Yu; Hu, Ming; Li, Yin; Ou, Wei; Kuo, Chin Ho; Chuang, Chieh Han; Kan, Jung Yu; Chen, Fang Ming; Hou, Ming‐Feng

doi:10.1007/s10549-018-4778-y

Cited by 12 publications

(32 citation statements)

References 20 publications

(31 reference statements)

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“…For the third or later-line treatment, the 1-year survival rate was reported as 52.0% in this study compared with 53.9% in a previous study [5]. Furthermore, TTF was reported as 4.2 months in this study compared with 3.91 months [23] and approximately 4 months (127 days) [16] in previous studies on eribulin as a first-, second-, third or later-line treatments. In comparison, 5.2 and 5.3 months [9] were reported in this and a previous study for eribulin as first-line treatment, respectively.…”

Section: Discussionmentioning

confidence: 40%

Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting

et al. 2020

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Background Data on eribulin as the first-or second-line treatment in a clinical setting, especially the overall survival (OS) of patients, are scarce. Therefore, we assessed the effectiveness and safety of eribulin as the first-, second-, and third-or later-line treatments in patients with human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in Japan. Methods This multicenter, prospective, post-marketing, observational study enrolled patients from September 2014 to February 2016 in Japan and followed them for 2 years. Patients were categorized by eribulin use into the first-, second-, and third-or later-line treatment groups. Results Of 651 registered patients, 637 patients were included in the safety and effectiveness analysis. In all, first-, second-, and third or later-line treatment groups, median OS (95% confidence interval) were 15.6 (13.8-17.6), 22.8 (17.3-31.0), 16.3 (12.4-19.9), and 12.6 (11.2-15.1) months and time to treatment failure (TTF) (95% confidence interval) were 4.2 (3.7-4.4), 5.2 (3.7-5.9), 4.2 (3.7-5.1), and 3.8 (3.5-4.2) months, respectively. Prolonged TTF was associated with complications of diabetes and the development of peripheral neuropathy after eribulin treatment, according to multivariate Cox regression analysis. Grade ≥ 3 adverse drug reactions (ADRs) were reported in 61.7% of the patients. Neutropenia (49.5%) was the most common grade ≥ 3 ADR in all groups. Conclusions The effectiveness and safety results of eribulin as the first-or second-line treatment were favorable. Thus, these suggest eribulin may be a first-line treatment candidate for patients with HER2-negative advanced breast cancer in Japan.

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Section: Discussionmentioning

confidence: 40%

Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting

et al. 2020

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“…A retrospective observational study in Taiwan reported neutropenia (21.3%), alopecia (26.4%), and fatigue (21.3%) as the most common all-grade AEs [57]. Grade 3/4 neutropenia and fatigue were seen in 12% and 1.6% of patients, respectively, in this study [57].…”

Section: Real-world Data For Eribulinmentioning

confidence: 47%

“…An Italian retrospective observational study reported all-grade neutropenia, asthenia/fatigue, and alopecia in 36.3%, 43.4%, and 16.8% of patients, respectively, whereas all-grade peripheral neuropathy occurred in 12.4% of patients treated with eribulin [56]; grade 3/4 neutropenia was seen in 19.5% of patients, while grade 3/4 asthenia/fatigue and peripheral neuropathy were seen in 4.4% and 0.9% of patients, respectively [56]. A retrospective observational study in Taiwan reported neutropenia (21.3%), alopecia (26.4%), and fatigue (21.3%) as the most common all-grade AEs [57]. Grade 3/4 neutropenia and fatigue were seen in 12% and 1.6% of patients, respectively, in this study [57].…”

Section: Real-world Data For Eribulinmentioning

confidence: 99%

The safety of eribulin for the treatment of metastatic breast cancer

Peréz-García

Cortés

2019

Expert Opinion on Drug Safety

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Introduction: Eribulin mesylate is a highly potent anticancer agent approved for use in pretreated metastatic breast cancer (MBC). Clinical trials of eribulin in MBC have demonstrated activity against this tumor type, and a phase 3 study in patients with MBC previously treated with an anthracycline and a taxane showed a significant increase in overall survival (OS) with eribulin versus control regimens. Areas covered: This review presents overviews of the development of eribulin, its pharmacology, and its efficacy in MBC. A detailed review of its safety profile is presented, and the safety of eribulin is compared with other agents commonly used to treat MBC. Expert opinion: As eribulin is the only drug shown to improve OS in patients with pretreated MBC, it is an important treatment option for many patients. Eribulin is currently considered a second-line (Europe) or third-line (United States) therapy, and studies have been examining use in the first-line setting. The use of eribulin in combination with other therapies is beginning to be explored because its manageable safety profile makes it an ideal combination-treatment partner. Emerging eribulin combinationtreatment data suggest a manageable toxicity profile, and eribulin is set to be a key drug for the treatment of MBC in the future.

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“…Considering these results and a pooled analysis of the two aforementioned trials, EM appears as a new therapeutic option in patients with MBC pretreated with taxanes and anthracyclines. In addition, numerous retrospective noncomparative series have been published evaluating the safety of EM in the real‐world setting . Despite its extensive use in MBC patients, EM clinical efficacy and safety in the real‐world patient population still need to be clearly evaluated, with regard to the efficacy profile of other validated agents in MBC treatment.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, numerous retrospective noncomparative series have been published evaluating the safety of EM in the real-world setting. [9][10][11][12][13][14] Despite its extensive use in MBC patients, EM clinical efficacy and safety in the real-world patient population still need to be clearly evaluated, with regard to the efficacy profile of other validated agents in MBC treatment.…”

Section: Introductionmentioning

confidence: 99%

Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program

Jacot

Heudel

Fraisse

et al. 2019

Intl Journal of Cancer

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Eribulin mesylate (EM) was recently approved for metastatic breast cancer (MBC) chemotherapy (CT) in late lines by the FDA, with debated results in second line. We evaluated outcomes in breast cancer patients receiving EM as second, third and fourth line in a national real‐life cohort of 16,703 consecutive MBC patients initiating their first metastatic therapeutic line between 2008 and 2014. Primary and secondary objectives were overall survival (OS) and progression‐free survival (PFS). An imbalance was seen for HER2+ tumors and concomitant anti‐HER2 targeted therapies use, we thus performed a subanalysis in HER2− patients. PFS and OS were significantly better in EM patients in third and fourth lines, compared to “Other chemotherapies” patients (PFS: 4.14 vs. 3.02 months, p = 0.0010; 3.61 vs. 2.53 months, p = 0.0102, third and fourth‐line; OS: 11.27 vs. 7.65 months, p = 0.0001; 10.91 vs. 5.95 months, p < 0.0001, third and fourth‐line). No significant difference was reported in second‐line (PFS: 5.06 vs. 4.14 months, p = 0.1171; OS: 13.99 vs. 11.66 months, p = 0.151). Among HER2− patients, a significant difference was seen for all lines, including 2nd‐line (PFS: 4.57 vs. 3.91 months, p = 0.0379; OS: 14.98 vs. 10.51 months, p = 0.0113). In this large real‐world database, HER2‐negative MBC patients receiving EM in second or later CT line presented significantly better PFS and OS. This difference disappeared in second line in the overall population, probably because of the imbalance in HER2‐targeted treatments use. Our results mirror those of the published randomized trials. The effect of anti‐HER2 therapies addition in this setting still needs to be defined.

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Effect of eribulin on patients with metastatic breast cancer: multicenter retrospective observational study in Taiwan

Cited by 12 publications

References 20 publications

Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting

Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting

The safety of eribulin for the treatment of metastatic breast cancer

Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program

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