First report of eribulin in combination with pertuzumab and trastuzumab for advanced HER2-positive breast cancer

Araki, Kazuhiro; Fukada, Ippei; Yanagi, Hiroyo; Kobayashi, Kokoro; Shibayama, Tomoko; Horii, Rie; Takahashi, Shunji; Akiyama, Futoshi; Ohno, Shinji; Ito, Yoshiaki

doi:10.1016/j.breast.2017.06.015

Cited by 23 publications

(30 citation statements)

References 33 publications

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“…It is possible that suboptimal treatment of HER2‐positive tumors could have induced negative results reported in the pivotal studies of EM in MBC. At the same time, phase II trials evaluating the combination of EM with anti‐HER2 targeted therapies, such as trastuzumab or the trastuzumab–pertuzumab doublet reported a favorable safety profile, and interesting response rates, warranting additional investigations and a better definition of the place of such combinations in the HER2‐positive MBC therapeutic strategy.…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

“…The median follow-up was 26 27] in the EM and Other CT groups, p = 0.1171). PFS was significantly better in patients treated with EM in third and fourth line as compared to PFS of patients treated with Other CT (Fig.…”

Section: Pfs In the Overall Populationmentioning

confidence: 92%

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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“…The safety profile of eribulin means that it is the ideal partner for combination therapies. The results of a few of these combination studies have been reported, and show manageable toxicity profiles, but the majority of these are in small populations (<60 patients) [34,67,[72][73][74][75][76][77][78]. Larger studies of combination therapy are required.…”

Section: Expert Opinionmentioning

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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“…During the past decade, advanced human epidermal growth factor receptor 2 (HER2)-targeted therapies have significantly improved outcomes for patients with HER2-positive advanced breast cancer (ABC) [ 1 ]. Clinical evaluations of pertuzumab and trastuzumab (PT) in combination with different chemotherapy regimens in the CLEOPATRA trial and our previous study have highlighted clinical benefits [ 2 , 3 ].…”

Section: Introductionmentioning

confidence: 99%

Predictive impact of absolute lymphocyte counts for progression-free survival in human epidermal growth factor receptor 2-positive advanced breast cancer treated with pertuzumab and trastuzumab plus eribulin or nab-paclitaxel

et al. 2018

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AbstractsBackgroundAlthough peripheral blood-based parameters (PBBPs) are reported as prognostic indicators in patients with breast cancers, their utility has not been studied in human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC). Tumor-infiltrating lymphocytes (TILs) might be a predictive factor in patients with HER2-positive ABC treated with pertuzumab and trastuzumab (PT) plus docetaxel. We aimed to evaluate whether PBBPs could have predictive value in HER2-positive ABC treated with pertuzumab and trastuzumab (PT) combined with eribulin (ERI) or nab-paclitaxel (Nab-PTX).MethodsData from 51 patients included in two single-arm, phase II trials were included in this retrospective-prospective study; the ERI + PT (N = 30) and Nab-PTX + PT (N = 21) combinations were registered under clinical trials number UMIN000012375 and UMIN000006838, respectively. We assessed PBBPs using prospectively collected data and investigated the association with progression-free survival (PFS); we evaluated absolute lymphocyte count (ALC), neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR). The cutoff values for ALC, NLR, and PLR were set at 1000 or 1500 cells/μL, 2, and 250, respectively.ResultsPFS was significantly improved in patients with ALC ≥1500/μL compared to those with ALC 1000–, <1500/μL or ALC < 1000/μL (P = 0.0106). High baseline ALC was significantly associated with improved PFS (≥1500/μL; hazard ratio [HR]: 0.3715; 95% confidence interval [CI]: 0.1735–0.7955; P = 0.0108). In contrast, improved PFS was not significantly associated with NLR or PLR. Improved PFS in patients with ALC ≥1500/μL was observed irrespective of visceral metastasis or chemotherapy regimen.ConclusionsOur results showed that baseline ALC was a predictive factor for PFS in HER2-positive ABC treated with PT irrespective of combined chemotherapy regimen. Anti-tumor effects might be mediated not only by the tumor microenvironment, but also by systemic peripheral circulating lymphocytes. Baseline systemic parameters such as peripheral lymphocyte count might be beneficial in addition to disease extent for predicting the efficacy of PT treatment.Trial registrationUMIN000012375, registration date: 21NOV2013, and UMIN000006838, registration date: 6DEC2011.

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First report of eribulin in combination with pertuzumab and trastuzumab for advanced HER2-positive breast cancer

Cited by 23 publications

References 33 publications

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

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

The safety of eribulin for the treatment of metastatic breast cancer

Predictive impact of absolute lymphocyte counts for progression-free survival in human epidermal growth factor receptor 2-positive advanced breast cancer treated with pertuzumab and trastuzumab plus eribulin or nab-paclitaxel

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