https://orcid.org/0009-0004-4274-4515
Figures
Abstract
Eribulin is used to treat metastatic breast cancer, but its adverse event (AE) profile requires comprehensive analysis using FDA Adverse Event Reporting System (FAERS) data to guide clinical use. We analyzed eribulin-related AE reports in FAERS (Q1 2011 - Q2 2024). Disproportionality analyses (ROR, PRR, MGPS, BCPNN) identified significant AE signals. Our study finalized 3570 AE reports with eribulin as the primary suspect drug from the FAERS database, including 7455 coded AE records. The included patients were predominantly female (90.1%) and aged 35–59 years (42.61%). Eribulin-associated AEs spanned 26 organ systems. Only “Blood and lymphatic system disorders” (n = 1,788) met significance across all four algorithms. At the preferred term level, 95 positive disproportionality signals emerged. Common expected AEs included neutropenia, febrile neutropenia, and leukopenia. Critically, serious unexpected AEs not consistently referenced in drug inserts were identified, such as pleural effusion, respiratory failure, and cardiac failure. Clinical use of eribulin requires great attention to blood and lymphatic adverse events, as well as enhanced monitoring and reporting of adverse events not mentioned in the insert to prevent serious AEs.
Citation: Zhou Y, Gong J, Shen L, Ling J, Wu S, Ge A, et al. (2026) Safety of eribulin: A real-world study based on a pharmacovigilance database. PLoS One 21(9): e0356800. https://doi.org/10.1371/journal.pone.0356800
Editor: Jingyu Wang, Peking University First Hospital, CHINA
Received: August 9, 2025; Accepted: July 20, 2026; Published: September 17, 2026
Copyright: © 2026 Zhou et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: The raw data for the figures and tables generated in this study are included in the accompanying supplementary information file.
Funding: This study was financially supported by the Key Projects of the Hunan Provincial Health Commission in the form of a grant (20257546) received by LL. This study was also financially supported by the Chinese Medicine Leading Talents Cultivation Project of the Hunan Provincial Administration of Traditional Chinese Medicine in the form of a grant (2022-5) received by LL.
Competing interests: The authors have declared that no competing interests exist.
Introduction
Breast cancer (BC), the most common malignant tumor in women, is estimated to have 2.3 million new breast cancer cases in 2022 alone [1]. In recent years, a variety of multimodal therapies and drugs for BC have been developed and applied, which increases the chance of cure for 70–80% of BC patients [2]. However, for patients with advanced or metastatic breast cancer (mBC), the highly aggressive and malignant nature of the disease still leads to a poor prognosis. Therefore, exploring more effective and safe treatments to improve the survival of mBC patients has become an urgent need in the field of breast cancer research.
Eribulin mesylate (Eribulin), a novel microtubule inhibitor, was approved by the U.S. Food and Drug Administration (FDA) on November 15, 2010, for treating patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease [3], including an anthracycline and a taxane in the adjuvant or metastatic setting. Unlike other microtubule inhibitors, eribulin directly binds to microtubule terminals, inhibiting microtubule protein growth and causing G2/M phase cell cycle arrest [4], thus exerting its cytotoxic effects. In addition, eribulin reprograms the tumor microenvironment to promote immune cell infiltration and activation, enhancing anti-tumor immunity [5,6]. This dual action not only strengthens its own anti-tumor activity but also supports synergistic combinations with immunotherapeutic drugs [7]. Thus, the application of eribulin in the treatment of mBC is promising.
Although targeted therapies and antibody-drug conjugates have expanded, chemotherapy remains a cornerstone for many patients with mBC. Since the EMBRACE study established eribulin’s therapeutic role in mBC patients [8], several studies have confirmed the benefit of eribulin in triple-negative mBC patients, HER2 + , and HR + /HER2- mBC patients [9–13]. Clinical studies have shown that the use of eribulin causes adverse effects, such as neutropenia, fatigue, alopecia, nausea, and anemia [14], and that peripheral neuropathy, despite its low incidence [15], is often a key factor leading to treatment interruption [8]. Given the expanding clinical use of eribulin, a better understanding of its rare adverse effects is particularly important.
However, the current understanding of adverse reactions associated with eribulin relies on limited real-world clinical data, which often lack systematic, in-depth analyses, making it particularly challenging to identify rare and serious adverse events. In contrast, the U.S. FDA Adverse Event Reporting System (FAERS) serves as a publicly available, and multisource pharmacovigilance database designed to enhance postmarketing safety monitoring of drugs [16]. This study aimed to comprehensively collect and analyze eribulin-related adverse reaction reports from FAERS, identify real-world pharmacovigilance risk signals based on disproportionality analysis, and provide scientific evidence to guide the safe clinical use of eribulin.
Materials and methods
Data sources
Based on the FAERS database (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-adverse-event-reporting-system-faers), we conducted a comprehensive analysis of AEs related to eribulin. FAERS is a publicly available database managed by the FDA that includes over 27 million adverse event reports, medication error reports, and drug quality reports [17].
We downloaded adverse event data relating to eribulin (“Eribulin,” “Eribulin mesylate,” “Eribulin mesilate”, “Halaven”) from the FAERS database website for the period from 1 January 2011 to 30 June 2024. In order to increase the credibility of the results, only data labeled as “Principal Suspect (ROLE_COD = PS)” in the drug file were selected for our study. Subsequently, according to the recommendations of the official FDA website, we used R software (Version 4.4.1) to organize the data to remove duplicates by selecting the most recent FDA_DT report when CASEID was the same, and selecting the higher PRIMARYID report when FDA_DT and CASEID were the same [18]. Ultimately, we standardized adverse events based on the Preferred Term (PT) and System Organ Class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA, version 26.1).
This study was conducted using publicly available, de-identified data from the FAERS database. As no identifiable personal information was accessed and no direct patient involvement occurred, ethical approval was not required.
Statistical methods
In this study, in order to assess the association between eribulin and its adverse events, we applied disproportionality analysis to detect safety signals. Disproportionality analysis includes the reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN) and the multi-item gamma poisson shrinker (MGPS) four algorithms. The calculation principles of these four algorithms are based on the 2 × 2 contingency table (S1 Table). An adverse event was defined a priori as a positive disproportionality signal only when it met the positivity criteria for all four algorithms. The formulas and positivity criteria are provided in S2 Table, and the data-analysis workflow is shown in Fig 1.
Note: DEMO: demographic and administrative information; DRUG: drug details; REAC: coded adverse events; PS: primary suspect.
Results
Baseline situation statistics
Between the first quarter of 2011 and the second quarter of 2024, a comprehensive retrieval of the FAERS database yielded a total of 18,715,332 individual demographic records (DEMO). Following data deduplication and organization, we obtained 3,570 adverse event reports with eribulin as the primary suspect drug, including a total of 7,455 coded adverse reaction records (Fig 1). Further statistical analysis revealed that the number of female patients using eribulin was higher than that of male patients (90.14% vs. 7.62%) (Table 1). In terms of age, the most affected patients were those aged 35–59 years, accounting for 42.61% of the total, followed by patients over 60 years old, comprising 36.95% of the total. Among the reporters, physicians submitted the highest number of cases (n = 2,257, 63.22%), with health professionals being the second largest group (n = 585, 16.39%). Among the reporting countries, Japan (n = 1,137, 31.85%), China (n = 546, 15.29%), and the United States (n = 518, 14.51%) reported the highest number of cases.
Furthermore, we summarized the annual number of AE reports related to eribulin since 2011 (Fig 2). As illustrated in Fig 2, the number of eribulin-related AE reports increased annually from 2011 to 2016, declined from 2016 to 2020, and then rose again thereafter. The initial increase (2011–2016) may reflect postmarketing accumulation of clinical use and increased reporting awareness; the subsequent decline (2016–2020) may relate to changes in drug usage or market dynamics; the subsequent rise (post 2020) may be linked to new clinical concerns or safety monitoring updates.
The decline during 2016–2020 may be related to changes in drug utilization or market dynamics (e.g., introduction of new competing therapies).
Signal detection based on system organ classes
The initial search identified 7,455 coded adverse reaction records. After excluding 20 records where both the PT and SOC fields were blank, the remaining 7,435 coded reaction records were included in the SOC level analysis of adverse reactions.
A total of 26 different system organ classes (SOCs) were involved in the reports associated with eribulin (Table 2, Fig 3). Based on disproportionality analysis at the SOC level, only blood and lymphatic system disorders (n = 1788) simultaneously met all four algorithms: ROR, PRR, BCPNN, and MGPS. Hepatobiliary disorders (n = 181) met three algorithms (ROR, PRR, and MGPS). The following SOCs fulfilled only the ROR algorithm: Investigations (n = 696), Respiratory, thoracic and mediastinal disorders (n = 607), Infections and infestations (n = 536), Neoplasms benign, malignant and unspecified (incl cysts and polyps) (n = 399), and Metabolism and nutrition disorders (n = 269) (Table 2).
In terms of the frequency of reports for each SOC (Fig 3), the top 5 SOCs, based on the number of reports, were as follows: blood and lymphatic system disorders (n = 1788, 24.05%), general disorders and administration site conditions (n = 823, 11.07%), investigations (n = 696, 9.36%), gastrointestinal disorders (n = 638, 8.58%), and respiratory, thoracic, and mediastinal disorders (n = 607, 8.16%).
Signal detection based on preferred terms
At the preferred term (PT) level, we used four algorithms to analyze adverse event reports, and the results showed a total of 95 positive disproportionality signals related to eribulin that satisfied the four algorithms, involving 15 SOCs. In Table 3, we show the top 30 PTs and their corresponding SOCs in descending order of the number of reports among the 95 positive disproportionality signals. According to Table 3, we can see that neutropenia (n = 556), febrile neutropenia (n = 413), malignant neoplasm progression (n = 299), myelosuppression (n = 291), and leukopenia (n = 195) were the most common signals associated with eribulin, and the neurological system showed neuropathy peripheral (n = 131). The top 10 reported adverse events were consistent with the drug insert except for “malignant neoplasm progression”.
Notably, the respiratory system manifested pleural effusion (n = 57), pulmonary embolism (n = 49) and respiratory failure (n = 28). Within the infections and infestations system, septic shock (n = 25) was reported. Additionally, the hepatic system exhibited hepatic failure (n = 22), and cardiac disorders manifested as cardiac failure (n = 41). Notably, none of these adverse events appear to have been previously reported in the product insert.
In addition, in Table 4, we show the top 30 PTs and their corresponding SOCs in descending order of ROR among the 95 positive adverse events. In addition to common hematologic toxicities, the top 3 AEs with the highest RORs were pseudocirrhosis (n = 8, ROR = 204.85), lymphangiosis carcinomatosa (n = 9, ROR = 73.31), peripheral motor neuropathy (n = 8, ROR = 50.53), which need to be taken seriously. It is worth noting that there are also some rare adverse events not reported in the drug label. First, in the category of injuries, poisonings, and procedural complications, recall phenomenon (n = 4, ROR = 42.96) has been observed. Second, in metabolic and nutritional disorders, fulminant type 1 diabetes mellitus (n = 5, ROR = 40.44) has been observed. In the nervous system, adverse events such as demyelinating polyneuropathy (n = 4, ROR = 34.41), vocal cord paralysis (n = 3, ROR = 14.51), and diplegia (n = 3, ROR = 12.99) have been reported. In the renal and urinary disorders, cystitis hemorrhagic (n = 8, ROR = 16.79) has been observed. In the vascular disorders, jugular vein thrombosis (n = 3, ROR = 14.47) has been noted. Although the number of these adverse events is small, they still deserve clinical attention.
It is important to note that the 95 positive PTs that met the four algorithms (S3 Table) did not include adverse events such as prolonged QT interval, alopecia, nausea, and constipation, which were included in the drug insert.
Time-to-onset analysis
A total of 2427 reports contained sufficient information in the THER file to calculate time to onset. The mean time to onset was 49.4 ± 108.3 days, and the median was 13 days (interquartile range [IQR]: 7–49 days). Fig 4 illustrates the number of reported cases and the percentage distribution of eribulin-associated AEs across various time intervals. Primarily, the majority of eribulin-related AEs emerged within 30 days post-dosing (n = 1591, 65.6%). Secondly, there was an increase in the number of AEs in the 181-360s day timeframe compared to the preceding period (i.e., within 151–180 days), rising from 1.9% to 4%. Notably, despite this escalation, the overall proportion of reports of AEs demonstrated a gradual decline over time subsequent to the initial 30 days of eribulin administration.
Fig 5 shows the time to onset for newly identified adverse events with ≥5 cases. As can be seen, lymphangiosis carcinomatosa, septic shock, pleural effusion and respiratory failure occurred earlier (median < 28 days), whereas cardiac failure, pulmonary embolism, hepatic failure and cystitis haemorrhagic occurred later (median ≥ 28 days). Furthermore, cystitis haemorrhagic had the widest interquartile range (IQR: 63–393 days), indicating greater variability. The aforementioned comparisons are descriptive in nature and do not establish any differences among these preferred terms with respect to incidence or risk.
Discussion
Eribulin, a fully synthetic analogue of halichondrin B, is a microtubule-targeting agent that uniquely inhibits microtubule dynamics. It exerts non-mitotic effects on tumors, influencing epithelial-mesenchymal transition and tumor vasculature. Its hematologic toxicity profile is well-documented, yet a comprehensive safety analysis remains lacking. In recent times, eribulin has shown synergy with tumor immunotherapy and remains a treatment option for mBC. Notably, a study utilizing eribulin as the payload in an antibody-drug conjugate (ADC) [19], termed MORAb-202, exhibited robust anti-tumor efficacy in a triple-negative breast cancer (TNBC) nude mouse model [20]. MORAb-202 has successfully completed a Phase 1 study in Japan [21], demonstrating antitumor activity against folate receptor α-positive tumors and exhibiting overall good tolerability. Concurrently, additional clinical research programs on MORAb-202 are underway globally.
These studies highlight eribulin’s versatile applications and underscore the importance for a thorough investigation of its adverse events. Using a real-world pharmacovigilance database, this study aims to systematically analyze eribulin-associated adverse events to mitigate future risks and improve clinical safety.
Our investigation revealed a heightened proportion of reports of adverse events among female patients administered eribulin, potentially attributable to eribulin’s predominant use in individuals with mBC. Notably, the number of adverse events was elevated in patients aged 35–59 years compared to those older than 60 years, aligning with the reported age of onset for metastatic BC in clinical studies, predominantly involving patients younger than 60 years [22–24]. Furthermore, the pharmacovigilance data obtained in this study were predominantly sourced from physicians’ uploads, thus assuring the reliability of our findings. The volume of reported cases in Japan underscores the nation’s emphasis on documenting eribulin-associated adverse reactions. It is worth highlighting that, despite a temporary decline, the number of eribulin-related adverse event reports has resurged since 2020, underscoring the need for increased vigilance.
Reports associated with eribulin are primarily linked to blood and lymphatic system disorders, as well as hepatobiliary disorders. Specifically, these disorders encompass neutropenia, febrile neutropenia, and myelosuppression, consistent with those in drug labeling and clinical study reports [25–27]. Eribulin’s antitumor mechanism hinges on its broad-spectrum antimitotic activity, which may impact normal blood cells. Notably, patients treated with eribulin have typically undergone multiple lines of chemotherapy, with residual effects that may exacerbate hematotoxicity [28]. Furthermore, hepatobiliary AEs include hepatic function abnormalities and hepatic failure, among others. Exposure to eribulin is increased in patients with hepatic impairment [29], necessitating a dosage reduction for patients with abnormal liver function [30]. However, the dosage form does not explicitly mention adverse reactions that may lead to hepatic failure. A case report detailing acute hepatic failure in a patient with breast cancer hepatic metastases treated with eribulin serves as a cautionary tale for clinicians [31].
Based on the analysis conducted at the PT level, the elevated number of AEs during malignant tumor progression may be attributed to patients’ suboptimal response to eribulin or the premature treatment termination. Furthermore, neurologic-related AEs, notably peripheral neuropathy, are significant in clinical studies involving eribulin. This adverse reaction involves sensory and motor disturbances, including numbness, tingling sensations, pain, and extremity weakness [32]. A clinical study conducted in Italy enrolled 170 patients for safety assessment, revealing that neurotoxicity occurred in 14.7% of these patients [33]. Another study confirmed that 7.6% of patients reduced, interrupted, or delayed eribulin due to peripheral neurotoxicity, and 6.7% discontinued it entirely [34].
Notably, our findings indicate that multiple respiratory-related AEs, such as pleural effusion, pulmonary embolism and respiratory failure, were omitted from the drug labeling, highlighting the need for enhanced lung imaging monitoring. Among respiratory-related AEs, a limited number of clinical trials have reported interstitial lung disease [21,35,36]. The underlying mechanism remains unclear, but it may be associated with eribulin’s pulmonary toxicity and impaired immune function.
Granulocytopenia can lead to fever and infection, including sepsis and septic shock, associated with reduced neutrophils and weakened immunity. Though rare, these outcomes can be fatal. For instance, a phase 1 study of balixafortide plus eribulin in heavily pretreated recurrent metastatic breast cancer reported one patient (1/56) dying from infectious shock [37]. Therefore, clinicians should monitor blood counts and neutrophil levels, considering dose reduction or discontinuation in severe cases. Furthermore, our study reported cardiac AEs such as cardiac failure, also not mentioned in the drug label.
Pseudocirrhosis is particularly noteworthy in AEs exhibiting high ROR values. A recent case report described pseudocirrhosis during eribulin treatment in five patients, leading to poor prognosis despite initial tumor shrinkage [38]. This could be associated with nodular regenerative hyperplasia, connective tissue proliferation/fibrosis, tumor infiltration, or drug-induced hepatotoxicity [39]. Our study revealed that eribulin may precipitate AEs in patients with fulminant type 1 diabetes mellitus. A Phase I clinical trial investigating eribulin in conjunction with everolimus for triple-negative mBC observed hyperglycemic AEs in 3 out of 27 patients [40]; however, it was unclear whether these were due to eribulin or drug interactions. Furthermore, several AEs, including vocal cord paralysis, diplegia, cystitis haemorrhagic, and jugular vein thrombosis, have not been documented in clinical studies. These unreported AEs necessitate further study to elucidate their mechanisms.
The median time to onset of eribulin-related AEs was 13 days, with the majority occurring within 30 days of treatment, defining an early high-risk period. However, the large standard deviation (108.3 days) and a late rise in number at 180–360 days may indicate interindividual variability and the potential for delayed toxicity. We also compiled data on the onset times of certain AEs not mentioned in the product information, and found that these findings underscore the necessity of close monitoring during the first month, continued follow-up beyond six months, and vigilance regarding highly variable adverse events such as cystitis haemorrhagic.
However, there are some limitations of this study. First, FAERS is a spontaneous-reporting database and is subject to underreporting, duplicate reporting, reporting bias, and missing or inaccurate information. Second, about 47% of eribulin-related AEs were from Japan and China, which may limit generalizability to other regions. Third, most FAERS-based studies are retrospective, introducing bias; disproportionality signal detection indicates reporting association, not causality. Finally, dose–response analysis was not feasible because dose and treatment-duration data were frequently missing or uninterpretable, units were inconsistent, and report counts for individual events were small.
Future research should integrate FAERS data with other real-world data to obtain more precise clinical information. For example, in clinical practice, combining evidence from randomised controlled trials and real-world cohort studies can help to establish a causal relationship between eribulin and adverse events, and to assess dose-response relationships more reliably.
Conclusion
In this study, the analysis identified eribulin-associated disproportionality signals, with the strongest and most consistent signals involving hematologic and lymphatic system disorders. In addition, respiratory failure, septic shock, pseudo-cirrhosis, and type 1 diabetes mellitus were not mentioned in the drug labeling, which need to be further strengthened in clinical monitoring and reporting. In the future, actively conducting clinical studies with large samples for more comprehensive safety assessment will be the key research direction.
Supporting information
S2 Table. Four algorithms for disproportionality analysis and their associated positivity thresholds.
https://doi.org/10.1371/journal.pone.0356800.s002
(DOCX)
S3 Table. 95 positive disproportionality signals and associated SOCs.
https://doi.org/10.1371/journal.pone.0356800.s003
(DOCX)
S4 Data. Raw data for Figs and Tables in this manuscript.
https://doi.org/10.1371/journal.pone.0356800.s004
(XLSX)
References
- 1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74:229–63. pmid:38572751
- 2. Trayes KP, Cokenakes S. Breast Cancer Treatment. Am Fam Physician. 2021;104:171–8. pmid:34383430
- 3. Swami U, Shah U, Goel S. Eribulin in Cancer Treatment. Mar Drugs. 2015;13(8):5016–58. pmid:26262627
- 4. Jordan MA, Kamath K. How do microtubule-targeted drugs work? An overview. Curr Cancer Drug Targets. 2007;7(8):730–42. pmid:18220533
- 5. Funahashi Y, Okamoto K, Adachi Y, Semba T, Uesugi M, Ozawa Y, et al. Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sci. 2014;105(10):1334–42. pmid:25060424
- 6. Goto W, Kashiwagi S, Asano Y, Takada K, Morisaki T, Fujita H, et al. Eribulin Promotes Antitumor Immune Responses in Patients with Locally Advanced or Metastatic Breast Cancer. Anticancer Res. 2018;38(5):2929–38. pmid:29715119
- 7. Liu J, Wang Y, Tian Z, Lin Y, Li H, Zhu Z, et al. Multicenter phase II trial of Camrelizumab combined with Apatinib and Eribulin in heavily pretreated patients with advanced triple-negative breast cancer. Nat Commun. 2022;13(1):3011. pmid:35641481
- 8. Cortes J, O’Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377(9769):914–23. pmid:21376385
- 9. Twelves C, Awada A, Cortes J, Yelle L, Velikova G, Olivo MS, et al. Subgroup analyses from a phase 3, open-label, randomized study of eribulin mesylate versus capecitabine in pretreated patients with advanced or metastatic breast cancer. Breast Cancer (Auckl). 2016;10:77–84. pmid:27398025
- 10. Sakaguchi K, Nakatsukasa K, Koyama H, Kato M, Sakuyama A, Matsuda T, et al. Phase II Clinical Trial of First-line Eribulin Plus Trastuzumab for Advanced or Recurrent HER2-positive Breast Cancer. Anticancer Res. 2018;38(7):4073–81. pmid:29970533
- 11. Inoue K, Ninomiya J, Saito T, Okubo K, Nakakuma T, Yamada H, et al. Eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: a phase II, multicenter, collaborative, open-label, single-arm clinical trial. Invest New Drugs. 2019;37(3):538–47. pmid:30848403
- 12. Kobayashi K, Masuda N, Mizuno T, Miura K, Tokuda Y, Yoshinami T, et al. Phase II trial of biweekly administration with eribulin after three cycles of induction therapy in hormone receptor-positive, HER2-negative metastatic breast cancer (JACCRO BC-03). Breast Cancer Res Treat. 2023;201(3):409–15. pmid:37480384
- 13. Oey O, Wijaya W, Redfern A. Eribulin in breast cancer: Current insights and therapeutic perspectives. World J Exp Med. 2024;14(2):92558. pmid:38948420
- 14. Perry CM. Eribulin. Drugs. 2011;71:1321–31. pmid:21770478
- 15. Tarasiuk O, Cavaletti G, Meregalli C. Clinical and preclinical features of eribulin-related peripheral neuropathy. Exp Neurol. 2022;348:113925. pmid:34801586
- 16. Tian X, Chen L, Gai D, He S, Jiang X, Zhang N. Adverse Event Profiles of PARP Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS. Front Pharmacol. 2022;13:851246. pmid:35401230
- 17. Feng Z, Li X, Tong WK, He Q, Zhu X, Xiang X, et al. Real-world safety of PCSK9 inhibitors: A pharmacovigilance study based on spontaneous reports in FAERS. Front Pharmacol. 2022;13:894685. pmid:36506552
- 18. Yu M, Zhou L, Cao M, Ji C, Zheng Y. Post-marketing drug safety surveillance of enfortumab vedotin: an observational pharmacovigilance study based on a real-world database. Front Immunol. 2024;15:1397692. pmid:39234238
- 19. Cheng X, Li J, Tanaka K, Majumder U, Milinichik AZ, Verdi AC, et al. MORAb-202, an Antibody-Drug Conjugate Utilizing Humanized Anti-human FRα Farletuzumab and the Microtubule-targeting Agent Eribulin, has Potent Antitumor Activity. Mol Cancer Ther. 2018;17(12):2665–75. pmid:30262588
- 20. Furuuchi K, Rybinski K, Fulmer J, Moriyama T, Drozdowski B, Soto A, et al. Antibody-drug conjugate MORAb-202 exhibits long-lasting antitumor efficacy in TNBC PDx models. Cancer Sci. 2021;112(6):2467–80. pmid:33756060
- 21. Shimizu T, Fujiwara Y, Yonemori K, Koyama T, Sato J, Tamura K, et al. First-in-Human Phase 1 Study of MORAb-202, an Antibody-Drug Conjugate Comprising Farletuzumab Linked to Eribulin Mesylate, in Patients with Folate Receptor-α-Positive Advanced Solid Tumors. Clin Cancer Res. 2021;27(14):3905–15. pmid:33926914
- 22. Lin Y-J, Kuo C-N, Ko Y. Effectiveness and healthcare costs of eribulin versus capecitabine among metastatic breast cancer patients in Taiwan. Breast. 2021;57:18–24. pmid:33706025
- 23. Pellegrino B, Cavanna L, Boggiani D, Zamagni C, Frassoldati A, Schirone A, et al. Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC). ESMO Open. 2021;6(1):100019. pmid:33399082
- 24. Lück H-J, Schmidt M, Hesse T, Hoffmann O, Heinrich BJ, Park-Simon T-W, et al. Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE) in Locally Advanced or Metastatic Breast Cancer: Prospective Cohort Study. Oncologist. 2023;28(12):e1152–9. pmid:37555463
- 25. Aogi K, Iwata H, Masuda N, Mukai H, Yoshida M, Rai Y, et al. A phase II study of eribulin in Japanese patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2012;23(6):1441–8. pmid:21989327
- 26. Gui X, Liang X, Li H. Effectiveness, safety, and impact on quality of life of eribulin-based therapy in heavily pretreated patients with metastatic breast cancer: A real-world analysis. Cancer Med. 2023;12(16):16793–804. pmid:37403746
- 27. Chen L, Yan X, Luo T, Tian T, He P, Zhong X. Efficacy and safety of eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with anthracycline/taxanes. Cancer Med. 2024;13(10):e7295. pmid:38785215
- 28. Takada S, Hosokawa Y, Umehara K, Kimura Y, Fukai Y, Shikishima K, et al. Risk Factors for Eribulin-induced Severe Neutropenia in Patients With Recurrent Breast Cancer. In Vivo. 2024;38(1):500–5. pmid:38148090
- 29. Zhang Z-Y, King BM, Pelletier RD, Wong YN. Delineation of the interactions between the chemotherapeutic agent eribulin mesylate (E7389) and human CYP3A4. Cancer Chemother Pharmacol. 2008;62(4):707–16. pmid:18431572
- 30. Devriese LA, Witteveen PO, Marchetti S, Mergui-Roelvink M, Reyderman L, Wanders J, et al. Pharmacokinetics of eribulin mesylate in patients with solid tumors and hepatic impairment. Cancer Chemother Pharmacol. 2012;70(6):823–32. pmid:23010853
- 31. Xie X-F, Huang J-Y, Chen L-P, Lan X-F, Zhang Q-Y, Song L, et al. Acute-on-chronic liver failure following eribulin treatment for metastatic breast cancer: a case report. J Int Med Res. 2022;50(7). pmid:35899681
- 32. Cavaletti G, Marmiroli P. Chemotherapy-induced peripheral neurotoxicity. Nat Rev Neurol. 2010;6(12):657–66. pmid:21060341
- 33. La Verde N, Damia G, Garrone O, Santini D, Fabi A, Ciccarese M, et al. Tolerability of Eribulin and correlation between polymorphisms and neuropathy in an unselected population of female patients with metastatic breast cancer: results of the multicenter, single arm, phase IV PAINTER study. Breast Cancer Res. 2022;24(1):71. pmid:36307826
- 34. Tsurutani J, Sakata Y, Matsuoka T. Chemotherapy-induced peripheral neuropathy in breast cancer patients treated with eribulin: interim data from a post-marketing observational study. Breast Cancer. 2019;26(2):235–43. pmid:30324551
- 35. Nakamura K, Kato M, Miyashita Y, Nagashima O, Sasaki S, Tominaga S, et al. Development of interstitial pneumonia during treatment with eribulin: a case report. BMC Res Notes. 2017;10(1):557. pmid:29110735
- 36. Murakami M, Kanemura H, Tomishima Y, Nakano E, Tamura T. Eribulin-induced interstitial pneumonia: a case series and retrospective cohort study. Intern Med. 2020;59:563–7. pmid:31588076
- 37. Pernas S, Martin M, Kaufman PA, Gil-Martin M, Gomez Pardo P, Lopez-Tarruella S, et al. Balixafortide plus eribulin in HER2-negative metastatic breast cancer: a phase 1, single-arm, dose-escalation trial. Lancet Oncol. 2018;19(6):812–24. pmid:29706375
- 38. Akaishi Y, Tokunaga S, Omori R, Nakatani Y, Tanaka A, Akiyoshi K, et al. Five Cases of Pseudocirrhosis during Eribulin Treatment for Breast Cancer. Gan To Kagaku Ryoho. 2024;51(7):753–5. pmid:39191694
- 39. Sadlik G, Anderson R-C, Lei X, Cen SY, Duddalwar VA, Fong T-L. Pseudocirrhosis: A Case Series with Clinical and Radiographic Correlation and Review of the Literature. Dig Dis Sci. 2024;69(3):1004–14. pmid:38175453
- 40. Lee JS, Yost SE, Blanchard S, Schmolze D, Yin HH, Pillai R, et al. Phase I clinical trial of the combination of eribulin and everolimus in patients with metastatic triple-negative breast cancer. Breast Cancer Res. 2019;21(1):119. pmid:31703728