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Eribulin

Eribulin is a synthetic analog of the marine natural product halichondrin B, used as an antineoplastic agent for the treatment of certain types of cancer.
It functions by disrupting microtubule dynamics, leading to cell cycle arrest and apoptosis.
Eribulin has demonstrated efficacy in advanced or metastatic breast cancer and liposacroma, and is approved for clinical use in these indications.
Reserchers can utilize PubCompare.ai to optimize their Eribulin studies by easily locating and comparing protocols from literature, preprints, and patents, enhancing reproducibility and accuracy.
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Most cited protocols related to «Eribulin»

We conducted a randomized, two-group, open-label, phase 3 trial involving patients with HER2-low, unresectable or metastatic breast cancer. Trial enrollment was planned for 480 patients with hormone receptor–positive disease (immunoreactive for estrogen or progesterone receptor in ≥1% of tumor-cell nuclei according to local testing) and 60 patients with hormone receptor–negative disease, approximating the proportions of receptor subtype observed in HER2-low breast cancer.1 (link) Patients were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan or the physician’s choice of capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel. Randomization was stratified according to HER2-low status (IHC1+ vs. IHC 2+ and ISH-negative), the number of previous lines of chemotherapy for metastatic disease (one vs. two), and hormone-receptor status (positive [with vs. without previous CDK4/6 inhibitor therapy] vs. negative).
IHC scores for HER2 expression were determined through central testing of adequate archived or recent tumor-biopsy specimens with the use of an investigational IHC assay, the VENTANA HER2/neu (4B5) IUO (investigational use only) Assay system, according to an algorithm adapted from the 2018 American Society of Clinical Oncology/College of American Pathologists testing guidelines (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org).22 (link) Specimens that yielded central HER2 IHC scores of 2+ were reflexed to ISH testing with the use of the investigational INFORM HER2 Dual ISH DNA Probe Cocktail IUO Assay system.
Eligible patients must have received chemotherapy for metastatic disease or have had disease recurrence during or within 6 months after completing adjuvant chemotherapy; patients with hormone receptor–positive disease must have received at least one line of endocrine therapy. Patients with treated, stable brain metastases were eligible; patients were ineligible if they had a history of noninfectious interstitial lung disease requiring treatment with glucocorticoids or had suspected interstitial lung disease on imaging at screening.
Trastuzumab deruxtecan was administered intravenously every 3 weeks at a dose of 5.4 mg per kilogram of body weight, and the physician’s choice of chemotherapy was administered in accordance with local label or the National Comprehensive Cancer Network guidelines.6 More details are provided in the Supplementary Appendix.
Publication 2022
130-nm albumin-bound paclitaxel Biological Assay Biopsy Body Weight Brain Metastases Breast Capecitabine CDKN2A Gene Cell Nucleus Chemotherapy, Adjuvant DNA Probes ERBB2 protein, human eribulin Estrogens Gemcitabine Gene, BRCA1 Glucocorticoids Hormones Lung Diseases, Interstitial Malignant Neoplasm of Breast Malignant Neoplasms Neoplasm Metastasis Neoplasms Paclitaxel Pathologists Patients Pharmacotherapy Physicians Receptors, Progesterone Recurrence System, Endocrine trastuzumab deruxtecan
Histopathological assessment of predictive factors was made for core needle biopsy (CNB) specimens for primary lesions at the time of the breast cancer diagnosis. Histopathologic analysis of the percentage of TILs was evaluated on a single full-face hematoxylin and eosin (HE)-stained tumor section using criteria described by Salgado et al [19 (link)]. TILs were defined as the infiltrating lymphocytes within tumor stroma and were expressed in proportion to the field investigated [19 (link)–21 (link)]. The area of in situ carcinoma and crush artifacts were not included. Proportional scores were defined as 3, 2, 1, and 0 if the area of stroma with lymphoplasmacytic infiltration around invasive tumor cell nests was > 50%, > 10–50%, ≤ 10%, and absent, respectively (Fig 1). TILs were considered positive when scores were ≥ 2, and negative when scores were 1 and 0. Histopathologic evaluation of TILs was jointly performed by two breast pathologists, who were blinded to clinical information, including treatment allocation and outcomes.
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Publication 2017
Breast Breast Carcinoma Carcinoma in Situ Cells Core Needle Biopsy Diagnosis Eosin Facial Neoplasms Hematoxylin Lymphocyte Lymphocytes, Tumor-Infiltrating Neoplasms Pathologists
The EMBRACA study was an open-label, randomized, international phase 3 trial comparing the efficacy and safety of talazoparib to protocol-specified physician’s choice of single agent therapy (capecitabine, eribulin, gemcitabine, or vinorelbine) using a 2:1 randomization in patients with advanced breast cancer (Supplemental Figure S1). Patients were centrally randomized with stratification by number of prior cytotoxic chemotherapy regimens for advanced disease (0 vs. 1 to 3), receptor status (triple-negative vs. hormone receptor–positive), and a history of CNS metastases (yes vs. no). Patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer were not eligible for this trial.
The treatment arm consisted of talazoparib 1 mg orally once daily continuously in the fed or fasting state. Laboratory studies were monitored every 3 weeks with dose hold and dose reductions as outlined in the supplement.
The control arm was protocol-specified chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in accordance with the institution’s dose and regimen guidelines in 21-day cycles. The choice of drug was determined before randomization for each patient.
Treatment continued until disease progression, unacceptable toxicity, consent withdrawal, or physician decision. Cross-over from the control arm to the experimental arm was not permitted.
The study sponsor designed the protocol in collaboration with the authors. Local site investigators collected the data, which were analyzed by the sponsor. All authors had full access to study data after the primary analysis was conducted. The authors vouch for the accuracy and completeness of the data and for adherence of trial conduct to the study protocol (available at NEJM.org).
Editorial and medical writing support funded by Pfizer Inc. were provided by Edwin Thrower, PhD, Mary Kacillas, and Paula Stuckart of Ashfield Healthcare Communications.
Publication 2018
Prior to the ABC 3 Conference, a set of preliminary recommendation statements on the management of ABC were prepared, based on available published data and following the ESMO guidelines methodology. These recommendations were circulated to all 44 panel members by email for comments and corrections on content and wording. A final set of recommendations was presented, discussed and voted upon during the consensus session of ABC 3. All panel members were instructed to vote on all questions, with members with a potential conflict of interest or who did not feel comfortable answering the question (e.g. due to lack of expertise in a particular field) instructed to vote ‘abstain’. Additional changes in the wording of statements were made during the session. The statements related to management of side effects and difficult symptoms, included under the Supportive and Palliative care section, were not voted on during the consensus session, but discussed and unanimously agreed by email, and are considered to have 100% agreement.
Supplementary Table S1, available at Annals of Oncology online, lists all members of the ABC 3 consensus panel and their disclosures of any relationships with the pharmaceutical industry that could be perceived as a potential conflict of interest.
Table 1 describes the grading system used [7 (link)]. ABC1 [10 (link)] and ABC2 [1 ] statements with only minor updates or with no updates are listed in Table 2.

Grading system [7 (link)]

Grade of recommendation/descriptionBenefit versus risk and burdensMethodological quality of supporting evidenceImplications
1A/Strong recommendation, high quality evidenceBenefits clearly outweigh risk and burdens, or vice versaRCTs without important limitations or overwhelming evidence from observational studiesStrong recommendation, can apply to most patients in most circumstances without reservation
1B/Strong recommendation, moderate quality evidenceBenefits clearly outweigh risk and burdens, or vice versaRCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studiesStrong recommendation, can apply to most patients in most circumstances without reservation
1C/Strong recommendation, low quality evidenceBenefits clearly outweigh risk and burdens, or vice versaObservational studies or case seriesStrong recommendation, but may change when higher quality evidence becomes available
2A/Weak recommendation, high quality evidenceBenefits closely balanced with risks and burdenRCTs without important limitations or overwhelming evidence from observational studiesWeak recommendation, best action may differ depending on circumstances or patients’ or societal values
2B/Weak recommendation, moderate quality evidenceBenefits closely balanced with risks and burdenRCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studiesWeak recommendation, best action may differ depending on circumstances or patients’ or societal values
2C/Weak recommendation, low quality evidenceBenefits closely balanced with risks and burdenObservational studies or case seriesVery weak recommendation, other alternatives may be equally reasonable

Other ABC1 [10 (link)] and ABC2 [1 ] statements with only minor updates or with no updates

RecommendationsLoE% Consensus
ABC IMPORTANT DEFINITIONS
 VISCERAL CRISIS is defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies, and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important visceral compromise leading to a clinical indication for a more rapidly efficacious therapy, particularly since another treatment option at progression will probably not be possible.Expert opinion95

  PRIMARY ENDOCRINE RESISTANCE is defined as: Relapse while on the first 2 years of adjuvant ET, or PD within first 6 months of 1st line ET for MBC, while on ET.

  SECONDARY (ACQUIRED) ENDOCRINE RESISTANCE is defined as: Relapse while on adjuvant ET but after the first 2 years, or Relapse within 12 months of completing adjuvant ET, or PD ≥ 6 months after initiating ET for MBC, while on ET.

  Note: resistance is a continuum and these definitions help mainly clinical trials and not necessarily clinical practice

Expert opinion67
GENERAL STATEMENTS
The management of ABC is complex and, therefore, involvement of all appropriate specialties in a multidisciplinary team (including but not restricted to medical, radiation, surgical oncologists, imaging experts, pathologists, gynecologists, psycho-oncologists, social workers, nurses and palliative care specialists), is crucial.Expert opinion100
From the time of diagnosis of ABC, patients should be offered appropriate psychosocial care, supportive care, and symptom-related interventions as a routine part of their care. The approach must be personalized to meet the needs of the individual patient.Expert opinion100

  Following a thorough assessment and confirmation of MBC, the potential treatment goals of care should be discussed. Patients should be told that MBC is incurable but treatable, and that some patients can live with MBC for extended periods of time (many years in some circumstances).

  This conversation should be conducted in accessible language, respecting patient privacy and cultural differences, and whenever possible, written information should be provided.

Expert opinion97
Patients (and their families, caregivers or support network, if the patient agrees) should be invited to participate in the decision-making process at all times. When possible, patients should be encouraged to be accompanied by persons who can support them and share treatment decisions (e.g. family members, caregivers, support network).Expert opinion100
There are few proven standards of care in ABC management. After appropriate informed consent, inclusion of patients in well-designed, prospective, independent trials must be a priority whenever such trials are available and the patient is willing to participate.Expert opinion100
The medical community is aware of the problems raised by the cost of ABC treatment. Balanced decisions should be made in all instances; patients’ well-being, length of life and preferences should always guide decisions.Expert opinion100
Specialized oncology nurses (if possible specialized breast nurses) should be part of the multidisciplinary team managing ABC pts. In some countries this role may be played by a physician assistant or another trained and specialized health care practitioner.Expert opinion92
All ABC patients should be offered comprehensive, culturally sensitive, up-to-date and easy to understand information about their disease and its management.1 B97
The age of the patient should not be the sole reason to withhold effective therapy (in elderly patients) nor to overtreat (in young patients). Age alone should not determine the intensity of treatment.1 B100
ASSESSMENT GUIDELINES
Minimal staging workup for MBC includes a history and physical examination, hematology and biochemistry tests, and imaging of chest, abdomen and bone.2 C67
Brain imaging should not be routinely performed in asymptomatic patients. This approach is applicable to all patients with MBC including those patients with HER-2+ and/or TNBC MBC.Expert opinion94
The clinical value of tumor markers is not well established for diagnosis or follow-up after adjuvant therapy, but their use is reasonable (if elevated) as an aid to evaluate response to treatment, particularly in patients with non-measurable metastatic disease. A change in tumor markers alone should not be used to initiate a change in treatment.2 C89

  Evaluation of response to therapy should generally occur every 2–4 months for ET or after two to four cycles for CT, depending on the dynamics of the disease, the location and extent of metastatic involvement, and type of treatment.

  Imaging of target lesions may be sufficient in many patients. In certain patients, such as those with indolent disease, less frequent monitoring is acceptable.

  Additional testing should be performed in a timely manner, irrespective of the planned intervals, if PD is suspected or new symptoms appear. Thorough history and physical examination must always be performed.

Expert opinion81
TREATMENT GENERAL GUIDELINES
Treatment choice should take into account at least these factors: HR and HER-2 status, previous therapies and toxicities, disease-free interval, tumour burden (defined as number and site of metastases), biological age, performance status, co-morbidities (including organ dysfunctions), menopausal status (for ET), need for a rapid disease/symptom control, socio-economic and psychological factors, available therapies in the patient’s country and patient preference.Expert opinion100
ER +/HER-2 NEGATIVE ABC
Endocrine treatment after CT (maintenance ET) to maintain benefit is a reasonable option, although this approach has not been assessed in randomized trials.1 C88
Concomitant CT+ET has not shown a survival benefit and should not be performed outside of a clinical trial.1 B100
CHEMOTHERAPY AND BIOLOGICAL THERAPY
Both combination and sequential single agent CT are reasonable options. Based on the available data, we recommend sequential monotherapy as the preferred choice for MBC. Combination CT should be reserved for patients with rapid clinical progression, life-threatening visceral metastases, or need for rapid symptom and/or disease control1 B96
In the absence of medical contraindications or patient concerns, anthracycline or taxane based regimens, preferably as single agents, would usually be considered as first line CT for HER-2 negative MBC, in those patients who have not received these regimens as (neo)adjuvant treatment and for whom chemotherapy is appropriate. Other options are, however, available and effective, such as capecitabine and vinorelbine, particularly if avoiding alopecia is a priority for the patient.1 A71
In patients with taxane-naive and anthracycline-resistant MBC or with anthracycline maximum cumulative dose or toxicity (i.e. cardiac) who are being considered for further CT, taxane-based therapy, preferably as single agents, would usually be considered as treatment of choice. Other options are, however, available and effective, such as capecitabine and vinorelbine, particularly if avoiding alopecia is a priority for the patient.1 A59
In patients pre-treated (in the adjuvant and/or metastatic setting) with an anthracycline and a taxane, and who do not need combination CT, single agent capecitabine, vinorelbine or eribulin are the preferred choices. Additional choices include gemcitabine, platinum agents, taxanes, and liposomal anthracyclines. The decision should be individualized and take into account different toxicity profiles, previous exposure, patient preferences, and country availability.1 B77
If given in the adjuvant setting, a taxane can be re-used as 1st line therapy, particularly if there has been at least 1 year of disease-free survival.1 A92
Duration of each regimen and the number of regimens should be tailored to each individual patient.Expert opinion96

  Usually each regimen (except anthracyclines) should be given until progression of disease or unacceptable toxicity.

  What is considered unacceptable should be defined together with the patient.

1 B72
OTHER AGENTS
Bevacizumab combined with a chemotherapy as 1st or 2nd line therapy for MBC provides only a moderate benefit in PFS and no benefit in OS. The absence of known predictive factors for bevacizumab efficacy renders recommendations on its use difficult. Bevacizumab can only therefore be considered as an option in selected cases in these settings and is not recommended after 1st/2nd line.1 A74
SPECIFIC POPULATIONS: TREATMENT OF METASTATIC MALE MBC
For ER+ Male MBC, which represents the majority of the cases, ET is the preferred option, unless there is concern or proof of endocrine resistance or rapidly progressive disease needing a fast response.Expert opinion100
For ER+ Male MBC tamoxifen is the preferred option.Expert opinion83

  For male patients with MBC who need to receive an AI, a concomitant LHRH agonist or orchidectomy is the preferred option. AI monotherapy may also be considered, with close monitoring of response.

  Clinical trials are needed in this patient population.

Expert opinion86
SPECIFIC SITES OF METASTASES
BONE METASTASES
Radiological assessments are required in patients with persistent and localized pain due to bone metastases to determine whether there are impending or actual pathological fractures. If a fracture of a long bone is likely or has occurred, an orthopaedic assessment is required as the treatment of choice may be surgical stabilization, which is generally followed by RT. In the absence of a clear fracture risk, RT is the treatment of choice.1 A96
Neurological symptoms and signs which suggest the possibility of spinal cord compression must be investigated as a matter of urgency. This requires a full radiological assessment of potentially affected area as well as adjacent areas of the spine. MRI is the method of choice. An emergency surgical opinion (neurosurgical or orthopaedic) may be required for surgical decompression. If no decompression/stabilization is feasible, emergency radiotherapy is the treatment of choice and vertebroplasty is also an option.1 B100
BRAIN METASTASES
Patients with a single or small number of potentially resectable brain metastases should be treated with surgery or radiosurgery. Radiosurgery is also an option for some unresectable brain metastases.1 B92
If surgery/radiosurgery is performed it may be followed by whole brain radiotherapy but this should be discussed in detail with the patient, balancing the longer duration of intracranial disease control and the risk of neurocognitive effects.1 B72
Because patients with HER2+ve MBC and brain metastases can live for several years, consideration of long-term toxicity is important and less toxic local therapy options (e.g. stereotactic RT) should be preferred to whole brain RT, when available and appropriate (e.g. in the setting of a limited number of brain metastases).1C89
LIVER METASTASES
Prospective randomized clinical trials of local therapy for BC liver metastases are urgently needed, since available evidence comes only from series in highly selected patients. Since there are no randomized data supporting the effect of local therapy on survival, every patient must be informed of this when discussing a potential local therapy technique. Local therapy should only be proposed in very selected cases of good performance status, with limited liver involvement, no extra-hepatic lesions, after adequate systemic therapy has demonstrated control of the disease. Currently, there are no data to select the best technique for the individual patient (surgery, stereotactic RT, intra-hepatic CT…).Expert opinion83
MALIGNANT PLEURAL EFFUSIONS
Malignant pleural effusions require systemic treatment with/without local management. Thoracentesis for diagnosis should be performed if it is likely that this will change clinical management. False negative results are common. Drainage is recommended in patients with symptomatic, clinically significant pleural effusion. Use of an intrapleural catheter or intrapleural administration of talc or drugs (e.g. bleomycin, biological response modifiers) can be helpful. Clinical trials evaluating the best technique are needed.2B86
CHEST WALL AND REGIONAL (NODAL) RECURRENCES
Due to the high risk of concomitant distant metastases, patients with chest wall or regional (nodal) recurrence should undergo full restaging, including assessment of chest, abdomen and bone.Expert opinion100
Chest wall and regional recurrences should be treated with surgical excision when feasible with limited risk of morbidity.1 B97
Locoregional radiotherapy is indicated for patients not previously irradiated.1 B97
For patients previously irradiated, re-irradiation of all or part of the chest wall may be considered in selected cases.Expert opinion97

In addition to local therapy (surgery and/or RT), in the absence of distant metastases, the use of systemic therapy (CT, ET and/or anti-HER-2 therapy) should be considered.

CT after first local or regional recurrence improves long-term outcomes primarily in ER negative disease. ET in this setting improves long-term outcomes for ER positive disease.

The choice of systemic treatment depends on tumor biology, previous treatments, length of disease free interval, and patient-related factors (co-morbidities and preferences).

1 B95

In patients with disease not amenable to radical local treatment, the choice of palliative systemic therapy should be made according to principles previously defined for metastatic BC.

These patients may still be considered for palliative local therapy.

Expert opinion97
SUPPORTIVE AND PALLIATIVE CARE
Supportive care allowing safer and more tolerable delivery of appropriate treatments should always be part of the treatment plan.1 A100
Early introduction of expert palliative care, including effective control of pain and other symptoms, should be a priority.1 A100
Access to effective pain treatment (including morphine, which is inexpensive) is necessary for all patients in need of pain relief.1 A100
Optimally, discussions about patient preferences at the end of life should begin early in the course of metastatic disease. However, when active treatment no longer is able to control widespread and life-threatening disease, and the toxicities of remaining options outweigh benefits, physicians and other members of the healthcare team should initiate discussions with the patient (and family members/friends, if the patient agrees) about end-of-life care.Expert Opinion96
ABC STATEMENTS FOR LABC (Note: For the purpose of these recommendations, LABC means inoperable, non-metastatic locally advanced breast cancer)
Before starting any therapy, a core biopsy providing histology and biomarker (ER, PR, HER-2, proliferation/grade) expression is indispensable to guide treatment decisions.1 B97
Since LABC patients have a significant risk of metastatic disease, a full staging workup, including a complete history, physical examination, lab tests and imaging of chest and abdomen (preferably CT) and bone, prior to initiation of systemic therapy is highly recommended.1 B100
PET-CT, if available, may be used (instead of and not on top of CTs and bone scan).2 B100

  Systemic therapy (not surgery or RT) should be the initial treatment.

  If LABC remains inoperable after systemic therapy and eventual radiation, ‘palliative’ mastectomy should not be done, unless the surgery is likely to result in an overall improvement in quality of life.

Expert opinion100
A combined treatment modality based on a multidisciplinary approach (systemic therapy, surgery and radiotherapy) is strongly indicated in the vast majority of cases.1 A100
For Triple Negative LABC, Anthracycline- and-taxane-based chemotherapy is recommended as initial treatment.1 A85
For HER-2+ LABC, concurrent taxane and anti-HER-2 therapy is recommended since it increases the rate of pCR.1 A92
For HER-2+ LABC, anthracycline-based chemotherapy should be incorporated in the treatment regimen.1 A72
When an anthracycline is given, it should be administered sequentially with the anti-HER-2 therapy.1 A87
Options for HR+ LABC include an anthracycline- and taxane-based chemotherapy regimen, or endocrine therapy.1 A85
The choice of CT versus ET, as initial treatment, will depend on tumor (grade, biomarker expression) and patient (menopausal status, performance status, comorbidities, preference) considerations.Expert Opinion85
Following effective neoadjuvant systemic therapy with or without radiotherapy, surgery will be possible in many patients. This will consist of mastectomy with axillary dissection in the vast majority of cases, but in selected patients with a good response, breast conserving surgery may be possible.2 B98
INFLAMMATORY LABC
For inflammatory LABC, overall treatment recommendations are similar to those for non-inflammatory LABC, with systemic therapy as first treatment.1 B93
Mastectomy with axillary dissection is recommended in almost all cases, even when there is good response to primary systemic therapy.I B95
Immediate reconstruction is generally not recommended in patients with inflammatory LABC.Expert opinion95
Loco-regional radiotherapy (chest wall and lymph nodes) is required, even when a pCR is achieved with systemic therapy.1 B98

GENERAL RECOMMENDATIONS

GUIDELINE STATEMENTLoEConsensus
The ABC community strongly calls for clinical trials addressing important unanswered clinical questions in this setting, and not just for regulatory purposes. Clinical trials should continue to be performed, even after approval of a new treatment, providing real world performance of the therapy.Expert opinion

 Voters: 43

 Yes: 100%

 Every advanced breast cancer patient must have access to optimal cancer treatment and supportive care according to the highest standards of patient centered care, as defined by:

 • Open communication between patients and their cancer care teams as a primary goal.

 • Educating patients about treatment options and supportive care, through development and dissemination of evidence-based information in a clear, culturally appropriate form.

 • Encouraging patients to be proactive in their care and to share decision-making with their health care providers.

 • Empowering patients to develop the capability of improving their own quality of life within their cancer experience.

 • Always taking into account patient preferences, values and needs as essential to optimal cancer care.

Expert opinion

 Voters: 44

 Yes: 100%

We strongly recommend the use of objective scales, such as the ESMO Magnitude of Clinical Benefit Scale or the ASCO Value Framework, to evaluate the real magnitude of benefit provided by a new treatment and help prioritize funding, particularly in countries with limited resources.Expert opinion

 Voters: 40

 Yes: 87.5% (35)

 Abstain: 5% (2)

The use of telemedicine oncology to help management of patients with ABC living in remote places, is an important option to consider when geographic distances are a problem and provided that issues of connectivity are solved.Expert opinion

 Voters: 42

 Yes: 92.8% (39)

 Abstain: 4.7% (2)

Strong consideration should be given to the use of validated PROMs (patient-reported outcome measures) for patients to record the symptoms of disease and side effects of treatment experienced as a regular part of clinical care. These PROMs should be simple, and user-friendly to facilitate their use in clinical practice, and thought needs to be given to the easiest collection platform, e.g. tablets or smartphones. Systematic monitoring would facilitate communication between patients and their treatment teams by better characterizing the toxicities of all anticancer therapies. This would permit early intervention of supportive care services enhancing quality of life1 C

 Voters: 39

 Yes: 87.1% (34)

 Abstain: 5.1% (2)

 As survival is improving in many patients with ABC, consideration of survivorship issues should be part of the routine care of these patients. Health professionals should therefore be ready to change and adapt treatment strategies to disease status, treatment adverse effects and quality of life, patients’ priorities and life plans.

 Attention to chronic needs for home and family care, job and social requirements, should be incorporated in the treatment planning and periodically updated.

Expert opinion

 Voters: 40

 Yes: 95% (38)

 Abstain: 5% (2)

ABC patients who desire to work or need to work for financial reasons should have the opportunity to do so, with needed and reasonable flexibility in their working schedules to accommodate continuous treatment and hospital visits.Expert opinion

 Voters: 42

 Yes: 100%

ABC patients with stable disease, being treated as a ‘chronic condition’, should have the option to undergo breast reconstruction.Expert opinion

 Voters: 39

 Yes: 82% (32)

 Abstain: 7.6% (3)

In ABC patients with long-standing stable disease, screening breast imaging should be an option.Expert opinion

 Voters: 40

 Yes: 52.5% (21)

 N: 47.5% (19)

Breast imaging should also be performed when there is a suspicion of loco-regional progression.Expert opinion

 Voters: 40

 Yes: 100%

A biopsy (preferably providing histology) of a metastatic lesion should be performed, if easily accessible, to confirm diagnosis particularly when metastasis is diagnosed for the first time.1 B

 Voters: 43

 Yes: 98% (42)

Biological markers (especially HR and HER-2) should be reassessed at least once in the metastatic setting, if clinically feasible. Depending on the metastatic site (e.g. bone tissue), technical considerations need to be discussed with the pathologist.1 B

 Voters: 44

 Yes: 98% (43)

If the results of tumour biology in the metastatic lesion differ from the primary tumor, it is currently unknown which result should be used for treatment-decision making. Since a clinical trial addressing this issue is difficult to undertake, we recommend considering the use of targeted therapy (ET and/or anti-HER-2 therapy) when receptors are positive in at least one biopsy, regardless of timing.Expert Opinion87%

 To date, the removal of the primary tumor in patients with de novo stage IV breast cancer has not been associated with prolongation of survival, with the possible exception of the subset of patients with bone only disease. However, it can be considered in selected patients, particularly to improve quality of life, always taking into account the patient’s preferences. Of note, some studies suggest that surgery is only valuable if performed with the same attention to detail (e.g. complete removal of the disease) as in patients with early stage disease.

 Additional prospective clinical trials evaluating the value of this approach, the best candidates and best timing are currently ongoing

2 B

 Voters: 44

 Yes: 70.4% (31)

 A small but very important subset of patients with ABC, for example those with oligo-metastatic disease or low volume metastatic disease that is highly sensitive to systemic therapy, can achieve complete remission and a long survival.

 A multimodal approach, including local-regional treatments with curative intent, should be considered for these selected patients.

Expert opinion

 Voters: 43

 Yes: 91% (39)

LoE, available level of evidence; consensus, percentage of panel members in agreement with the statement.

Publication 2016
Routine disease management costs, including hospitalizations, outpatient visits, and laboratory scans, were modeled using data from Xie et al. (2015) and applied monthly to the PF and PD states (Table 1).20 (link)Subsequent (second- and third-line) treatment costs were applied one-off at the start of the model evaluation. Not all patients were assumed to receive further treatment, and the case mix of subsequent therapies varied depending on whether a CDK 4/6 inhibitor was received at first line, to reflect the availability and expected use of palbociclib at second line after letrozole monotherapy. The use of a CDK 4/6 inhibitor after progression on a CDK 4/6 inhibitor at first line was not considered.
Total cost of subsequent treatment was calculated by multiplying the mean treatment duration in months by the monthly treatment cost and the market shares in a second-line or third-line setting. Market share and treatment data were sourced from Novartis, and the lowest WAC formulation on the market was used (data on file, Novartis, e-mail communications, 2016). Eribulin was chosen as a proxy representing all chemotherapies because it was the highest-cost first-line chemotherapy.
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Publication 2018
Disease Progression eribulin Hospitalization Letrozole Outpatients palbociclib Patients Pharmacotherapy Radionuclide Imaging

Most recents protocols related to «Eribulin»

Eribulin was administered intravenously at a dose of 1.4 mg/m2 on days 1 and 8 of each 21-day cycle. The physician could adjust the eribulin dose based on the severity of adverse events. The treatment was continued until the disease being progressed or encounter intolerable of toxicity.
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Publication 2024
Patient demographics, clinical characteristics, and eribulin treatment characteristics were collected by physicians from the information available in patient medical records.
Clinical outcomes from the initiation of eribulin treatment were assessed. The physician-reported real-world best overall response was abstracted from patient’s medical chart as recorded by the physician at the time of assessment and categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Real-world progression-free survival (rwPFS) was calculated from the date of eribulin initiation to the earliest date of physician-reported progression or death due to any cause while on eribulin treatment or within 90 days after eribulin treatment discontinuation, as long as no subsequent treatments had been initiated. Patients with no documented progression or death event were censored at 90 days after eribulin discontinuation, start of the new line of therapy, or at the last available follow-up in the medical record, whichever was earliest. Overall survival (OS) was calculated from the date of eribulin initiation to death due to any cause; if no death event occurred, patients were censored at the last available follow-up in the medical record.
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Publication 2024
For this retrospective cohort study, data were retrieved from the electronic medical records (eMRs) of patients with A/MBC treated with eribulin at China Medical University Hospital (CMUH) between 1 January 2015 and 30 June 2019. Female patients with locally recurrent or metastatic breast cancer, age ≥ 20 years and who received at least one cycle of eribulin for A/MBC were included. Patients with a second cancer or who did not have complete blood counts at the initiation of eribulin treatment or at 1, 3 and 6 months following eribulin initiation were excluded for further analysis.
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Publication 2024
A total of 40 patients diagnosed with MBC and treated with eribulin in Xi'an International Medical Center Hospital, Xi'an, China, from May 2022 to 2023 were retrospectively enrolled in this study. The patients included in the study had MBC and received treatment containing eribulin. All molecular subtypes were eligible for inclusion. However, patients with contraindications for anti-angiogenic therapy were excluded from the study. Patients' medical information was extracted from medical records, including patients' characteristics, treatment outcomes, treatment line, pretreated medicine history, and other combined treatments.
The specific regimen was determined based on guideline recommendations and the doctor's choice. A total of 40 patients received treatment including eribulin, with 22 patients receiving monotherapy with eribulin and 18 patients receiving eribulin in combination with anti-angiogenic medicine (bevacizumab or anlotinib). Combination therapy with anti-human epidermal growth factor receptor-2(HER-2) targeted treatment was allowed for HER-2-positive patients. The patient received 1.4 mg/m 2 of eribulin intravenous chemotherapy on the 1 st and 8 th day of each cycle, with bevacizumab (7.5 mg/kg, administered on the 1 st day of each cycle) or anlotinib (12 mg once daily for 14 consecutive days followed by a 7-day break) as an anti-angiogenic agent. The treatment regimen consisted of a 21-day cycle and continued until the disease progressed or intolerable toxicity occurred. After every two treatment cycles, the efficacy of the anti-tumour treatment was evaluated according to the response evaluation criteria in solid tumours (RECIST) version 1.1. 12 Ten clinical variables were recorded: Patient age, Eastern Cooperative Oncology Group (ECOG) performance status, hormone receptor (HR) (includes oestrogen receptor, ER, and / or progesterone receptor, PR) expression status, HER-2 expression status, Ki-67 levels, number of metastases, number of lines of eribulin treatment, whether combined with anti-angiogenic medicine therapy, history of taxane resistance, and the occurrence of grade 3-4 neutropenia after eribulin treatment.
Statistical analysis was performed using IBM SPSS 19.0 software. Qualitative variables were described by frequencies and percentages, continuous and ordinal variables by mean ± SD and median and interquartile ranges. The Kaplan-Meier method was used to calculate the median PFS (the time from the start of eribulin treatment to the time of disease progression) and the corresponding 95% confidence interval (CI). The log-rank test was used to compare differences in PFS between different groups. The Cox regression model was used for multivariate analysis. The Fisher exact probability test was used to compare the difference in adverse reactions between the two groups, with a level of significance set at p-value <0.05.
Publication 2024
This study focussed on the effect of eribulin after its initiation irrespective of whether it was continued or discontinued. Complete blood counts -including white blood cells, neutrophils and lymphocytes - were evaluated at four time points, which were determined based on the time since the eribulin initiation date (the index date). Practically, the lab data closest to the defined time points (within 2 weeks) were used for analysis. The first time point is baseline, just prior to the initial eribulin dose. At CMUH, a complete blood count is usually obtained at the beginning of each planed treatment cycle as part of the routine clinical practice. The subsequent three time points were at 1, 3 and 6 months after eribulin initiation. The NLR was calculated by dividing the number of neutrophils by the number of lymphocytes. The ALC and NLR were classified as high or low using a cut-off of 1000/µl for the ALC and 3 for the NLR; these values were chosen based on the available studies [5 (link), 14 (link), 22 (link), 23 (link)]. The trends in the ALC and NLR 1, 3 and 6 months after eribulin initiation were categorised as decreasing if the ALC and NLR were lower compared with baseline and non-decreasing (including increasing) if they were equal or higher compared with baseline.
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Publication 2024

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Eribulin is a synthetic analog of the natural product halichondrin B. It is a microtubule dynamics inhibitor that acts by binding to the plus end of microtubules, preventing their assembly and leading to cell cycle arrest and apoptosis.
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MDA-MB-231 is a cell line derived from a human breast adenocarcinoma. This cell line is commonly used in cancer research and is known for its aggressive and metastatic properties.
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The RNeasy Mini Kit is a laboratory equipment designed for the purification of total RNA from a variety of sample types, including animal cells, tissues, and other biological materials. The kit utilizes a silica-based membrane technology to selectively bind and isolate RNA molecules, allowing for efficient extraction and recovery of high-quality RNA.
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Paclitaxel is a pharmaceutical compound used in the production of various cancer treatment medications. It functions as a microtubule-stabilizing agent, which plays a crucial role in the development and regulation of cells. Paclitaxel is a key ingredient in the manufacture of certain anti-cancer drugs.
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MCF-7 is a cell line derived from human breast adenocarcinoma. It is an adherent epithelial cell line that can be used for in vitro studies.
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The BT549 is a laboratory instrument for cell culture applications. It is designed to provide a controlled environment for the growth and maintenance of cell lines.
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β-actin is a protein that is found in all eukaryotic cells and is involved in the structure and function of the cytoskeleton. It is a key component of the actin filaments that make up the cytoskeleton and plays a critical role in cell motility, cell division, and other cellular processes.
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Taq DNA polymerase is a thermostable enzyme derived from the bacterium Thermus aquaticus. Its primary function is to catalyze the synthesis of DNA strands during the polymerase chain reaction (PCR) process, which is a widely used technique in molecular biology and genetics.
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DMSO is a versatile organic solvent commonly used in laboratory settings. It has a high boiling point, low viscosity, and the ability to dissolve a wide range of polar and non-polar compounds. DMSO's core function is as a solvent, allowing for the effective dissolution and handling of various chemical substances during research and experimentation.
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Eribulin mesylate is a chemical compound developed by Eisai. It is a synthetic analog of the natural marine product halichondrin B, which is isolated from a species of marine sponge. Eribulin mesylate functions as an antineoplastic agent, specifically as a microtubule dynamics inhibitor.

More about "Eribulin"

Eribulin, a synthetic analog of the marine natural product halichondrin B, is an antineoplastic agent used for the treatment of certain types of cancer.
It functions by disrupting microtubule dynamics, leading to cell cycle arrest and apoptosis.
Eribulin has demonstrated efficacy in advanced or metastatic breast cancer and liposarcoma, and is approved for clinical use in these indications.
Researchers can utilize PubCompare.ai, an AI-powered platform, to optimize their Eribulin studies.
This tool allows them to easily locate and compare protocols from literature, preprints, and patents, enhancing reproducibility and accuracy.
The intelligent comparisons provided by PubCompare.ai can help researchers identify the best procedures and products for their Eribulin research, taking their studies to the next level.
In addition to Eribulin, researchers may also work with other related compounds and cell lines, such as MDA-MB-231, MCF-7, and BT549 breast cancer cell lines.
Commonly used techniques and reagents in Eribulin research include the RNeasy Mini Kit for RNA extraction, Paclitaxel as a microtubule-targeting agent, β-actin as a housekeeping gene, Taq DNA polymerase for PCR, and DMSO as a solvent.
By leveraging the insights and tools provided by PubCompare.ai, researchers can optimize their Eribulin studies and advance the understanding and treatment of cancer.