MEET KIM, A PATIENT WITH
HR+, HER2/neu- mBC with progressive visceral metastases
Socially and physically active; ECOG PS: 0
Left breast pain and palpable mass
ER=estrogen receptor; PR=progesterone receptor; HER2/neu=human epidermal growth factor receptor 2.
Adjuvant AC-T chemotherapy followed by radiation and adjuvant endocrine therapy with anastrozole
Diagnosis of metastatic disease
1.5 years after starting anastrozole, Kim presented with abdominal discomfort
Multiple lymph nodes and liver lesions were evident on PET/CT scan
Biopsy confirmed that her receptor status was unchanged
HR=hormone receptor; mBC=metastatic breast cancer; ECOG PS=Eastern Cooperative Oncology Group performance status; AC-T=doxorubicin hydrochloride+ cyclophosphamide, followed by paclitaxel; PET=positron emission tomography; CT=computerized tomography.
*This case study presents a hypothetical patient. HALAVEN® (eribulin mesylate) Injection (0.5 mg per mL) is not appropriate for all patients.
This information should not substitute for the independent medical judgment of the treating physician.
Kim's mBC treatment history
HORMONAL TREATMENT: CDK4/6 inhibitor + fulvestrant
Stable disease for 5 months, then progression to new liver and lung metastases
FIRST-LINE CHEMOTHERAPY: Single-agent paclitaxel
Liver and lung metastases initially responded to treatment
Noted progression of visceral disease after 9 months
SECOND-LINE CHEMOTHERAPY: Single-agent capecitabine
Disease progressed after 4 months
Kim reported abdominal pain and worsening dyspnea
Kim's laboratory findings showed normal blood cell counts but indicated rapidly progressing liver metastases
KIM'S CLINICAL FACTORS INCLUDE:
Symptomatic visceral disease
Rapid progression of disease-liver/lung
2 prior chemotherapies for mBC
mBC=metastatic breast cancer; CDK4/6=cyclin-dependent kinase 4/6.
HALAVEN® may be an appropriate treatment for Kim
Best viewed on flat surface in landscape view.
EMBRACE=Eisai Metastatic Breast Cancer Study Assessing Physician's Choice versus E7389 (Eribulin); ECOG PS=Eastern Cooperative Oncology Group performance status; ER=estrogen; PR=progesterone; HER2/neu=human epidermal growth factor receptor 2; mBC=metastatic breast cancer.
Metastatic Breast Cancer
HALAVEN (eribulin mesylate) Injection is indicated for the treatment of patients with metastatic breast cancer (mBC) who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Important Safety Information
Warnings and Precautions
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.
Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.
QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).
In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).
Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.
Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.
Reference: 1. Data on file, Eisai Inc.