Case study*

N.S., a patient with triple-negative mBC and visceral metastases

Patient history and treatment
  • N.S. is a 62-year-old, postmenopausal woman

  • She has a past medical history of hypertension

  • N.S. underwent left lumpectomy plus sentinel lymph node sampling



INITIAL SURGERY/LABORATORY FINDINGS
Tumor type Invasive ductal carcinoma Lymph node status None
Clinical tumor size 3 cm ER status <1%
Histologic grade 2 PR status 0
Stage pT2 N0 HER2/neu status 0 by IHC
Tumor Type Invasive ductal carcinoma
Clinical tumor size 3 cm
Histologic grade 2
Stage pT2 NO
Lymph node status None
ER status <1%
PR status 0
HER2/neu status 0 by IHC

ER=estrogen receptor; PR=progesterone receptor; HER2/neu=human epidermal growth factor receptor 2;
IHC=immunohistochemistry.


Adjuvant treatment
  • N.S. was treated with dose-dense AC (doxorubicin and cyclophosphamide) followed by dose-dense paclitaxel for 4 cycles

  • She also received radiation therapy to the left breast


Disease progression
  • About 1.5 years later, N.S. presented to her primary physician with fatigue and vague gastrointestinal complaints

  • Her blood work revealed mildly increased liver function tests

  • An extent of disease workup with CT scans of chest, abdomen, and pelvis, along with a bone scan, revealed the presence of liver and bone metastases

  • A liver biopsy was consistent with mBC that was ER, PR, and HER2/neu negative

CT=computed 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.

Anthracyclines were the standard of care in adjuvant treatment at the time.

mBC treatment history


PREVIOUS METASTATIC TREATMENT

Clinical findings

  • ECOG PS: 1
LABORATORY FINDINGS
PARAMETER PATIENT N.S.'S RESULTS
Liver GGT 87 U/L
ALP 200 U/L
ALT 52 U/L
Serum creatinine 0.9 g/dL
WBC 7.9 x 103/μL
Hemoglobin 11.5 g/dL
Platelets 158 x 103/μL

ECOG PS=Eastern Cooperative Oncology Group performance status; GGT=gamma-glutamyl transferase; ALP=alkaline phosphatase; ALT=alanine aminotransferase; WBC=white blood cell.


WHAT FACTORS DO YOU TAKE INTO ACCOUNT WHEN CHOOSING A METASTATIC REGIMEN FOR YOUR PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER?



Based on the Phase III EMBRACE trial, N.S. was identified as appropriate for treatment with HALAVEN®1

After receiving an anthracycline and a taxane in the adjuvant setting and following the 2 prior chemotherapies for mBC, N.S. may begin third-line treatment with HALAVEN


SELECTED PATIENT FACTORS
PATIENT N.S.'S BASELINE
CHARACTERISTICS
EMBRACE BASELINE
PATIENT CHARACTERISTICS

HALAVEN (n=508)
ECOG PS: 1 48%
Triple negative
(HER2/neu-, ER-, PR-)
18%
Site of involvement: lung 39%
2 prior mBC
chemotherapy regimens
43%
N.S.'S BASELINE
CHARACTERISTICS
ECOG PS: 1
Triple negative
(HER2/neu-, ER-, PR-)
Site of involvement: lung
2 prior mBC
chemotherapy regimens
EMBRACE BASELINE PATIENT CHARACTERISTICS
HALAVEN (n=508)
ECOG PS: 1 48%
Triple negative
(HER2/neu-, ER-, PR-)
18%
Site of involvement: lung 39%
2 prior mBC
chemotherapy regimens
43%

EMBRACE=Eisai Metastatic Breast Cancer Study Assessing Physician's Choice versus E7389 (Eribulin).

*Subject to patient eligibility.

Indications

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.

Liposarcoma

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.

Adverse Reactions

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.