mBC is a multidimensional disease

Important characteristics to consider about your patients include1:


  • Quantification of general well-being and progression of disease
    • ECOG PS

  • Receptor status
    • Tumor ER/PR and HER2/neu status of metastatic site

  • Treatment history
    • Prior lines of therapy in adjuvant and metastatic breast cancer setting

  • Sites of involvement
    • Visceral vs nonvisceral metastases


TAKING ALL FACTORS INTO ACCOUNT ENABLES YOU TO ADDRESS THE NEEDS OF YOUR PATIENTS WITH mBC

ECOG PS=Eastern Cooperative Oncology Group performance status;
ER=estrogen receptor; PR=progesterone receptor; HER2/neu=human epidermal growth factor receptor 2.


Visceral disease indicates a more aggressive cancer in patients with mBC2-6


The prevalence of visceral disease shouldn't be underestimated2-5


Studies in patients with mBC have shown that


A range of 51.5%-82.9% of patients with mBC had visceral metastases in 3 retrospective studies (n=263-640) and 1 prospective study (n=486) conducted in various European countries.




The site of first metastases is a prognostic factor that is associated with patient survival6


SURVIVAL BY SITE OF FIRST METASTASIS

*Survival=interval between first distant metastasis and death or last follow-up.

Retrospective data from 648 patients with mBC who were first treated between 1977 and 1985 were statistically analyzed.




These studies analyzed the impact of patient and tumor characteristics on efficacy measures such as OS and do not reflect the efficacy outcomes of the clinical trial of HALAVEN® (eribulin mesylate) Injection vs TPC (13.2 months in the HALAVEN arm vs 10.6 months in the TPC arm).3,6,7

OS=overall survival; TPC=Treatment of Physician's Choice.

*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.

 

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2017. © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed January 11, 2018. 2. Savci-Heijink CD, Halfwerk H, Hooijer GKJ, Horlings HM, Wesseling J, van de Vijer MJ. Retrospective analysis of metastatic behaviour of breast cancer subtypes. Breast Cancer Res Treat. 2015;150(3):547-557. 3. Bonotto M, Gerratana L, Poletto E, et al. Measures of outcome in metastatic breast cancer: insights from a real-world scenario. Oncologist. 2014;19(6):608-615. 4. Wallwiener M, Hartkopf AD, Baccelli I, et al. The prognostic impact of circulating tumor cells in subtypes of metastatic breast cancer. Breast Cancer Res Treat. 2013;137:503-510. 5. Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005;104(8):1742-1750. 6. Solomayer EF, Diel IJ, Meyberg GC, Gollan C, Bastert G. Metastatic breast cancer: clinical course, prognosis and therapy related to the first site of metastasis. Breast Cancer Res Treat. 2000;59(3):271-278. 7. HALAVEN [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2016.