Breast Cancer – NERLYNX for Leptomeningeal Metastases


The spread of cancer cells beyond the original site of the tumor is a very challenging process. When cancer cells of the breast are found somewhere distant (e.g., the brain, lungs), we say that the tumor has metastasized.

Unfortunately, the outcome of patients with metastatic cancers is often poor. Moreover, when the tumor affects certain body parts, complications rapidly occur. A prime example of this process is metastases that reach the brain.

In this article, we will cover the new evidence for the effectiveness of Neratinib in the management of leptomeningeal metastases of HER2+ breast cancer.

What is Neratinib?

Neratinib is an irreversible pan-HER inhibitor that helps patients with HER2-positive breast cancer.

Mainly, this drug is used to treat the early stages of HER2-positive breast cancer after surgery. You might hear doctors refer to it as extended adjuvant therapy.

To understand how this drug works, we first need to tackle the concept of HER2-positive breast cancer. In simple words, this type of cancer means that the tumor cells produce the HER2 proteins in excessive quantities. These proteins serve as receptors on the surface of cancer cells. Once activated, they send signals to the cells to grow and proliferate.

Neratinib helps in this situation by blocking the activation of HER2 proteins. The drug irreversibly binds to the receptors, preventing any signals that activate the growth of the tumor.

Neratinib received approval from the United States Food and Drug Administration (FDA) on July 17, 2017, for extended adjuvant treatment of early stage HER2-positive breast cancer.

We should note that around a quarter of all breast cancer cases are HER2-positive.

What are leptomeningeal metastases?

Doctors refer to cancers that spread to the lining membranes of the brain and spinal cord as leptomeningeal metastases.

In medicine, the leptomeninges are thin membranes that cover the brain and spinal cord. Between these membranes, we can find the cerebrospinal fluid (CSF).

While this type of tumor spread is relatively uncommon in breast cancer – around 5% of HER2-positive cases, they have a very poor survival odds, which motivated researchers to look for effective solutions.

What does the new study tell breast cancer patients?

The study that inspected the effects of Neratinib on leptomeningeal metastases of HER2-positive breast cancer had the following inclusion criteria:

  • Patients had to be over the age of 18 years
  • Histological evidence of HER2-positive
  • A Karnofsky Performance Status Scale ≥60 (a special score the patient’s basic capacities)
  • Systemic disease with a life expectancy of at least 3 months

The drug – Neratinib – was administered daily continuously at a dose of 240 mg. The primary endpoint was the survival after getting diagnosed with leptomeningeal metastases.

Secondary endpoints included:

  • The time until the disease progressed under the treatment with Neratinib, also called Progression-free survival (PFS)
  • Neurological benefit
  • Radiological response rate
  • Tolerability of the drug

The study enrolled 9 patients with leptomeningeal metastases during a 40-month period. After the start of the treatment, the survival was around 3.5 months. Two out of the nine patients experienced significant neurological improvement, whereas four patients achieved neurological stabilization that lasted over 5 months.

As for the side effects, only 2 patients experienced mild diarrhea.

Takeaway message in breast cancer

Finding new therapies for leptomeningeal metastases of HER2-positive is crucial to improve the overall survival of these patients. Neratinib might be a good candidate for this position.

Speak with your doctor to see whether you are a candidate for this treatment.

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Breast Cancer - NERLYNX (Neratinib) for Leptomeningeal Metastases
Breast Cancer – NERLYNX (Neratinib) for Leptomeningeal Metastases


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