Another Good News for Breast Cancer Patients (with ER positive, HER2 negative)

When to go for hormonal therapy in advanced breast cancer?

In advanced breast cancer, two criteria when deciding suitability for hormonal therapy are:

• Estrogen receptor (ER) positive and HER2 negative
• NOT in visceral crisis

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.

4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)

Examples are:

• Brain leptomeningeal metastases
• Significant liver metastases causing liver functional compromise (raised bilirubin in absence of extrahepatic obstruction, significantly elevated transaminases)
• Widespread lung metastasis or lymphangitis carcinomatosis causing impending respiratory failure
• Bone marrow infiltration causing pancytopenia/ bicytopenia

Just a quick recap

As can see from above, newer and more effective hormonal combination therapies emerged since the past few years.

Results from addition of CDK 4/6 inhibitors (below) onto hormonal therapy backbone were positive (see below table).

Progression free survival DOUBLED with addition of CDK 4/6 inhibitors (palbociclib, ribociclib or abemaciclib) onto hormonal therapy (letrozole/ anastrozole) in advanced breast cancer ER positive, HER2 negative. Overall survival was similar because availability of more effective treatments post-progression of breast cancer.

All CDK 4/6 inhibitors are fairly similar in efficacy (reducing risk of progression by 42% – 46%)

The difference between CDK 4/6 inhibitors are mainly at the side effect profiles.

• Less hepatotoxicity with palbociclib
• Potential for QT interval prolongation with ribociclib
• Less neutropenia with abemaciclib (compared to palbociclib and ribociclib)
• Slightly more diarrhea associated with abemaciclib

Above are adverse events for CDK 4/6 inhibitors (palbociclib, ribociclib and abemaciclib). Grade 3 and grade 4 adverse event/ side effects are side effects that require hospital admission and dose adjustment/ reduction.

As you can see from above, abemaciclib’s side effect, diarrhea is less worrisome and easily managed.

Good news?

However, abemaciclib is not available in Malaysia yet but will be coming to Malaysia soon.

Before arriving at Malaysia, Abemaciclib Named Patient Use (NPU) program will allow patients early assess to abemaciclib.

A Named Patient Use (NPU) programme provides patients and physicians access to medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a NPU.

How to apply?

The program will commenced soon, with limited number of candidates per country.

Talk to your oncologist.

If you fulfil all the criteria, then you will benefit from this medication earlier.

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