CDK4/6 anticancer drug is very active in early breast cancer

Conversation between Nadia Harbeck and Professor Lim Seok-ah

Korean breast cancer with many young patients, higher risk of recurrence

It is more cost-effective to spend a limited period of time as a benefit early on

The activity of CDK4/6 inhibitors in early breast cancer is not limited to Verzenio.

 

Kisqali also presented data on adjuvant therapy after successful surgery at ASCO held in June.

 

Although they are the same class of drugs, the clinical designs of the two drugs in early breast cancer are different in many ways.

 

First, Verzenio was targeted for high-risk patients with lymph node metastasis.

 

On the other hand, Kisqali did not limit the presence of lymph node metastases.

 

Relatively less risky patient groups were also included in the clinical trial.

 

The dose and duration of administration are also different.

 

Verzenio uses the same dose as for metastatic breast cancer, and after two years of administration, only endocrine therapy is continued.

 

On the other hand, Kisqali lowered the dose by two-thirds and set the duration of administration to 3 years while conducting clinical trials.

 

It appears to be intended to lower the risk of side effects by reducing the dose.

 

CDK4/6 inhibitor options are increasing in early breast cancer, but their use in the field is still limited.

 

This is because there are no drugs that have entered the right to benefit.

 

HIRA reviewed Verzenio's early breast cancer reimbursement standards in May but did not set standards.

 

There is also a prejudice against early cancer.

 

It is a view that the patient group is wider than terminal cancer and that life is not in a relatively dangerous situation.

 

At the same time, there are practical questions about whether it would be cost-effective to spend significant drug costs on all 100 people to reduce the risk of recurrence in several people.

 

Dailypharm listened to changes and improvements in treatment strategies for early breast cancer through a conversation with Professor Nadia Harbeck, head of the breast center at Munich University, Germany, and Professor Lim Seok-ah, Department of Hematology and Oncology, Seoul National University Hospital.

 

Professor Lim Seok-ah

-There are increasing cases of CDK 4/6 inhibitors spreading to early breast cancer.

 

How to expect to meet the prognosis and unmet needs of early breast cancer patients in terms of quality of life.

 

=Professor Lim Seok-ah: Korea has a well-operated breast cancer screening system, so there are many early breast cancer cases.

 

About 80% of breast cancers are of the HR+ type, and the number of patients with this type is relatively high among young people between the ages of 45 and 55.

 

In the West, premenopausal female patients account for 20-30% of all breast cancer patients, but in Korea, they account for almost half.

 

Young women's breast cancer has a slightly more aggressive characteristic, especially among the HR+ types, the luminal B type has a faster tumor growth rate than the luminal A type.

 

In light of treatment experience, the proportion of patients with Luminal B type is higher in HR+ breast cancer among women in their 40s and 50s in Korea.

 

In these patients, relapse is quite common during the first 2 to 3 years of endocrine therapy for 5 years after surgery.

 

Personally, I believe that reducing the recurrence rate by using Verzenio for 2-3 years, when the recurrence frequency is high, can yield important results that increase the patient's chance and possibility of a full recovery.

 

Korea has recently started to use ovarian function inhibitors and aromatase inhibitors as adjuvant therapy for HR+/HER2- breast cancer.

 

Now, with the addition of Verzenio, we believe that the treatment strategy will proceed in the direction of improving the prognosis by reducing the recurrence rate of early breast cancer patients, including premenopausal women.

 

=Professor Nadia Harbeck: Patients with HR+/HER2- early breast cancer had significant unmet needs in the past.

 

Even if patients underwent endocrine therapy or chemotherapy, the data in terms of survival were not good.

 

It is very encouraging that Verzenio can now be used in early patients to increase the chances of a full recovery.

 

This is because cure is the ultimate treatment goal in early breast cancer.

 

Professor Nadia Harbeck

-Recently, following Verzenio, other CDK 4/6 inhibitors also released new data in the field of early breast cancer.

 

What are the prospects for the use of CDK 4/6 inhibitors in the field of early breast cancer in the future?

 

Along with this, there are opinions that administering drugs to 100 patients to prevent the risk of recurrence in about 3 patients is not cost-effective.

 

What do you think?

 

=Professor Lim: The appearance of CDK 4/6 inhibitors is providing hope to early breast cancer patients who have been fearful of recurrence due to limited treatment options.

 

In addition, as clinical trials were conducted for patients with a high risk of recurrence, it plays an important role in preventing high-risk early breast cancer patients from spreading to recurrent and metastatic breast cancer.

 

If other clinical studies are successfully completed, the use of CDK 4/6 inhibitors in reducing the risk of recurrence of early breast cancer will be broadened.

 

Treatment for early breast cancer has a fixed duration.

 

If the recurrence of a patient can be prevented through active therapeutic intervention in the early stage of breast cancer for a certain period of time, the social and economic medical costs of the patient in the stage of metastatic and advanced breast cancer can be reduced.

 

When reviewing cost-effectiveness, these factors should also be considered.

 

- Since Verzenio was approved in Germany last year, reimbursement was applied immediately.

 

What are the criteria for determining the salary?

 

What are the effects experienced in actual clinical settings?

 

=Professor Harbeck: In Germany, reimbursement starts immediately for drugs approved by the European Medicines Agency (EMA).

 

Verzenio's prescription and reimbursement are conducted according to the monarchE research standards, and overall, both medical staff and patients are having a fairly positive experience.

 

As a participant in one of the actual monarchE clinical research sites, following the experience in the research process, prescriptions are being routinely conducted in the real world.

 

In actual clinical settings, there are patients who need dose adjustment due to some diarrhea or fatigue at the beginning of treatment, but most of them are satisfied with the treatment and have excellent treatment compliance.

 

Because patients know that they are at high risk of recurrence, they are very satisfied that there is a new treatment available to them that can protect them from the risk of recurrence.