Rapidly changing breast cancer treatment

Ribociclib recommendation

[Invitation] Ae-Ri Han, Chairperson of Treatment Recommendation, Academic Chairperson In-Hye Park, Breast Cancer Society

The Korean Breast Cancer Society revised the treatment recommendation on the 27th.

 

Combination drug treatment using a combination of an antibody and an anticancer drug has emerged as a hot issue, and as the new anticancer drug Enhertu for HER2-positive metastatic breast cancer received domestic approval in September last year, the reflection of this is emerging as a concern.

 

In the case of new drugs, society reflects them if there is evidence, while also preparing new recommendations for rare cases that have been neglected.

 

It means that it presented an 'answer' based on expert consensus in areas where large-scale randomized clinical studies were lacking due to the small number of patients, such as male breast cancer, osteoporosis treatment in breast cancer patients, and familial breast cancer, which depended on individual judgment of medical staff.

 

Given that the clinical field of breast cancer is rapidly changing due to the emergence of various new drugs and treatments, society adheres to preparing revisions every two years.

 

Even with a 'short cycle' of 2 years, it contains a lot of changes.

 

We met Ae-Ri Han (Department of Breast Surgery, Yonsei Wonju University) and In-Hye Park (Department of Oncology, Korea University Guro Hospital), chair of the Breast Cancer Society, to hear about major changes.

 

Usually, guidelines and recommendations are based on data.

 

After the evidence is accumulated and verified over time, it goes through the usual procedure reflected in the guidelines.

 

The problem is in the case of rare cancers, where it is difficult to accumulate data despite the passage of time.

 

The need for a minimum 'guidance' that relied entirely on the judgment of medical staff has been a demand in the clinical field.

 

(From left) Han Ae-ri, chair of the breast cancer society, and Park In-hye, chair of the academic committee

Chairman Han expressed the biggest change in this recommendation as 'interest in the minority.

 

"Because recommendations are not standard medical guidelines, they do not mean that they must be done as they are," she said.

 

Usually, for rare cases, foreign studies are referred to.

 

It was not easy to find high-quality research data abroad for the rare cases included in this guideline.

 

Chairman Han said, "The most reliable data is a randomized clinical trial involving a long period of time and a large number of patients, but the cases mentioned above have physical limitations in conducting such clinical trials.

 

This is the same situation in Korea as well as abroad." Explained.

 

The society decided to support smooth use through recommendations on the use of Enhertu, which is on the verge of reimbursement.

 

Enhertu drew attention last year with a national consent petition urging 50,000 people to request rapid approval.

 

Even after the domestic approval in September of last year, as 50,000 people urged public consent for health insurance, it emerged as a topic of interest in the breast cancer academic community.

 

Park In-hye, chairman of the Academic Committee (Korea University Guro Hospital), said, “Enhertu’s insurance review has already been completed and some adjustments remain, so the review will begin again in May soon.” Since locals use it a lot, I think a similar level of decision will come out." She said, "I think that insurance benefits will be available to patients after the review in May in Korea." She said, “Especially, as the treatment indications for Enhertu are getting wider, the number of patients who can be treated with Enhertu is expected to gradually increase.” Chairman Han Ae-ri said, "Because the level of evidence must be high, it is difficult to unconditionally reflect in the recommendation that a new drug has been released, but all cases that meet the criteria such as Enhertu are reflected in this guideline." I thought it was, so I didn't reflect it," she explained.

 

“The National Comprehensive Cancer Network (NCCN) has recommended Ribociclib as a first-class among CDK 4/6 inhibitors,” she said.

 

“In Korea, Palbociclib was first launched in 2016 and is a generic drug.

 

Abemaciclib and Ribociclib are competing, but experts are also divided on whether to switch to another drug if they are currently taking Palbociclib.” Although not enough data has been accumulated to change the recommendation, it was not easy to make a decision because the recommendation level for late-comer drugs is being raised overseas.

 

In particular, it was also pointed out that if the prognosis worsens after first administering Ribociclib, there is no other drug that can be used.

 

Chairman Han said, “There was an opinion that existing drugs should be used first and new drugs should be used as a last resort in preparation for a worsening prognosis, but in the end, there were more opinions that good drugs should be used from the beginning.” I also gave a lecture about using good medicine first from the beginning.” "Currently, the market is changing due to competition in generics such as Ribociclib, and the recommended level is also changing, so it is true that there is confusion in the clinical field," said Han.

 

Chairman Han added, "If there is an effective treatment, I think it is the mission of the society to reflect and recommend it."