Ribociclib (Kisqali) as part of subsequent hormone therapy for advanced breast cancer in women after menopause

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last looked into the advantages and disadvantages of ribociclib (Kisqali) when used as part of subsequent hormone therapy for advanced hormone-receptor-positive and HER2-negative breast cancer in women after menopause when compared with the standard treatments. Ribociclib was assessed in combination with fulvestrant.

The manufacturer provided one study comparing the combination of ribociclib and fulvestrant with the standard treatment fulvestrant in combination with a placebo (fake treatment).

The data of a total of 139 women was analyzed for this assessment. 100 of these participants had treatment with ribociclib and fulvestrant, and the remaining 39 were given fulvestrant with a placebo. This is what was found:

What are the advantages of ribociclib?

Health-related quality of life: The patients were asked whether they had emotional problems such as feeling irritable, down, worried or tense. The results suggest that, in patients over the age of 65, these problems are less common in those who have treatment with ribociclib and fulvestrant than in those who use fulvestrant on its own. About 20 out of 100 women who had treatment with ribociclib and fulvestrant reported experiencing emotional problems, compared to about 56 out of 100 women in the comparison group.

What are the disadvantages of ribociclib?

Serious side effects: The study suggests that ribociclib has a disadvantage here: About 81 out of 100 people had severe side effects during treatment with ribociclib and fulvestrant, compared to about 28 out of 100 people who had treatment with fulvestrant alone.  

These serious side effects included blood disorders and lymphatic system disorders. Severe neutropenia was the most common. In neutropenia the person has a lack of cells. About 48 out of 100 women developed blood or lymphatic system disorders while having treatment with ribociclib and fulvestrant, compared to 5 out of 100 women in the other group.

Skin problems: The study suggests that ribociclib has a disadvantage in terms of this side effect, too. About 56 out of 100 women who had treatment with ribociclib and fulvestrant developed skin problems, compared to about 21 out of 100 women who used fulvestrant on its own.

Treatment stopped due to side effects: Here too, the study suggests that ribociclib and fulvestrant has a disadvantage compared to fulvestrant on its own. About 24 out of 100 women who had treatment with ribociclib and fulvestrant stopped their treatment early due to the side effects, compared to about 5 out of 100 women in the other group.

No difference

Life expectancy: There was no difference here between the patients who had treatment with ribociclib and fulvestrant and the patients who were given fulvestrant on its own.

Symptoms of the disease: The study showed no difference between the two groups in terms of symptoms of the disease.

Health-related quality of life: There was no difference here either, aside from emotional problems.

What remains unanswered?

The manufacturer didn’t provide any usable data regarding overall health or pain.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of ribociclib (Kisqali).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ribociclib (breast cancer; combination with fulvestrant)  – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-22. May 28, 2020. (IQWiG reports; Volume 918).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on July 16, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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