Ribociclib (Kisqali) as part of hormone therapy in subsequent treatment of advanced breast cancer in women before and during menopause

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of ribociclib as part of hormone therapy in subsequent treatment of advanced hormone-receptor-positive and HER2-negative breast cancer before and during menopause, compared with the standard treatments. Ribociclib was assessed in combination with an aromatase inhibitor and in combination with the anti-estrogen drug fulvestrant.

Ribociclib in combination with an aromatase inhibitor

The manufacturer provided data from one study. 100 women received ribociclib – mostly in combination with the aromatase inhibitor letrozole – and 105 women were given the standard treatment of letrozole in combination with a placebo (fake medication). All of the women also received a GnRH analogue as part of their treatment. This is what was found:

What are the advantages of ribociclib?

Pain: Early results suggest that ribociclib has an advantage here.

Perspective on the future and cognitive functioning: The initial results suggest that ribociclib has an advantage in these aspects of quality of life. In the study, women who had also had treatment with ribociclib were more optimistic about their future. They were also better able to concentrate and remember things. There was no difference in any of the other aspects of quality of life. The study doesn’t include any suitable data on satisfaction with sexuality.

What are the disadvantages of ribociclib?

Serious side effects: Overall, the study suggests that ribociclib has a disadvantage here. In the group that had additional treatment with ribociclib, about 80 out of 100 women experienced serious side effects. This was the case in about 38 out of 100 women who had the standard treatment.

These serious side effects included blood disorders and lymphatic system disorders: The study suggests that ribociclib has a disadvantage here as well: In the group of women who also had treatment with ribociclib, about 56 out of 100 women developed one of the disorders – compared to about 8 out of 100 women who only had treatment with letrozole.

No difference

Life expectancy: There was no difference here. The women in each group passed away after an average (median value) of about 37 months.

Symptoms of the disease: The available data doesn't show any (relevant) differences regarding many of the symptoms of the disease, such as:

  • Exhaustion
  • Nausea and vomiting
  • Breathing problems
  • Sleep problems
  • Loss of appetite
  • Constipation
  • Diarrhea
  • Problems affecting the arms
  • Problems affecting the chest area

Treatment stopped due to side effects: There was no difference here either.

What remains unanswered?

General health: The study didn’t include any suitable data about the effect of ribociclib on general health.

Distress caused by hair loss: The study didn’t offer any suitable data about possible distress caused by hair loss, either.

Ribociclib combined with fulvestrant

The manufacturer didn’t provide any suitable studies on this combination.

So it's not possible to tell whether the combination of ribociclib and fulvestrant has any advantages or disadvantages compared to the standard treatment for advanced hormone-receptor-positive and HER2-negative breast cancer in women before and during menopause when previous hormone therapy was unsuccessful.

More information

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

Labels: C50, Kisqali, Ribociclib