KISQALI® (ribociclib) quality of life in eBC

Indications:¹

• KISQALI in combination with an aromatase inhibitor (AI), is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) at high risk of recurrence (see section 5.1 of the SmPC for eligibility criteria)

• In pre– or perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist

KISQALI is not recommended to be used in combination with tamoxifen.¹

For more information on the safety profile of KISQALI in eBC, click here. 

Please consult your local Summary of Product Characteristics (SmPC) for the full KISQALI safety and tolerability profile.

In a pre-specified health-related quality of life (HRQoL) analysis of the NATALEE trial, KISQALI + NSAI showed no clinically meaningful difference in QoL vs NSAI at 3 years*^2,3

The NATALEE trial was a multicentre, randomised, open-label Phase III clinical trial of KISQALI + NSAI vs NSAl alone in the adjuvant treatment of HR+/HER2– eBC (N= 5101). Patients received KISQALI 400 mg/d (3 weeks on/1 week off) + NSAl for 3 years while NSAl continued ≥5 years. Any ET was permitted for ≤1 year prior to randomisation. Men and premenopausal women also received goserelin.^4,5

The primary endpoint of the NATALEE trial^† was met at the primary analysis (cut-off: 11 January 2023). A statistically significant improvement in invasive disease-free survival (iDFS) (HR=0.748: 95% CI: 0.618–0.906, 1-sided stratified log-rank test p=0.0014) was demonstrated in patients receiving KISQALI + NSAI vs NSAI alone.¹ A secondary endpoint of the NATALEE trial was HRQoL.^2,3

Prespecified HRQoL analysis

The European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC QLQ–30) incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status/QoL scale, and a number of single items.⁶

Treatment goals extend beyond prolonging survival and can include preserving QoL and improving adherence⁷

Poor adherence to treatment has been associated with disease recurrence and deterioration in QoL^2,7

The following study was supported by Novartis who provided funding and editorial assistance.

In this study, women with self-reported stage II or III eBC thought the most important attributes of treatment were efficacy and low risk of symptomatic AEs⁷

Relative importance of each treatment attribute:^§

Adapted from Mayer EL, et al. 2023.⁷

Summary of safety profile for KISQALI

The most common adverse drug reactions (reported at a frequency ≥20%) in the dataset for which the frequency for KISQALI + NSAI exceeds the frequency for NSAI alone were neutropenia, infections, nausea, headache, fatigue, leukopenia and abnormal liver function tests. The most common grade 3/4 adverse drug reactions (reported at a frequency of ≥2%) in the dataset for which the frequency for KISQALI + NSAI exceeds the frequency for NSAI alone were neutropenia, abnormal liver function tests and leukopenia.¹

Dose reduction and permanent discontinuation due to adverse events, occurred in 22.8% and 19.5% of patients receiving KISQALI + AI, respectively, in the NATALEE trial.⁸ Permanent discontinuation was reported in 19.7% of patients receiving KISQALI + AI in the Phase III clinical study.¹

For more information, see the SmPC.

*QoL was assessed using the EORTC QLQ-C30 questionnaire, a validated tool used worldwide to assess QoL in patients with cancer. QoL was a secondary endpoint measured by patient-reported outcomes, and was assessed at baseline and throughout treatment. The physical functioning scale of EORTC QLQ-C30 was the prespecified primary HRQoL of interest for NATALEE.² The EORTC OLQ-C30 incorporates five functional scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea and vomiting), a global health status/QoL, scale, and a number of single items.^6
†IDFS per STEEP criteria.^4
‡No difference from baseline was observed in either arm based on established thresholds for interpreting changes in each of these scores. No difference is deemed as –5 to 2 for physical functioning, –5 to 5 for global health status and –6 to 3 for social functioning.^2
§Percentages shown are the relative importance scores of each attribute in the overall population.⁷

AE, adverse event; AI, aromatase inhibitor; CDK4/6, cyclin dependent kinase 4/6; eBC, early breast cancer; ECG, electrocardiogram; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer, core quality of life questionnaire; ET, endocrine therapy; HER2–, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQoL, health-related quality of life; iDFS, invasive disease-free survival; LHRH, luteinising hormone-releasing hormone; NSAI, non-steroidal aromatase inhibitor; QoL, quality of life; SmPC, Summary of Product Characteristics; STEEP, standardised definitions for efficacy end points.

References

1. KISQALI® (ribociclib) Summary of Product Characteristics.

2. Fasching PA, et al. Clin Cancer Res 2025;31(9):1625–1635.

3. Fasching PA, et al. VP3-2023. European Society for Medical Oncology. 14–15 September 2023, virtual.

4. Slamon DJ, et al. Ther Adv Med Oncol 2023;15:17588359231178125.

5. Slamon D, et al. N Engl J Med 2024;390(12):1080–1091.

6. Aaronson NK, et al. J Natl Cancer Inst 1993;85(5):365–376.

7. Mayer EL, et al. Breast Cancer Res Treat 2025;211(1):121–130.

8. Hortobagyi GN, et al. Ann Oncol 2025;36(2):149–157.

UK | April 2026 | FA-11644881