Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer

Gabe S. Sonke (), Annemiek Ommen-Nijhof, Noor Wortelboer, Vincent Noort, Astrid C. P. Swinkels, Hedwig M. Blommestein, Cristina Guerrero Paez, Linda Mol, Aart Beeker, Karin Beelen, Lisanne C. Hamming, Joan B. Heijns, Aafke H. Honkoop, Paul C. Jong, Quirine C. Rossum-Schornagel, Christa Schaik- van de Mheen, Jolien Tol, Cathrien S. Tromp- van Driel, Suzan Vrijaldenhoven, A. Elise Leeuwen-Stok, Inge R. Konings and Agnes Jager
Additional contact information
Gabe S. Sonke: Netherlands Cancer Institute
Annemiek Ommen-Nijhof: Netherlands Cancer Institute
Noor Wortelboer: Erasmus Medical Center Cancer Institute
Vincent Noort: Netherlands Cancer Institute
Astrid C. P. Swinkels: Netherlands Comprehensive Cancer Organisation
Hedwig M. Blommestein: Erasmus University Rotterdam
Cristina Guerrero Paez: Dutch Breast Cancer Society
Linda Mol: Netherlands Comprehensive Cancer Organisation
Aart Beeker: Spaarne Gasthuis
Karin Beelen: Rijnstate Hospital
Lisanne C. Hamming: Medical Center Leeuwarden
Joan B. Heijns: Amphia
Aafke H. Honkoop: Isala Clinics
Paul C. Jong: St Antonius Hospital
Quirine C. Rossum-Schornagel: Franciscus Gasthuis & Vlietland
Christa Schaik- van de Mheen: Meander Medical Center
Jolien Tol: Jeroen Bosch Hospital
Cathrien S. Tromp- van Driel: Gelre Hospital
Suzan Vrijaldenhoven: Northwest Hospital Group
A. Elise Leeuwen-Stok: BOOG Study Center
Inge R. Konings: Cancer Center Amsterdam
Agnes Jager: Erasmus Medical Center Cancer Institute

Nature, 2024, vol. 636, issue 8042, 474-480

Abstract: Abstract Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) in combination with endocrine therapy improve the outcomes of patients with hormone-receptor (HR)-positive, HER2-negative advanced breast cancer and can be used early as first-line treatment or deferred to second-line treatment1–7. Randomized data comparing the use of CDK4/6i in the first- and second-line setting are lacking. The phase 3 SONIA trial (NCT03425838) randomized 1,050 patients who had not received previous therapy for advanced breast cancer to receive CDK4/6i in the first- or second-line setting8. All of the patients received the same endocrine therapy, consisting of an aromatase inhibitor for first-line treatment and fulvestrant for second-line treatment. The primary end point was defined as the time from randomization to disease progression after second-line treatment (progression-free survival 2 (PFS2)). We observed no statistically significant benefit for the use of CDK4/6i as a first-line compared with second-line treatment (median, 31.0 versus 26.8 months, respectively; hazard ratio = 0.87; 95% confidence interval = 0.74–1.03; P = 0.10). The health-related quality of life was similar in both groups. First-line CDK4/6i use was associated with a longer CDK4/6i treatment duration compared with second-line use (median CDK4/6i treatment duration of 24.6 versus 8.1 months, respectively) and more grade ≥3 adverse events (2,763 versus 1,591, respectively). These data challenge the need for first-line use of a CDK4/6i in all patients.

Date: 2024
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DOI: 10.1038/s41586-024-08035-2

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