SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy

Brufsky, Adam; Park, Yeon; Bidard, François-Clément; Mayer, Erica; Janni, Wolfgang; Ma, Cynthia; Cristofanilli, Massimo; Bianchini, Giampaolo; Iwata, Hiroji; Fasching, Peter; Nowecki, Zbigniew; Pascual, Javier; Chen, Shin-Cheh; Moreau, Lionel; Ruiz-Borrego, Manuel; Shai, Ayelet; KARADURMUŞ, Nuri; Jung, Kyung; Kikawa, Yuichiro; Baird, Richard; Habash, Ranya; Sugarman, Rebecca; Fox, Steven; Selvi Miralles, Manuel; Huang Bartlett, Cynthia; Turner, Nicholas

doi:10.1093/oncolo/oyag278

SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy

Brufsky A., Park Y. H., Bidard F., Mayer E. L., Janni W., Ma C., ...Daha Fazla

Oncologist, cilt.31, sa.9, 2026 (SCI-Expanded, Scopus)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 31 Sayı: 9
Basım Tarihi: 2026
Doi Numarası: 10.1093/oncolo/oyag278
Dergi Adı: Oncologist
Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, CINAHL, EMBASE, MEDLINE, Directory of Open Access Journals, Biomedical Reference Collection: Corporate Edition (EBSCO), Health Research Premium Collection (ProQuest), Sociology Source Ultimate (EBSCO)
Anahtar Kelimeler: ophthalmology, vision tests, quality of life, patient reported outcome measure, breast neoplasms
Sağlık Bilimleri Üniversitesi Adresli: Evet

Özet

Background: We report ophthalmological assessments, patient-reported visual symptoms/functioning, and characterization of visual effect AEs from the SERENA-6 study. Materials and methods: This double-blind, placebo-controlled phase III study included 315 patients with ER-positive advanced breast cancer receiving first-line aromatase inhibitor (AI)+CDK4/6 inhibitor (CDK4/6i). Patients with emerging ESR1 mutations in ctDNA and no radiological progression were randomized 1:1 to switch to camizestrant+CDK4/6i or continue AI+CDK4/6i. Predefined group term visual effect AEs were graded (NCI-CTCAE v5.0). Ophthalmological assessments were conducted at baseline, as indicated, and at the end of treatment. Analyses of patient-reported visual effects/functioning were exploratory. Results: Visual effect AEs were reported in 49 (31.6%) patients receiving camizestrant+CDK4/6i and 25 (16.1%) patients receiving AI+CDK4/6i; 90% were grade 1; none led to discontinuation. No changes in visual acuity or ocular structure were observed. Patient-reported visual effects occurred early (by week 2) and were reversible post-treatment. The proportion of patients in the camizestrant+CDK4/6i and AI+CDK4/6i arm reporting short-lived visual effects (<1 minute) ranged from 60% to 67% vs 50% to 69%, respectively; visual effects causing no/a low degree of bother: 78%-88% vs 50%-75%, respectively. During treatment, visual functioning was comparable to baseline and between arms. Conclusion: If experienced, patient-reported visual effects (including photopsia) with camizestrant+CDK4/6i were short-lived and reversible post-treatment. Visual effect AEs with camizestrant+CDK4/6i were mostly mild and did not require treatment discontinuation or ophthalmological management. There was no impact on ocular structure, function, or visual acuity; visual effects had little/no impact on daily functioning. These findings support clinical decision-making by further characterizing the visual safety profile of camizestrant in this setting. Clinical trial registration: ClinicalTrials.gov, NCT04964934.