SERENA-6 visual patient-reported outcomes & safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy
In brief
Camizestrant adds visual side effects in 32% vs 16% with aromatase inhibitor
In the SERENA-6 phase III trial of 315 patients with ESR1-mutated advanced breast cancer, short-lived visual adverse events occurred in about one-third of those switched to camizestrant + CDK4/6 inhibitor versus one-sixth on standard aromatase inhibitor + CDK4/6 inhibitor; 90% were mild and none required stopping therapy. Vision acuity and eye structure were unchanged, and patient-reported functioning remained stable, suggesting the visual effects are reversible and clinically manageable.
- Journal
- The oncologist (Q1)
- Published
- 24 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Adam Brufsky, Yeon Hee Park, François-Clément Bidard, Erica L Mayer, Wolfgang Janni, Cynthia Ma, et al.
- PMID
- 42496653
- DOI
- 10.1093/oncolo/oyag278
Why clinicians should know about it
- Picked for Ophthalmology (top studies of the week, 26 July 2026): High-quality evidence in a top journal
Abstract
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). Ophthalmologic assessments were conducted at baseline, as indicated, and 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 (<1min) ranged from 60%-67% vs 50%-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 ophthalmologic 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.
Abstract as published, via PubMed.
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