{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T17:39:53Z","timestamp":1786642793398,"version":"build-2736575974"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Women\u2019s Cancer Institute of Institut Curie","award":["0000-0001-7071-6483"],"award-info":[{"award-number":["0000-0001-7071-6483"]}]},{"name":"National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre","award":["NIHR203312"],"award-info":[{"award-number":["NIHR203312"]}]},{"name":"the NIHR Cambridge Clinical Research Facility"},{"name":"Cambridge Experimental Cancer Medicine Centre","award":["C96\/A25177\/RG86728"],"award-info":[{"award-number":["C96\/A25177\/RG86728"]}]},{"name":"the Cancer Research UK Cambridge Centre","award":["C9685\/A25117"],"award-info":[{"award-number":["C9685\/A25117"]}]},{"name":"the Cambridge Human Research Tissue Bank"},{"name":"NIHR Cambridge Biomedical Research Centre and Biomedical Research Centre-JCB Hub services","award":["BRC-1215-20014"],"award-info":[{"award-number":["BRC-1215-20014"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We report ophthalmological assessments, patient-reported visual symptoms\/functioning, and characterization of visual effect AEs from the SERENA-6 study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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 (&amp;lt;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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov, NCT04964934.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/oncolo\/oyag278","type":"journal-article","created":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T11:55:52Z","timestamp":1784807752000},"source":"Crossref","is-referenced-by-count":0,"title":["SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging\n                    <i>ESR1<\/i>\n                    m advanced breast cancer during first-line endocrine-based therapy"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8080-7960","authenticated-orcid":false,"given":"Adam","family":"Brufsky","sequence":"first","affiliation":[{"name":"UPMC Magee-Womens Hospital Department of Medicine, , Pittsburgh, PA 15213,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4156-9212","authenticated-orcid":false,"given":"Yeon Hee","family":"Park","sequence":"additional","affiliation":[{"name":"Sungkyunkwan University School of Medicine Samsung Medical Center, , Seoul 06351,","place":["Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5932-8949","authenticated-orcid":false,"given":"Fran\u00e7ois-Cl\u00e9ment","family":"Bidard","sequence":"additional","affiliation":[{"name":"Institut Curie Department of Medical Oncology, , 75005 Paris,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5430-8957","authenticated-orcid":false,"given":"Erica L","family":"Mayer","sequence":"additional","affiliation":[{"name":"Dana-Farber Cancer Institute Medical Oncology, , Boston, MA 02215,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5911-2400","authenticated-orcid":false,"given":"Wolfgang","family":"Janni","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Ulm Department of Gynecology and Obstetrics, , 89081 Ulm ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8156-7492","authenticated-orcid":false,"given":"Cynthia","family":"Ma","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine Department of Medicine, , St. Louis, MO 63110,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Cristofanilli","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine\/New York-Presbyterian Hospital Medical Oncology, , New York, NY 10065,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6790-6267","authenticated-orcid":false,"given":"Giampaolo","family":"Bianchini","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale San Raffaele Department of Medical Oncology, , 20132 Milan,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0242-4718","authenticated-orcid":false,"given":"Hiroji","family":"Iwata","sequence":"additional","affiliation":[{"name":"Nagoya City University Department of Clinical Research Strategy, , Nagoya 467-8601,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4885-8471","authenticated-orcid":false,"given":"Peter A","family":"Fasching","sequence":"additional","affiliation":[{"name":"University Hospital Erlangen Comprehensive Cancer Center Erlangen-EMN, , 91054 Erlangen,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zbigniew","family":"Nowecki","sequence":"additional","affiliation":[{"name":"Narodowy Instytut Onkologii im. Marii Sk\u0142odowskiej-Curie Department of Breast Cancer and Reconstructive Surgery, , 02-781 Warsaw,","place":["Poland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Pascual","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen de la Victoria Medical Oncology Department, , 29010 M\u00e1laga,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin-Cheh","family":"Chen","sequence":"additional","affiliation":[{"name":"Chang Gung Medical Foundation Linkou Branch Department of General Surgery, , 333 Taoyuan City,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lionel","family":"Moreau","sequence":"additional","affiliation":[{"name":"P\u00f4le Sant\u00e9 R\u00e9publique Medical Oncology, , 63100 Clermont-Ferrand,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1181-5622","authenticated-orcid":false,"given":"Manuel","family":"Ruiz-Borrego","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen del Rocio Oncology Department, , 41013 Seville,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayelet","family":"Shai","sequence":"additional","affiliation":[{"name":"Rambam Health Care Campus Department of Oncology, , Haifa 3109601,","place":["Israel"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nuri","family":"Karadurmus","sequence":"additional","affiliation":[{"name":"G\u00fclhane Training and Research Hospital, University of Health Sciences Medical Oncology Department, , 06010 Ankara,","place":["Turkey"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyung Hae","family":"Jung","sequence":"additional","affiliation":[{"name":"University of Ulsan College of Medicine Asan Medical Center, , Seoul 05505,","place":["Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3852-5991","authenticated-orcid":false,"given":"Yuichiro","family":"Kikawa","sequence":"additional","affiliation":[{"name":"Kansai Medical University Hospital Department of Breast Surgery, , Hirakata City, Osaka 573-1191,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard D","family":"Baird","sequence":"additional","affiliation":[{"name":"Cancer Research UK Cambridge Centre Department of Oncology, , Cambridge, CB2 0RE,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ranya","family":"Habash","sequence":"additional","affiliation":[{"name":"Bascom Palmer Eye Institute\/University of Miami Department of Ophthalmology, , Miami, FL 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