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Annotated Bibliography of NSABP Publications

Long-Term Tamoxifen Citrate Use and Potential Ocular Toxicity
Gorin MB, Day R, Costantino JP, Fisher B, Redmond CK, Wickerham L, Gomolin JE, Margolese RG, Mathen MK, Bowman DM, Kaufman DI, Dimitrov NV, Singerman LJ, Bornstein R, Wolmark N
American Journal of Ophthalmololy 125(4):493-501, April 1998

Purpose: To estimate the prevalence of abnormalities in visual function and ocular structures associated with the long-term use of tamoxifen citrate.

Methods: A single-masked, cross-sectional study involving multiple community and institutional ophthalmologic departments was conducted with a volunteer sample of 303 women with breast cancer currently taking part in a randomized clinical trial to determine the efficacy of tamoxifen (20 mg/day) in preventing recurrences. Participants included women who had never been on drug (n=85); women who had taken tamoxifen for an average of 4.8 years, then been off the drug for an average of 2.7 years (n=140); and women who had been on tamoxifen continuously for an average of 7.8 years (n=78). Women were evaluated by questionnaire, psychophysical testing, and clinical examination to determine any abnormalities in visual function and the comparative prevalences of corneal, lens, retinal, and optic nerve pathology.

Results: There were no cases of vision-threatening ocular toxicity among the tamoxifen-treated participants. Compared with nontreated participants, the tamoxifen-treated women had no differences in the activities of daily vision, visual acuity measurements, or other tests of visual function except for color screening. Intraretinal crystals (odds ratio [OR]=3.58, P=.178) and posterior subcapsular opacities (OR=4.03, P=.034) were more frequent in the tamoxifen-treated group.

Conclusions: Women should have a thorough baseline ophthalmic evaluation within the first year of initiating tamoxifen therapy and receive appropriate follow-up evaluations.

Department of Ophthalmology, School of Medicine, University of Pittsburgh, Pittsburgh, PA.