title: Ocular toxicity during adjuvant chemoendocrine therapy for early breast cancer: results from International Breast Cancer Study Group trials.
abstract: BACKGROUND
  Others have reported ocular toxicity after adjuvant chemoendocrine therapy, but this study looked at ocular toxicity in similarly treated patients from large randomized clinical trials.
  
  
  METHODS
  Information was retrieved on incidence and timing of ocular toxicity from the International Breast Cancer Study Group (IBCSG) database of 4948 eligible patients randomized to receive tamoxifen or toremifene alone or in combination with chemotherapy (either concurrently or sequentially). Case reports of patients with ocular toxicity were evaluated to determine whether ocular toxicity occurred during chemotherapy and/or hormonal therapy. Additional information was obtained from participating institutions for patients in whom ocular toxicity occurred after chemotherapy but during administration of tamoxifen or toremifene.
  
  
  RESULTS
  Ocular toxicity was reported in 538 of 4948 (10.9%) patients during adjuvant treatment, mainly during chemotherapy. Forty-five of 4948 (0.9%) patients had ocular toxicity during hormone therapy alone, but only 30 (0.6%) patients had ocular toxicity reported either without receiving any chemotherapy or beyond 3 months after completing chemotherapy and, thus, possibly related to tamoxifen or toremifene. In 3 cases, retinal alterations, without typical aspects of tamoxifen toxicity, were reported; 4 patients had cataract (2 bilateral), 12 impaired visual acuity, 10 ocular irritation, 1 optical neuritis, and the rest had other symptoms.
  
  
  CONCLUSIONS
  Ocular toxicity during adjuvant therapy is a common side effect mainly represented by irritative symptoms due to chemotherapy. By contrast, ocular toxicity during hormonal therapy is rare and does not appear to justify a regular program of ocular examination. However, patients should be informed of this rare side effect so that they may seek prompt ophthalmic evaluation for ocular complaints.
authors.affiliation: Division of Oncology and Hematology, Hospital degli Infermi, Rimini, Italy. lgianni@auslrn.net
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Gianni
authors.forename: Ilaria
authors.initials: I
authors.lastname: Panzini
authors.forename: Sigui
authors.initials: S
authors.lastname: Li
authors.forename: Richard D
authors.initials: RD
authors.lastname: Gelber
authors.forename: John
authors.initials: J
authors.lastname: Collins
authors.forename: Stig B
authors.initials: SB
authors.lastname: Holmberg
authors.forename: Diana
authors.initials: D
authors.lastname: Crivellari
authors.forename: Monica
authors.initials: M
authors.lastname: Castiglione-Gertsch
authors.forename: Aron
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: Alan S
authors.initials: AS
authors.lastname: Coates
authors.forename: Alberto
authors.initials: A
authors.lastname: Ravaioli
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D016208:Databases, Factual; D005123:Eye / Q000187:drug effects; D005128:Eye Diseases / Q000139:chemically induced*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D013629:Tamoxifen / Q000009:adverse effects*; D017312:Toremifene / Q000009:adverse effects*; D014792:Visual Acuity
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen; D017312:Toremifene