The effect of raloxifene on the incidence of ovarian cancer in postmenopausal women.
OBJECTIVE
The aim of this study was to determine the incidence of ovarian cancer in postmenopausal women treated with raloxifene compared with placebo.


METHODS
This analysis comprises integrated data from seven randomized, placebo-controlled trials of raloxifene (N = 9837). Ovarian cancer cases were identified from the safety database and reviewed by a gynecologic adjudication review board.


RESULTS
Sixteen cases of ovarian cancer were reported: 8 women (79.4/100,000 patient-years) on placebo and 8 (37.4/100,000 patient-years) on pooled raloxifene doses. The relative risk of ovarian cancer associated with raloxifene therapy was 0.50 (95% confidence interval, 0.19-1.35).


CONCLUSIONS
Raloxifene use was not associated with an increased risk for ovarian cancer.
Neven
Patrick
P
Department of Obstetrics and Gynecology, Algemene Kliniek St.-Jan, Broekstraat 114, B-1000 Brussels, Belgium. Patrick.neven@uz.kuleuven.ac.be
Goldstein
Steven R
SR
Ciaccia
Angelina V
AV
Zhou
Lifen
L
Silfen
Sheryl L
SL
Muram
David
D
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000139:chemically induced* / Q000453:epidemiology / Q000473:pathology; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects*
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride