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Ovarian cancer is a highly lethal disease and represents one of the leading causes of cancer death among women in Western countries. Since effective methods of screening and early diagnosis are lacking, prevention is being sought as one of the most promising ways to reduce mortality. While prophylactic oophorectomy is increasingly used for high-risk women, its short- and long-term morbidity is unknown. More important, most ovarian cancers are sporadic, and the widespread use of prophylactic oophorectomy in average-risk women is unimaginable. An epidemiologic study (1) has shown that oral contraceptive use is associated with reduced ovarian cancer risk among the general population as well as in BRCA1 heterozygotes. In women with a family history of breast cancer, however, oral contraceptive use is associated with additional risk of that disease (2). Thus, other agents are being studied that might replace or be combined with oral contraceptives for prevention of ovarian cancer. Among these agents, retinoids have been the subject of the most intensive investigation of their potential to prevent cancer (3). The first evidence of an in vivo effect by retinoids on ovarian cancer came from the study by Formelli and Cleris (4) using the retinoic acid analogue fenretinide (N-4-hydroxyphenylretinamide). The potential of retinoids for the prevention of ovarian cancer was subsequently confirmed in the phase III trial of fenretinide for the reduction in the incidence of second breast cancer (5). During the 5-year intervention period, a statistically significant lower incidence of ovarian cancer was noted in the fenretinide group compared with the control group (no cases versus six cases, respectively) (6). However, because of the unexpected results and the limited number of events, the observation should be viewed with extreme caution. In addition, the apparent benefit was partially lost during the subsequent followup period, suggesting that the potential preventive effect of fenretinide was not lasting and that treatment would have to be continued indefinitely for the benefit to continue (5). However, attention to secondary clinical trial endpoints often yields new hypotheses for exploration. Thus, the finding prompted different laboratories to provide further insight into this clinical finding. Since that initial clinical observation (6), several in vivo and in vitro studies (4,7–9) have consistently shown that fenretinide,

Retinoids for Ovarian Cancer Prevention: Laboratory Data Set the Stage for Thoughtful Clinical Trials