Authors: Ruta D Rao Melody A Cobleigh Robert Gray Mark L Graham Larry Norton Silvana Martino George Thomas Budd James N Ingle William C Wood
Publish Date: 2010/09/28
Volume: 28, Issue: 1, Pages: 39-47
Abstract
Fenretinide and tamoxifen have additive antitumor effects preclinically We performed a randomized placebocontrolled doubleblind adjuvant trial in breast cancer patients treated for 5 years with tamoxifen with or without fenretinide Between October 1995 and October 1999 426 postmenopausal women with hormone receptorpositive breast cancer were randomized Patients were monitored for efficacy and toxicity Four hundred and nineteen patients were evaluable The study was terminated early due to slow accrual There were no significant differences between treatment groups in DFS TTR or survival More patients stopped treatment early on the fenretinide arm than on placebo P = 002 Grade 3/4 toxicities including visual problems and musculoskeletal complaints were more common in patients receiving fenretinide P = 0007 A Night Blindness Questionnaire was used to monitor nyctalopia which was slightly but not significantly more common on fenretinide In this underpowered study no significant difference was observed in efficacy between treatment groups This trial provides important toxicity information about fenretinide a retinoid that has been used in the prevention setting because it is the only placebocontrolled doubleblind randomized study ever performedThis study was conducted by the Eastern Cooperative Oncology Group Robert L Comis MD Chair and supported in part by Public Health Service Grants CA23318 CA66636 CA21115 CA47559 CA07968 CA04919 CA25224 and CA37404 and from the National Cancer Institute National Institutes of Health and the Department of Health and Human Services Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer InstituteStudy has also been published in abstract form Cobleigh M Gray R Graham M et al Fenretinide FEN vs placebo in postmenopausal breast cancer patients receiving adjuvant tamoxifen TAM an Eastern Cooperative Oncology Group Phase III Intergroup Trial EB193 INT0151 Proc Am Soc Clin Oncol 2000 abstr
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