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Author Notes:

Corresponding author: Ruta Rao, MD, Rush University Medical Center, 1725 W. Harrison St, Suite 809, Chicago, IL 60612, Phone: 312 563 2691, Fax: 312 942 3192, Email: ruta_d_rao@rush.edu

Subjects:

Research Funding:

This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D., Chair) and supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA47559, CA07968, CA04919, CA25224, andCA37404 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 Institute.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Oncology
  • ONCOLOGY
  • Tamoxifen
  • Fenretinide
  • Postmenopausal
  • Retinoid
  • Retinamides
  • Adenocarcinoma of the breast
  • Nyctalopia
  • Estrogen and progesterone positive
  • BREAST-CANCER CELLS
  • GROWTH-FACTOR-I
  • TRANS-RETINOIC ACID
  • RAT MAMMARY-CANCER
  • SURGICAL REMOVAL
  • VITAMIN-A
  • N-(4-HYDROXYPHENYL)RETINAMIDE
  • APOPTOSIS
  • PREVENTION
  • RISK

Phase III double-blind, placebo-controlled, prospective randomized trial of adjuvant tamoxifen vs. tamoxifen and fenretinide in postmenopausal women with positive receptors (EB193): an intergroup trial coordinated by the Eastern Cooperative Oncology Group

Tools:

Journal Title:

Medical Oncology

Volume:

Volume 28, Number SUPPL. 1

Publisher:

, Pages S39-S47

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Fenretinide and tamoxifen have additive antitumor effects preclinically. We performed a randomized, placebo-controlled, double-blind 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 receptor-positive 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 = 0.02). Grade 3/4 toxicities, including visual problems and musculoskeletal complaints were more common in patients receiving fenretinide (P = 0.007). 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 placebo-controlled, double-blind randomized study ever performed. © 2010 Springer Science+Business Media, LLC.

Copyright information:

© Springer Science+Business Media, LLC 2010

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