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

Ruta D. Rao, Melody A. Cobleigh, Robert Gray, Mark L. Graham, Larry Norton, Silvana Martino, George Thomas Budd, James N. Ingle, William C. Wood

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish (US)
JournalMedical Oncology
Volume28
Issue numberSUPPL. 1
DOIs
StatePublished - Dec 2011

Fingerprint

Fenretinide
Tamoxifen
Randomized Controlled Trials
Placebos
Night Blindness
Breast Neoplasms
Retinoids
Double-Blind Method
Hormones
Survival
Therapeutics

Keywords

  • Adenocarcinoma of the breast
  • Estrogen and progesterone positive
  • Fenretinide
  • Nyctalopia
  • Postmenopausal
  • Retinamides
  • Retinoid
  • Tamoxifen

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Hematology

Cite this

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. / Rao, Ruta D.; Cobleigh, Melody A.; Gray, Robert; Graham, Mark L.; Norton, Larry; Martino, Silvana; Budd, George Thomas; Ingle, James N.; Wood, William C.

In: Medical Oncology, Vol. 28, No. SUPPL. 1, 12.2011.

Research output: Contribution to journalArticle

Rao, Ruta D. ; Cobleigh, Melody A. ; Gray, Robert ; Graham, Mark L. ; Norton, Larry ; Martino, Silvana ; Budd, George Thomas ; Ingle, James N. ; Wood, William C. / 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. In: Medical Oncology. 2011 ; Vol. 28, No. SUPPL. 1.
@article{40df7cba5c9c45029930260b3106a5c9,
title = "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",
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.",
keywords = "Adenocarcinoma of the breast, Estrogen and progesterone positive, Fenretinide, Nyctalopia, Postmenopausal, Retinamides, Retinoid, Tamoxifen",
author = "Rao, {Ruta D.} and Cobleigh, {Melody A.} and Robert Gray and Graham, {Mark L.} and Larry Norton and Silvana Martino and Budd, {George Thomas} and Ingle, {James N.} and Wood, {William C.}",
year = "2011",
month = "12",
doi = "10.1007/s12032-010-9682-1",
language = "English (US)",
volume = "28",
journal = "Medical Oncology and Tumor Pharmacotherapy",
issn = "1357-0560",
publisher = "Humana Press",
number = "SUPPL. 1",

}

TY - JOUR

T1 - Phase III double-blind, placebo-controlled, prospective randomized trial of adjuvant tamoxifen vs. tamoxifen and fenretinide in postmenopausal women with positive receptors (EB193)

T2 - An intergroup trial coordinated by the Eastern Cooperative Oncology Group

AU - Rao, Ruta D.

AU - Cobleigh, Melody A.

AU - Gray, Robert

AU - Graham, Mark L.

AU - Norton, Larry

AU - Martino, Silvana

AU - Budd, George Thomas

AU - Ingle, James N.

AU - Wood, William C.

PY - 2011/12

Y1 - 2011/12

N2 - 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.

AB - 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.

KW - Adenocarcinoma of the breast

KW - Estrogen and progesterone positive

KW - Fenretinide

KW - Nyctalopia

KW - Postmenopausal

KW - Retinamides

KW - Retinoid

KW - Tamoxifen

UR - http://www.scopus.com/inward/record.url?scp=84655170226&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84655170226&partnerID=8YFLogxK

U2 - 10.1007/s12032-010-9682-1

DO - 10.1007/s12032-010-9682-1

M3 - Article

C2 - 20878269

AN - SCOPUS:84655170226

VL - 28

JO - Medical Oncology and Tumor Pharmacotherapy

JF - Medical Oncology and Tumor Pharmacotherapy

SN - 1357-0560

IS - SUPPL. 1

ER -