RAZOR: a phase II open randomized trial of screening plus goserelin and raloxifene versus screening alone in premenopausal women at increased risk of breast cancer
RAZOR: a phase II open randomized trial of screening plus goserelin and raloxifene versus screening alone in premenopausal women at increased risk of breast cancer
Background: Ovarian suppression in
premenopausal women is known to reduce breast cancer risk. This study
aimed to assess uptake and compliance with ovarian suppression using the
luteinizing hormone releasing hormone (LHRH) analogue, goserelin, with
add-back raloxifene, as a potential regimen for breast cancer
prevention.
Methods: Women at ≥30%
lifetime risk breast cancer were approached and randomized to
mammographic screening alone (C-Control) or screening in addition to
monthly subcutaneous injections of 3.6 mg goserelin and continuous 60 mg
raloxifene daily orally (T-Treated) for 2 years. The primary endpoint
was therapy adherence. Secondary endpoints were toxicity/quality of
life, change in bone density, and mammographic density.
Results:
A total of 75/950 (7.9%) women approached agreed to randomization. In
the T-arm, 20 of 38 (52%) of women completed the 2-year period of study
compared with the C-arm (27/37, 73.0%). Dropouts were related to
toxicity but also the wish to have established risk-reducing procedures
and proven chemoprevention. As relatively few women completed the study,
data are limited, but those in the T-arm reported significant increases
in toxicity and sexual problems, no change in anxiety, and less cancer
worry. Lumbar spine bone density declined by 7.0% and visually assessed
mammographic density by 4.7% over the 2-year treatment period.
58-66
Howell, Anthony
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Ashcroft, Linda
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Fallowfield, Lesley
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Eccles, Diana M.
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Eeles, Rosalind A.
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Ward, Ann
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Brentnall, Adam R.
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Dowsett, Mitchell
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Cuzick, Jack M.
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Greenhalgh, Rosemary
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Boggis, Caroline
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Motion, Jamie
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Sergeant, Jamie C.
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Adams, Judith
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Evans, D. Gareth
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1 January 2018
Howell, Anthony
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Ashcroft, Linda
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Fallowfield, Lesley
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Eccles, Diana M.
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Eeles, Rosalind A.
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Ward, Ann
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Brentnall, Adam R.
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Dowsett, Mitchell
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Cuzick, Jack M.
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Greenhalgh, Rosemary
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Boggis, Caroline
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Motion, Jamie
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Sergeant, Jamie C.
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Adams, Judith
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Evans, D. Gareth
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Howell, Anthony, Ashcroft, Linda, Fallowfield, Lesley, Eccles, Diana M., Eeles, Rosalind A., Ward, Ann, Brentnall, Adam R., Dowsett, Mitchell, Cuzick, Jack M., Greenhalgh, Rosemary, Boggis, Caroline, Motion, Jamie, Sergeant, Jamie C., Adams, Judith and Evans, D. Gareth
(2018)
RAZOR: a phase II open randomized trial of screening plus goserelin and raloxifene versus screening alone in premenopausal women at increased risk of breast cancer.
Cancer Epidemiology, Biomarkers & Prevention, 27 (1), .
(doi:10.1158/1055-9965.EPI-17-0158).
Abstract
Background: Ovarian suppression in
premenopausal women is known to reduce breast cancer risk. This study
aimed to assess uptake and compliance with ovarian suppression using the
luteinizing hormone releasing hormone (LHRH) analogue, goserelin, with
add-back raloxifene, as a potential regimen for breast cancer
prevention.
Methods: Women at ≥30%
lifetime risk breast cancer were approached and randomized to
mammographic screening alone (C-Control) or screening in addition to
monthly subcutaneous injections of 3.6 mg goserelin and continuous 60 mg
raloxifene daily orally (T-Treated) for 2 years. The primary endpoint
was therapy adherence. Secondary endpoints were toxicity/quality of
life, change in bone density, and mammographic density.
Results:
A total of 75/950 (7.9%) women approached agreed to randomization. In
the T-arm, 20 of 38 (52%) of women completed the 2-year period of study
compared with the C-arm (27/37, 73.0%). Dropouts were related to
toxicity but also the wish to have established risk-reducing procedures
and proven chemoprevention. As relatively few women completed the study,
data are limited, but those in the T-arm reported significant increases
in toxicity and sexual problems, no change in anxiety, and less cancer
worry. Lumbar spine bone density declined by 7.0% and visually assessed
mammographic density by 4.7% over the 2-year treatment period.
Text
RAZOR printed CEBP accepted April 2017
- Accepted Manuscript
More information
Accepted/In Press date: 17 October 2017
e-pub ahead of print date: 2 November 2017
Published date: 1 January 2018
Identifiers
Local EPrints ID: 414174
URI: http://eprints.soton.ac.uk/id/eprint/414174
PURE UUID: db4450b6-f7c7-4e93-accf-484881960c57
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Date deposited: 15 Sep 2017 16:30
Last modified: 16 Mar 2024 05:41
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Contributors
Author:
Anthony Howell
Author:
Linda Ashcroft
Author:
Lesley Fallowfield
Author:
Rosalind A. Eeles
Author:
Ann Ward
Author:
Adam R. Brentnall
Author:
Mitchell Dowsett
Author:
Jack M. Cuzick
Author:
Rosemary Greenhalgh
Author:
Caroline Boggis
Author:
Jamie Motion
Author:
Jamie C. Sergeant
Author:
Judith Adams
Author:
D. Gareth Evans
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