Adjuvant ovarian function suppression and cognitive function in women with breast cancer.
To examine the effect on cognitive function of adjuvant ovarian function suppression (OFS) for breast cancer.



The Suppression of Ovarian Function (SOFT) trial randomised premenopausal women with hormone receptor-positive breast cancer to 5 years adjuvant endocrine therapy with tamoxifen+OFS, exemestane+OFS or tamoxifen alone. The Co-SOFT substudy assessed objective cognitive function and patient reported outcomes at randomisation (T0), and 1 year later (T1); the primary endpoint was change in global cognitive function, measured by the composite objective cognitive function score. Data were compared for the pooled tamoxifen+OFS and exemestane+OFS groups vs the tamoxifen alone group using the Wilcoxon rank-sum test.



Of 86 participants, 74 underwent both T0 and T1 cognitive testing; 54 randomised to OFS+ either tamoxifen (28) or exemestane (26) and 20 randomised to tamoxifen alone. There was no significant difference in the changes in the composite cognitive function scores between the OFS+ tamoxifen or exemestane groups and the tamoxifen group (mean±s.d., -0.21±0.92 vs -0.04±0.49, respectively, P=0.71, effect size=-0.20), regardless of prior chemotherapy status, and adjusting for baseline characteristics.



The Co-SOFT study, although limited by small samples size, provides no evidence that adding OFS to adjuvant oral endocrine therapy substantially affects global cognitive function.
Division of Cancer Medicine, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, VIC 3002, Australia.|Sir Peter MacCallum Department of Oncology, The University of Melbourne, Grattan Street, Parkville, VIC 3010, Australia.|Australia and New Zealand Breast Cancer Trials Group (ANZBCTG), Platt Street, Waratah, NSW 2298, Australia.|International Breast Cancer Study Group, Bern CH-3008, Switzerland.
Kelly-Anne
KA
Phillips
International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.|Harvard Medical School, Department of Medicine, Boston, MA 02115, USA.
Meredith M
MM
Regan
International Breast Cancer Study Group Coordinating Center, Effingerstrasse 40, Bern CH-3008, Switzerland.
Karin
K
Ribi
Division of Cancer Medicine, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, VIC 3002, Australia.|Sir Peter MacCallum Department of Oncology, The University of Melbourne, Grattan Street, Parkville, VIC 3010, Australia.|Australia and New Zealand Breast Cancer Trials Group (ANZBCTG), Platt Street, Waratah, NSW 2298, Australia.|International Breast Cancer Study Group, Bern CH-3008, Switzerland.
Prudence A
PA
Francis
International Breast Cancer Study Group, Bern CH-3008, Switzerland.|Department of Medical Oncology, University Hospital of Udine, Piazzale S.M. Misericordia 15, Udine 33100, Italy.|School of Medical Oncology, The University of Udine, Udine 33100, Italy.
Fabio
F
Puglisi
Vall d'Hebron Institute of Oncology (VHIO) and Vall d'Hebron University Hospital, Barcelona 08035, Spain.|SOLTI Group, Barcelona 08008, Spain.
Meritxell
M
Bellet
International Breast Cancer Study Group, Bern CH-3008, Switzerland.|CRO Aviano, IRCCS, National Cancer Institute, Via F. Gallini 2, Aviano 33081, Italy.
Simon
S
Spazzapan
International Breast Cancer Study Group, Bern CH-3008, Switzerland.|Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Röda stråket 16, Gothenburg 413 45, Sweden.
Per
P
Karlsson
Monter Cancer Center of the North Shore-LIJ Health System, 450 Lakeville Road, Lake Success, NY 11042, USA.|NRG Oncology, Four Penn Center, 1600 JFK Blvd, Suite 1020, Philadelphia, PA 19103, USA.
Daniel R
DR
Budman
International Breast Cancer Study Group, Bern CH-3008, Switzerland.|Department of Oncology, Breast Center CHUV, Rue du Bugnon 46, Lausanne 1011, Switzerland.
Khalil
K
Zaman
Australia and New Zealand Breast Cancer Trials Group (ANZBCTG), Platt Street, Waratah, NSW 2298, Australia.|International Breast Cancer Study Group, Bern CH-3008, Switzerland.|Tweed Heads Hospital, Tweed Heads, Griffith University, Gold Coast, Powell Street, Tweed Heads, NSW 2485, Australia.
Ehtesham A
EA
Abdi
Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA.|ECOG-ACRIN, 1818 Market Street, Suite 1100, Philadelphia, PA 19103, USA.
Susan M
SM
Domchek
International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.
Yang
Y
Feng
International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.|Frontier Science and Technology Research Foundation.
Karen N
KN
Price
Australia and New Zealand Breast Cancer Trials Group (ANZBCTG), Platt Street, Waratah, NSW 2298, Australia.|International Breast Cancer Study Group, Bern CH-3008, Switzerland.|University of Sydney, Sydney, NSW 2006, Australia.
Alan S
AS
Coates
International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.|Frontier Science and Technology Research Foundation.|Harvard T.H. Chan School of Public Health, Department of Biostatistics, Boston, MA 02115, USA.
Richard D
RD
Gelber
Cogstate Ltd, 2/255 Bourke Street, Melbourne, VIC 3000, Australia.
Paul
P
Maruff
Australia and New Zealand Breast Cancer Trials Group (ANZBCTG), Platt Street, Waratah, NSW 2298, Australia.|International Breast Cancer Study Group, Bern CH-3008, Switzerland.|Mater Hospital, 40 Rocklands Road, North Sydney, NSW 2060, Australia.
Frances
F
Boyle
International Breast Cancer Study Group, Bern CH-3008, Switzerland.|University of Newcastle, Calvary Mater Newcastle Hospital, Australia.|Australia and New Zealand Breast Cancer Trials Group (ANZBCTG), NBN Telethon Mater Institute, Locked Bag 7 HRMC, Newcastle, NSW 2298, Australia.
John F
JF
Forbes
Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 641 Lexington Ave Fl 7, New York, NY 10022, USA.|Alliance for Clinical Trials in Oncology, Chicago, IL 60637, USA.
Tim
T
Ahles
Alliance for Clinical Trials in Oncology, Chicago, IL 60637, USA.|The University of Chicago Medical Center, 5841 South Maryland Ave, MC 2115, Chicago, IL 60637, USA.
Gini F
GF
Fleming
International Breast Cancer Study Group Coordinating Center, Effingerstrasse 40, Bern CH-3008, Switzerland.|Inselspital, Bern University Hospital, Bern CH-3010, Switzerland.
Jürg
J
Bernhard
D000276:Adjuvants, Immunologic; D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy; D003071:Cognition; D005260:Female; D006801:Humans; D008875:Middle Aged; D010053:Ovary / Q000378:metabolism*; D017697:Premenopause; D011788:Quality of Life; D013629:Tamoxifen / Q000627:therapeutic use*
D000276:Adjuvants, Immunologic; D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen