Frailty and Adherence to Adjuvant Hormonal Therapy in Older Women With Breast Cancer: CALGB Protocol 369901

Sheppard, Vanessa B.; Faul, Leigh Anne; Luta, George; Clapp, Jonathan D.; Yung, Rachel L.; Wang, Judy Huei-yu; Kimmick, Gretchen; Isaacs, Claudine; Tallarico, Michelle; Barry, William T.; Pitcher, Brandelyn N.; Hudis, Clifford; Winer, Eric P.; Cohen, Harvey J.; Muss, Hyman B.; Hurria, Arti; Mandelblatt, Jeanne S.

doi:10.1200/jco.2013.51.7367

Cited by 91Frailty in Older AdultsBreast Cancer Treatment StudiesMenopause: Health Impacts and Treatments

Frailty and Adherence to Adjuvant Hormonal Therapy in Older Women With Breast Cancer: CALGB Protocol 369901

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Sheppard, Vanessa B., Faul, Leigh Anne, Luta, George, Clapp, Jonathan D., Yung, Rachel L., Wang, Judy Huei-yu, Kimmick, Gretchen, Isaacs, Claudine +9 more·2014·Journal of Clinical Oncology

DOI 10.1200/jco.2013.51.7367PMC PMC4105485

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Abstract

Purpose: Most patients with breast cancer age ≥ 65 years (ie, older patients) are eligible for adjuvant hormonal therapy, but use is not universal. We examined the influence of frailty on hormonal therapy noninitiation and discontinuation. Patients and Methods: A prospective cohort of 1,288 older women diagnosed with invasive, nonmetastatic breast cancer recruited from 78 sites from 2004 to 2011 were included (1,062 had estrogen receptor–positive tumors). Interviews were conducted at baseline, 6 months, and annually for up to 7 years to collect sociodemographic, health care, and psychosocial data. Hormonal initiation was defined from records and discontinuation from self-report. Baseline frailty was measured using a previously validated 35-item scale and grouped as prefrail or frail versus robust. Logistic regression and proportional hazards models were used to assess factors associated with noninitiation and discontinuation, respectively. Results: Most women (76.4%) were robust. Noninitiation of hormonal therapy was low (14%), but in prefrail or frail (v robust) women the odds of noninitiation were 1.63 times as high (95% CI, 1.11 to 2.40; P = .013) after covariate adjustment. Nonwhites (v whites) had higher odds of noninitiation (odds ratio, 1.71; 95% CI, 1.04 to 2.80; P = .033) after covariate adjustment. Among initiators, the 5-year continuation probability was 48.5%. After adjustment, the risk of discontinuation was higher with increasing age (P = .005) and lower for stage ≥ IIB (v stage I) disease (P = .003). Conclusion: Frailty is associated with noninitiation of hormonal therapy, but it does not seem to be a major predictor of early discontinuation in older patients.

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An index derived from data other than a CGA can predict initiation or non-initiation of adjuvant hormonal therapy in older women with breast cancer.
“We previously reported that an index derived from data other than a CGA can predict initiation or non-initiation of adjuvant hormonal therapy in older women with breast cancer.(16)”
From Frailty as determined by a comprehensive geriatric assessment-derived deficit-accumulation index in older patients with cancer who receive chemotherapy (2016) · cites this paper as [16]
The frailty categories were defined as robust/non-frail 0.0<0.2, pre-frail 0.2<0.35, and frail ≥0.35.
“Our cutpoints were as follows: Robust/Non-frail: 0.0 < 0.2; Pre-frail: 0.2 < 0.35; Frail: ≥ 0.35.”
From Frailty as determined by a comprehensive geriatric assessment-derived deficit-accumulation index in older patients with cancer who receive chemotherapy (2016) · cites this paper as [16]
The frailty distribution in this cohort had fewer robust patients and more pre-frail/frail patients than a previous study of older women with breast cancer.
“The frailty distribution of the subjects reported here showed fewer patients in the robust category and more in the pre-frail and frail categories than in that study, perhaps reflecting the presence of more active disease or later stage in our cohort.”
From Frailty as determined by a comprehensive geriatric assessment-derived deficit-accumulation index in older patients with cancer who receive chemotherapy (2016) · cites this paper as [16]

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Early Discontinuation and Nonadherence to Adjuvant Hormonal Therapy in a Cohort of 8,769 Early-Stage Breast Cancer Patients
Hershman, D. L., Kushi, L. H., Shao, T. H., Buono, D. L., Kershenbaum, A., Tsai, W., Fehrenbacher, L., Gomez, S. L., Miles, S. Q., & Neugut, A. I. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.25.9655 · Cited by 834 · see citing works
Association between frailty and clinical outcomes in older adults with early breast cancer: Results from the Hurria Older Patients (HOPE) study.
Zektser, Y., Ji, J., Sun, C., Dale, W., Katheria, V., Saleem, A. M., Baclig, N. V., Vatanatham, C. C., Olivera, J. D., Synold, K. S., et al. (2025) · Journal of Clinical Oncology · doi:10.1200/jco.2025.43.16_suppl.11040

Authors: Sheppard, V. B., Faul, L. A., Luta, G., Clapp, J. D., Yung, R. L., Wang, J. H.-Y., Kimmick, G., Isaacs, C., Tallarico, M., Barry, W. T., Pitcher, B. N., Hudis, C., Winer, E. P., Cohen, H. J., Muss, H. B., Hurria, A., & Mandelblatt, J. S.
Affiliations: University of North Carolina at Chapel Hill (US)
Georgetown University Medical Center (US)
Georgetown University (US)
City Of Hope National Medical Center (US)
ORCID: Sheppard, Vanessa B.
Luta, George
Clapp, Jonathan D.
Yung, Rachel L.
Wang, Judy Huei-yu
Kimmick, Gretchen
Isaacs, Claudine
Hudis, Clifford
Winer, Eric P.
Cohen, Harvey J.
Muss, Hyman B.
Hurria, Arti
Mandelblatt, Jeanne S.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2014-08-01
Volume: 32
Issue: 22
Pages: 2318-2327
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2013.51.7367
PMC: PMC4105485
OpenAlex: W2055029444
Cited by: 91
References: 54
Citations by year: 2026: 2 · 2025: 4 · 2024: 1 · 2023: 10 · 2022: 8 · 2021: 6 · 2020: 9 · 2019: 5 · 2018: 9 · 2017: 15 · 2016: 11 · 2015: 11
FWCI: 6.23
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Amgen
National Institutes of Health (369901, CA84131, CA31946)
National Cancer Institute (CA84131, R01CA154848, CA96940, CA-33601, CA124924, U10CA033601, UG1CA189823, R01CA124924, U10CA084131, U10CA031946, CA127617, K05CA096940, U10CA180838, CA154848, R01CA127617, 369901, P30CA051008, CA-31946)
Topics: Health Sciences › Medicine › Geriatrics and Gerontology › Frailty in Older Adults
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
Keywords: frailty, adjuvant endocrine therapy, breast cancer, older women, treatment discontinuation, estrogen receptor-positive breast cancer, racial disparities
MeSH terms: Age Factors, Aged, Aged, 80 and over, Breast Neoplasms, Female, Humans, Prospective Studies, Cohort Studies, Treatment Outcome, Chemotherapy, Adjuvant, Antineoplastic Agents, Hormonal, Medication Adherence

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Frailty and Adherence to Adjuvant Hormonal Therapy in Older Women With Breast Cancer: CALGB Protocol 369901

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