Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I)

Smith, Samuel George; Sestak, Ivana; Howell, Anthony; Forbes, John; Cuzick, Jack

doi:10.1200/jco.2016.71.7439

Cited by 51Medication Adherence and ComplianceCancer survivorship and careBreast Cancer Treatment Studies

Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I)

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Smith, Samuel George, Sestak, Ivana, Howell, Anthony, Forbes, John, Cuzick, Jack·2017·Journal of Clinical Oncology

DOI 10.1200/jco.2016.71.7439PMC PMC5549455

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Abstract

Purpose: To assess the role of participant-reported symptoms on long-term adherence to preventive therapy in the United Kingdom sample of the International Breast Cancer Intervention Study (IBIS-I). IBIS-I was a randomized controlled trial that investigated the effectiveness of tamoxifen in reducing the risk of breast cancer among women at increased risk of the disease. Participants and Methods: Women were randomly assigned to tamoxifen versus placebo (20 mg/day; n = 4,279). After 456 exclusions, 3,823 women were included in this analysis. Adherence (< 4.5 years or ≥ 4.5 years) was calculated using data from six monthly clinical visits. Analyses were adjusted for age, Tyrer-Cuzick risk, smoking, use of hormone replacement therapy, menopausal status, baseline menopausal symptoms, and treatment. Results: Overall, 69.7% of women were adherent for at least 4.5 years (tamoxifen: 65.2% v placebo: 74.0%; P < .001). Differences in adherence between treatment arms were observed from 12 months onward (all P < .01) and were largest at 54 months. Dropout rates were highest in the first 12 to 18 months and decreased thereafter. Women reporting nausea/vomiting were less likely to be adherent in both the tamoxifen (odds ratio [OR], 0.57; 95% CI, 0.37 to 0.86; P = .007) and placebo (OR, 0.58; 95% CI, 0.37 to 0.93; P = .023) arms. Headaches were associated with adherence only in the placebo arm (OR, 0.62; 95% CI, 0.42 to 0.91; P = .016), whereas gynecologic symptoms were significant only in the tamoxifen arm (OR, 0.77; 95% CI, 0.62 to 0.97; P = .024). Effect sizes for each symptom on adherence were not significantly different between the treatment groups ( P > .05). In both treatment arms, we observed significant trends for lower adherence with increasing severity for all symptoms ( P < .01) except headaches ( P = .054). Conclusion: In the IBIS-I trial, experiencing predefined symptoms in the first 6 months reduced long-term adherence. Effects were similar between treatment arms, suggesting that women were attributing age-related symptoms to preventive therapy. Interventions were required to support symptom management.

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Most symptoms occur in the first year of using HT.
“Most symptoms occur in the first year of using HT, suggesting this period could be the optimal opportunity for delivering supportive care for this patient group [20–22].”
From Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial (2022) · cites this paper as [20]
The Discussion says that the majority of symptoms assessed in IBIS-I occur within the first year of therapy, and the Introduction specifies the predefined symptoms. This supports the timing, but the claim broadens a finding about selected symptoms in a tamoxifen prevention trial to symptoms during HT generally. (LLM, conf=0.84)
Experimental — accuracy not yet measured
The first year of using HT could be the optimal opportunity for delivering supportive care for this patient group.
“Most symptoms occur in the first year of using HT, suggesting this period could be the optimal opportunity for delivering supportive care for this patient group [20–22].”
From Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial (2022) · cites this paper as [20]

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Abstract S5-03: Menopausal symptoms as predictors of long-term adherence in the International breast cancer intervention study (IBIS-1)
Smith, S. G., Šestak, I., Forbes, J., Howell, A., & Cuzick, J. M. (2017) · Cancer Research · doi:10.1158/1538-7445.sabcs16-s5-03
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Participant-reported symptoms as predictors of long-term adherence of endocrine therapy in the International breast cancer intervention studies 2 (IBIS-2)
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Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1
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Authors: Smith, S. G., Sestak, I., Howell, A., Forbes, J., & Cuzick, J.
Affiliations: University of Leeds (GB)
Samuel George Smith, Leeds Institute of Health Science, University of Leeds, Leeds; Samuel George Smith, Ivana Sestak, and Jack Cuzick, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London; Anthony Howell, Institute of Cancer Sciences, University of Manchester, Manchester, United Kingdom; and John Forbes, Calvary Mater Newcastle Hospital, Newcastle, Australia.
Corresponding author: Smith, Samuel George
ORCID: Smith, Samuel George
Howell, Anthony
Forbes, John
Cuzick, Jack
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2017-08-10
Volume: 35
Issue: 23
Pages: 2666-2673
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2016.71.7439
PMC: PMC5549455
OpenAlex: W2619605504
Cited by: 51
References: 43
Citations by year: 2026: 5 · 2025: 2 · 2024: 2 · 2023: 9 · 2022: 4 · 2021: 11 · 2020: 5 · 2019: 7 · 2018: 3 · 2017: 3
FWCI: 5.14
Type: journal article
Language: en
Update notices: correction (2018-01-20)
Open access: hybrid
doi.org
Licence: cc-by
Locations: Journal of Clinical Oncology (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
Figshare (submittedVersion, cc-by)
Research Explorer (The University of Manchester) (submittedVersion, cc-by)
Queen Mary Research Online (Queen Mary University of London) (submittedVersion, cc-by)
NOVA (University of Newcastle Australia) (submittedVersion, cc-by)
Funders: Cancer Research UK (C42785/A17965, C569-A16891, 16891, 16893)
Topics: Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
Health Sciences › Medicine › Oncology › Cancer survivorship and care
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Keywords: medication adherence, tamoxifen, breast cancer chemoprevention, nausea and vomiting, headache, gynecologic symptoms, dropout, adverse drug reactions, high-risk women, long-term adherence, symptom severity, hormone replacement therapy, menopausal symptoms, trial retention
MeSH terms: Breast Neoplasms, Female, Genital Diseases, Female, Headache, Humans, Middle Aged, Nausea, Patient Dropouts, Placebos, Risk Factors, Tamoxifen, Time Factors, Vomiting, Drug Monitoring, Antineoplastic Agents, Hormonal, Self Report, Symptom Assessment

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Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I)

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