The patient’s anastrozole compliance to therapy (PACT) program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer
Open accessAbstract
Background Compliance and persistence are often overlooked in adjuvant breast cancer treatment.Patients and methods PACT was a prospective, multicenter, randomized, open, parallel-group study assessing whether educational materials (EMs) enhanced compliance with aromatase inhibitor (AI) therapy in postmenopausal women with early, hormone-receptor-positive (HR+) breast cancer. The primary end points were compliance (proportion taking ≥ 80% anastrozole) at 12 months and persistence (proportion reporting anastrozole intake during the study period).Results Four thousand eight hundred and forty-four patients were randomly assigned 1:1 to receive standard therapy or standard therapy with EMs. There was no difference between arms in compliance (N = 2740; 88.5%/88.8%, respectively, P = 0.81) or persistence rates (N = 2740; 40.5%/43.0%, respectively, P = 0.18). Modified end point analyses found no differences in compliance between arms based on the classification of: (i) patients with missing documentation or follow-up visit <9 months as non-compliant (N = 4397, P = 0.15); (ii) patients with early (≤ 292 days) 12-month follow-up documentation excluded (N = 4091, P = 0.19); (iii) patients reaching ≥ 80% compliance during individual follow-up as compliant (N = 4397, P = 0.26). Modified persistence analyses found no difference between arms (N = 4397, P = 0.37).Conclusions Addition of EMs to standard therapy did not significantly affect compliance and persistence with adjuvant anastrozole. CLINICALTRIALS ID: NCT00555867.
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There is no gold standard for measuring adherence because of accuracy limitations of assessment methods.
“Due to the accuracy limitations of the methods to assess adherence (e.g., self-report, pill counts, pharmacy records, medical records, electronic medication caps),11 there is no gold standard for measuring adherence.12-14”
From Behavioral interventions to enhance adherence to hormone therapy in breast cancer survivors: a systematic literature review (2016) · cites this paper as [13]
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“breast cancer patients [44] and the smallest inclusive of 9 evaluable patients [45].”
BackgroundResultInfluentialMedication taking behaviors among breast cancer patients on adjuvant endocrine therapy
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“Declined to respond 1 (2) 2 (4) 3 (3) Breast cancer stage 0 5 (10) 3 (6) 8 (8) I 36 (72) 41 (82) 77 (77) II 6 (12) 10 (20) 16 (16) III 3 (6) 2 (4) 5 (5) Type of AET Aromatase inhibitor 28 (56) 32 (64) 60 (60) Tamoxifen 22 (44) 18 (36) 40 (40) Primary treatment type Surgery only 10 (20) 13 (26) 23 (23) Surgery and radi…”
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“Five studies included follow-up interventions that occurred at periods ranging from one week to 12 months (34-36, 39, 42).”
InfluentialPatientenadhärenz in der oralen medizinischen Onkologie
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- Authors
- Hadji, P., Blettner, M., Harbeck, N., Jackisch, C., Lück, H.-J., Windemuth-Kieselbach, C., Zaun, S., & Kreienberg, R.
- Affiliations
- Philipps University of Marburg (DE)
- Johannes Gutenberg University Mainz (DE)
- Ludwig-Maximilians-Universität München (DE)
- Sana Klinikum Offenbach (DE)
- AstraZeneca (Germany) (DE)
- Universität Ulm (DE)
- Corresponding author
- Hadji, P.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2013-06
- Volume
- 24
- Issue
- 6
- Pages
- 1505-1512
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2133428293
- Cited by
- 122
- References
- 28
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 7 · 2023: 6 · 2022: 10 · 2021: 8 · 2020: 13 · 2019: 12 · 2018: 12 · 2017: 12 · 2016: 11 · 2015: 11 · 2014: 10 · 2013: 6
- FWCI
- 10.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- AstraZeneca
- 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
- anastrozole, medication adherence, treatment persistence, adjuvant endocrine therapy, aromatase inhibitors, early breast cancer, hormone receptor-positive breast cancer, postmenopausal women, patient education materials
- MeSH terms
- Anastrozole, Aged, Breast Neoplasms, Female, Follow-Up Studies, Humans, Middle Aged, Nitriles, Patient Compliance, Prospective Studies, Triazoles, Postmenopause, Antineoplastic Agents, Hormonal, Early Detection of Cancer, Medication Adherence
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