title: 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.
abstract: BACKGROUND
  Compliance and persistence are often overlooked in adjuvant breast cancer treatment.
  
  
  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.
authors: Department of Gynecology, Endocrinology and Oncology, Phillips-University of Marburg, Marburg, Germany.
authors: P
authors: P
authors: Hadji
authors: M
authors: M
authors: Blettner
authors: N
authors: N
authors: Harbeck
authors: C
authors: C
authors: Jackisch
authors: H-J
authors: HJ
authors: Lück
authors: C
authors: C
authors: Windemuth-Kieselbach
authors: S
authors: S
authors: Zaun
authors: R
authors: R
authors: Kreienberg
mesh_terms: D000368:Aged; D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D055088:Early Detection of Cancer / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055118:Medication Adherence / Q000523:psychology; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage*; D010349:Patient Compliance / Q000523:psychology; D017698:Postmenopause / Q000187:drug effects* / Q000523:psychology; D011446:Prospective Studies; D014230:Triazoles / Q000008:administration & dosage*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole
keywords: adherence; anastrozole; breast cancer; compliance; endocrine therapy; persistence