COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy

Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18.

Abstract

Background: This prospective study evaluated the relationship between arthralgia and compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer.

Patients and methods: COMPliance and Arthralgia in Clinical Therapy (COMPACT) was an open-label, multicenter, noninterventional study conducted in Germany. Patients had started adjuvant anastrozole 3-6 months before the study start. The primary end points were arthralgia, compliance, and the relationship between compliance and arthralgia, assessed at specific time points.

Results: Overall, 1916 patients received upfront anastrozole. Mean arthralgia scores were increased from baseline at each visit up to 9 months. Compliance with anastrozole therapy gradually decreased over time from baseline to 9 months (P<0.001). At 9 months, investigators estimated that >95% of patients were compliant versus patient reports of <70%. There was a significant association between arthralgia mean scores and noncompliance at 6 months (P<0.0001), 9 months (P<0.0001), and overall (P<0.0001). Over time, new events or impairment of existing arthralgias were reported in 14% (3 months), 11% (6 months), and 9% (9 months) of patients.

Conclusion: Arthralgia is important in the clinical management of women with early breast cancer and may contribute to noncompliance and clinical outcomes.

Clinicaltrialsgov identifier: NCT00857012.

Keywords: anastrozole; aromatase inhibitors; arthralgia; breast neoplasms; patient compliance.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anastrozole
  • Antineoplastic Agents, Hormonal / adverse effects*
  • Antineoplastic Agents, Hormonal / therapeutic use
  • Arthralgia / chemically induced
  • Arthralgia / epidemiology*
  • Breast Neoplasms / drug therapy*
  • Chemotherapy, Adjuvant
  • Drug Substitution
  • Female
  • Humans
  • Incidence
  • Medication Adherence
  • Middle Aged
  • Nitriles / adverse effects*
  • Nitriles / therapeutic use
  • Prospective Studies
  • Treatment Outcome
  • Triazoles / adverse effects*
  • Triazoles / therapeutic use

Substances

  • Antineoplastic Agents, Hormonal
  • Nitriles
  • Triazoles
  • Anastrozole

Associated data

  • ClinicalTrials.gov/NCT00857012