Patient-reported symptoms and discontinuation of adjuvant aromatase inhibitor therapy

Cancer. 2014 Aug 15;120(16):2403-11. doi: 10.1002/cncr.28756. Epub 2014 May 6.

Abstract

Background: Aromatase inhibitor (AI) therapy results in substantial survival benefits for patients with hormone receptor-positive breast cancer. The rates of poor adherence and discontinuation of AI therapy are high, primarily because of treatment-related toxicities like musculoskeletal pain. Although pain-related symptoms may worsen during AI therapy, the authors hypothesized that nonpersistence with AI therapy was associated with symptoms that were present before treatment initiation.

Methods: Postmenopausal women initiating AI therapy who were enrolled in a prospective clinical trial completed questionnaires at baseline to assess sleep, fatigue, mood, and pain. Reasons for treatment discontinuation during the first year of treatment were recorded. Associations between baseline patient-reported symptoms and treatment discontinuation because of toxicity were identified using logistic regression.

Results: Four hundred forty-nine patients were evaluable. The odds of treatment discontinuation were higher in patients who reported a greater number of symptoms before AI initiation. Baseline poor sleep quality was associated with early treatment discontinuation, with an odds ratio (OR) of 1.91 (95% confidence interval [CI], 1.26-2.89; P = .002). Baseline presence of tired feeling and forgetfulness had similar ORs for discontinuation (tired feeling: OR, 1.76; 95% CI, 1.15-2.67; P = .009; forgetfulness: OR, 1.66; 95% CI, 1.11-2.48; P = .015). An increasing total number of baseline symptoms was associated with an increased likelihood of treatment discontinuation, with an OR of 1.89 (95% CI, 1.20-2.96; P = .006) for 3 to 5 symptoms versus 0 to 2 symptoms.

Conclusions: Symptom clusters in breast cancer survivors that are present before the initiation of adjuvant AI therapy may have a negative impact on a patient's persistence with therapy. Interventions to manage these symptoms may improve breast cancer outcomes and quality of life.

Trial registration: ClinicalTrials.gov NCT00228956.

Keywords: aromatase inhibitor; breast cancer; nonpersistence; patient-reported outcomes; symptoms.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use
  • Aromatase Inhibitors / adverse effects*
  • Aromatase Inhibitors / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / metabolism
  • Female
  • Humans
  • Letrozole
  • Middle Aged
  • Nitriles / adverse effects
  • Nitriles / therapeutic use
  • Prospective Studies
  • Surveys and Questionnaires
  • Survival Analysis
  • Treatment Outcome
  • Triazoles / adverse effects
  • Triazoles / therapeutic use

Substances

  • Androstadienes
  • Aromatase Inhibitors
  • Nitriles
  • Triazoles
  • Letrozole
  • exemestane

Associated data

  • ClinicalTrials.gov/NCT00228956