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Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1. | LitMetric

Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1.

J Natl Cancer Inst

National Surgical Adjuvant Breast and Bowel Project (now a part of NRG Oncology), Pittsburgh, PA (SRL, DLW, PAG); Division of Cancer Control and Population Sciences (SRL) and Division of Cancer Prevention (FLW), National Cancer Institute, Rockville, MD; NRG Oncology, Pittsburgh, PA and Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA (QL, JPC); Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA (DLW); UCLA Schools of Medicine and Public Health, and Jonsson Comprehensive Cancer Center, Division of Cancer Prevention & Control Research, Department of Health Services, Los Angeles, CA (PAG).

Published: April 2016

AI Article Synopsis

  • Tamoxifen reduces breast cancer risk in high-risk women, but many do not complete the recommended five-year therapy.
  • A study examined the link between participant-reported outcomes (like quality of life and symptoms) and adherence to medication over 12 months in a trial with over 10,000 participants.
  • Key predictors of adherence included mental quality of life and certain symptoms, with notable findings that moderate alcohol consumption and specific symptoms like gynecologic and sexual issues influenced adherence rates.

Article Abstract

Background: Tamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations.

Methods: P-1 participants were randomly assigned to placebo vs tamoxifen (20mg/day). Mixed effects logistic regression was used to evaluate whether baseline or three-month SF-36 quality of life (QOL) mental and physical component summaries (MCS, PCS), and participant-reported symptoms (gynecologic, vasomotor, sexual, and other) predicted 12-month drug adherence (76-100% of assigned medication). The evaluation accounted for age, treatment, estimated breast cancer risk, education, baseline smoking, alcohol consumption, and obesity. All statistical tests were two-sided.

Results: Participants enrolled at least three years before trial unblinding and without medically indicated discontinuation before 12 months were eligible for the present analyses (n = 10 576). At 12 months, 84.3% were adherent. Statistically significant predictors of adherence were: three-month MCS (odds ratio [OR] = 1.15 per 10 points, 95% confidence interval [CI] = 1.06 to 1.25); three-month gynecologic symptoms among moderate alcohol drinkers (OR = .79, 95% CI = 0.72 to 0.88); baseline vasomotor symptoms among participants assigned tamoxifen (OR = .88, 95% CI = 0.80 to 0.97); and three-month sexual symptoms among younger participants (OR = .89 at age 41 years, 95% CI = 0.80 to 0.99). The strongest association was with three-month other symptoms (OR = .77, 95% CI = 0.63 to 0.93). PCS was not associated with adherence. Symptom and QOL associations were not modified by smoking or obesity.

Conclusions: Promoting QOL and managing symptoms early in therapy may be important strategies to improve adherence.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675829PMC
http://dx.doi.org/10.1093/jnci/djv365DOI Listing

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