Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer

N. Lynn Henry, Faouzi Azzouz, Zeruesenay Desta, Lang Li, Anne T. Nguyen, Suzanne Lemler, Jill Hayden, Karineh Tarpinian, Elizabeth Yakim, David A. Flockhart, Vered Stearns, Daniel F. Hayes, Anna Maria Storniolo

Research output: Contribution to journalArticle

176 Citations (Scopus)

Abstract

Purpose: Aromatase inhibitors (AIs) are effective for treatment of hormone receptor-positive breast cancer, but adherence and persistence with therapy are poor. Predictors of treatment discontinuation are not clearly defined. It is unknown whether patients with intolerable toxicity from one AI are able to tolerate another. Patients and Methods: Women with early-stage breast cancer initiating AI therapy were enrolled onto a multicenter, prospective, open-label randomized trial of exemestane versus letrozole. Patients completed symptom questionnaires at baseline and serially during therapy. Patients who developed AIassociated intolerable symptoms and discontinued treatment were given the option to switch to the other study AI after a 2- to 8-week washout period. Results: Of the 503 enrolled women, 32.4% discontinued initial AI therapy within 2 years because of adverse effects; 24.3% discontinued specifically because of musculoskeletal symptoms. Median time to treatment discontinuation as a result of any symptom was 6.1 months (range, 0.1 to 21.2 months) and was significantly shorter in patients randomly assigned to exemestane (hazard ratio [HR], 1.5; 95% CI, 1.1 to 2.1; P = .02). Younger age and taxane-based chemotherapy were associated with higher likelihood of treatment discontinuation (HR, 1.4; 95% CI, 1.02 to 1.9; P =.04; and HR, 1.9; 95% CI, 1.00 to 3.6; P = .048, respectively). Of the 83 patients who chose to switch to the second AI, 38.6% continued the alternate AI for a median of 13.7 months. Conclusion: Premature discontinuation of initial AI therapy as a result of symptoms is common, although more than one third of patients may be able to tolerate a different AI medication. Additional research is needed to identify predictive tools and interventions for AI-associated treatment-emergent symptoms.

Original languageEnglish
Pages (from-to)936-942
Number of pages7
JournalJournal of Clinical Oncology
Volume30
Issue number9
DOIs
StatePublished - Mar 20 2012

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Aromatase Inhibitors
Breast Neoplasms
exemestane
Therapeutics
letrozole
Hormones

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. / Henry, N. Lynn; Azzouz, Faouzi; Desta, Zeruesenay; Li, Lang; Nguyen, Anne T.; Lemler, Suzanne; Hayden, Jill; Tarpinian, Karineh; Yakim, Elizabeth; Flockhart, David A.; Stearns, Vered; Hayes, Daniel F.; Storniolo, Anna Maria.

In: Journal of Clinical Oncology, Vol. 30, No. 9, 20.03.2012, p. 936-942.

Research output: Contribution to journalArticle

Henry, NL, Azzouz, F, Desta, Z, Li, L, Nguyen, AT, Lemler, S, Hayden, J, Tarpinian, K, Yakim, E, Flockhart, DA, Stearns, V, Hayes, DF & Storniolo, AM 2012, 'Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer', Journal of Clinical Oncology, vol. 30, no. 9, pp. 936-942. https://doi.org/10.1200/JCO.2011.38.0261
Henry, N. Lynn ; Azzouz, Faouzi ; Desta, Zeruesenay ; Li, Lang ; Nguyen, Anne T. ; Lemler, Suzanne ; Hayden, Jill ; Tarpinian, Karineh ; Yakim, Elizabeth ; Flockhart, David A. ; Stearns, Vered ; Hayes, Daniel F. ; Storniolo, Anna Maria. / Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. In: Journal of Clinical Oncology. 2012 ; Vol. 30, No. 9. pp. 936-942.
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title = "Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer",
abstract = "Purpose: Aromatase inhibitors (AIs) are effective for treatment of hormone receptor-positive breast cancer, but adherence and persistence with therapy are poor. Predictors of treatment discontinuation are not clearly defined. It is unknown whether patients with intolerable toxicity from one AI are able to tolerate another. Patients and Methods: Women with early-stage breast cancer initiating AI therapy were enrolled onto a multicenter, prospective, open-label randomized trial of exemestane versus letrozole. Patients completed symptom questionnaires at baseline and serially during therapy. Patients who developed AIassociated intolerable symptoms and discontinued treatment were given the option to switch to the other study AI after a 2- to 8-week washout period. Results: Of the 503 enrolled women, 32.4{\%} discontinued initial AI therapy within 2 years because of adverse effects; 24.3{\%} discontinued specifically because of musculoskeletal symptoms. Median time to treatment discontinuation as a result of any symptom was 6.1 months (range, 0.1 to 21.2 months) and was significantly shorter in patients randomly assigned to exemestane (hazard ratio [HR], 1.5; 95{\%} CI, 1.1 to 2.1; P = .02). Younger age and taxane-based chemotherapy were associated with higher likelihood of treatment discontinuation (HR, 1.4; 95{\%} CI, 1.02 to 1.9; P =.04; and HR, 1.9; 95{\%} CI, 1.00 to 3.6; P = .048, respectively). Of the 83 patients who chose to switch to the second AI, 38.6{\%} continued the alternate AI for a median of 13.7 months. Conclusion: Premature discontinuation of initial AI therapy as a result of symptoms is common, although more than one third of patients may be able to tolerate a different AI medication. Additional research is needed to identify predictive tools and interventions for AI-associated treatment-emergent symptoms.",
author = "Henry, {N. Lynn} and Faouzi Azzouz and Zeruesenay Desta and Lang Li and Nguyen, {Anne T.} and Suzanne Lemler and Jill Hayden and Karineh Tarpinian and Elizabeth Yakim and Flockhart, {David A.} and Vered Stearns and Hayes, {Daniel F.} and Storniolo, {Anna Maria}",
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T1 - Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer

AU - Henry, N. Lynn

AU - Azzouz, Faouzi

AU - Desta, Zeruesenay

AU - Li, Lang

AU - Nguyen, Anne T.

AU - Lemler, Suzanne

AU - Hayden, Jill

AU - Tarpinian, Karineh

AU - Yakim, Elizabeth

AU - Flockhart, David A.

AU - Stearns, Vered

AU - Hayes, Daniel F.

AU - Storniolo, Anna Maria

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N2 - Purpose: Aromatase inhibitors (AIs) are effective for treatment of hormone receptor-positive breast cancer, but adherence and persistence with therapy are poor. Predictors of treatment discontinuation are not clearly defined. It is unknown whether patients with intolerable toxicity from one AI are able to tolerate another. Patients and Methods: Women with early-stage breast cancer initiating AI therapy were enrolled onto a multicenter, prospective, open-label randomized trial of exemestane versus letrozole. Patients completed symptom questionnaires at baseline and serially during therapy. Patients who developed AIassociated intolerable symptoms and discontinued treatment were given the option to switch to the other study AI after a 2- to 8-week washout period. Results: Of the 503 enrolled women, 32.4% discontinued initial AI therapy within 2 years because of adverse effects; 24.3% discontinued specifically because of musculoskeletal symptoms. Median time to treatment discontinuation as a result of any symptom was 6.1 months (range, 0.1 to 21.2 months) and was significantly shorter in patients randomly assigned to exemestane (hazard ratio [HR], 1.5; 95% CI, 1.1 to 2.1; P = .02). Younger age and taxane-based chemotherapy were associated with higher likelihood of treatment discontinuation (HR, 1.4; 95% CI, 1.02 to 1.9; P =.04; and HR, 1.9; 95% CI, 1.00 to 3.6; P = .048, respectively). Of the 83 patients who chose to switch to the second AI, 38.6% continued the alternate AI for a median of 13.7 months. Conclusion: Premature discontinuation of initial AI therapy as a result of symptoms is common, although more than one third of patients may be able to tolerate a different AI medication. Additional research is needed to identify predictive tools and interventions for AI-associated treatment-emergent symptoms.

AB - Purpose: Aromatase inhibitors (AIs) are effective for treatment of hormone receptor-positive breast cancer, but adherence and persistence with therapy are poor. Predictors of treatment discontinuation are not clearly defined. It is unknown whether patients with intolerable toxicity from one AI are able to tolerate another. Patients and Methods: Women with early-stage breast cancer initiating AI therapy were enrolled onto a multicenter, prospective, open-label randomized trial of exemestane versus letrozole. Patients completed symptom questionnaires at baseline and serially during therapy. Patients who developed AIassociated intolerable symptoms and discontinued treatment were given the option to switch to the other study AI after a 2- to 8-week washout period. Results: Of the 503 enrolled women, 32.4% discontinued initial AI therapy within 2 years because of adverse effects; 24.3% discontinued specifically because of musculoskeletal symptoms. Median time to treatment discontinuation as a result of any symptom was 6.1 months (range, 0.1 to 21.2 months) and was significantly shorter in patients randomly assigned to exemestane (hazard ratio [HR], 1.5; 95% CI, 1.1 to 2.1; P = .02). Younger age and taxane-based chemotherapy were associated with higher likelihood of treatment discontinuation (HR, 1.4; 95% CI, 1.02 to 1.9; P =.04; and HR, 1.9; 95% CI, 1.00 to 3.6; P = .048, respectively). Of the 83 patients who chose to switch to the second AI, 38.6% continued the alternate AI for a median of 13.7 months. Conclusion: Premature discontinuation of initial AI therapy as a result of symptoms is common, although more than one third of patients may be able to tolerate a different AI medication. Additional research is needed to identify predictive tools and interventions for AI-associated treatment-emergent symptoms.

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