Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2008 Sep;111(2):365-72.
doi: 10.1007/s10549-007-9774-6. Epub 2007 Oct 6.

Prospective characterization of musculoskeletal symptoms in early stage breast cancer patients treated with aromatase inhibitors

N Lynn Henry  1 , Jon T Giles, Dennis Ang, Monika Mohan, Dina Dadabhoy, Jason Robarge, Jill Hayden, Suzanne Lemler, Karineh Shahverdi, Penny Powers, Lang Li, David Flockhart, Vered Stearns, Daniel F Hayes, Anna Maria Storniolo, Daniel J Clauw
Affiliations
Randomized Controlled Trial

Prospective characterization of musculoskeletal symptoms in early stage breast cancer patients treated with aromatase inhibitors

N Lynn Henry et al. Breast Cancer Res Treat. 2008 Sep.

Abstract

Purpose: Aromatase inhibitors (AIs) are increasingly used as adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. AIs are commonly associated with musculoskeletal symptoms. The primary objective of this study was to describe the musculoskeletal symptoms that developed in the first 100 subjects enrolled who had at least 6 months follow-up.

Methods: Women with early stage hormone receptor-positive breast cancer were recruited into a multicenter randomized clinical trial to study the pharmacogenomics of two AIs, exemestane, and letrozole. Patients completed the Health Assessment Questionnaire (HAQ) and Visual Analog Scale (VAS) at baseline, 1, 3, 6, and 12 months to assess changes in function and pain, respectively. Patients were referred for evaluation by a rheumatologist if their HAQ and/or VAS scores exceeded a predefined threshold.

Results: Forty-four of 97 eligible patients (45.4%) met criteria for rheumatologic referral. Three patients were ineligible because of elevated baseline HAQ (2) and failure to initiate AI therapy (1). No baseline characteristics were significantly associated with referral. Median time to onset of symptoms was 1.6 months (range 0.4-10 months). Clinical and laboratory evaluation of patients evaluated by rheumatology suggested that the majority developed either non-inflammatory musculoskeletal symptoms or inflammation localized to tenosynovial structures. Thirteen patients discontinued AI therapy because of musculoskeletal toxicity after a median 6.1 months (range 2.2-13 months).

Conclusions: Musculoskeletal side effects were common in AI-treated patients, resulting in therapy discontinuation in more than 10% of patients. There are no identifiable pre-therapy indicators of risk, and the etiology remains elusive.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Distribution of rheumatology referrals over time. Light gray bars represent patients eligible for referral who did not qualify for referral at a given timepoint. Black bars represent patients eligible for referral who did qualify for referral at a given timepoint. Percentage at top of each bar represents percent of patients referred to rheumatology at each timepoint
Fig. 2
Fig. 2
Frequency of symptoms reported by patients referred to rheumatology (n = 38)
See this image and copyright information in PMC

References

    1. Baum M, Budzar AU, Cuzick J, et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomized trial. Lancet. 2002;359:2131–2139. - PubMed
    1. Coombes RC, Hall E, Gibson LJ, et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004;350:1081–1092. - PubMed
    1. Goss PE, Ingle JN, Martino S, et al. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003;349:1793–1802. - PubMed
    1. Coates AS, Keshaviah A, Thurlimann B, et al. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1–98. J Clin Oncol. 2007;25:486–492. - PubMed
    1. Boccardo F, Rubagotti A, Puntoni M, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian Tamoxifen Anastrozole trial. J Clin Oncol. 2005;23:5138–5147. - PubMed

Publication types

Substances