Clinical Trial

Breast Cancer Research and Treatment

, Volume 111, Issue 2, pp 365-372

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

  • N. Lynn HenryAffiliated withBreast Oncology Program, University of Michigan Comprehensive Cancer Center
  • , Jon T. GilesAffiliated withDivision of Rheumatology, Johns Hopkins University
  • , Dennis AngAffiliated withDepartment of Medicine, Indiana University School of Medicine
  • , Monika MohanAffiliated withDivision of Rheumatology, Department of Internal Medicine, University of Michigan Medical School
  • , Dina DadabhoyAffiliated withDivision of Rheumatology, Department of Internal Medicine, University of Michigan Medical School
  • , Jason RobargeAffiliated withDepartment of Medicine, Indiana University School of Medicine
  • , Jill HaydenAffiliated withBreast Oncology Program, University of Michigan Comprehensive Cancer Center
  • , Suzanne LemlerAffiliated withDepartment of Medicine, Indiana University School of Medicine
  • , Karineh ShahverdiAffiliated withBreast Cancer Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
    • , Penny PowersAffiliated withBreast Cancer Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
    • , Lang LiAffiliated withDepartment of Medicine, Indiana University School of Medicine
    • , David FlockhartAffiliated withDepartment of Medicine, Indiana University School of Medicine
    • , Vered StearnsAffiliated withBreast Cancer Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
    • , Daniel F. HayesAffiliated withBreast Oncology Program, University of Michigan Comprehensive Cancer Center Email author 
    • , Anna Maria StornioloAffiliated withDepartment of Medicine, Indiana University School of Medicine
    • , Daniel J. ClauwAffiliated withDivision of Rheumatology, Department of Internal Medicine, University of Michigan Medical School

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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.

Keywords

Aromatase inhibitor Arthralgia Breast cancer Musculoskeletal symptoms Rheumatology