Abstract
Purpose
To assess the joint symptoms and the impact on patients’ health-related quality of life (HRQOL) due to 5 years of anastrozole from the baseline data in the N-SAS BC 05 trial, a randomized clinical trial was designed to assess the efficacy of 5 additional years of anastrozole among women with breast cancer.
Methods
Joint symptoms and HRQOL were evaluated using an original questionnaire for joint symptoms, the Short Form 36-item Health Survey (SF-36), the EuroQol EQ-5D-3L, and a subscale of the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES).
Results
Baseline joint symptom and HRQOL data were collected from 330 patients between November 2007 and March 2010. Joint pain and joint stiffness were reported by 61.6 and 59.1 % of patients, respectively, although these symptoms did not affect the activities of daily living in 96.0 and 97.9 % of patients, respectively. Joint pain was reported in the knee by 61.0 % of patients and in the hand by 36.0 % of patients. Joint stiffness mainly affected the hand (67.9 %), especially the proximal interphalangeal joint, and typically occurred upon waking up or in the morning. Most SF-36 domains had good average scores, although slight decreases in physical functioning and role-physical were observed (compared to the national standard scores). The mean EQ-5D utility score was 0.86, and the total FACT-ES subscale score was 62.2/76.
Conclusions
After 5 years of anastrozole, many of the patients reported joint pain and stiffness in mainly the hand and knee with mild symptoms and good HRQOL.
Similar content being viewed by others
References
Coombes RC, Hall E, Gibson LJ, et al (2004) A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med 350:1081–1092
Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists’ Group, Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M (2008) Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol 9:45–53
Regan MM, Neven P, Giobbie-Hurder A, et al (2011) Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up. Lancet Oncol 12:1101–1108
Mouridsen HT (2006) Incidence and management of side effects associated with aromatase inhibitors in the adjuvant treatment of breast cancer in postmenopausal women. Curr Med Res Opin 22:1609–1621
Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS, ATAC Trialists’ Group (2005) Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet 365:60–62
Arimidex, Tamoxifen, Alone or in Combination Trialists’ Group, Buzdar A, Howell A, et al (2006) Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Lancet Oncol 7:633–643
Crew KD, Greenlee H, Capodice J, et al (2007) Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol 25:3877–3883
Henry NL, Azzouz F, Desta Z, et al (2012) Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. J Clin Oncol 30:936–942
Chim K, Xie SX, Stricker CT, et al (2013) Joint pain severity predicts premature discontinuation of aromatase inhibitors in breast cancer survivors. BMC Cancer 13:401
1998) Tamoxifen for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists’ Collab Group Lancet 351:1451–1467
Ohsumi S, Shimozuma K (2013) Current status and future perspectives of patient-reported outcome research in clinical trials for patients with breast cancer in Japan. Breast Cancer 20:296–301
Ware JE, Jr SF-36 Health Survey Update. http://www.sf-36org/tools/sf36s.html.
McHorney CA, Ware Jr JE, Raczek AE (1993) The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 31:247–263
Fukuhara S, Ware Jr JE, Kosinski M, Wada S, Gandek B (1998) Psychometric and clinical tests of validity of the Japanese SF-36 Health Survey. J Clin Epidemiol 51:1045–1053
Fukuhara S, Bito S, Green J, Hsiao A, Kurokawa K (1998) Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan. J Clin Epidemiol 51:1037–1044
EQ-5D-3L. http://www.euroqolorg/eq-5d-products/eq-5d-3l.html.
EuroQol Group (1990) EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16:199–208
Tsuchiya A, Ikeda S, Ikegami N, et al (2002) Estimating an EQ-5D population value set: the case of Japan. Health Econ 11:341–353
Fallowfield LJ, Leaity SK, Howell A, Benson S, Cella D (1999) Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B. Breast Cancer Res Treat 55:189–199
Aaronson NK, Ahmedzai S, Bergman B, et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365–376
Cella DF, Tulsky DS, Gray G, et al (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 11:570–579
Kurihara M, Shimizu H, Tsuboi K, et al (1999) Development of quality of life questionnaire in Japan: quality of life assessment of cancer patients receiving chemotherapy. Psychooncology 8:355–563
Shimozuma K, Ohashi Y, Takeuchi A, et al (2009) Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer 17:1483–1491
Shiroiwa T, Fukuda T, Shimozuma K, et al (2011) Comparison of EQ-5D scores among anthracycline-containing regimens followed by taxane and taxane-only regimens for node-positive breast cancer patients after surgery: the N-SAS BC 02 trial. Value Health 14:746–751
Velikova G, Wright P, Smith AB, et al (2001) Self-reported quality of life of individual cancer patients: concordance of results with disease course and medical records. J Clin Oncol 19:2064–2073
Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM (2004) How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol 22:3485–3490
Ruhstaller T, von Moos R, Rufibach K, et al (2009) Breast cancer patients on endocrine therapy reveal more symptoms when self-reporting than in pivotal trials: an outcome research study. Oncology 76:142–148
Mao JJ, Stricker C, Bruner D, et al (2009) Patterns and risk factors associated with aromatase inhibitor-related arthralgia among breast cancer survivors. Cancer 115:3631–3639
Pickard AS, Wilke CT, Lin HW, Lloyd A (2007) Health utilities using the EQ-5D in studies of cancer. PharmacoEconomics 25:365–384
Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A (2006) Quality of life of postmenopausal women in the ATAC (“Arimidex”, tamoxifen, alone or in combination) trial after completion of 5 years’ adjuvant treatment for early breast cancer. Breast Cancer Res Treat 100:273–284
Whelan TJ, Goss PE, Ingle JN, et al (2005) Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. J Clin Oncol 23:6931–6940
Muss HB, Tu D, Ingle JN, et al (2008) Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG Intergroup Trial MA.17. J Clin Oncol 26:1956–1964
Davies C, Pan H, Godwin J, et al (2013) Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet 381:805–816
Higgins MJ, Liedke PE, Goss PE (2013) Extended adjuvant endocrine therapy in hormone dependent breast cancer: the paradigm of the NCIC-CTG MA.17/BIG 1-97 trial. Crit Rev Oncol Hematol 86:23–32
Acknowledgments
This study was supported by the Comprehensive Support Project for Oncology Research (CSP-OR) and the Comprehensive Support Project for Health Outcomes Research (CSP-HOR) of the Public Health Research Foundation. The corporate and individual sponsors of this study are listed on the CSP-OR website (http://www.csp.or.jp/cspor/kyousan_e.html). The pharmaceutical manufacturer/distributor played no role in this study, except in providing information regarding the proper use of the study drugs. All decisions concerning the planning, implementation, and publication of this study were made exclusively by the executive committee. We would like to thank Editage (www.editage.jp) for the English language editing.
Disclosures
The authors declare that they have no competing interests.
Author information
Authors and Affiliations
Corresponding author
Electronic supplementary material
Below is the link to the electronic supplementary material.
ESM 1
(DOC 2.44 mb)
Rights and permissions
About this article
Cite this article
Yagata, H., Ohtsu, H., Komoike, Y. et al. Joint symptoms and health-related quality of life in postmenopausal women with breast cancer who completed 5 years of anastrozole. Support Care Cancer 24, 683–689 (2016). https://doi.org/10.1007/s00520-015-2830-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-015-2830-6