Objectives: The purpose of this investigation was firstly to assess the overall frequency of subjectively experienced symptoms self-reported by patients receiving endocrine therapy and secondly to compare these symptoms with side effects assessed by clinicians in pivotal trials. Methods: Unselected patients with early and advanced breast cancer receiving endocrine therapy were approached consecutively during a routine outpatient visit. They received a questionnaire called Checklist for Patients with Endocrine Therapy (C-PET), a validated self-assessment tool to determine prespecified symptoms associated with endocrine therapy. Data on toxicity were also obtained from previously published trials. Results: 405 patients were approached and 373 agreed to participate in this study. Some symptoms were significantly more often recorded by the women in the adjuvant setting completing the C-PET than by physicians’ reports in pivotal trials: hot flushes/sweats (C-PET 70%, ATAC 40% and BIG1-98 38%), low energy (C-PET 45%, ATAC 15% and BIG1-98 9%), fluid retention (C-PET 22% and BIG1-98 7%) and vaginal dryness (C-PET 30% and BIG1-98 3%). Similar differences were observed in the metastatic and adjuvant setting. Conclusions: A simple tool like the C-PET questionnaire is able to reflect the treatment burden of endocrine therapies and may be helpful to improve communication between patients and care providers. Some symptoms were significantly more often reported by the women in the C-PET than by physicians in pivotal trials.

Jonat W: Luteinizing hormone-releasing hormone analogues – the rationale for adjuvant use in premenopausal women with early breast cancer. Br J Cancer 1998;78(suppl 14):5–8.
Ganz PA: Impact of tamoxifen adjuvant therapy on symptoms, functioning, and quality of life. J Natl Cancer Inst Monogr 2001;30:130–134.
Fellowes D, Fallowfield LJ, Saunders CM, Houghton J: Tolerability of hormone therapies for breast cancer: how informative are documented symptom profiles in medical notes for ‘well-tolerated’ treatments? Breast Cancer Res Treat 2001;66:73–81.
Hopwood P: A Checklist for patients on endocrine therapy (C-PET). Eur J Cancer Care 1996;5:7–8.
Hopwood P: Living with advanced breast cancer: development and application of a clinical checklist for patients on endocrine therapy. Breast 1998;7:14–21.
Ribi K, Bernhard J, Rufibach K, et al: Endocrine symptom assessment in women with breast cancer: what a simple ‘yes’ means. Support Care Cancer 2007;15:1349–1356.
BIG 1-98 Collaborative Group: A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 2005;353:2747–2757.
Sterne TE: Some remarks on confidence or fiducial limits. Biometrika 1954;41:275–278.
Baum M, Budzar AU, Cuzick J, Forbes J, Houghton JH, Klijn JG, Sahmoud T; ATAC Trialists’ Group: 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 randomised trial. Lancet 2002;359:2131–2139.
Bonneterre J, Thurlimann B, Robertson JF, et al: Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability Study. J Clin Oncol 2000;18:3748–3757.
Nabholtz JM, Buzdar A, Pollak M, et al: Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 2000;18:3758–3767.
Mouridsen H, Gershanovich M, Sun Y, et al: Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group. J Clin Oncol 2001;19:2596–2606.
Leonard RCF, Lee L, Harrison ME: Impact of side-effects associated with endocrine treatments for advanced breast cancer: clinicians’ and patients’ perceptions. Breast 1996;5:259–264.
Coster S, Fallowfield LJ: The impact of endocrine therapy on patients with breast cancer: a review of the literature. Breast 2002;11:1–12.
Fallowfield L, Cella D, Cuzick J, et al: Quality of life of postmenopausal women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial. J Clin Oncol 2004;22:4261–4271.
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