Breast Cancer Patients on Endocrine Therapy Reveal More Symptoms when Self-Reporting than in Pivotal Trials: An Outcome Research Study

Abstract

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.

Is the toxicity of adjuvant aromatase inhibitor therapy underestimated? Complementary information from patient-reported outcomes (PROs)

“…Our results, thereby, confirm the presumption that PROs reveal a higher level of symptom burden than conventional pivotal clinical trials [11,12,25,26]. Ruhstaller et al [16] reported comparable results in their PRO-based study. Though differing sample characteristics (i.e., treatment with tamoxifen) precluded direct comparison with our study results, their findings support the notion that the use of PROs leads to reporting of increased symptom frequency.…”

“…Although health care providers are supposed to be at the best position to report on toxicity [6], several studies on endocrine strategies in breast cancer treatment [9,[13][14][15] have shown a poor concordance of expert ratings and patient-reported frequencies for treatment-related non-life threatening symptoms. In the only study to date comparing patient-reported outcomes (PROs) in breast cancer patients receiving endocrine therapy with expert ratings [16], numerous symptoms (e.g., hot flushes/ sweats, low energy, and vaginal dryness) have been reported in a significantly higher percentage by the patients than by physicians. There is a lack of prevalence data generated in prospective studies specifically aiming for the assessment of adverse effects in this treatment group.…”

Getting the Whole Picture: Adding Patient-reported Outcomes to Adjuvant Endocrine Treatment Evaluation in Premenopausal Breast Cancer Patients

“…Our PRO study confirms a notably high level of psychosocial burden and physical side effects in premenopausal BC patients undergoing adjuvant TT. Evidence published only recently seems to support these findings claiming higher frequencies of several symptoms when subjectively reported, e.g., hot flushes/sweats or weight gain than known from previous pivotal studies (8). The frequencies of several symptoms herein distinctively exceed the reported frequencies for adverse events for premenopausal women in the ABCSG-12 study.…”

Provider perspectives on patient-provider communication for adjuvant endocrine therapy symptom management

“…Previous studies suggest incorporating patient-reported outcome assessments into follow-up appointments for survivors receiving AET significantly increases symptom reporting [35, 36]. Future research could examine strategies for routinely incorporating patient-reported outcome assessments into sur-vivorship care and optimal implementation such as collecting data at patient check-in and determining how best to organize, present, and respond to patient-reported AET symptoms within electronic health records [37, 38].…”