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Assessment of fatigue in cancer patients treated with ribociclib and endocrine therapy according to patient reported outcomes at the University hospital for tumors

Around 70% of metastatic breast cancers have hormone receptor (HR) positive, HER2-negative biol- ogy and selective cyclin- dependent kinases 4/6 (CDK 4/6) inhibitors, in addition to endocrine therapy (ET), are standard of care in the first line, and effective treatment option in subsequent lines of therapy. One of the main purposes of treatment in a metastatic setting is maintaining a good quality of life. These agents have shown acceptable and easily manageable toxicity profile. It has been described that health care pro- fessionals underestimate side effects of specific antineoplastic treatment, such as endocrine therapy, com- pared with patients themselves. Fatigue is indistinct, not well defined, multidimensional symptom which is not easily measurable. It is well known that menopause also can cause fatigue, as well as endocrine treatment so it’s challenging to determine if this symptom is predominantly caused by menopausal status or specific oncological treatment, but it is most likely that the impact of these factors overlap. Nevertheless, fatigue is a symptom that negatively impacts patients’ quality of life. This analysis evaluated patient- reported outcomes (PROs) to assess fatigue and its impact on health-related quality of life in patients with HR-positive, HER- 2 negative metastatic disease treated at University hospital for tumors. We obtained data from 99 patients with HR- positive HER2- negative breast cancer who were treated at the Division of Medical Oncology with ribociclib and endocrine therapy, in the period from 08/2018 to 12/2020 and had reported fatigue as an adverse event. Patients had to complete at least one four-week cycle of therapy and fill in the questionnaires. PRO assessments were evaluable for 87 female patients, median age of 60 years, all postmenopausal. Endocrine partners in treatment with ribociclib were aromatase inhibitors in around 65%, predominantly anastrozole, while in around 35% of patients partner was fulvestrant. During therapy with ribociclib, 80% of patients reported fatigue as an adverse effect of this specific antineoplastic treat- ment. We have shown that fatigue is common in this observed population, and with this analysis from real clinical practice, we indicate the requirement for a better understanding of symptoms experienced by patients on this precise therapy. Since this symptom is not easy to define, we consider that it is necessary to carefully plan further researches to better identify and objectify it. Although not a life- threatening adverse event this is challenging symptom for patients, because of its feasible severe distress potential

HR+ breast cancer, ribociclib, CDK 4/6 inhibitors, fatigue

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