Background
cancer, ER-positive breast cancer, breast cancer
ER-POSITIVE BREAST CANCER, BREAST CANCER, CANCER, DISEASE, WASTED, CELLULAR PROLIFERATION
Despite adjuvant therapy improvements in HR + /HER2 − breast cancer, a substantial proportion of patients still progresses to the metastatic stage. In the metastatic setting, when planning a therapy or therapy sequence, the focus is not only on efficacy, but also quality of life (QoL). Recently, some therapies have been approved for MBC to overcome hormone resistance such as everolimus or CDK 4/6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib) which are administered orally.Palbociclib is the first inhibitor of cyclin-dependent kinases (CDK) 4 and 6 that was approved in breast cancer. In vitro, palbociclib reduced cellular proliferation of ER-positive breast cancer cell lines by blocking progression of cells from G1 into S phase of the cell cycle. Based on the three large studies PALOMA-1, -2, and -3 [The steady increase of oral drugs in anticancer treatment requires changes in patient management. Adherence to therapy over the entire course of treatment is a prerequisite for efficacy. While oral administration provides advantages compared to intravenous application of antineoplastic medications regarding QoL (e.g., flexibility, less wasted time and effort), patient responsibility is higher; there can be a loss of physician assistance and monitoring of the treatment. Maintaining adherence thus presents a challenge to disease management. In this context, factors influencing adherence include QoL factors such as patient satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients, particularly MBC patients, are needed. An eHealth-based platform such as CANKADO can help to support therapy management by probing the QoL status of the patient continuously throughout the course of treatment and, ideally, providing a basis for intensified care when indicated.QoL combines different aspects of personal health status of an individual [All these aspects are well covered in the FACT-G scale. The FACT-G as a part of the breast cancer questionnaire FACT-B is multidimensional, consisting of subscales assessing Physical Well-Being (PWB), Emotional Well-Being (EWB), Social Well-Being (SWB), and Functional Well-Being (FWB). The FACT-G yields a total score, as well as individual subscale scores, with higher scores reflecting better QoL [Having a continuous PRO feedback can heighten physicians’ awareness of their patients’ QoL [Additionally, uncertainty, lack of confidence, or anxieties related to the physician are factors that are known to influence outpatient communication [The “ISPOR ePRO Good Research Practices Task Force” reported that data from an electronic PRO (ePRO) questionnaire adapted from a paper-based questionnaire had equivalent or superior performance (e.g., exhibited higher reliability) than the data from the original paper version [Giving patients the opportunity to document complaints and QoL continuously at home provides a more detailed overview about their progress and can be used for directed questions from the physician. It also facilitates a more granular and reliable longitudinal overview. Such reports can improve the understanding of QoL of cancer patients receiving oral therapies.The PreCycle trial was designed to evaluate the impact of ePROs in MBC using CANKADO (