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Abstract
Introduction/Background*In the treatment of both platinum-resistant recurrent ovarian cancer (ROC) and metastatic breast cancer (MBC), symptom control and maintenance of quality of life (QoL) play a crucial role. In the advanced stage of disease, metronomic chemotherapy (MCT) may be a favourable treatment option. The aim of this study is to assess the QoL of heavily pretreated patients with ROC and MBC treated with MCT.
Methodology PROmetronomic, FoR.UM 19-02193, is a monocentric, open-label, single-arm observational study to assess health-related patient-reported outcome data in ROC and MBC patients treated with MCT (cyclophosphamide 50 mg p.o. daily ± methotrexate 2.5 mg p.o. every other day). QoL data are evaluated using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0, EORTC QLQ-OV28 version 1.0 (ROC)/EORTC QLQ-BR23 version 1.0 (MBC), and Hospital anxiety and depression scale (HADS-D) questionnaires via an internet-based therapy support system CANKADO. Patients previously treated with at least 1 line of platinum-based and 1 platinum-free chemotherapy (ROC)/at least 2 lines of endocrine therapy (for hormone receptor-positive cancer) and at least 2 lines of chemotherapy (MBC) are included. Secondary endpoints are disease control rate at 12 and 24 weeks, duration of response, progression-free survival and overall survival. Assessment of safety and tolerability is conducted according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. As part of the translational research approach, potentially relevant anti-angiogenic and immunomodulatory biomarkers are being investigated.
Result(s)*Until 2021-05-01, 4 ROC and 3 MBC patients have been enrolled. It is planned to include a total of 65 patients until 08/2023.
Conclusion*Potentially toxic chemotherapy is often required to achieve disease control in patients with metastatic cancer. However, well-being and personal preferences must not be neglected. MCT could provide an efficacious treatment option with limited toxicities and positive impact on QoL.