Patient Reported Outcome in metastatic breast cancer and platinum-resistant recurrent ovarian cancer treated with metronomic cyclophosphamide ± methotrexate: PROmetronomic - FoR.UM 19-02193

Purpose In the treatment of both metastatic breast cancer (MBC) and platinum-resistant recurrent ovarian cancer (ROC), 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 MBC and ROC treated with MCT.

Methods PROmetronomic is a monocentric, open-label, single-arm observational study to assess health-related patient-reported outcome data in MBC and ROC treated with MCT (cyclophosphamide 50 mg daily ± methotrexate 2.5 mg every other day). QoL data, symptoms and adverse events are evaluated using EORTC QLQ-C30 version 3.0, EORTC QLQ-BR23 version 1.0 (MBC)/EORTC QLQ-OV28 version 1.0 (ROC) questionnaires and HADS-D in the CANKADO programme. Patients previously treated with at least 2 lines of endocrine therapy (for hormone receptor-positive cancer) and at least 2 lines of chemotherapy (MBC)/at least 1 line of platinum-based and 1 platinum-free chemotherapy (ROC) are included. Secondary endpoints are disease control rate at 12 and 24 weeks, progression-free survival and overall survival.

Results Until 2021-02-28, 3 MBC and 3 ROC patients have been enrolled. It is planned to include a total of 65 patients until 08/2023.

Conclusions 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.

Publication History

Article published online:
01 June 2021