Geriatric assessment of elderly chemotherapy-naïve patients treated with trabectedin for advanced soft tissue sarcomas (STS): The E-TRAB study of the German Interdisciplinary Sarcoma Group (GISG-13)

Abstract

Background: More than half of soft tissue sarcoma (STS) patients are diagnosed older than 60 years and prognosis for advanced disease is unfavourable with a median overall survival (OS) of ∼12 months remaining substantially unchanged during the last 20 years. Quality of Life (QoL), especially when collected directly from the patients as Patient Reported Outcome (PRO) measures, has gained increasing interest in cancer care; however, existing data among elderly STS patients are scarce. The rationale of the E-TRAB study is to analyze QoL and PRO data in the elderly population (aged ≥ 60 years) with advanced STS, considered to be unsuited to receive anthracycline-based chemotherapy, and treated with trabectedin as a 1st line therapy. Trial design: The E-TRAB (GISG-13) study is designed as a non-interventional trial (n=110). Primary endpoints to be evaluated are OS and QoL. It is hypothesized that OS will not be<10 months in this population. As secondary endpoints a comprehensive geriatric assessment is performed, and whenever feasible captured as PRO, in order to predict for safety parameters consisting of the Instrumental Activities of Daily Living (IADL), the Mini Nutritional Assessment (MNA), the Charlson Comorbidity Index (CCI), the Geriatric Depression Scale (GDS) and Time up & Go. The predictive value of two geriatric screening tools (G8, CARG prediction tool) is investigated with regards to unplanned hospitalizations, grade 4 toxicities and early death within the first six months. The EORTC QLQ-C30 and 18 PRO-CTCAE items are used to evaluate PRO. As translational research the tumour microenvironment is analyzed immunohistochemically using a new multicolor-immunofluorescence-histology technology (OPAL). This trial benefits from a cooperation of sarcoma centers in Austria, Germany and Switzerland under the German Interdisciplinary Sarcoma Group (GISG). The recruitment of patients is ongoing.