Abstract 589P
Background
A good fitness level is required for patients (pts) wishing to enrol on most early phase cancer trials (EPCT). This is assessed by performance status and scoring systems such as the Royal Marsden Hospital (RMH) Score and MD Anderson Cancer Centre (MDACC) score. Reduced muscle mass (sarcopenia) as measured on CT scan at the level of L3 vertebrae is a prognostic biomarker for many cancers and may increase risk of drug toxicity. Our aim was to validate the RMH and MDACC scores in a cohort of Christie Hospital NHS Foundation Trust pts enrolled on early phase clinical trials and assess the impact of sarcopenia.
Methods
Retrospective case note review of pts data from 2014-2019, CT images taken from trial baseline and the L3 CT slice identified by the author. Demographics including age, gender, co-morbidities and prior treatment were collected. Software to delineate skeletal muscle from bone, fat and subcutaneous tissues was used to calculate skeletal muscle area, density (SMD) and skeletal muscle index (SMI). Dose modifying toxicity (DMT) defined as any drug-related cause of drug interruption or dose reduction.
Results
Full analysis including CT images was possible on 220/357 pts enrolled over 29 EPCTs. Pts omitted if on >1 trial or if no available imaging. Mean age 59 years, 58% of pts were female. Median RMH and MDACC scores were 1 (range 0-3 and 0-5), mean body mass index (BMI) 26.5 and sarcopenia was present in 17.27% of pts. RMH and MDACC scores correlated with poorer survival on univariate analysis (p<0.001) and with 90-day mortality (p 0.014 and 0.018 respectively) but not with DMTs (p 0.34 and 0.61 respectively). Sarcopenia was associated with poorer survival on log-rank analysis (p 0.043) and showed a trend towards significance on multivariate analysis (p 0.075) but not 90-day mortality (p 0.26), or DMT (p 0.36). On multivariate analysis reduced SMD approached significance (p0.054) and MDACC score and weight loss >3% were significantly associated with reduced survival (p 0.016 and 0.002).
Conclusions
The RMH and MDACC scores both demonstrated validity in our cohort. Fitness was good and rates of sarcopenia were low. RMH, MDACC scores and sarcopenia were not associated with DMTs in our cohort. However, despite low rates, pts with sarcopenia did have poorer survival outcomes.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.