LAUSR

The aim of this study was to evaluate the efficacy and safety of 177Lu‐DOTATATE therapy in advanced metastatic disease. A retrospective analysis of 395 patients (180 female, 215 males, mean age 62) with progressive metastatic neuroendocrine tumours (NETs) who were treated with 177Lu‐DOTATATE was performed. Overall, 115 patients had less than four cycles and 280 completed four cycles of treatment. Progression‐free survival (PFS) and overall survival (OS) was performed using Kaplan–Meier analysis. Analysis of survival predictors was performed using Cox regression model. Toxicity was defined using the Common Terminology Criteria for Adverse Events version 5 (CTCAE 5.0). The percentage of patients with liver and skeletal metastases were 91 and 57%, respectively. Median PFS and OS were calculated at 33 months (95% CI: 29–37 months) and 46 months (95% CI: 48–56 months), respectively. End of treatment response assessment was performed using cross sectional imaging demonstrated partial response in 22%, stable disease in 64% and progressive disease in 14% of patients. Overall, grade 3 and 4 bone marrow toxicity was seen in 8%. One patient (0.3%) developed irreversible grade 4 nephrotoxicity. Myelodysplastic disease was recorded in one patient (0.3%). Univariate analysis of PFS predictors showed that body mass index (BMI), baseline chromogranin A (CgA) >400 ng/l, baseline alkaline phosphatase (ALP) >130 mg/dl, liver tumour volume and overall tumour burden were significant. On multivariate analysis only Ki67, high CgA and low BMI retained significance. 177Lu‐DOTATATE is an effective treatment in advanced NETs with generally high‐volume metastases. It is well‐tolerated. Ki‐67, CgA and BMI appear to be predictors for PFS.