Safety of Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE in Neuroendocrine Tumor Patients with Chronic Kidney Disease

Purpose: To assess efficacy and safety of 177Lu-DOTATATE in patients with neuroendocrine tumours (NETs) with reduced renal function i.e., eGFR below 60 ml/min/1.73 m2. Methods: A single-centre retrospective analysis was performed in 33 patients with eGFR less than 60 ml/min/1.73 m2. Of these 33 patients, 26 patients had chronic kidney disease (CKD) stage 3a (eGFR between 45-60 ml/min/1.73 m2) and 7 patients had CKD stage 3b (eGFR between 30-45 ml/min/1.73 m2). Renal toxicity and temporal changes in eGFR were recorded. Association of potential risk factors and any kidney function deterioration (>10% reduction of eGFR) was evaluated. Survival, radiological response assessment and quality of life data was collected. Results: The incidence of permanent grade 3/4 nephrotoxicity was 3% (single patient with grade 4 nephrotoxicity). The mean annual reduction of eGFR estimated at 2.5%. Permanent decline of >10% eGFR of any grade was recorded in 45% of patients (n = 15). Nine patients moved into higher CKD categories (eight patients who moved from CKD 3a to CKD 3b and one patient who moved from CKD3b to CKD 5). No significant relationship was found between renal risk factors and permanent reduction of renal function. Grade 3/4 bone marrow toxicity was observed in 9% of patients. The estimated median progression-free survival (PFS) was 42 months and median overall survival (OS) was 47 months. At the end of the treatment, the radiological assessment showed partial response in 33%, stable disease in 55%, and progressive disease in 12%. There was an improvement in global quality of life and endocrine score (EORTC QLQ-GI-NET21) (p value: 0.046 and 0.041 respectively). Conclusion:177Lu-DOTATATE appears to be generally well-tolerated in patients with pre-existing CKD stage 3 with a low incidence of permanent major nephrotoxicity. 177Lu-DOTATATE appears to have a good therapeutic effect; with most patients reporting improvement in quality of life.