Abstract
Our purpose was to assess the efficacy and safety of (177)Lu-DOTATATE in neuroendocrine tumor patients with reduced renal function. Methods: A single-center retrospective analysis was performed on 33 patients with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m(2) Of these, 26 had chronic kidney disease (CKD) stage 3a (eGFR, 45-60 mL/min/1.73 m(2)) and 7 had CKD 3b (eGFR, 30-45 mL/min/1.73 m(2)). Renal toxicity and temporal changes in eGFR were recorded. The association between potential risk factors and any kidney function deterioration (>10% reduction in eGFR) was evaluated. Data on survival, the radiologic response assessment, and quality of life were collected. Results: The incidence of permanent grade 3 or 4 nephrotoxicity was 3% (a single patient with grade 4 nephrotoxicity). The mean annual reduction in eGFR was estimated at 2.5%. A permanent decline of less than 10% in eGFR of any grade was recorded in 45% of patients (n = 15). Nine patients moved into higher CKD categories (8 patients who moved from CKD 3a to CKD 3b and 1 patient who moved from CKD 3b to CKD 5). No significant relationship was found between renal risk factors and a permanent reduction in renal function. Grade 3 or 4 bone marrow toxicity was observed in 9% of patients. The estimated median progression-free survival was 42 mo, and the median overall survival was 47 mo. At the end of treatment, the radiologic assessment showed a 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 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Gastrointestinal NET-21) (P = 0.046 and 0.041, respectively). Conclusion: (177)Lu-DOTATATE appears to be generally well tolerated in patients with preexisting CKD 3, with a low incidence of permanent major nephrotoxicity. (177)Lu-DOTATATE appears to have a good therapeutic effect, with most patients reporting improvement in quality of life.