Long-term efficacy, survival and safety of [177Lu-DOTA0,Tyr3]octreotate in patients with gastroenteropancreatic and bronchial neuroendocrine tumors

Purpose<br /> Bronchial and gastroenteropancreatic neuroendocrine tumors (NETs) are slow-growing tumors, which frequently express somatostatin receptors on their cell membranes. These receptors are targets for therapy with Lutetium-177-labeled somatostatin analogs. We have treated over 1200 patients with peptide receptor radionuclide therapy (PRRT) with ¹⁷⁷Lu-DOTA⁰,Tyr³]octreotate (¹⁷⁷Lu-DOTATATE) since the year 2000 and present the results on efficacy, survival and toxicity of this therapy. <p>Patients and methods<br /> For safety analysis, 610 patients treated with a cumulative dose of at least 100 mCi (3.7 GBq) ¹⁷⁷Lu-DOTATATE were included. A subgroup of 443 Dutch patients who were treated with a cumulative dose of at least 600 mCi (22.2 GBq) ¹⁷⁷Lu-DOTATATE before 2013 was further analyzed for efficacy and survival.</p> <p>Results<br /> The objective response rate (ORR) of the total group of patients was 39%. Stable disease (SD) was reached in 43% of patients. Progression free survival (PFS) and overall survival (OS) for all NET patients were 29 months (95% CI 26-33 months) and 63 months (95% CI 55-72 months). Long-term toxicity included acute leukemia in 4 patients (0.7%) and myelodysplastic syndrome in 9 patients (1.5%). No therapy-related long-term renal or hepatic failure occurred.</p> <p>Conclusion <br /> PRRT with ¹⁷⁷Lu-DOTATATE is a favorable therapeutic option in patients with metastatic bronchial and gastroenteropancreatic NETs that express somatostatin receptors. PRRT with ¹⁷⁷Lu-DOTATATE is safe with few side-effects and shows a good response rates with PFS of 29 months and OS of 63 months.

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