Drug updated on 10/29/2024
| Dosage Form | Injection (intravenous; 370 MBq/mL [10 mCi/Ml]) |
| Drug Class | Radiolabeled somatostatin analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Disease Control Rate (DCR): The pooled DCR for 177Lu-DOTATATE and 90Y-DOTATOC in metastatic pheochromocytomas (PCCs) and paragangliomas (PGLs) was 0.83 (95% CI: 0.75-0.88) and 0.76 (95% CI: 0.56-0.89), respectively, with an overall pooled DCR of 0.81 (95% CI: 0.74-0.87). In advanced/metastatic pancreatic neuroendocrine tumors (pNETs), the pooled DCR was 77% (95% CI: 62%-92%).
- Progression-Free Survival (PFS): For advanced/metastatic pNETs, the pooled PFS was 21.59 months (95% CI: 17.65-25.53 months). Lu-DOTATATE demonstrated a longer PFS of 25.7 months compared to 14.7 months with Everolimus in advanced pNETs.
- Objective Response Rate (ORR): Lu-DOTATATE had a significantly higher ORR of 47% compared to 12% for Everolimus in advanced pNETs, highlighting its superior effectiveness in this population.
- Hematologic Toxicity: Hematologic toxicity was the most common side effect of 177Lu-DOTATATE in advanced/metastatic pancreatic neuroendocrine tumors (pNETs), with Grade III hematologic toxicity occurring in 4% of patients (7/174). In comparison, Lu-DOTATATE showed fewer Grade 3/4 hematologic toxicities (5%) compared to Everolimus (11%).
- Nephrotoxicity and Hepatotoxicity: Mild nephrotoxicity and hepatotoxicity were observed in 4% and 1% of patients treated with 177Lu-DOTATATE in advanced/metastatic pNETs, respectively. Lu-DOTATATE had a lower incidence of nephrotoxicity (1%) compared to Everolimus (2.5%).
- The studies primarily included patients with advanced or metastatic pancreatic neuroendocrine tumors (pNETs), inoperable or metastatic neuroendocrine tumors (NETs), and metastatic pheochromocytomas (PCCs) and paragangliomas (PGLs), with median ages ranging from 32.5 to 60.4 years. Additionally, SDHB mutations were the most frequent genetic alterations in the study of metastatic PCCs and PGLs.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lutathera (lutetium Lu 177 dotatate) Prescribing Information. | 2024 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Response to Peptide Receptor Radionuclide Therapy in Pheocromocytomas and Paragangliomas: A Systematic Review and Meta-Analysis | 2023 | Journal of Clinical Medicine |
| Efficacy and safety of (177)Lu-DOTATATE targeted therapy in advanced/metastatic pulmonary neuroendocrine tumors: A systematic review and meta-analysis | 2022 | Frontiers in Oncology |
| The efficacy of (177)Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) in patients with metastatic neuroendocrine tumours: a systematic review and meta-analysis | 2020 | Journal of Cancer Research and Clinical Oncology |
| The therapeutic efficacy of 177Lu-DOTATATE/DOTATOC in advanced neuroendocrine tumors: A meta-analysis | 2020 | Medicine |
| 177Lu-DOTATATE peptide receptor radionuclide therapy versus Everolimus in advanced pancreatic neuroendocrine tumors: a systematic review and meta-analysis | 2019 | Nuclear Medicine Communications |