Multicenter Phase I Study of Triapine in Combination with [177Lu]Lutetium-Dotatate in Patients with Well-Differentiated Neuroendocrine Tumors (ETCTN 10388).
Aman Chauhan, Heidi L Weiss, Charles Kunos et al.
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In 30 seconds
This multicenter phase I dose-escalation and dose-expansion study evaluated [177Lu]lutetium-dotatate plus oral triapine in patients with well-differentiated gastroenteropancreatic neuroendocrine tumors. Thirty-one patients received treatment; the selected recommended phase II dose was 200 mCi of [177Lu]lutetium-dotatate with triapine 150 mg on days 1–14. Grade ≥3 treatment-related adverse events occurred in 77% of patients, chiefly cytopenias. Among 28 evaluable patients, the objective response rate was 21.4%; median progression-free survival had not been reached at a median follow-up of 23.7 months.
Key findings
- The recommended phase II regimen was [177Lu]lutetium-dotatate 200 mCi plus oral triapine 150 mg on days 1–14.
- Grade ≥3 treatment-related adverse events occurred in 77% of patients; lymphopenia (58%) and neutropenia (35%) were prominent.
- Among 28 evaluable patients, the objective response rate was 21.4%; median progression-free survival was not reached at median follow-up of 23.7 months.
- Nine patients experienced dose-limiting toxicities, including seven cases of grade 4 neutropenia.
Why it matters
The study provides early clinical evidence on combining a radiation sensitizer with peptide receptor radionuclide therapy in well-differentiated GEP-NET. The response findings suggest preliminary antitumour activity, while the frequency of severe treatment-related events—particularly cytopenias—underscores the importance of safety monitoring. These phase I results can inform further evaluation but do not establish comparative benefit.
What to keep in mind
This was a phase I study with 31 treated patients; efficacy estimates were based on 28 evaluable patients, and the abstract reports no comparator group.