177Lutetium-octreotate (OCLU) can improve progression-free survival (PFS), compared with sunitinib, in patients with advanced, progressive pancreatic neuroendocrine tumors (panNETs), according to results from the OCLURANDOM trial.
This phase 2 study is the first randomized trial of a peptide-receptor radionuclide therapy (PRRT) in patients with panNETs and suggests that OCLU could be practice-changing in this setting, according to Eric Baudin, MD, PhD, of Gustave Roussy – Cancer Campus in Villejuif, France.
Dr Baudin presented these findings at ESMO Congress 2022.
The OCLURANDOM trial (ClinicalTrials.gov Identifier: NCT02230176) enrolled pretreated patients with unresectable, progressive, metastatic, somatostatin receptor imaging-positive panNETs. The main exclusion criteria were receipt of more than 1 line of cytotoxic therapy, previous PRRT or tyrosine kinase inhibitor therapy, and abnormal cardiac or kidney function.
Patients were randomly assigned to receive OCLU (n=41) or sunitinib (n=43). OCLU was given as 4 infusions of 7.4 GBq each, at intervals of 8 ± 1 weeks. Sunitinib was given at 37.5 mg per day until progression or intolerance.
In both arms, 81% of patients had grade 2-3 tumors, and 37% had Ki-67 levels greater than 10%. The proportion of patients who received 2 or more prior lines of therapy was 42% in the OCLU arm and 44% in the sunitinib arm.
The median follow-up was 40 months. The 12-month PFS rate was 80% in the OCLU arm and 42% in the sunitinib arm. The median PFS was 20.7 months in the OCLU arm and 11.0 months in the sunitinib arm.
Grade 3-4 adverse events (AEs) were reported in 44% of patients in the OCLU arm and in 63% of patients in the sunitinib arm.
Grade 3-4 AEs (in the OCLU and sunitinib arms, respectively) included decreased blood counts (12% vs 23%), digestive AEs (12% vs 21%), fatigue (7% vs 12%), and hypertension (12% vs 19%).
Withdrawal of the study drug due to AEs was reported in 5% of patients in the OCLU arm and in 21% of those in the sunitinib arm.
Disclosures: This research was supported, in part, by Advanced Accelerator Applications, a Novartis company. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Baudin E, Walter TA, Beron A, et al. First multicentric randomized phase II trial investigating the antitumor efficacy of peptide receptor radionucleide therapy with 177lutetium-octreotate (OCLU) in unresectable progressive neuroendocrine pancreatic tumor: Results of the OCLURANDOM trial. Presented at ESMO 2022; September 9-13, 2022. Abstract 887O.