[177Lu]Lu-dota-tate evaluated against sunitinib in randomized phase 2 trial for metastatic pancreatic neuroendocrine tumours

Metastatic pancreatic neuroendocrine tumours (pNETs) present a significant challenge, with no prior randomized trials evaluating peptide receptor radionuclide therapy (PRRT) in this specific patient population. Current treatments often fall short, necessitating novel approaches. This study addresses this critical gap by comparing the antitumour activity and safety of [177Lu]Lu-dota-tate, a somatostatin receptor-targeting PRRT, against standard-of-care sunitinib.

OCLURANDOM, a randomized, open-label, non-comparative phase 2 trial, enrolled 84 patients with pretreated, progressive, somatostatin receptor-positive, metastatic pNETs. Patients were randomized 1:1 to receive intravenous [177Lu]Lu-dota-tate (7·4 GBq every 8 weeks up to four cycles) with concomitant amino acid infusion, or oral sunitinib (37·5 mg once daily). The amino acid infusion (arginine and lysine) aimed to protect kidneys. The primary endpoint was progression-free survival at 12 months, centrally reviewed using RECIST 1.1.

Between Feb 13, 2015, and July 16, 2020, 84 patients were enrolled and randomized: n=41 to the [177Lu]Lu-dota-tate group and n=43 to the sunitinib group. The cohort comprised 44 (52%) women and 40 (48%) men. Median follow-up was 72·5 months (IQR 61·4-88·4). > The provided abstract is truncated and does not include the primary outcome data for progression-free survival or detailed safety results. Therefore, specific numerical findings regarding the comparative efficacy or adverse events of [177Lu]Lu-dota-tate versus sunitinib cannot be reported from this text.