First multicentric randomized phase II trial investigating the antitumor efficacy of peptide receptor radionuclide therapy with 177Lutetium – Octreotate (OCLU) in unresectable progressive neuroendocrine pancreatic tumor: Results of the OCLURANDOM trial, on behalf of the ENDOCAN RENATEN network and GTE - 25/09/22
, T. Walter, Pr b, C. Docao, Dr c, M. Haissaguerre, Dr d, J. Hadoux, Dr a, D. Taieb, Pr e, C. Ansquer, Dr f, L. Dierickx, Dr g, L. De Mestier, Dr h, E. Deshayes, Dr i, E. Quak, Dr j, S. Foulon, Dr k
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Résumé |
We report the results of the first multicentric randomized open-label non-comparative phase II study assessing PRRT-177Lu-Octreotate antitumor efficacy (OCLU, OCLURANDOM trial: EudraCT No: 2013-004032-30).
Patients (pts) with progressive advanced PaNET according to RECIST1.1 were randomized 1:1 to OCLU (7.4 GBqX4/8w) or sunitinib (SUN) 37.5mg/d. Primary endpoint was: progression-free survival (PFS) rate at 12 months according to RECIST 1.1 real-time central review. The sample size calculation of the OCLU arm assumed a 25% increase (from 35% to 60%) of the 12-m PFS rate. 40 pts had to be included in a single stage Fleming design with type I error=type II error=5%. The SUN group served as an internal control to validate the null hypothesis with a 12 months PFS rate of 35%.
84 pts were enrolled. Main characteristics were well balanced. The primary endpoint was met with a 12m-PFS rate at 80.5% in the OCLU arm (IC90%: 67.5–89.9, n=33 pts without progression at 12 months/41) vs. 41.9% in the SUN arm (IC90%: 29.1–55.5,including 35% the null hypothesis; n=18/43). Median PFS was 20.7 in the OCLU arm (90CI: 17.2–23.7) vs. 11 months in the SUN arm (90CI: 8.8–12.4).
The OCLURANDOM study met its primary endpoint.
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Vol 83 - N° 5
P. 289-290 - octobre 2022 Retour au numéro
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