E. Baudina (Dr), E. Baudin*b (Dr), T. Walterc (Pr), C. Docaod (Dr), M. Haissaguerree (Dr), J. Hadouxb (Dr), D. Taiebf (Pr), C. Ansquerg (Dr), L. Dierickxh (Dr), L. De Mestieri (Dr), E. Deshayesj (Dr), E. Quakk (Dr), S. Foulonl (Dr)

a Gustave Roussy, Villejuif, FRANCE ; b Department of Imaging, Endocrine Oncology Unit, Gustave Roussy Institut de Cancérologie, Villejuif, FRANCE ; c Department of Medical Oncology, Hospice Civils de Lyon, Lyon, FRANCE ; d Department of Endocrinology, CHU Lille, Lille, FRANCE ; e Department of Endocrinology, CHU Bordeaux, Bordeaux, FRANCE ; f Department of Central Biophysics and Nuclear Medicine, La Timone Hospital, Marseille, FRANCE ; g Department of Nuclear Medicine, Hôtel Dieu University Hospital Center, Nantes, FRANCE ; h Department of Nuclear Medicine Claudius Regaud Institute, Toulouse, FRANCE ; i Department of Gastroenterology-Pancreatology, Beaujon Hospital, Clichy, FRANCE ; j Department of Medical Oncology, CHU Montpellier, Montpellier, FRANCE ; k Department of Nuclear Medicine François Baclesse Center, Caen, FRANCE ; l Biostatistics and Epidemiology Department , Gustave Roussy, Villejuif, FRANCE


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 N°: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) 37.5 mg/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.

L’auteur n’a pas transmis de déclaration de conflit d’intérêt.