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Efficacy and safety of pasireotide LAR or everolimus alone, or in combination in patients with advanced carcinoids (NET) of the lung/thymus: Results from the randomized, phase 2 LUNA study

2016; Elsevier BV; Volume: 27; Linguagem: Inglês

10.1093/annonc/mdw369.01

1569-8041

Piero Ferollà, M.P. Brizzi, Tim Meyer, Wasat Mansoor, Julien Mazières, Christine Do Cao, H. Léna, Alfredo Berruti, V. Damiano, Wieneke A. Buikhuisen, Miona Stankovic, Neha Singh, E Chiodini, Gabriella Gislimberti, Kjell Öberg, Éric Baudin,

Neuroblastoma Research and Treatments

Advanced lung/thymus carcinoid is an area of high unmet medical need. In recent phase 3 RADIANT-4 study, everolimus (E) showed progression-free survival (PFS) benefit in patients (pts) with GI/lung NET. Pasireotide LAR (P, somatostatin analog [SSA]), has also shown potential antitumor activity in previous studies in NET. This phase 2 study evaluated efficacy and safety of E, P, and P + E in pts withprogressive carcinoids of lung/thymus. Adult pts with metastatic RECIST progressive carcinoids of lung/thymus were randomized (1:1:1) to P (60 mg/month [mo] i.m.), E (10 mg/day orally) and P + E. Primary endpoint was progression free rate at mo 9 (PFR-9): proportion of pts at mo 9 with complete (CR), partial (PR) response or stable disease (SD) according to RECIST v.1.1. Key secondary end points were PFS, disease control rate and safety. 124 pts were randomized to P (41), E (42), P + E (41). Median age = 64 yrs; atypical/typical carcinoid = 68.5%/31.5%; WHO performance status: 0/1/2 = 64%/34%/2%; primary tumor site: lung/thymus = 93.5%/6.5%; prior treatment (Tx): medication = 44%; radiotherapy = 27%; surgery/locoregional therapy = 97%; prior SSA = 48%. Tx discontinuation was seen in 65% pts (during core phase of 12 mos), mainly due to adverse events (AEs; 27%) and disease progression (PD; 27%). Primary endpoint, PFR-9: P = 39.0% (95% CI, 24.2, 55.5); E = 33.3% (19.6, 49.5); P + E = 58.5% (42.1, 73.7). Best overall response (9-mo) in all arms are listed in the table. AEs were primarily grade 1/2 in each arm; most common AEs regardless of study drug relationship in the P + E arm were hyperglycemia (88%), diarrhea (78%), weight decrease (56%), asthenia (37%), and stomatitis (34%).Tabled 1PEP + ECR, %000PR, %222SD, %343149PD, %1720Not assessed, %446042 Open table in a new tab LUNA study is the first randomized trial designed for lung and thymic carcinoids. The study met its primary endpoint showing promising PFR-9 in all Tx arms; particularly in the combination arm. No new safety signals were observed.