Updated overall survival and time to progression results in NETs treated with everolimus combination with octreotide LAR as first-line treatment.
2014; Lippincott Williams & Wilkins; Volume: 32; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2014.32.15_suppl.e15160
ISSN1527-7755
AutoresEmilio Bajetta, Laura Catena, Sara Pusceddu, Francesca Spada, Nicola Fazio, Giusi Blanco, Sergio Ricci, Michele Aieta, Francesca Pucci, Monica Valente, Nadia Bianco, Italo Sarno, Giandomenico Di Menna,
Tópico(s)Adenosine and Purinergic Signaling
Resumoe15160 Background: We previously presented data about this phase II study showing that the combination of Everolimus and octreotide LAR in the first line setting for advanced NETs, is an active and a safe treatment. At a medium follow-up of 277 days, the median time to progression (TTP) and the overall survival (OS) have not been reached (ASCO 2013 Abs. 4136). Methods: We performed a phase 2, multicenter trial using a Simon two-stage minmax design. Patients with advanced well differentiated, previously untreated NETs of a gastroenteropancreatic (GEP) tract and of a lung, received ocreotide LAR 30mg every 28 days in combination with everolimus 10mg per day continuously. The primary end point was objective response rate (ORR). Currently we perform a further analysis of OS and TTP at a median follow-up of 17.8 months. Results: A total of 50 patients (58% males) were enrolled. The median age was 60.5 years (range 25-76). Primary tumor site was pancreas in 14 (28%), unknown in 14 (28%), lung in 11 (22%), ileum in 9 (18%), jejunum in 1 and duodenum in 1 of patients. One patient add a complete response, 16% a partial response and 72% achieved stable disease. At a median follow-up of 17.8 months of a median TTP is 33.2 months (95% CI 19-41.7). The median overall survival has not been reached. Currently 13 patients are still benefiting from the treatment (11 NETs of the GEP tract and 2 typical carcinoid of the lung). Conclusions: Everolimus in combination with octreotide LAR has shown to be active and well tolerated in advanced NETs. The current analysis showed a futher prolungation of TTP suggesting a possible long term benefit of this combination in NETs. Aknowledgments:Italian Trials in Medical Oncology (I.T.M.O.) Group, Giacinto Facchetti Foundation and Novartis.
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