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Phase II study of everolimus in combination with octreotide LAR as first line setting for patients with neuroendocrine tumors (I.T.M.O. study): a 5-years update

2015; Elsevier BV; Volume: 26; Linguagem: Inglês

10.1093/annonc/mdv348.01

1569-8041

E. Bajetta, Laura Catena, Sara Pusceddu, Nicola Fazio, Giuseppina Blanco, Stefano Ricci, Michele Aieta, Francesca Pucci, Italo Sarno, Francesca Spada, Giandomenico Di Menna, Lorenzo Dottorini,

Neuroblastoma Research and Treatments

Background: We previously presented data of this phase II study showing that the combination of Everolimus and Octreotide LAR for advanced neuroendocrine tumors (NETs), as first line setting, is an active and safe treatment (ASCO 2013,Abs. 4136). This abstract is an update after 5 years. Methods: We performed a phase II, multicenter trial using a Simon two-stage minmax design. Patients withadvanced well differentiated, previously untreated neuroendocrine tumorsof the gastroenteropancreatic (GEP) tract and of the lung, continuously received Octreotide LAR 30 mg every 28 days in combination with Everolimus 10 mg per day. The primary endpoint was Objective Response Rate (ORR). Results: A total of 50 patients (58% males) were enrolled; 36 (72%) of these patients have been treated for more than 1 year. The median exposure to study drugs is 118 weeks (range 47-242). Currently 4 patients are still taking advantage from the above mentioned treatment. The primary tumor site was: liver 2 pts, pancreas 11 pts, small intestine 8 pts, lung 7 ptsand unknown in 8 pts. Approximately 70% of these patients had no carcinoid syndrome and 50% have been surgically treated at the primary tumor site. The ORR was: CR 1 pt, PR 8 (22%) pts, SD 27 (75%) pts. The median TTP is 38 months (95% CI 19–n.d.) and the median OS has not been reached. The updated data up to 06/2015 will be presented during the next meeting. Conclusion: Everolimus in combination with octreotide LAR has shown to be active in advanced NETs. The current study showed a further prolongation of TTP, as well a long exposure to the study drug without unexpected long term side effects. The treatment with two drugs has induced objective responses, but also long duration SD. Acknowledgements:Italian Trials in Medical Oncology (I.T.M.O.) group, Giacinto Facchetti Foundation and Novartis.