title: Safety and efficacy of everolimus in gastrointestinal and pancreatic neuroendocrine tumors after (177)Lu-octreotate.
abstract: Although (177)Lu-octreotate is an effective treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), some patients will fail or develop disease progression necessitating further treatment. We examined whether the safety and efficacy of everolimus after prior treatment with (177)Lu-octreotate is different from the published safety profile of everolimus in GEP-NETs. In this multicenter study, 24 GEP-NET patients were included. Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Tumor response was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. Major clinical adverse events (grade 3 or 4) during treatment with everolimus were hyperglycemia (20.8%), fatigue (8.3%), thrombocytopenia (8.3%), and elevated alanine transaminase levels (8.3%). By radiological review, there were four partial responses (16.7%), five patients (62.5%) with stable disease, and three patients (12.5%) with progressive disease. For two patients (8.3%), no data on tumor response were available. Median progression-free survival (PFS) was 13.1 months (95% CI, 11.5-21.2). Median PFS of the current study was longer when compared with the RADIANT-3 trial (13.1 vs 11.4 months) and shorter when compared with the RADIANT-1 trial (13.1 vs 16.7 months). In conclusion, the safety profile of everolimus is not influenced by previous treatment with peptide receptor radiotherapy.
authors.affiliation: Sector of Endocrinology, Department of Internal Medicine Department of Nuclear Medicine, Erasmus Medical Center, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands Centro de Oncologia, Hospital Sírio Libanês, São Paulo, Brazil Department of Pathophysiology, National University of Athens, Athens, Greece.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Kamp
authors.forename: Brenda
authors.initials: B
authors.lastname: Gumz
authors.forename: Richard A
authors.initials: RA
authors.lastname: Feelders
authors.forename: Dik J
authors.initials: DJ
authors.lastname: Kwekkeboom
authors.forename: Gregory
authors.initials: G
authors.lastname: Kaltsas
authors.forename: Frederico P
authors.initials: FP
authors.lastname: Costa
authors.forename: Wouter W
authors.initials: WW
authors.lastname: de Herder
mesh_terms: D000328:Adult; D000368:Aged; D001859:Bone Neoplasms; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007414:Intestinal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D008113:Liver Neoplasms; D008187:Lutetium / Q000627:therapeutic use; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D015282:Octreotide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D011379:Prognosis; D012189:Retrospective Studies; D012449:Safety; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D015996:Survival Rate
chemical_list: C554548:177Lu-octreotate; D007166:Immunosuppressive Agents; D008187:Lutetium; D000068338:Everolimus; D015282:Octreotide; D020123:Sirolimus
keywords: GEP; everolimus; multicenter; neuroendocrine tumor; post-177Lu-tate; safety