Sökning: WFRF:(Wolin Edward M)
> (2013) >
Everolimus Plus Oct...
Everolimus Plus Octreotide Long-Acting Repeatable in Patients With Advanced Lung Neuroendocrine Tumors Analysis of the Phase 3, Randomized, Placebo-Controlled RADIANT-2 Study
-
Fazio, Nicola (författare)
-
- Granberg, Dan (författare)
- Karolinska Institutet,Uppsala universitet,Onkologisk endokrinologi
-
Grossman, Ashley (författare)
-
visa fler...
-
Saletan, Stephen (författare)
-
Klimovsky, Judith (författare)
-
Panneerselvam, Ashok (författare)
-
Wolin, Edward M. (författare)
-
visa färre...
-
(creator_code:org_t)
- Elsevier BV, 2013
- 2013
- Engelska.
-
Ingår i: Chest. - : Elsevier BV. - 0012-3692 .- 1931-3543. ; 143:4, s. 955-962
- Relaterad länk:
-
https://urn.kb.se/re...
-
visa fler...
-
https://doi.org/10.1...
-
http://kipublication...
-
visa färre...
Abstract
Ämnesord
Stäng
- Background: The incidence of neuroendocrine tumors (NETs) has increased approximately fivefold since the 1980s. A similar increase in the incidence of lung NETs has been reported, but therapy has not been optimized. Methods: This exploratory subanalysis evaluated the efficacy and safety of everolimus plus octreotide long-acting repeatable (LAIR) in a cohort of patients with low- to intermediate-grade advanced lung NET from the phase 3, randomized, placebo-controlled RADIANT-2 (RAD001 in Advanced Neuroendocrine Tumors) study. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate, overall survival, change from baseline in biomarker levels, and safety outcomes. Results: Patients were randomly assigned to everolimus plus octreotide LAIR (n = 33) or placebo plus octreotide LAIR (n = 11). Median PFS was 13.63 months in the everolimus plus octreotide LAIR arm compared with 5.59, months in the placebo plus octreotide LAIR arm (relative risk for progression: HR, 0.72; 95% CI, 0.31-1.68; P = .228). More patients receiving everolimus plus octreotide LAR (67%) experienced minor tumor shrinkage (not partial response as per RECIST [Response Evaluation Criteria in Solid Tumors]) than those receiving placebo plus octreotide LAIR (27%). Most frequently reported adverse events (AEs) included stomatitis, rash, diarrhea, and asthenia. This was consistent with the overall RADIANT-2 trial and the safety profile of everolimus. Conclusions: This exploratory subgroup analysis of the RADIANT-2 trial indicates that in patients with advanced lung NET, the addition of everolimus to octreotide LAIR improves median PFS by 2.4-fold compared with placebo plus octreotide LAIR. These clinically significant observations support the continued evaluation of everolimus treatment regimens in this patient population. Trial registry: ClinicalTrials.gov; No.: NCT00412061; PRL: www.clinicaltrials.gov CHEST 2013; 143(4):955-962
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
-
Chest
(Sök värdpublikationen i LIBRIS)
Till lärosätets databas