Impact of prior therapies on everolimus activity: an exploratory analysis of RADIANT-4.
Onco Targets Ther
; 10: 5013-5030, 2017.
Article
em En
| MEDLINE
| ID: mdl-29081664
ABSTRACT
BACKGROUND:
Recently, everolimus was shown to improve median progression-free survival (PFS) by 7.1 months in patients with advanced, progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of lung or gastrointestinal (GI) tract compared with placebo (HR, 0.48; 95% CI, 0.35-0.67; P<0.00001) in the Phase III, RADIANT-4 study. This post hoc analysis evaluates the impact of prior therapies (somatostatin analogs [SSA], chemotherapy, and radiotherapy) on everolimus activity. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT01524783. PATIENTS ANDMETHODS:
Patients were randomized (21) to everolimus 10 mg/day or placebo, both with best supportive care. Subgroups of patients who received prior SSA, chemotherapy, or radiotherapy (including peptide receptor radionuclide therapy) were analyzed and reported.RESULTS:
A total of 302 patients were enrolled, of whom, 163 (54%) had any prior SSA use (mostly for tumor control), 77 (25%) received chemotherapy, and 63 (21%) were previously exposed to radiotherapy. Patients who received everolimus had longer median PFS compared with placebo, regardless of previous SSA (with SSA 11.1 vs 4.5 months [HR, 0.56 {95% CI, 0.37-0.85}]; without SSA 9.5 vs 3.7 months [0.57 {0.36-0.89}]), chemotherapy (with chemotherapy 9.2 vs 2.1 months [0.35 {0.19-0.64}]; without chemotherapy 11.2 vs 5.4 months [0.60 {0.42-0.86}]), or radiotherapy (with radiotherapy 9.2 vs 3.0 months [0.47 {0.24-0.94}]; without radiotherapy 11 vs 5.1 months [0.59 {0.42-0.83}]) exposure. The most frequent drug-related adverse events included stomatitis (59%-65%), fatigue (27%-35%), and diarrhea (24%-34%) among the subgroups.CONCLUSION:
These results suggest that everolimus improves PFS in patients with advanced, progressive lung or GI NET, regardless of prior therapies. Safety findings were consistent with the known safety profile of everolimus in NET.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
3_ND
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Idioma:
En
Revista:
Onco Targets Ther
Ano de publicação:
2017
Tipo de documento:
Article