Baseline demographics of patients from the randomized, placebo-controlled, double-blind, phase III RADIANT-4 study of everolimus in nonfunctional gastrointestinal (GI) or lung neuroendocrine tumors (NET)
| Autor: | Singh, S., Buzzoni, R., Carnaghi, C., Fazio, N., Pavel, M. E., Wolin, E. M., Tomasek, J., Raderer, M., Lahner, Harald, Lam, D. H., Cauwel, H., Valle, J. W., Delle Fave, G., Van Cutsem, E., Strosberg, J. R., Tesselaar, M. E., Shimada, Y., Oh, D. Y., Kulke, M. H., Yao, J. C., RADIANT-4 Study Grp |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Medizin Neuroendocrine tumors Placebo 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Clinical endpoint 030304 developmental biology 0303 health sciences Everolimus Lung Performance status business.industry medicine.disease 3. Good health Surgery medicine.anatomical_structure 030220 oncology & carcinogenesis Concomitant business Progressive disease medicine.drug |
| Popis: | 276 Background: NET are malignant tumors arising from neuroendocrine cells throughout the body. Everolimus (EVE), a mammalian target of rapamycin inhibitor, is approved for the treatment of advanced, well-differentiated pancreatic NET. There is an unmet medical need in GI and lung NET; targeted therapies, such as everolimus, are of particular interest. Methods: Patients with advanced nonfunctional NET of GI or lung origin with progressive disease (PD) within the past 6 months were randomized (2:1) to EVE 10 mg/d or placebo, both with best supportive care. Concomitant use of somatostatin analogue (SSA) was not allowed during the study, except for control of emergent carcinoid symptoms not manageable by standard therapy. Patients were stratified based on tumor sites, prior SSA exposure, and WHO performance status (PS) at baseline. Primary endpoint was progression-free survival (PFS) as assessed by central radiology review using modified RECIST 1.0 criteria. Primary analysis is planned after ~176 PFS events. Crossover to open label EVE after progression would not be allowed prior to the primary analysis. Overall survival was the key secondary endpoint. Results: Recruitment is completed. Of 388 patients screened, 302 were randomized (planned, 285). Median age was 63 years, 53% were females, and majority of them (76.2%) were white. The most common tumor sites were lung (29.8%), ileum (23.5%), and rectum (13.2%). WHO PS was 0 in 219 (72.5%) patients and 1 in 82 (27.2%) patients; 52% had received SSA prior to study entry. As of Sep 16, 2013, 173 (57.3%) patients remain on treatment, 127 (42.1%) discontinued treatment and 2 (0.7%) were not treated. PD (24.2%) and adverse events (10.6%) were the most common reasons for treatment discontinuation. Results of primary analysis are expected by early 2015. Conclusions: RADIANT-4 is the first phase III study to assess the efficacy and safety of EVE in patients with nonfunctional NET of GI or lung origin. Non-crossover design and prospective stratification of the population based on known prognostic factors should minimize confounding in the estimation of the treatment effect. Clinical trial information: NCT01524783. |
| Databáze: | OpenAIRE |
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