التفاصيل البيبلوغرافية
العنوان: |
Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia |
المؤلفون: |
Furman, Richard R, Sharman, Jeff P, Coutre, Steven E, Cheson, Bruce D, Pagel, John M, Hillmen, Peter, Barrientos, Jacqueline C, Zelenetz, Andrew D, Kipps, Thomas J, Flinn, Ian, Ghia, Paolo, Eradat, Herbert, Ervin, Thomas, Lamanna, Nicole, Coiffier, Bertrand, Pettitt, Andrew R, Ma, Shuo, Stilgenbauer, Stephan, Cramer, Paula, Aiello, Maria, Johnson, Dave M, Miller, Langdon L, Li, Daniel, Jahn, Thomas M, Dansey, Roger D, Hallek, Michael, O'Brien, Susan M |
المصدر: |
New England Journal of Medicine, vol 370, iss 11 |
بيانات النشر: |
eScholarship, University of California |
سنة النشر: |
2014 |
المجموعة: |
University of California: eScholarship |
مصطلحات موضوعية: |
Cancer, Lymphoma, Clinical Research, Clinical Trials and Supportive Activities, Hematology, Patient Safety, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Aged, 80 and over, Antibodies, Monoclonal, Murine-Derived, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Kidney Diseases, Leukemia, Lymphocytic, Chronic, B-Cell, Lymph Nodes, Male, Middle Aged, Phosphoinositide-3 Kinase Inhibitors |
جغرافية الموضوع: |
997 - 1007 |
الوصف: |
BackgroundPatients with relapsed chronic lymphocytic leukemia (CLL) who have clinically significant coexisting medical conditions are less able to undergo standard chemotherapy. Effective therapies with acceptable side-effect profiles are needed for this patient population.MethodsIn this multicenter, randomized, double-blind, placebo-controlled, phase 3 study, we assessed the efficacy and safety of idelalisib, an oral inhibitor of the delta isoform of phosphatidylinositol 3-kinase, in combination with rituximab versus rituximab plus placebo. We randomly assigned 220 patients with decreased renal function, previous therapy-induced myelosuppression, or major coexisting illnesses to receive rituximab and either idelalisib (at a dose of 150 mg) or placebo twice daily. The primary end point was progression-free survival. At the first prespecified interim analysis, the study was stopped early on the recommendation of the data and safety monitoring board owing to overwhelming efficacy.ResultsThe median progression-free survival was 5.5 months in the placebo group and was not reached in the idelalisib group (hazard ratio for progression or death in the idelalisib group, 0.15; P<0.001). Patients receiving idelalisib versus those receiving placebo had improved rates of overall response (81% vs. 13%; odds ratio, 29.92; P<0.001) and overall survival at 12 months (92% vs. 80%; hazard ratio for death, 0.28; P=0.02). Serious adverse events occurred in 40% of the patients receiving idelalisib and rituximab and in 35% of those receiving placebo and rituximab.ConclusionsThe combination of idelalisib and rituximab, as compared with placebo and rituximab, significantly improved progression-free survival, response rate, and overall survival among patients with relapsed CLL who were less able to undergo chemotherapy. (Funded by Gilead; ClinicalTrials.gov number, NCT01539512.). |
نوع الوثيقة: |
article in journal/newspaper |
وصف الملف: |
application/pdf |
اللغة: |
unknown |
العلاقة: |
qt11q3j03k; https://escholarship.org/uc/item/11q3j03kTest |
الإتاحة: |
https://escholarship.org/uc/item/11q3j03kTest |
حقوق: |
public |
رقم الانضمام: |
edsbas.1D81A8C3 |
قاعدة البيانات: |
BASE |