التفاصيل البيبلوغرافية
| العنوان: |
Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study |
| المؤلفون: |
Ansell, Stephen M, Minnema, Monique C, Johnson, Peter, Timmerman, John M, Armand, Philippe, Shipp, Margaret A, Rodig, Scott J, Ligon, Azra H, Roemer, Margaretha G M, Reddy, Nishitha, Cohen, Jonathon B, Assouline, Sarit, Poon, Michelle, Sharma, Manish, Kato, Kazunobu, Samakoglu, Selda, Sumbul, Anne, Grigg, Andrew |
| المساهمون: |
MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells |
| سنة النشر: |
2019 |
| مصطلحات موضوعية: |
Adult, Aged, 80 and over, Antineoplastic Agents, Immunological/adverse effects, Chromosomes, Human, Pair 9, Disease Progression, Female, Hematopoietic Stem Cell Transplantation/adverse effects, Humans, Lymphoma, Large B-Cell, Diffuse/drug therapy, Male, Middle Aged, Nivolumab/adverse effects, Programmed Cell Death 1 Receptor/antagonists & inhibitors, Progression-Free Survival, Remission Induction, Time Factors, Transplantation, Autologous/adverse effects, Treatment Failure, Young Adult, Clinical Trial, Phase II, Journal Article, Multicenter Study |
| الوصف: |
PURPOSE: Treatment options are limited for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Tumor cells can exploit the programmed death-1 checkpoint pathway to evade immune surveillance. In the current study, we evaluated the efficacy and safety of programmed death-1 blockade by nivolumab in patients with relapsed/refractory DLBCL. METHODS: In this phase II, open-label study, patients with relapsed/refractory DLBCL who were ineligible for autologous hematopoietic cell transplantation (auto-HCT) or who had experienced failure with auto-HCT received nivolumab 3 mg/kg every 2 weeks. We assessed the efficacy and safety of nivolumab as well as genetic alterations of 9p24.1. RESULTS: Among 121 treated patients, patients in the auto-HCT-failed cohort (n = 87) received a median of four nivolumab doses and a median of three doses were administered to those in the auto-HCT-ineligible cohort (n = 34). At a median follow-up of 9 months in the auto-HCT-failed cohort and 6 months in the auto-HCT-ineligible cohort, independently assessed objective response rates were 10% and 3%, and median durations of response were 11 and 8 months, respectively. Median progression-free survival and overall survival were 1.9 and 12.2 months in the auto-HCT-failed cohort and 1.4 and 5.8 months in the auto-HCT-ineligible cohort respectively. All three patients with complete remission-3% of the auto-HCT-failed cohort-had durable response (11 or more, 14 or more, and 17 months). Treatment-related grade 3 and 4 adverse events were reported in 24% of patients. The most common were neutropenia (4%), thrombocytopenia (3%), and increased lipase (3%). Of all evaluable samples for 9p24.1 analysis, 16% exhibited low-level copy gain and 3% had amplification. CONCLUSION: Nivolumab monotherapy is associated with a favorable safety profile but a low overall response rate among patients with DLBCL who are ineligible for auto-HCT or who experienced failure with auto-HCT. Genetic alterations of 9p24.1 are infrequent in DLBCL. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
image/pdf |
| اللغة: |
English |
| تدمد: |
0732-183X |
| العلاقة: |
https://dspace.library.uu.nl/handle/1874/390524Test |
| الإتاحة: |
https://dspace.library.uu.nl/handle/1874/390524Test |
| حقوق: |
info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: |
edsbas.1ACC5ADB |
| قاعدة البيانات: |
BASE |
