Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study
| 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 |
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| المؤلفون: | Monique C. Minnema, Margaret A. Shipp, Stephen M. Ansell, Nishitha Reddy, Scott J. Rodig, Jonathon B. Cohen, Selda Samakoglu, Kazunobu Kato, Margaretha G.M. Roemer, Sarit Assouline, Philippe Armand, Anne Sumbul, Michelle Poon, Peter Johnson, Azra H. Ligon, Manish Sharma, John M. Timmerman, Andrew Grigg |
| المصدر: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 37(6), 481. American Society of Clinical Oncology |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, Oncology, Diffuse/drug therapy, Cancer Research, Time Factors, Lymphoma, Programmed Cell Death 1 Receptor, Phases of clinical research, Transplantation, Autologous/adverse effects, Clinical Trial, Phase II, Antineoplastic Agents, Immunological, immune system diseases, hemic and lymphatic diseases, Immunological/adverse effects, 80 and over, Treatment Failure, Non-U.S. Gov't, Aged, 80 and over, Research Support, Non-U.S. Gov't, Programmed Cell Death 1 Receptor/antagonists & inhibitors, Remission Induction, Hematopoietic Stem Cell Transplantation, ORIGINAL REPORTS, Middle Aged, Clinical Trial, Progression-Free Survival, Phase II, Multicenter Study, Nivolumab, Lymphoma, Large B-Cell, Diffuse/drug therapy, Disease Progression, Female, Lymphoma, Large B-Cell, Diffuse, Chromosomes, Human, Pair 9, Human, Pair 9, Antineoplastic Agents, Immunological/adverse effects, Adult, medicine.medical_specialty, Autologous/adverse effects, Antineoplastic Agents, Research Support, Transplantation, Autologous, Chromosomes, N.I.H, Young Adult, Research Support, N.I.H., Extramural, Refractory, Internal medicine, Large B-Cell, Journal Article, medicine, Humans, Autologous transplantation, Progression-free survival, Hematopoietic Stem Cell Transplantation/adverse effects, Aged, Transplantation, business.industry, Extramural, Nivolumab/adverse effects, medicine.disease, business, Diffuse large B-cell lymphoma |
| 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. |
| وصف الملف: | text; image/pdf |
| تدمد: | 1527-7755 0732-183X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::55bd249e2e8165cc0d45938a170ea405Test https://doi.org/10.1200/jco.18.00766Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....55bd249e2e8165cc0d45938a170ea405 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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