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2. Nivolumab for relapsed or refractory Hodgkin lymphoma: real-life experience

Author

H. Beköz, N. Karadurmuş, S. Paydaş, A. Türker, T. Toptaş, T. Fıratlı Tuğlular, M. Sönmez, Z. Gülbaş, E. Tekgündüz, A.H. Kaya, M. Özbalak, N. Taştemir, L. Kaynar, R. Yıldırım, I. Karadoğan, M. Arat, F. Pepedil Tanrıkulu, V. Özkocaman, H. Abalı, M. Turgut, M. Kurt Yüksel, M. Özcan, M.H. Doğu, S. Kabukçu Hacıoğlu, I. Barışta, M. Demirkaya, F.D. Köseoğlu, S.K. Toprak, M. Yılmaz, H.C. Demirkürek, O. Demirkol, B. Ferhanoğlu, Acibadem University Dspace, OMÜ, Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Hematoloji Anabilim Dalı., Uludağ Üniversitesi/Tıp Fakültesi/Tıbbi Onkoloji Anabilim Dalı/Çocuk Sağlığı ve Hastalıkları Anabilim Dalı., Özkocaman, Vildan, Demirkaya, Metin, AAH-1854-2021, Çukurova Üniversitesi, Ege Üniversitesi, and İç Hastalıkları

Subjects
cancer pain, allograft, Hypophosphatemia, retrospective study, thrombocytopenia, Septic shock, middle aged, immunopathology, Medicine, Disease free survival, catheter infection, progression free survival, Hematology, adult, steroid, clinical trial, Chronic graft versus host disease, nausea, Allografts, Survival Rate, Clinical trial, aged, priority journal, Oncology, drug withdrawal, Photopheresis, 030220 oncology & carcinogenesis, medicine.medical_specialty, gynecomastia, muscle cramp, Major clinical study, visual disorder, Article, 03 medical and health sciences, Hypothyroidism, brentuximab vedotin, neutropenia, Cancer recurrence, Retrospective Studies, Aged, hypophosphatemia, treatment response, Upper respiratory tract infection, major clinical study, Resistant, drug efficacy, multicenter study, Pancreatitis, monoclonal antibody, fatigue, drug safety, peripheral neuropathy, Immunoconjugates, drug response, pancreatitis, PD-1 blockade, rash, hypocalcemia, allogeneic stem cell transplantation, immune system diseases, hemic and lymphatic diseases, Monoclonal, Edema, pain, Overall survival, Visual disorder, Cancer pain, appetite disorder, Fatigue, Priority journal, treatment withdrawal, Hodgkin Disease, Programmed death 1 receptor, photopheresis, arthritis, scrotal pain, young adult, Gynecomastia, medicine.drug, Adult, Abdominal pain, Neutropenia, chronic graft versus host disease, side effect, Adolescent, overall survival, Drug response, Pain, overall response rate, macromolecular substances, Relapsed Disease, Rash, Refractory Hodgkin Lymphoma, hyperthyroidism, pneumonia, Stomatitis, Hypocalcemia, business.industry, Pruritus, allergic encephalitis, mycophenolate mofetil, hypercalcemia, programmed death 1 receptor, pruritus, Cancer survival, Allogeneic stem cell transplantation, Surgery, Drug efficacy, Graft versus host reaction, cancer recurrence, classical Hodgkin lymphoma, septic shock, edema, Hodgkin lymphoma, 030215 immunology, Male, encephalitis, diarrhea, Agent, sepsis, phlebitis, 0302 clinical medicine, infusion related reaction, cancer survival, Drug safety, Brentuximab vedotin, disease free survival, Antibody conjugate, autoimmune liver disease, Stem cell transplantation, Headache, Antibodies, Monoclonal, Scrotal pain, General Medicine, cohort analysis, anemia, Antineoplastic, Multicenter study, Retrospective study, Nivolumab, named patient program, Infection, Human, Diarrhea, resistant/relapsed disease, heart infarction, Antineoplastic Agents, Cancer mortality, Disease-Free Survival, cancer growth, multiple cycle treatment, Humans, human, autoimmune pneumonitis, Adverse effect, cystitis, Steroid, nivolumab, cancer immunotherapy, Brentuxımab vedotın, Chlorambucil, Arthritis, abdominal pain, Pneumonia, medicine.disease, mortality, infection, Retrospective studies, Graft-versus-host disease, lymphocytopenia, upper respiratory tract infection, Hypercalcemia, Muscle cramp, drug hypersensitivity, lung disease, Peripheral neuropathy, antibody conjugate, Turkey (republic), cancer mortality, Middle aged, antineoplastic agent, fever, Allergic encephalitis, Mycophenolate mofetil, Antibodies, Monoclonal/*therapeutic use, Antineoplastic Agents/therapeutic use, Brentuximab Vedotin, Female, Hodgkin Disease/*drug therapy/therapy, Immunoconjugates/therapeutic use, Middle Aged, Stem Cell Transplantation, Young Adult, Anemia, female, Decreased appetite, Encephalitis, headache, Hodgkin's Disease, Refractory Materials, Monoclonal antibody, Hodgkin disease, Fever, Disease-free survival, stem cell transplantation, Hypertransaminasemia, Antibodies, programmed death 1 (PD-1) blocker, Internal medicine, follow up, controlled study, decreased appetite, dermatitis, graft versus host reaction, Lymphocytopenia, hypertransaminasemia, Agents, Thrombocytopenia, stomatitis, Transplantation, Young adult, Lung disease, Progression free survival, Infusion related reaction, hypothyroidism, business, Controlled study, Follow-Up Studies
Abstract

WOS: 000411827200025, PubMed ID: 28961828, Background: Reed-Sternberg cells of classical Hodgkin's lymphoma (cHL) are characterized by genetic alterations at the 9p24.1 locus, leading to over-expression of programmed death-ligand 1 and 2. In a phase 1b study, nivolumab, a PD-1-blocking antibody, produced a high response in patients with relapsed or refractory cHL, with an acceptable safety profile. Patients and methods: We present a retrospective analysis of 82 patients (median age: 30 years; range: 18-75) with relapsed/refractory HL treated with nivolumab in a named patient program from 24 centers throughout Turkey. The median follow-up was 7 months, and the patients had a median of 5 (2-11) previous lines of therapy. Fifty-seven (70%) and 63 (77%) had been treated by stem-cell transplantation and brentuximab vedotin, respectively. Results: Among 75 patients evaluated after 12 weeks of nivolumab treatment, the objective response rate was 64%, with 16 complete responses (CR; 22%); after 16 weeks, it was 60%, with 16 (26%) patients achieving CR. Twenty patients underwent subsequent transplantation. Among 11 patients receiving allogeneic stem-cell transplantation, 5 had CR at the time of transplantation and are currently alive with ongoing response. At the time of analysis, 41 patients remained on nivolumab treatment. Among the patients who discontinued nivolumab, the main reason was disease progression (n = 19). The safety profile was acceptable, with only four patients requiring cessation of nivolumab due to serious adverse events (autoimmune encephalitis, pulmonary adverse event, and two cases of graft-versus-host disease aggravation). The 6-month overall and progression-free survival rates were 91.2% (95% confidence interval: 0.83-0.96) and 77.3% (0.66-0.85), respectively. Ten patients died during the follow-up; one of these was judged to be treatment-related. Conclusions: Nivolumab represents a novel option for patients with cHL refractory to brentuximab vedotin, and may serve as a bridge to transplantation; however, it may be associated with increased toxicity.

Published
2017
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3. Nivolumab for relapsed or refractory Hodgkin lymphoma: real-life experience.

Author

Beköz H, Karadurmuş N, Paydaş S, Türker A, Toptaş T, Fıratlı Tuğlular T, Sönmez M, Gülbaş Z, Tekgündüz E, Kaya AH, Özbalak M, Taştemir N, Kaynar L, Yıldırım R, Karadoğan I, Arat M, Pepedil Tanrıkulu F, Özkocaman V, Abalı H, Turgut M, Kurt Yüksel M, Özcan M, Doğu MH, Kabukçu Hacıoğlu S, Barışta I, Demirkaya M, Köseoğlu FD, Toprak SK, Yılmaz M, Demirkürek HC, Demirkol O, and Ferhanoğlu B

Subjects
Adolescent, Adult, Aged, Antineoplastic Agents therapeutic use, Brentuximab Vedotin, Disease-Free Survival, Female, Hodgkin Disease therapy, Humans, Immunoconjugates therapeutic use, Male, Middle Aged, Nivolumab, Retrospective Studies, Stem Cell Transplantation, Young Adult, Antibodies, Monoclonal therapeutic use, Hodgkin Disease drug therapy
Abstract

Background: Reed-Sternberg cells of classical Hodgkin's lymphoma (cHL) are characterized by genetic alterations at the 9p24.1 locus, leading to over-expression of programmed death-ligand 1 and 2. In a phase 1b study, nivolumab, a PD-1-blocking antibody, produced a high response in patients with relapsed or refractory cHL, with an acceptable safety profile., Patients and Methods: We present a retrospective analysis of 82 patients (median age: 30 years; range: 18-75) with relapsed/refractory HL treated with nivolumab in a named patient program from 24 centers throughout Turkey. The median follow-up was 7 months, and the patients had a median of 5 (2-11) previous lines of therapy. Fifty-seven (70%) and 63 (77%) had been treated by stem-cell transplantation and brentuximab vedotin, respectively., Results: Among 75 patients evaluated after 12 weeks of nivolumab treatment, the objective response rate was 64%, with 16 complete responses (CR; 22%); after 16 weeks, it was 60%, with 16 (26%) patients achieving CR. Twenty patients underwent subsequent transplantation. Among 11 patients receiving allogeneic stem-cell transplantation, 5 had CR at the time of transplantation and are currently alive with ongoing response. At the time of analysis, 41 patients remained on nivolumab treatment. Among the patients who discontinued nivolumab, the main reason was disease progression (n = 19). The safety profile was acceptable, with only four patients requiring cessation of nivolumab due to serious adverse events (autoimmune encephalitis, pulmonary adverse event, and two cases of graft-versus-host disease aggravation). The 6-month overall and progression-free survival rates were 91.2% (95% confidence interval: 0.83-0.96) and 77.3% (0.66-0.85), respectively. Ten patients died during the follow-up; one of these was judged to be treatment-related., Conclusions: Nivolumab represents a novel option for patients with cHL refractory to brentuximab vedotin, and may serve as a bridge to transplantation; however, it may be associated with increased toxicity., (© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2017
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