التفاصيل البيبلوغرافية
| العنوان: |
Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial |
| المؤلفون: |
Broeckelmann, Paul J., Goergen, Helen, Keller, Ulrich, Meissner, Julia, Ordemann, Rainer, Halbsguth, Teresa V., Sasse, Stephanie, Soekler, Martin, Kerkhoff, Andrea, Mathas, Stephan, Huettmann, Andreas, Bormann, Matthias, Zimmermann, Andreas, Mettler, Jasmin, Fuchs, Michael, von Tresckow, Bastian, Baues, Christian, Rosenwald, Andreas, Klapper, Wolfram, Kobe, Carsten, Borchmann, Peter, Engert, Andreas |
| بيانات النشر: |
AMER MEDICAL ASSOC |
| سنة النشر: |
2020 |
| المجموعة: |
Cologne University: KUPS |
| مصطلحات موضوعية: |
ddc:no |
| الوصف: |
Question What is the efficacy of concomitant or sequential nivolumab and doxorubicin, vinblastine, and dacarbazine (N-AVD) as first-line treatment for early-stage unfavorable classic Hodgkin lymphoma? Findings In this investigator-sponsored phase 2 randomized clinical trial including 109 adult patients, very high interim complete remission rates were observed after treatment with 2 cycles of N-AVD (87%) or 4 doses of nivolumab (51%). After end of treatment with 4 cycles of N-AVD and 30-Gy involved-site radiotherapy, efficacy measures, such as complete remission rates, 1-year progression-free survival, and 1-year overall survival were excellent in both groups. Meaning Nivolumab-based first-line treatment is highly effective in patients with early-stage unfavorable classic Hodgkin lymphoma and warrants further investigation. This phase 2 randomized clinical trial assesses the efficacy of concomitant and sequential treatment with nivolumab and doxorubicin, vinblastine, and dacarbazine (AVD) for patients with early-stage unfavorable Hodgkin lymphoma. IMPORTANCE In early-stage unfavorable classic Hodgkin lymphoma (cHL), conventional therapy induces high cure rates but also relevant acute and long-term toxic effects. Nivolumab is well tolerated and highly effective in relapsed/refractory cHL but has not been adequately studied in first-line treatment of early-stage cHL. The NIVAHL trial evaluated nivolumab in this setting with the aim to develop a highly effective yet tolerable systemic therapy to ultimately mitigate morbidity in patients who survive cHL. OBJECTIVE To evaluate efficacy of 2 experimental nivolumab-based first-line treatment strategies in patients with early-stage unfavorable cHL. DESIGN, SETTING, AND PARTICIPANTS This was an open-label, multicenter, phase 2 randomized clinical trial, open between April 2017 and October 2018. The trial took place at 35 trial centers across Germany, ranging from academic centers to private offices. Eligibility was defined by age 18 to 60 years, cHL confirmed by expert ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| العلاقة: |
Broeckelmann, Paul J., Goergen, Helen, Keller, Ulrich, Meissner, Julia, Ordemann, Rainer, Halbsguth, Teresa V., Sasse, Stephanie, Soekler, Martin, Kerkhoff, Andrea, Mathas, Stephan, Huettmann, Andreas, Bormann, Matthias, Zimmermann, Andreas, Mettler, Jasmin, Fuchs, Michael, von Tresckow, Bastian, Baues, Christian, Rosenwald, Andreas, Klapper, Wolfram, Kobe, Carsten, Borchmann, Peter and Engert, Andreas (2020). Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial. JAMA Oncol., 6 (6). S. 872 - 881. CHICAGO: AMER MEDICAL ASSOC. ISSN 2374-2445 |
| الإتاحة: |
https://kups.ub.uni-koeln.de/33159Test/ |
| رقم الانضمام: |
edsbas.4F4E9B8D |
| قاعدة البيانات: |
BASE |
