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Verfasst von:Bröckelmann, Paul Jan [VerfasserIn]   i
 Bühnen, Ina [VerfasserIn]   i
 Meißner, Julia [VerfasserIn]   i
 Trautmann-Grill, Karolin [VerfasserIn]   i
 Herhaus, Peter [VerfasserIn]   i
 Halbsguth, Teresa V. [VerfasserIn]   i
 Schaub, Valdete [VerfasserIn]   i
 Kerkhoff, Andrea [VerfasserIn]   i
 Mathas, Stephan [VerfasserIn]   i
 Bormann, Matthias [VerfasserIn]   i
 Dickhut, Andreas [VerfasserIn]   i
 Kaul, Helen [VerfasserIn]   i
 Fuchs, Michael [VerfasserIn]   i
 Kobe, Carsten [VerfasserIn]   i
 Baues, Christian [VerfasserIn]   i
 Borchmann, Peter [VerfasserIn]   i
 Engert, Andreas [VerfasserIn]   i
 von Tresckow, Bastian [VerfasserIn]   i
Titel:Nivolumab and Doxorubicin, Vinblastine, and Dacarbazine in early-stage unfavorable Hodgkin Lymphoma
Titelzusatz:final analysis of the randomized German Hodgkin Study Group Phase II NIVAHL trial
Verf.angabe:Paul J. Bröckelmann, Ina Bühnen, Julia Meissner, Karolin Trautmann-Grill, Peter Herhaus, Teresa V. Halbsguth, Valdete Schaub, Andrea Kerkhoff, Stephan Mathas, Matthias Bormann, Andreas Dickhut, Helen Kaul, Michael Fuchs, Carsten Kobe, Christian Baues, Peter Borchmann, Andreas Engert, and Bastian von Tresckow
E-Jahr:2023
Jahr:February 20, 2023
Umfang:12 S.
Fussnoten:Online veröffentlicht: 12. Dezember 2022 ; Gesehen am 23.06.2023
Titel Quelle:Enthalten in: Journal of clinical oncology
Ort Quelle:Alexandria, Va. : American Society of Clinical Oncology, 1983
Jahr Quelle:2023
Band/Heft Quelle:41(2023), 6 vom: Feb., Seite 1193-1199, appendix
ISSN Quelle:1527-7755
Abstract:Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. - - In the investigator-sponsored randomized phase II NIVAHL trial for early-stage unfavorable classical Hodgkin lymphoma (HL), two schedules of four cycles of nivolumab, doxorubicin, vinblastine, and dacarbazine followed by 30 Gy involved-site radiotherapy resulted in high complete remission rates and an unprecedented 1-year progression-free survival in 109 patients. In this article, we report the preplanned final analysis conducted three years after the registration of the last patient including long-term safety results. No survival events were observed since the primary analysis, and after a median follow-up (FU) of 41 months, the overall survival was 100% in both treatment groups. The progression-free survival was 98% and 100% in the sequential and concomitant nivolumab, doxorubicin, vinblastine, and dacarbazine treatment groups, respectively. At last FU, the mean forced expiratory pressure in one second was 95.5% (standard deviation 12.7%), the mean diffusion capacity for carbon monoxide adjusted for hemoglobin was 82.8% (standard deviation 15.4%), and the left ventricular ejection fraction was in the normal range in 95% of patients. Hypothyroidism requiring long-term medication occurred in 15% of patients, who were nearly exclusively female (87%). No second primary malignancies occurred, and no patient required corticosteroid treatment at last FU. Patient-reported normalized global quality-of-life score measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 improved over time. This preplanned FU analysis of the largest anti-programmed death protein 1 HL first-line trial to date confirms the outstanding efficacy and relatively favorable safety profile of this therapeutic approach.
DOI:doi:10.1200/JCO.22.02355
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: https://doi.org/10.1200/JCO.22.02355
 Volltext: https://ascopubs.org/doi/10.1200/JCO.22.02355
 DOI: https://doi.org/10.1200/JCO.22.02355
Datenträger:Online-Ressource
Sprache:eng
K10plus-PPN:185091463X
Verknüpfungen:→ Zeitschrift

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