Phase II trial of nivolumab plus doxorubicin, vinblastine, dacarbazine as frontline therapy in older adults with Hodgkin lymphoma Journal Article


Authors: Torka, P.; Feldman, T.; Savage, K. J.; Ganesan, N.; Drill, E.; Hancock, H.; Davey, T.; Perez, L.; Capadona, C.; Subzwari, S.; Galasso, N.; Yang, J.; Post, M.; Boardman, A.; Caron, P.; David, K.; Epstein-Peterson, Z.; Falchi, L.; Ghione, P.; Hamlin, P.; Horwitz, S. M.; Intlekofer, A. M.; Johnson, W.; Kumar, A.; Lue, J.; Noy, A.; Owens, C.; Palomba, M. L.; Salles, G. A.; Steiner, R.; Stuver, R.; Vardhana, S.; Yahalom, J.; Dogan, A.; Zelenetz, A. D.; Schöder, H.; Moskowitz, A. J.
Article Title: Phase II trial of nivolumab plus doxorubicin, vinblastine, dacarbazine as frontline therapy in older adults with Hodgkin lymphoma
Abstract: PURPOSE We conducted a phase I/II study evaluating nivolumab plus doxorubicin, vinblastine, dacarbazine (N-AVD) as frontline therapy for treatment-naïve older adults (OA) with classical Hodgkin lymphoma (cHL; ClinicalTrials.gov identifier: NCT03033914).METHODSPatients age ≥60 years with newly diagnosed, any stage, cHL were treated with six cycles of AVD at standard doses plus nivolumab 240 mg intravenously once every 2 weeks (on days 1 and 15) of each cycle. A geriatric assessment was performed before therapy initiation. The primary end point was progression-free survival (PFS).RESULTSPatient characteristics (N = 40) included median age of 66 years (range, 60-78 years) with 38% ≥70 years, 78% with stage III/IV disease, 68% with International Prognostic Score of ≥3, 82% dependent in ≥1 activities of daily living, 23% dependent in ≥1 instrumental activities of daily living, 50% with impaired timed up and go test, and 40% with polypharmacy. Among 37 response-evaluable patients, the median follow-up was 49 months and 3-year PFS and overall survival (OS) were 79% and 97%, respectively. Overall, 50% patients experienced grade 3/4 treatment-related adverse events (TRAEs), including febrile neutropenia in 8%. Four (10%) patients stopped therapy due to TRAEs. There was no correlation between baseline geriatric impairments and survival outcomes or toxicities. Positron emission tomography-2 was not predictive of PFS or OS.CONCLUSIONN-AVD is a highly effective and well-tolerated frontline regimen in OA with cHL across a wide range of geriatric impairments. © 2024 by American Society of Clinical Oncology.
Keywords: aged; middle aged; clinical trial; mortality; doxorubicin; antineoplastic agent; dacarbazine; progression free survival; phase 2 clinical trial; antineoplastic combined chemotherapy protocols; vinblastine; hodgkin disease; phase 1 clinical trial; drug therapy; geriatric assessment; progression-free survival; nivolumab; humans; human; male; female
Journal Title: Journal of Clinical Oncology
Volume: 43
Issue: 8
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2025-03-10
Start Page: 985
End Page: 993
Language: English
DOI: 10.1200/jco-24-01278
PUBMED: 39661923
PROVIDER: scopus
DOI/URL:
Notes: Article -- MSK corresponding author is Alison Moskowitz -- Source: Scopus
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MSK Authors
  1. Joachim Yahalom
    634 Yahalom
  2. Ariela Noy
    369 Noy
  3. Maria Lia Palomba
    442 Palomba
  4. Steven M Horwitz
    664 Horwitz
  5. Heiko Schoder
    551 Schoder
  6. Andrew D Zelenetz
    781 Zelenetz
  7. Alison Moskowitz
    355 Moskowitz
  8. Paul Hamlin
    291 Hamlin
  9. Philip C Caron
    100 Caron
  10. Anita Kumar
    195 Kumar
  11. Esther Naomi Drill
    96 Drill
  12. Ahmet Dogan
    469 Dogan
  13. Colette Ngozi Owens
    78 Owens
  14. Santosha Adipudi Vardhana
    112 Vardhana
  15. Natasha   Galasso
    43 Galasso
  16. Leslie Ann Perez
    15 Perez
  17. Theresa Davey
    26 Davey
  18. Nivetha Ganesan
    54 Ganesan
  19. Paola Ghione
    88 Ghione
  20. Helen Hancock
    24 Hancock
  21. Lorenzo Falchi
    131 Falchi
  22. Gilles Andre Salles
    303 Salles
  23. William Thomas Johnson
    55 Johnson
  24. Robert Nicolais Stuver
    73 Stuver
  25. Jennifer Kimberly Lue
    52 Lue
  26. Pallawi Torka
    62 Torka
  27. Kevin Andrew David
    23 David
  28. Raphael Eric Steiner
    18 Steiner