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Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024

Phase II Trial of Nivolumab Plus Doxorubicin, Vinblastine, Dacarbazine as Frontline Therapy in Older Adults With Hodgkin Lymphoma.

Клиническое исследование I фазыКлиническое исследование II фазыСтатьяПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Torka Pallawi, Feldman Tatyana, Savage Kerry J, Ganesan Nivetha, Drill Esther, Hancock Helen, Davey Theresa, Perez Leslie, Capadona Charisse, Subzwari Sarima, Galasso Natasha, Yang Jinshu, Post Michelle, Boardman Alexander, Caron Philip, David Kevin, Epstein-Peterson Zachary, Falchi Lorenzo, Ghione Paola, Hamlin Paul, Horwitz Steven M, Intlekofer Andrew M, Johnson William, Kumar Anita, Lue Jennifer, Noy Ariela, Owens Colette, Palomba M Lia, Salles Gilles A, Steiner Raphael, Stuver Robert, Vardhana Santosha, Yahalom Joachim, Dogan Ahmet, Zelenetz Andrew D, Schöder Heiko, Moskowitz Alison J

Аннотация

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).

METHODS: Patients 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).

RESULTS: Patient 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.

CONCLUSION: N-AVD is a highly effective and well-tolerated frontline regimen in OA with cHL across a wide range of geriatric impairments.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты