2026-03-31 バッファロー大学（UB)
＜関連情報＞
- https://www.buffalo.edu/news/releases/2026/03/Clinical-trial-classical-Hodgkin-lymphoma-UB-Roswell-Park.html
- https://ascopubs.org/doi/abs/10.1200/JCO-25-00203
- https://www.nejm.org/doi/10.1056/NEJMoa2405888
S1826試験における進行期古典的ホジキンリンパ腫の青年患者を対象としたニボルマブ-AVD療法とブレンツキシマブベドチン-AVD療法の3年間の追跡調査 Three-Year Follow-Up of Nivolumab-AVD Versus Brentuximab Vedotin–AVD in Adolescents With Advanced-Stage Classic Hodgkin Lymphoma on S1826
Sharon M. Castellino, MD, MSc, Hongli Li, MS, Alex F. Herrera, MD, Michael LeBlanc, PhD, Susan K. Parsons, MD, MRP, Joseph M. Unger, PhD, MS
Journal of Clinical Oncology Published:January 09, 2026
DOI:https://doi.org/10.1200/JCO-25-00203
Abstract
We present a subset analysis on the adolescent cohort of the S1826 randomized phase three trial, comparing nivolumab, doxorubicin, vinblastine, dacarbazine (N-AVD) to brentuximab vedotin-AVD (BV-AVD) in newly diagnosed advanced-stage (AS, stages III and IV) classic Hodgkin lymphoma (cHL). Among 994 patients enrolled, 24% (n = 240) were age 12-17 years. The 3-year progression-free survival (PFS) was significantly higher in the N-AVD group (93% [95% CI, 87 to 96]) compared with the BV-AVD group (82% [95% CI, 73 to 88]; hazard ratio, 0.37 [95% CI, 0.17 to 0.80]). One N-AVD and two BV-AVD patients received protocol-specified residual site radiotherapy (RT). Rates of febrile neutropenia and sepsis were low in both groups. Severe immune-related adverse events were infrequent, although thyroid dysfunction was seen in 7% with N-AVD. Sensory neuropathy (grade ≥2) was more frequent with BV-AVD (14% v 7%) by clinician report. Although premature discontinuation of therapy was reported in 12 N-AVD patients and four BV-AVD patients, no PFS events were noted in the N-AVD group. Patient-reported outcomes indicated less toxicity with N-AVD. N-AVD demonstrated high 3-year PFS in adolescents with AS cHL, with minimal RT use. S1826 exemplifies the benefits of harmonized clinical trial protocols, resulting in timely access to novel agents for adolescents.
進行期古典的ホジキンリンパ腫に対するニボルマブ＋AVD療法 Nivolumab+AVD in Advanced-Stage Classic Hodgkin’s Lymphoma
Alex F. Herrera, M.D., Michael LeBlanc, Ph.D., Sharon M. Castellino, M.D., Hongli Li, M.S., Sarah C. Rutherford, M.D., Andrew M. Evens, D.O., Kelly Davison, M.D., Ph.D., +39 , and Jonathan W. Friedberg, M.D.
New England Journal of Medicine Published: October 16, 2024
DOI:10.1056/NEJMoa2405888
Abstract
Background
Incorporating brentuximab vedotin into the treatment of advanced-stage classic Hodgkin’s lymphoma improves outcomes in adult and pediatric patients. However, brentuximab vedotin increases the toxic effects of treatment in adults, more than half of pediatric patients who receive the drug undergo consolidative radiation, and relapse remains a challenge. Programmed death 1 blockade is effective in Hodgkin’s lymphoma, including in preliminary studies involving previously untreated patients.
Methods
We conducted a phase 3, multicenter, open-label, randomized trial involving patients at least 12 years of age with stage III or IV newly diagnosed Hodgkin’s lymphoma. Patients were randomly assigned to receive brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (BV+AVD) or nivolumab with doxorubicin, vinblastine, and dacarbazine (N+AVD). Prespecified patients could receive radiation therapy directed to residual metabolically active lesions. The primary end point was progression-free survival, defined as the time from randomization to the first observation of progressive disease or death from any cause.
Results
Of 994 patients who underwent randomization, 970 were included in the intention-to-treat population for efficacy analyses. At the second planned interim analysis, with a median follow-up of 12.1 months, the threshold for efficacy was crossed, indicating that N+AVD significantly improved progression-free survival as compared with BV+AVD (hazard ratio for disease progression or death, 0.48; 99% confidence interval [CI], 0.27 to 0.87; two-sided P=0.001). Owing to the short follow-up time, we repeated the analysis with longer follow-up; with a median follow-up of 2.1 years (range, 0 to 4.2 years), the 2-year progression-free survival was 92% (95% CI, 89 to 94) with N+AVD, as compared with 83% (95% CI, 79 to 86) with BV+AVD (hazard ratio for disease progression or death, 0.45; 95% CI, 0.30 to 0.65). Overall, 7 patients received radiation therapy. Immune-related adverse events were infrequent with nivolumab; brentuximab vedotin was associated with more treatment discontinuation.
Conclusions
N+AVD resulted in longer progression-free survival than BV+AVD in adolescents and adults with stage III or IV advanced-stage classic Hodgkin’s lymphoma and had a better side-effect profile. (Funded by the National Cancer Institute of the National Institutes of Health and others; S1826 ClinicalTrials.gov number, NCT03907488.)
