| |
著者: S Horwitz, O A O'Connor, B Pro, L Trümper, S Iyer, R Advani, N L Bartlett, J H Christensen, F Morschhauser, E Domingo-Domenech, G Rossi, W S Kim, T Feldman, T Menne, D Belada, Á Illés, K Tobinai, K Tsukasaki, S-P Yeh, A Shustov, A Hüttmann, K J Savage, S Yuen, P L Zinzani, H Miao, V Bunn, K Fenton, M Fanale, M Puhlmann, T Illidge
雑誌名: Ann Oncol. 2022 Mar;33(3):288-298. doi: 10.1016/j.annonc.2021.12.002. Epub 2021 Dec 16.
Abstract/Text
BACKGROUND: For patients with peripheral T-cell lymphoma (PTCL), outcomes using frontline treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like therapy are typically poor. The ECHELON-2 study demonstrated that brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A+CHP) exhibited statistically superior progression-free survival (PFS) per independent central review and improvements in overall survival versus CHOP for the frontline treatment of patients with systemic anaplastic large cell lymphoma or other CD30-positive PTCL.
PATIENTS AND METHODS: ECHELON-2 is a double-blind, double-dummy, randomized, placebo-controlled, active-comparator phase III study. We present an exploratory update of the ECHELON-2 study, including an analysis of 5-year PFS per investigator in the intent-to-treat analysis group.
RESULTS: A total of 452 patients were randomized (1 : 1) to six or eight cycles of A+CHP (N = 226) or CHOP (N = 226). At median follow-up of 47.6 months, 5-year PFS rates were 51.4% [95% confidence interval (CI): 42.8% to 59.4%] with A+CHP versus 43.0% (95% CI: 35.8% to 50.0%) with CHOP (hazard ratio = 0.70; 95% CI: 0.53-0.91), and 5-year overall survival (OS) rates were 70.1% (95% CI: 63.3% to 75.9%) with A+CHP versus 61.0% (95% CI: 54.0% to 67.3%) with CHOP (hazard ratio = 0.72; 95% CI: 0.53-0.99). Both PFS and OS were generally consistent across key subgroups. Peripheral neuropathy was resolved or improved in 72% (84/117) of patients in the A+CHP arm and 78% (97/124) in the CHOP arm. Among patients who relapsed and subsequently received brentuximab vedotin, the objective response rate was 59% with brentuximab vedotin retreatment after A+CHP and 50% with subsequent brentuximab vedotin after CHOP.
CONCLUSIONS: In this 5-year update of ECHELON-2, frontline treatment of patients with PTCL with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, with a manageable safety profile, including continued resolution or improvement of peripheral neuropathy.
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
PMID 34921960 Ann Oncol. 2022 Mar;33(3):288-298. doi: 10.1016/j.annonc.2021.12.002. Epub 2021 Dec 16.
|
