TY - JOUR
T1 - Older patients (aged ≥60 years) with previously untreated advanced-stage classical Hodgkin the phase lymphoma
T2 - III ECHELON-1 a detailed study analysis from the phase III ECHELON-1 study
AU - Evens, Andrew M.
AU - Connors, Joseph M.
AU - Younes, Anas
AU - Ansell, Stephen M.
AU - Kim, Won Seog
AU - Radford, John
AU - Feldman, Tatyana
AU - Tuscano, Joseph
AU - Savage, Kerry J.
AU - Oki, Yasuhiro
AU - Grigg, Andrew
AU - Pocock, Christopher
AU - Dlugosz-Danecka, Monika
AU - Fenton, Keenan
AU - Forero-Torres, Andres
AU - Liu, Rachael
AU - Jolin, Hina
AU - Gautam, Ashish
AU - Gallamini, Andrea
N1 - Funding Information:
Funding This work was supported by Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (grant number not applicable); and Seagen, Inc., Bothell, WA, USA (grant number not applicable).
Funding Information:
This work was supported by Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (grant number not applicable); and Seagen, Inc., Bothell, WA, USA (grant number not applicable).
Funding Information:
The authors would like to thank the patients who participated in this study and their families. They would also like to acknowledge other investigators and staff at all ECHELON-1 clinical sites and the members of the Independent Data Monitoring Committee and Independent Review Committee. The authors acknowledge the writing assistance of Laura Webb and Hedley Coppock of Ashfield MedComms, an Ashfield Health company, part of UDG Healthcare plc, during the development of this manuscript, which was funded by Millennium Pharmaceuticals, Inc., and complied with the Good Publication Practice 3 ethical guidelines.39
Publisher Copyright:
2022 Ferrata Storti Foundation
PY - 2022/5
Y1 - 2022/5
N2 - Effective and tolerable treatments are needed for older patients with classical Hodgkin lymphoma. We report results for older patients with classical Hodgkin lymphoma treated in the large phase III ECHELON-1 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Modified progression-free survival per independent review facility for older versus younger patients (aged ≥60 vs. <60 years) was a pre-specified subgroup analysis; as the ECHELON-1 study was not powered for these analyses, reported P-values are descriptive. Of 1,334 enrolled patients, 186 (14%) were aged ≥60 years (A+AVD: n=84, ABVD: n=102); results below refer to this age group. Modified progression-free survival per independent review facility was similar in the two arms at 24 months (A+AVD: 70.3% [95% confidence interval (CI): 58.4–79.4], ABVD: 71.4% [95% CI: 60.5–79.8], hazard ratio (HR)=1.00 [95% CI: 0.58–1.72], P=0.993). After a median follow-up of 60.9 months, 5-year progression-free survival per investigator was 67.1% with A+AVD versus 61.6% with ABVD (HR=0.820 [95% CI: 0.494–1.362], P=0.443). Comparing A+AVD versus ABVD, grade 3/4 peripheral neuropathy occurred in 18% versus 3%; any-grade febrile neutropenia in 37% versus 17%; and any-grade pulmonary toxicity in 2% versus 13%, respectively, with three (3%) pulmonary toxicity-related deaths in patients receiving ABVD (none in those receiving A+AVD). Altogether, A+AVD showed overall similar efficacy to ABVD with survival rates in both arms comparing favorably to those of prior series in older patients with advanced-stage classical Hodgkin lymphoma. Compared to ABVD, A+AVD was associated with higher rates of neuropathy and neutropenia, but lower rates of pulmonary-related toxicity. Trials registered at ClinicalTrials.gov identifiers: NCT01712490; EudraCT number: 2011-005450-60.
AB - Effective and tolerable treatments are needed for older patients with classical Hodgkin lymphoma. We report results for older patients with classical Hodgkin lymphoma treated in the large phase III ECHELON-1 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Modified progression-free survival per independent review facility for older versus younger patients (aged ≥60 vs. <60 years) was a pre-specified subgroup analysis; as the ECHELON-1 study was not powered for these analyses, reported P-values are descriptive. Of 1,334 enrolled patients, 186 (14%) were aged ≥60 years (A+AVD: n=84, ABVD: n=102); results below refer to this age group. Modified progression-free survival per independent review facility was similar in the two arms at 24 months (A+AVD: 70.3% [95% confidence interval (CI): 58.4–79.4], ABVD: 71.4% [95% CI: 60.5–79.8], hazard ratio (HR)=1.00 [95% CI: 0.58–1.72], P=0.993). After a median follow-up of 60.9 months, 5-year progression-free survival per investigator was 67.1% with A+AVD versus 61.6% with ABVD (HR=0.820 [95% CI: 0.494–1.362], P=0.443). Comparing A+AVD versus ABVD, grade 3/4 peripheral neuropathy occurred in 18% versus 3%; any-grade febrile neutropenia in 37% versus 17%; and any-grade pulmonary toxicity in 2% versus 13%, respectively, with three (3%) pulmonary toxicity-related deaths in patients receiving ABVD (none in those receiving A+AVD). Altogether, A+AVD showed overall similar efficacy to ABVD with survival rates in both arms comparing favorably to those of prior series in older patients with advanced-stage classical Hodgkin lymphoma. Compared to ABVD, A+AVD was associated with higher rates of neuropathy and neutropenia, but lower rates of pulmonary-related toxicity. Trials registered at ClinicalTrials.gov identifiers: NCT01712490; EudraCT number: 2011-005450-60.
UR - http://www.scopus.com/inward/record.url?scp=85129251976&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85129251976&partnerID=8YFLogxK
U2 - 10.3324/haematol.2021.278438
DO - 10.3324/haematol.2021.278438
M3 - Article
C2 - 34162178
AN - SCOPUS:85129251976
SN - 0390-6078
VL - 107
SP - 1086
EP - 1094
JO - Haematologica
JF - Haematologica
IS - 5
ER -