TY - JOUR
T1 - Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma
AU - Ramchandren, Radhakrishnan
AU - Advani, Ranjana H.
AU - Ansell, Stephen M.
AU - Bartlett, Nancy L.
AU - Chen, Robert
AU - Connors, Joseph M.
AU - Feldman, Tatyana
AU - Forero-Torres, Andres
AU - Friedberg, Jonathan W.
AU - Gopal, Ajay K.
AU - Gordon, Leo I.
AU - Kuruvilla, John
AU - Savage, Kerry J.
AU - Younes, Anas
AU - Engley, Gerald
AU - Manley, Thomas J.
AU - Fenton, Keenan
AU - Straus, David J.
N1 - Funding Information:
R. Ramchandren and N.L. Bartlett is a consultant/advisory board member for Seattle Genetics. R.H. Advani is a consultant/advisory board member for Seattle Genetics and Takeda. R. Chen and J.M. Connors report receiving speakers bureau honoraria from and are consultant/advisory board members for Seattle Genetics. T. Feldman reports receiving commercial research grants from Amgen, Bristol-Myers Squibb, Cell Medica, Eisai, Genentech, Idera Pharmaceutical, Janssen, Kyowa, Millennium, Pfizer, Portola, Roche, Seattle Genetics, Viracta, and Trillium, speakers bureau honoraria from Takeda (Millenium), Seattle Genetics, Abbvie, Pharmacyclics, Janssen, Celgene, and Kite Pharma, is a consultant/advisory board member for Bristol-Myers Squibb and Seattle Genetics. A. Forero is an employee of and holds ownership interest (including patents) in Seattle Genetics. J.W. Friedberg is a consultant/advisory board member for Bayer and Astellas. A.K. Gopal reports receiving commercial research grants from Seattle Genetics, Teva, Bristol-Myers Squibb, Pfizer, Merck, Takeda, Janssen, and Gilead, and is a consultant/advisory board member for Seattle Genetics, Janssen, Takeda, Pfizer, Amgen, Sanofi, Gilead, Acerta, and Aptevo.
Publisher Copyright:
© 2019 American Association for Cancer Research
PY - 2019
Y1 - 2019
N2 - Purpose: To evaluate safety and efficacy outcomes for subjects on the ECHELON-1 study treated in North America (NA). Patients and Methods: ECHELON-1 is a global, open-label, randomized phase III study comparing doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (AþAVD) versus ABVD (AVD þ bleomycin) as first-line therapy in subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490). Subjects were randomized 1:1 to receive AþAVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to 6 cycles. Results: The NA subgroup consisted of 497 subjects in the AþAVD (n ¼ 250) and ABVD (n ¼ 247) arms. Similar to the primary analysis based on the intent-to-treat population, the primary endpoint [modified progression-free survival (PFS) per independent review] demonstrated an improvement among subjects who received AþAVD compared with ABVD (HR ¼ 0.60; P ¼ 0.012). For PFS, the risk of progression or death was also reduced (HR ¼ 0.50; P ¼ 0.002). Subsequent anticancer therapies were lower in the AþAVD arm. Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the AþAVD arm as compared with ABVD. Noted differences between arms included higher rates of febrile neutropenia (20% vs. 9%) and peripheral neuropathy (80% vs. 56%), but lower rates of pulmonary toxicity (3% vs. 10%) in subjects treated with AþAVD versus ABVD. Conclusions: The efficacy benefit and manageable toxicity profile observed in the NA subgroup of ECHELON-1 support AþAVD as a frontline treatment option for patients with stage III or IV cHL.
AB - Purpose: To evaluate safety and efficacy outcomes for subjects on the ECHELON-1 study treated in North America (NA). Patients and Methods: ECHELON-1 is a global, open-label, randomized phase III study comparing doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (AþAVD) versus ABVD (AVD þ bleomycin) as first-line therapy in subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490). Subjects were randomized 1:1 to receive AþAVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to 6 cycles. Results: The NA subgroup consisted of 497 subjects in the AþAVD (n ¼ 250) and ABVD (n ¼ 247) arms. Similar to the primary analysis based on the intent-to-treat population, the primary endpoint [modified progression-free survival (PFS) per independent review] demonstrated an improvement among subjects who received AþAVD compared with ABVD (HR ¼ 0.60; P ¼ 0.012). For PFS, the risk of progression or death was also reduced (HR ¼ 0.50; P ¼ 0.002). Subsequent anticancer therapies were lower in the AþAVD arm. Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the AþAVD arm as compared with ABVD. Noted differences between arms included higher rates of febrile neutropenia (20% vs. 9%) and peripheral neuropathy (80% vs. 56%), but lower rates of pulmonary toxicity (3% vs. 10%) in subjects treated with AþAVD versus ABVD. Conclusions: The efficacy benefit and manageable toxicity profile observed in the NA subgroup of ECHELON-1 support AþAVD as a frontline treatment option for patients with stage III or IV cHL.
UR - http://www.scopus.com/inward/record.url?scp=85062998536&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-18-2435
DO - 10.1158/1078-0432.CCR-18-2435
M3 - Article
C2 - 30617130
AN - SCOPUS:85062998536
VL - 25
SP - 1718
EP - 1726
JO - Clinical Cancer Research
JF - Clinical Cancer Research
SN - 1078-0432
IS - 6
ER -