ASCO 2016 | ACT-2 Phase III International Trial Final Results – Improved CR with A-CHOP Compared to CHOP Alone in Elderly Patients with pTNHL

This ASCO 2016 oral abstract presentation took place on Sunday June 5, 9:45am–12:45pm, during the ‘Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia’ session. This session was chaired by Pr Gilles Salles, Head of the Hematology Department in South Lyon hospitals, Lyon, France.

The abstract (#7500) was presented by Prof. Lorenz H Trumper, Department of Hematology and Oncology, University of Göttingen, Georg-August-Universität, Göttingen, Germany.

Currently, high rates of early progression occure with standard treatment for Peripheral T-Cell Lymphoma (PTCL). Alemtuzumab is an anti-CD52 monoclonal antibody, which has been shown to have good efficacy in relapsed PTCL patients. Moreover, a range of phase II trials have shown the feasibility of combining alemtuzumab with CHOP (A-CHOP).

In this abstract presentation, the final analysis of the international ACT-2 phase III randomized trial in elderly patients comparing standard CHOP to A-CHOP were reported (NCT00725231). This interventional, randomized, open-label, phase III study, which began in February 2008, had a primary outcome measure of EFS. Inclusion criteria included age between 61 and 80 years, all risk groups of PTCL, and an ECOG performance status of 0–2.

Overall, 116 patients from 52 centers were randomized to receive either 6 cycles of CHOP (n=58) or A-CHOP (n=58) at 14-day intervals with G-CSF support. Patients received a total of 360mg of alemtuzumab (until patient 39) or 120mg.

• Median age = 69 years; male = 58%
• Treatment was completed as planned in 79% CHOP pts and 57% A-CHOP pts
• ATL = 41%; PTCL NOS = 39%; ALCL = 6%; other = 14%
• CR: A-CHOP = 60%; CHOP = 43%
• No significant differences found between CHOP and A-CHOP in terms of EFS, PFS, and OS at 3 yrs
• Bulky disease (HR, 2.2), extranodal disease >1 (HR, 2.3), and male gender (HR, 2.5) were the most prominent risk factors for EFS
• Grade 3–4 leukocytopenia: A-CHOP = 70%; CHOP = 54%
• Grade 3–4 thrombocytopenia: A-CHOP = 19%; CHOP = 13%
• ≥Grade 3 infections: A-CHOP = 40%; CHOP = 21%

	CHOP	A-CHOP	all pts
CR	43 (30;57)	60 (47; 73)	52 (42; 61)
Relapse	48 (28; 69)	43 (26; 61)	45 (32; 58)
EFS	23 (12; 35)	26 (13; 38)	24 (16; 33)
PFS	29 (17; 41)	26 (14; 38)	28 (19; 36)
OS	56 (43; 69)	38 (24; 51)	48 (38; 57)
Results in % with 95% confidence intervals.

In elderly PTCL patients, the addition of alemtuzumab to CHOP increased CR rate, but not EFS, PFS, or OS by univariate and multivariate analyses. Survival was not improved primarily because of treatment related toxicity. Lastly, Lorenz Trumper emphasized again that it is crucial we identify novel agents for PTCL which are more efficient and have acceptable safety profiles.