Phase II Study of Alemtuzumab (CAMPATH-1) in Patients with HTLV-1-Associated Adult T-cell Leukemia/lymphoma

Therapeutic regimens for adult T-cell leukemia/lymphoma (ATL) are limited with unsatisfactory results, thereby warranting development of novel therapies. This study investigated antitumor activity and toxicity of alemtuzumab with regard to response, duration of response, progression-free survival, a...

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Published in:	Clinical cancer research 2017-01, Vol.23 (1), p.35-42
Main Authors:	Sharma, Kamal, Janik, John E, O'Mahony, Deirdre, Stewart, Donn, Pittaluga, Stefania, Stetler-Stevenson, Maryalice, Jaffe, Elaine S, Raffeld, Mark, Fleisher, Thomas A, Lee, Cathryn C, Steinberg, Seth M, Waldmann, Thomas A, Morris, John C
Format:	Article
Language:	eng
Subjects:	Adult Aged Alemtuzumab - administration & dosage Alemtuzumab - adverse effects Alemtuzumab - therapeutic use Anemia Anticancer properties Antigenemia Antineoplastic Agents, Immunological - administration & dosage Antineoplastic Agents, Immunological - adverse effects Antineoplastic Agents, Immunological - therapeutic use Antitumor activity Antiviral agents Cancer Cell survival Confidence intervals Cytomegalovirus Experimental design Female Herpesviridae HTLV-I Infections - complications HTLV-I Infections - virology Human T-lymphotropic virus 1 Humans Immunophenotyping Immunotherapy Intravenous administration Kaplan-Meier Estimate Leukemia Leukemia-Lymphoma, Adult T-Cell - diagnosis Leukemia-Lymphoma, Adult T-Cell - drug therapy Leukemia-Lymphoma, Adult T-Cell - etiology Leukemia-Lymphoma, Adult T-Cell - mortality Leukopenia Lymphocytes T Lymphoma Male Middle Aged Monoclonal antibodies Neoplasm Staging Neutropenia Patients Retreatment Retroviridae Survival Thrombocytopenia Toxicity Treatment Outcome Viruses Young Adult
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Summary:	Therapeutic regimens for adult T-cell leukemia/lymphoma (ATL) are limited with unsatisfactory results, thereby warranting development of novel therapies. This study investigated antitumor activity and toxicity of alemtuzumab with regard to response, duration of response, progression-free survival, and overall survival in patients with human T-cell lymphotropic virus-1 (HTLV-1)-associated ATL. Twenty-nine patients with chronic, acute, and lymphomatous types of ATL were enrolled in a single-institution, nonrandomized, open-label phase II trial wherein patients received intravenous alemtuzumab 30 mg three times weekly for a maximum of 12 weeks. Twenty-nine patients were evaluable for response and toxicity. The overall objective response was 15 of 29 patients [95% confidence interval (CI), 32.5%-70.6%]. The 15 patients who responded manifested a median time to response of 1.1 months. Median response duration was 1.4 months for the whole group and 14.5 months among responders. Median progression-free survival was 2.0 months. Median overall survival was 5.9 months. The most common adverse events were 2 with vasovagal episodes (7%) and 3 with hypotensive episodes (10%), leukopenia (41%) grade 3 and (17%) grade 4, lymphocytopenia (59%) grade 3, neutropenia (31%) grade 3, anemia (24%), and thrombocytopenia (10%). All patients developed cytomegalovirus antigenemia (CMV). Three were symptomatic and all responded to antiviral therapy. Grade 3 or 4 infections were reported in 4 (14%) of patients. Alemtuzumab induced responses in patients with acute HTLV-1-associated ATL with acceptable toxicity, but with short duration of responses. These studies support inclusion of alemtuzumab in novel multidrug therapies for ATL. Clin Cancer Res; 23(1); 35-42. ©2016 AACR.
ISSN:	1078-0432 1557-3265