title: Subcutaneous injections of low doses of humanized anti-CD20 veltuzumab: a phase I study in chronic lymphocytic leukemia.
abstract: To evaluate the potential of subcutaneous (SC) injections with anti-CD20 antibody veltuzumab in chronic lymphocytic leukemia (CLL), 21 patients received 80, 160, or 320 mg injections every 2 weeks × 4 doses (n = 11) or 160 or 320 mg twice-weekly × 16 doses (n = 10). Treatment was well tolerated with only occasional, mild-moderate, transient injection reactions. Lymphocytosis decreased in all patients (maximum decrease, 5-91%), with 12 patients obtaining >50% decreases. Of 14 patients with lymphadenopathy on CT imaging, 5 (36%) achieved 14-61% reductions (sum of perpendicular diameters). By NCI-WG criteria, two patients achieved partial responses (10%). SC veltuzumab appeared active in all dose groups, with no obvious exposure-response relationship, despite cumulative doses ranging from 320-5120 mg. Overall median progression-free survival was 7.7 months; three patients remained progression-free >1 year (2 ongoing at 2-year study completion). These data suggest further studies of SC veltuzumab in CLL are warranted.
authors.affiliation: a Cleveland Clinic Taussig Cancer Institute , Cleveland , OH , USA .
authors.forename: Matt E
authors.initials: ME
authors.lastname: Kalaycio
authors.affiliation: b Low Country Cancer Care Associates , Savannah , GA , USA .
authors.forename: O
authors.initials: O
authors.lastname: George Negrea
authors.affiliation: c Hofstra North Shore - LIJ School of Medicine , Lake Success , NY , USA .
authors.forename: Steven L
authors.initials: SL
authors.lastname: Allen
authors.affiliation: c Hofstra North Shore - LIJ School of Medicine , Lake Success , NY , USA .
authors.forename: Kanti R
authors.initials: KR
authors.lastname: Rai
authors.affiliation: d Hematology Oncology Specialists , Denville , NJ , USA , and.
authors.forename: Rashid M
authors.initials: RM
authors.lastname: Abbasi
authors.affiliation: e Immunomedics, Inc. , Morris Plains , NJ , USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Horne
authors.affiliation: e Immunomedics, Inc. , Morris Plains , NJ , USA.
authors.forename: William A
authors.initials: WA
authors.lastname: Wegener
authors.affiliation: e Immunomedics, Inc. , Morris Plains , NJ , USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Goldenberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D053208:Kaplan-Meier Estimate; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C493846:veltuzumab
keywords: Antibody; CD20; chronic lymphocytic leukemia; subcutaneous therapy; veltuzumab