Phase III randomized multicenter study of a humanized anti-CD33 monoclonal antibody, lintuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia.

2.50
Hdl Handle:
http://hdl.handle.net/10541/76779
Title:
Phase III randomized multicenter study of a humanized anti-CD33 monoclonal antibody, lintuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia.
Authors:
Feldman, Eric J; Brandwein, Joseph; Stone, Richard; Kalaycio, Matt; Moore, Joseph; O'Connor, Julie; Wedel, Nancy; Roboz, Gail J; Miller, Carole; Chopra, Rajesh; Jurcic, Joseph C; Brown, Randy; Ehmann, W Christopher; Schulman, Philip; Frankel, Stanley R; De Angelo, Daniel; Scheinberg, David
Abstract:
PURPOSE: Lintuzumab (HuM195) is an unconjugated humanized murine monoclonal antibody directed against the cell surface myelomonocytic differentiation antigen CD33. In this study, the efficacy of lintuzumab in combination with induction chemotherapy was compared with chemotherapy alone in adults with first relapsed or primary refractory acute myeloid leukemia (AML). PATIENTS AND METHODS: Patients with relapsed or primary resistant AML (duration of first response, zero to 12 months) were randomly assigned to receive either mitoxantrone 8 mg/m(2), etoposide 80 mg/m(2), and cytarabine 1 g/m(2) daily for 6 days (MEC) in combination with lintuzumab 12 mg/m(2), or MEC alone. Overall response, defined as the rate of complete remission (CR) and CR with incomplete platelet recovery (CRp), was the primary end point of the study, with additional analyses of survival time and toxicity. RESULTS: A total of 191 patients were randomly assigned from November 1999 to April 2001. The percent CR plus CRp with MEC plus lintuzumab was 36% v 28% in patients treated with MEC alone (P = .28). The overall median survival was 156 days and was not different in the two arms of the study. Apart from mild antibody infusion-related toxicities (fever, chills, and hypotension), no differences in chemotherapy-related adverse effects, including hepatic and cardiac dysfunction, were observed with the addition of lintuzumab to induction chemotherapy. CONCLUSION: The addition of lintuzumab to salvage induction chemotherapy was safe, but did not result in a statistically significant improvement in response rate or survival in patients with refractory/relapsed AML.
Affiliation:
Weill Medical College of Cornell University, 525 E 68th St, New York, NY 10021, USA. ejf2001@med.cornell.edu
Citation:
Phase III randomized multicenter study of a humanized anti-CD33 monoclonal antibody, lintuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia. 2005, 23 (18):4110-6 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
20-Jun-2005
URI:
http://hdl.handle.net/10541/76779
DOI:
10.1200/JCO.2005.09.133
PubMed ID:
15961759
Type:
Article
Language:
en
ISSN:
0732-183X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorFeldman, Eric J-
dc.contributor.authorBrandwein, Joseph-
dc.contributor.authorStone, Richard-
dc.contributor.authorKalaycio, Matt-
dc.contributor.authorMoore, Joseph-
dc.contributor.authorO'Connor, Julie-
dc.contributor.authorWedel, Nancy-
dc.contributor.authorRoboz, Gail J-
dc.contributor.authorMiller, Carole-
dc.contributor.authorChopra, Rajesh-
dc.contributor.authorJurcic, Joseph C-
dc.contributor.authorBrown, Randy-
dc.contributor.authorEhmann, W Christopher-
dc.contributor.authorSchulman, Philip-
dc.contributor.authorFrankel, Stanley R-
dc.contributor.authorDe Angelo, Daniel-
dc.contributor.authorScheinberg, David-
dc.date.accessioned2009-08-10T10:16:25Z-
dc.date.available2009-08-10T10:16:25Z-
dc.date.issued2005-06-20-
dc.identifier.citationPhase III randomized multicenter study of a humanized anti-CD33 monoclonal antibody, lintuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia. 2005, 23 (18):4110-6 J. Clin. Oncol.en
dc.identifier.issn0732-183X-
dc.identifier.pmid15961759-
dc.identifier.doi10.1200/JCO.2005.09.133-
dc.identifier.urihttp://hdl.handle.net/10541/76779-
dc.description.abstractPURPOSE: Lintuzumab (HuM195) is an unconjugated humanized murine monoclonal antibody directed against the cell surface myelomonocytic differentiation antigen CD33. In this study, the efficacy of lintuzumab in combination with induction chemotherapy was compared with chemotherapy alone in adults with first relapsed or primary refractory acute myeloid leukemia (AML). PATIENTS AND METHODS: Patients with relapsed or primary resistant AML (duration of first response, zero to 12 months) were randomly assigned to receive either mitoxantrone 8 mg/m(2), etoposide 80 mg/m(2), and cytarabine 1 g/m(2) daily for 6 days (MEC) in combination with lintuzumab 12 mg/m(2), or MEC alone. Overall response, defined as the rate of complete remission (CR) and CR with incomplete platelet recovery (CRp), was the primary end point of the study, with additional analyses of survival time and toxicity. RESULTS: A total of 191 patients were randomly assigned from November 1999 to April 2001. The percent CR plus CRp with MEC plus lintuzumab was 36% v 28% in patients treated with MEC alone (P = .28). The overall median survival was 156 days and was not different in the two arms of the study. Apart from mild antibody infusion-related toxicities (fever, chills, and hypotension), no differences in chemotherapy-related adverse effects, including hepatic and cardiac dysfunction, were observed with the addition of lintuzumab to induction chemotherapy. CONCLUSION: The addition of lintuzumab to salvage induction chemotherapy was safe, but did not result in a statistically significant improvement in response rate or survival in patients with refractory/relapsed AML.en
dc.language.isoenen
dc.subjectLeukaemiaen
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntibodies, Monoclonal-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshCytarabine-
dc.subject.meshEtoposide-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLeukemia, Myeloid, Acute-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshMitoxantrone-
dc.subject.meshProportional Hazards Models-
dc.subject.meshRecurrence-
dc.subject.meshSurvival Analysis-
dc.subject.meshTreatment Outcome-
dc.titlePhase III randomized multicenter study of a humanized anti-CD33 monoclonal antibody, lintuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia.en
dc.typeArticleen
dc.contributor.departmentWeill Medical College of Cornell University, 525 E 68th St, New York, NY 10021, USA. ejf2001@med.cornell.eduen
dc.identifier.journalJournal of Clinical Oncologyen

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