Journal article
Consolidation Therapy With Subcutaneous Alemtuzumab After Fludarabine and Rituximab Induction Therapy for Previously Untreated Chronic Lymphocytic Leukemia: Final Analysis of CALGB 10101
Journal of clinical oncology, Vol.28(29), pp.4500-4506
10/10/2010
DOI: 10.1200/JCO.2010.29.7978
PMCID: PMC2988639
PMID: 20697069
Abstract
Purpose: To determine if alemtuzumab consolidation improves response rate and progression-free survival (PFS) after induction chemoimmunotherapy in previously untreated symptomatic patients with chronic lymphocytic leukemia.
Patients and methods: Patients (n = 102) received fludarabine 25 mg/m(2) intravenously days 1 to 5 and rituximab 50 mg/m(2) day 1, 325 mg/m(2) day 3, and 375 mg/m(2) day 5 of cycle 1 and then 375 mg/m(2) day 1 of cycles 2 to 6; fludarabine plus rituximab (FR) administration was repeated every 28 days for six cycles. Three months after completion of FR, patients with stable disease or better response received subcutaneous alemtuzumab 3 mg day 1, 10 mg day 3, and 30 mg day 5 and then 30 mg three times per week for 5 weeks.
Results: Overall response (OR), complete response (CR), and partial response (PR) rates were 90%, 29%, and 61% after FR, respectively; 15% of patients were minimal residual disease (MRD) negative. Of 102 patients, 58 received alemtuzumab; 28 (61%) of 46 patients achieving PR after FR attained CR after alemtuzumab. By intent to treat (n = 102), OR and CR rates were 90% and 57% after alemtuzumab, respectively; 42% of patients became MRD negative. With median follow-up of 36 months, median PFS was 36 months, 2-year PFS was 72%, and 2-year OS was 86%. In patients achieving CR after FR, alemtuzumab was associated with five deaths resulting from infection (viral and Listeria meningitis and Legionella, cytomegalovirus, and Pneumocystis pneumonias), which occurred up to 7 months after last therapy. The study was amended to exclude CR patients from receiving alemtuzumab.
Conclusion: Alemtuzumab consolidation improved CR and MRD-negative rates after FR induction but caused serious infections in patients who had already achieved CR after induction and did not improve 2-year PFS or survival.
Details
- Title: Subtitle
- Consolidation Therapy With Subcutaneous Alemtuzumab After Fludarabine and Rituximab Induction Therapy for Previously Untreated Chronic Lymphocytic Leukemia: Final Analysis of CALGB 10101
- Creators
- Thomas S Lin - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILKathleen A Donohue - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILJohn C Byrd - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILMargaret S Lucas - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILEva E Hoke - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILElizabeth M Bengtson - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILKanti R Rai - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILJames N Atkins - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILBrian K Link - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, ILRichard A Larson - From The Ohio State University, Columbus, OH; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium, Goldsboro, NC; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Long Island Jewish Medical Center, New Hyde Park, NY; University of Iowa, Iowa City, IA; and University of Chicago, Chicago, IL
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.28(29), pp.4500-4506
- Publisher
- American Society of Clinical Oncology
- DOI
- 10.1200/JCO.2010.29.7978
- PMID
- 20697069
- PMCID
- PMC2988639
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- National Institutes of Health
- Language
- English
- Date published
- 10/10/2010
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984094310202771
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