Phase II study of alemtuzumab-rituximab therapy in previously untreated patients with chronic lymphocytic leukemia: short- and long-term outcomes.
We investigated the safety, efficacy, and long-term outcomes of alemtuzumab and rituximab (AR) combination therapy in previously untreated patients with CLL. Thirty patients, ages 28-80 years, 47% older than 60 years, 90% Rai clinical stages II-IV, and 67% without favorable cytogenetics received AR. Based on the NCI-WG 1996 criteria, OR was 100%, with 60% CR. With CT scans OR was 70%, with 23% CR, 47% PR, and 30% SD. Sixty-seven percent of patients showed no evidence of MRD in the bone marrow by 6-color flow cytometry. Median PFS, TFS, and 5-year OS were 24.4, 50.7 months, and 80%, respectively. Grade 3/4 neutropenia and thrombocytopenia were reported in 30% and 7% of patients, respectively. CMV reactivation, asymptomatic in all but one patient, occurred in 8 patients. Immunotherapy with alemtuzumab and rituximab results in robust responses and long asymptomatic therapy-free intervals. It is well tolerated with infrequent, predictable, and easily managed complications.
Northwestern University Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center , Chicago, IL , USA.
Olga
O
Frankfurt
Shuo
S
Ma
Leo
L
Gordon
Jane N
JN
Winter
Jeanne M
JM
Horowitz
Alfred
A
Rademaker
Bing Bing
BB
Weitner
LoAnn C
LC
Peterson
Jessica K
JK
Altman
Martin S
MS
Tallman
Adam
A
Petrich
Steven T
ST
Rosen
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000074323:Alemtuzumab; D000740:Anemia / Q000139:chemically induced; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D000074323:Alemtuzumab; D000069283:Rituximab
CLL; alemtuzumab; immunotherapy; rituximab