Remicade as TNF suppressor in patients with myelodysplastic syndromes.
Remicade, a chimeric human-murine monoclonal antibody capable of neutralizing tumor necrosis factor alpha was given to 37 low-risk myelodysplastic syndromes (MDS) patients in two cohorts; 5 and 10 mg/kg intravenously every 4 weeks for 4 cycles. Median age was 68 years, 33 had primary MDS, 14 had refractory anemia (RA), 14 RA with ringed sideroblasts, 9 RA with excess blasts. Nine patients stopped therapy prior to completing 4 cycles, 3 from cohort 1 and 6 from cohort 2 and response was evaluated using the International Working Group criteria in 28 patients who completed the 4 cycles. Six patients showed disease progression, 14 had stable disease and 8 showed hematologic responses, 3/15 (20%) in cohort 1 and 5/13 (38%) in cohort 2. Two patients had multi-lineage responses, 2 had > 100% increase in absolute neutrophils, 1 had > 1 gm/dl increase in hemoglobin, 1 had reduction in blasts from 7% to 1%, and 2 had minor cytogenetic responses (> 50% reduction in + 8 and 20q-metaphases respectively). We conclude that Remicade may have a variety of activities in low risk MDS patients, is well tolerated with a high patient compliance, and may be considered for combination therapy in the future.
Raza
A
A
Section of Myeloid Diseases, Rush University, Chicago, IL 60612-3515, USA. azra_raza@rush.edu
Candoni
A
A
Khan
U
U
Lisak
L
L
Tahir
S
S
Silvestri
F
F
Billmeier
J
J
Alvi
M Imran
MI
Mumtaz
M
M
Gezer
S
S
Venugopal
P
P
Reddy
P
P
Galili
N
N
D000368:Aged; D000753:Anemia, Refractory; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000633:toxicity; D002869:Chromosome Aberrations; D020732:Cytogenetic Analysis; D018450:Disease Progression; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D009190:Myelodysplastic Syndromes / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D010198:Pancytopenia / Q000188:drug therapy; D010349:Patient Compliance; D010865:Pilot Projects; D012074:Remission Induction; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab