Ofatumumab and high-dose methylprednisolone for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia.
Ofatumumab is a humanized anti-CD20 monoclonal antibody that has been approved by the FDA for the treatment of patients with chronic lymphocytic leukemia. We conducted a phase II single-arm study at a single center. Patients received ofatumumab (300 mg then 1000 mg weekly for 12 weeks) and methylprednisolone (1000 mg/m(2) for 3 days of each 28-day cycle). Twenty-one patients enrolled, including 29% with unfavorable cytogenetics (del17p or del11q). Ninety percent of patients received the full course without dose reductions or delays. The overall response rate was 81% (17/21) with 5% complete response, 10% nodular partial response, 67% partial response, 14% stable disease and 5% progressive disease. After a median follow-up of 31 months, the median progression-free survival was 9.9 months and the median time to next treatment was 12.1 months. The median overall survival has not yet been reached. The combination of high-dose methylprednisolone and ofatumumab is an effective and tolerable treatment regimen. This regimen may be useful for patients who are unable to tolerate more aggressive therapies, or have not responded to other treatments.
1] Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA [2] Chronic Lymphocytic Leukemia Research Consortium (CRC), La Jolla, CA, USA.
J E
JE
Castro
1] Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA [2] Chronic Lymphocytic Leukemia Research Consortium (CRC), La Jolla, CA, USA.
M Y
MY
Choi
Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
T
T
Carvajal
Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
E
E
Almahasnah
Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
J
J
Chang
Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
D F
DF
James
1] Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA [2] Chronic Lymphocytic Leukemia Research Consortium (CRC), La Jolla, CA, USA.
T J
TJ
Kipps
D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002872:Chromosome Deletion; D002880:Chromosomes, Human, Pair 11 / Q000235:genetics; D002886:Chromosomes, Human, Pair 17 / Q000235:genetics; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality* / Q000473:pathology; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D012008:Recurrence; D015996:Survival Rate
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C527517:ofatumumab; D008775:Methylprednisolone