title: Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia.
abstract: We observed that high-dose methylprednisolone (HDMP) and rituximab was well tolerated and had promising activity when used in combination to treat patients with fludarabine-refractory chronic lymphocytic leukemia (CLL). This prompted us to evaluate the use of these agents in frontline therapy. A total of 28 patients with a median age of 65 years enrolled in this study. Patients received HDMP at 1 g/m(2) each day for 3 days during each of the three 4-week cycles together with rituximab and prophylactic antimicrobial therapy. The treatment was well tolerated with few adverse events of grade III or higher. The overall response rate was 96% (N=27). Nine patients (32%) achieved a complete remission (CR), two of which were without detectable minimal residual disease (MRD). Six patients with MRD received consolidation with alemtuzumab; five of these patients achieved an MRD-negative CR. With over 3 years of follow-up median progression-free survival was 30.3 months with only 39% of patients requiring additional therapy, and an overall survival was 96%. This study demonstrates that HDMP and rituximab is an effective nonmyelosuppressive treatment combination for patients with CLL that warrants consideration particularly for patients with limited myeloid reserve that might not tolerate standard treatment regimens.
authors.affiliation: Moores UCSD Cancer Center, University of California, La Jolla, CA 92093-0820, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Castro
authors.forename: D F
authors.initials: DF
authors.lastname: James
authors.forename: J D
authors.initials: JD
authors.lastname: Sandoval-Sus
authors.forename: S
authors.initials: S
authors.lastname: Jain
authors.forename: J
authors.initials: J
authors.lastname: Bole
authors.forename: L
authors.initials: L
authors.lastname: Rassenti
authors.forename: T J
authors.initials: TJ
authors.lastname: Kipps
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D009367:Neoplasm Staging; D018365:Neoplasm, Residual / Q000175:diagnosis; D011379:Prognosis; D000069283:Rituximab; D015996:Survival Rate; D014018:Tissue Distribution
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D008775:Methylprednisolone
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