| Abstract | PURPOSE: To determine the feasibility and efficacy of pharmacokinetic (PK) -based maintenance dosing of rituximab and possibly design a more rational maintenance schedule. PATIENTS AND METHODS: Patients with CD20-positive lymphoproliferative disorders were treated with four weekly infusions of rituximab 375 mg/m(2). All patients without progressive disease were then monitored for 1 year and received a single infusion of 375 mg/m(2) when the level decreased below 25 microg/mL. RESULTS: Twenty-nine of 31 patients were assessable with a variety of histologic subtypes. The overall response rate (ORR) for the entire group was 59% with 27% complete responses (CRs) and 32% partial responses. The median PFS for all patients was 19 months, with a median follow-up of 25 months. In 22 patients with low-grade non-Hodgkin's lymphoma (LGNHL), the ORR was 63% with 36% CR and median progression-free survival (PFS) has not been reached. Of 29 assessable patients, 22 were available for PK-based maintenance. The median time to repeat bolus was 5 months (range, 1 to 9 months) for the first, 3.5 months (range, 2 to 5 months) for the second, and 3 months (range, 2 to 4 months) for the third infusion. Ninety-five percent of patients required three or fewer infusions to be maintained in the therapeutic range. CONCLUSION: Individualized PK dosing for rituximab produced efficacy comparable to other published maintenance strategies. PK data from this trial suggest that a rational maintenance strategy in patients with LGNHL would be a single dose of 375 mg/m(2) of rituximab every 3 to 4 months. |
| Authors | Lucio N Gordan, William B Grow, Annette Pusateri, Vonda Douglas, Nancy P Mendenhall, James W Lynch
(Affiliation: Division of Hematology/Oncology, Department of Medicine, University of Florida College of Medicine, Gainesville, FL 32610, USA.)
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| Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 23
Issue 6
Pg. 1096-102
(Feb 20 2005)
ISSN: 0732-183X United States |
| PMID | 15657402
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Antibodies, Monoclonal
- Antigens, CD20
- Antineoplastic Agents
- rituximab
|
| Topics |
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage)
- Antigens, CD20
(metabolism)
- Antineoplastic Agents
(administration & dosage)
- Disease-Free Survival
- Drug Administration Schedule
- Feasibility Studies
- Female
- Humans
- Lymphoma, B-Cell
(drug therapy, metabolism)
- Male
- Middle Aged
- Retreatment
- Treatment Outcome
|
