Annals of Oncology 15:821-830, 2004
© 2004 European Society for Medical Oncology
Original Paper |
Japanese multicenter phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma
Received 7 November 2003; revised 15 January 2004; accepted 16 January 2004Background:
To evaluate the efficacy and feasibility of rituximab monotherapy in Japanese patients with relapsed or refractory aggressive B-cell lymphoma.
Patients and methods:
Sixty-eight patients were treated with rituximab at 375 mg/m2 by eight consecutive weekly infusions. Pretreatment variables affecting overall response rate (ORR) and progression-free survival (PFS) and the relationship between pharmacokinetic parameters and efficacy were analyzed.
Results:
The ORRs of 68 enrolled patients and 57 eligible patients were 35% [95% confidence interval (CI) 24% to 48%] and 37% (95% CI 25% to 51%), respectively. Median PFS of 53 evaluable patients was 52 days, whereas time to progression of 21 eligible responders was 245 days. Mild to moderate infusion-related toxicities were observed frequently at the first infusion, but all of them were reversible. Elevated lactate dehydrogenase (LDH) and refractoriness to prior chemotherapy were unfavorable factors affecting ORR and PFS (P <0.01). Serum trough levels of rituximab and area under the concentration–time curve for responders were higher than for non-responders (P <0.05).
Conclusions:
Eight consecutive weekly infusions of rituximab have significant anti-lymphoma activity for relapsed or refractory aggressive B-cell lymphoma. Several pretreatment variables and serum rituximab levels are useful for predicting its efficacy.
1 Hematology and Clinical Laboratory Divisions, National Cancer Center Hospital, Tokyo; 2 Hematology and Oncology Division, National Cancer Center Hospital East, Kashiwa; 3 Third Department of Internal Medicine, Kyoto Prefectural University of Medicine, Kyoto; 4 Department of Hematology and Chemotherapy and Department of Pathology, Aichi Cancer Center Hospital, Nagoya; 5 First Department of Internal Medicine, Nagoya University School of Medicine, Nagoya; 6 Department of Hematology and Rheumatology, Tokai University School of Medicine, Isehara; 7 Department of Internal Medicine, Sapporo National Hospital, Sapporo; 8 Department of Internal Medicine, Nagoya National Hospital, Nagoya; 9 Department of Hematology/Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka; 10 Department of Pathology, Institute of Medical Science and Biostatistical Sciences, School of Health Science and Nursing Biostatistics, University of Tokyo, Tokyo, Japan
Key words: aggressive B-cell lymphoma, pharmacokinetics, prognostic factor, rituximab
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