Cited by 108Lymphoma Diagnosis and TreatmentChronic Lymphocytic Leukemia ResearchCNS Lymphoma Diagnosis and Treatment

Japanese multicenter phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma

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Tobinai, K., Igarashi, T., Itoh, K., Kobayashi, Y., Taniwaki, M., Ogura, M., Kinoshita, T., Hotta, T. +7 more·2004·Annals of Oncology

Abstract

Background 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/m(2) 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.

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  1. Harris NL, Jaffe ES, Stein H et al. A revised European-American classifi- cation of lymphoid neoplasms: a proposal from the International Lymph- oma Study Group. Blood 1994; 84: 1361-1392.
  2. Cheson BD, Horning SJ, Coiffier B et al. Report of an international work- shop to standardize response criteria for non-Hodgkin's lymphoma. J Clin Oncol 1999; 17: 1244-1253.

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Authors
Tobinai, K., Igarashi, T., Itoh, K., Kobayashi, Y., Taniwaki, M., Ogura, M., Kinoshita, T., Hotta, T., Aikawa, K., Tsushita, K., Hiraoka, A., Matsuno, Y., Nakamura, S., Mori, S., & Ohashi, Y.
Affiliations
  • National Cancer Center Hospital (JP)
  • National Cancer Center Hospital East (JP)
  • Kyoto Prefectural University of Medicine (JP)
  • Aichi Cancer Center (JP)
  • Nagoya University Hospital (JP)
  • Tokai University (JP)
  • Sapporo National Hospital (JP)
  • Higashi Nagoya National Hospital (JP)
  • Osaka International Cancer Institute (JP)
  • Institute of Medical Science, The University of Tokyo (JP)
Corresponding author
Tobinai, K.
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2004-05
Volume
15
Issue
5
Pages
821-830
ISSN
0923-7534 (ISSN-L)
OpenAlex
W2114676941
Cited by
108
References
36
Citations by year
2026: 3 · 2025: 1 · 2023: 3 · 2022: 4 · 2021: 6 · 2020: 5 · 2019: 7 · 2018: 4 · 2017: 7 · 2016: 5 · 2015: 6 · 2014: 7 · 2013: 4 · 2012: 6
FWCI
3.57
Type
journal article
Language
en
Open access
Locations
  • Annals of Oncology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • IC Design Education Center
  • Fujita Health University
  • National Cancer Institute
Topics
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
  • Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
  • Health Sciences › Medicine › Neurology › CNS Lymphoma Diagnosis and Treatment
Keywords
rituximab, relapsed or refractory B-cell lymphoma, aggressive B-cell lymphoma, rituximab monotherapy, pharmacokinetics, trough concentration, area under the concentration-time curve, overall response rate, progression-free survival, lactate dehydrogenase, infusion-related toxicity, Japanese patients, predictive biomarkers
MeSH terms
Rituximab, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Drug Administration Schedule, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Lymphoma, B-Cell, Disease-Free Survival, Antibodies, Monoclonal, Murine-Derived

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