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Japanese multicenter phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma
Open accessAbstract
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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“Previous comparisons of different dosing regimens [75, 76] revealed that trastuzumab or rituximab Cmax did not correlate with clinical efficacy.”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [75]
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Metadata
- 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
- bronze
- doi.org
- Licence
- 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 › Hematology › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Clinical 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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