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This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Coiffier, B. Articles by Reyes, F. Search for Related Content PubMed PubMed Citation Articles by Coiffier, B. Articles by Reyes, F. Related Collections Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, Vol. 92 No. 6 (September 15), 1998: pp. 1927-1932 Rituximab (Anti-CD20 Monoclonal Antibody) for the Treatment of Patients With Relapsing or Refractory Aggressive Lymphoma: A Multicenter Phase II Study B. Coiffier, C. Haioun, N. Ketterer, A. Engert, H. Tilly, D. Ma, P. Johnson, A. Lister, M. Feuring- Buske, J.A. Radford, R. Capdeville, V. Diehl, and F. Reyes From the Service d'Hématologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; the Service d'Hématologie, Hôpital Henri-Mondor, Créteil, France; the Klinik 1 fur Innere Medezin, Üniversität zu Köln, Köln, Germany; the Service d'Hématologie, Centre Henri Bécquerel, Rouen, France; the Department of Hematolgy, Royal North Shore Hospital, St Leonards, Australia; the Cancer Research Building, St James University Hospital, Leeds, UK; the Department of Medical Oncology, St Bartholomew's Hospital, London, UK; the Zentrum fur Innere Medizin, Abt. Hematologie und Onkologie, August Universität, Göttingen, Germany; the CRC Department of Medical Oncology, University of Manchester, Manchester, UK; and Hoffman-La Roche, Basel, Switzerland. Rituximab, a chimeric monoclonal antibody that binds specifically to the CD20 antigen, induced objective responses in 50% of patients with low-grade or follicular B-cell lymphoma. Because most nonfollicular B-cell lymphomas also express the CD20 antigen, we conducted a phase II study to evaluate the efficacy and tolerability of this new agent in patients with more aggressive types of lymphoma. Patients with diffuse large B-cell lymphoma (DLCL), mantle cell lymphoma (MCL), or other intermediate- or high-grade B-cell lymphomas according to the Working Formulation were included in this prospective randomized phase II study if they were in first or second relapse, if they were refractory to initial therapy, if they progressed after a partial response to initial therapy, or if they were elderly (age >60 years) and not previously treated. The patients received 8 weekly infusions of rituximab at the dose of 375 mg/m2 in arm A or one infusion of 375 mg/m2 followed by 7 weekly infusions of 500 mg/m2 in arm B. Patients were evaluated 2 months after the last rituximab infusion. Fifty-four patients were randomized from 9 centers in Europe and Australia (28 in arm A and 26 in arm B). A total of 5 complete responses (CR) and 12 partial responses (PR) were observed among the 54 enrolled patients, with no difference between the two doses. In an intent-to-treat analysis, the CR rate was 9% (CI95%, 3% to 20%) and the PR rate was 22% (CI95%, 12% to 36%), for an overall response rate of 31% (CI95%, 20% to 46%). An analysis of prognostic factors showed that response rates were lower in patients with refractory disease, patients with lymphoma not classified as DLCL, and patients with a tumor larger than 5 cm in diameter. DLCL and MCL patients had response rates of 37% and 33%, respectively. The median time to progression exceeded 246 days for the 17 responding patients. The most frequently reported adverse events were related to an infusion syndrome and were mild: 19% of the patients had a grade 3 related adverse event, slightly more in arm B, and only 1 patient had a grade 4 related adverse event in arm A. Two patients (3.7%) withdrew from treatment because of severe adverse events, one patient in each arm. In this first trial of rituximab in DLCL and MCL, patients experienced a significant clinical activity with a low toxicity. Rituximab has significant activity in DLCL and MCL patients and should be tested in combination with chemotherapy in such patients. © 1998 by The American Society of Hematology. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: C. Haioun, N. Mounier, J. F. Emile, D. Ranta, B. Coiffier, H. Tilly, C. Recher, C. Ferme, J. Gabarre, R. Herbrecht, et al. 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