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dc.contributor.authorForan, James Men
dc.contributor.authorRohatiner, Amaen
dc.contributor.authorCoiffier, Bertranden
dc.contributor.authorBarbui, Tizianoen
dc.contributor.authorJohnson, Stephen Aen
dc.contributor.authorHiddemann, Wolfgangen
dc.contributor.authorRadford, John Aen
dc.contributor.authorNorton, Andrew Jen
dc.contributor.authorTollerfield, Susan Men
dc.contributor.authorWilson, Martin Pen
dc.contributor.authorLister, T Andrewen
dc.date.accessioned2009-12-15T15:23:59Zen
dc.date.available2009-12-15T15:23:59Zen
dc.date.issued1999-02en
dc.identifier.citationMulticenter phase II study of fludarabine phosphate for patients with newly diagnosed lymphoplasmacytoid lymphoma, Waldenström's macroglobulinemia, and mantle-cell lymphoma. 1999, 17 (2):546-53 J. Clin. Oncol.en
dc.identifier.issn0732-183Xen
dc.identifier.pmid10080598en
dc.identifier.urihttp://hdl.handle.net/10541/88017en
dc.description.abstractPURPOSE: Fludarabine phosphate (F-AMP) has significant activity in follicular lymphoma and in B-cell chronic lymphatic leukemia, where it has demonstrated high complete response (CR) rates. Lymphoplasmacytoid (LPC) lymphoma, Waldenstrom's macroglobulinemia (WM), and mantle-cell lymphoma (MCL) also present with advanced-stage disease and are incurable with standard alkylator-based chemotherapy. A phase II trial was undertaken to determine the activity of F-AMP in patients newly diagnosed with these diseases. PATIENTS AND METHODS: Between 1992 and 1996, 78 patients (aged 18 to 75 years) received intravenous F-AMP (25 mg/m2/d for 5 days, every 4 weeks) until maximum response, plus two further cycles as consolidation. The primary end point was response rate; secondary end points included time to progression (TTP), duration of response, and overall survival (OS). RESULTS: Forty-four (62%) of 71 assessable patients had a response to F-AMP (LPC lymphoma, 63%; WM, 79%; MCL, 41%); the CR rate was 15%. At a median follow-up of 1.5 years, 19 of 44 responding patients have had progression of lymphoma; the median duration of response was 2.5 years. The median survival has not yet been reached. There was no significant difference in the duration of response or OS between patients with different histologies; TTP was shorter in patients with MCL (P = .015). Myelosuppression was relatively common, and the treatment-related mortality (TRM) was 5%, mostly associated with pancytopenia and infection. CONCLUSION: Single-agent fludarabine phosphate is active in previously untreated LPC lymphoma and WM, with only moderate activity in MCL. However, the CR rate is low, and the TRM is relatively high. Its role in combination chemotherapy remains to be demonstrated.
dc.language.isoenen
dc.subjectLeukaemiaen
dc.subject.meshAdulten
dc.subject.meshAgeden
dc.subject.meshAntimetabolites, Antineoplasticen
dc.subject.meshDisease Progressionen
dc.subject.meshDrug Administration Scheduleen
dc.subject.meshFemaleen
dc.subject.meshFollow-Up Studiesen
dc.subject.meshHumansen
dc.subject.meshInfusions, Intravenousen
dc.subject.meshLeukemia, Lymphocytic, Chronic, B-Cellen
dc.subject.meshLymphoma, Non-Hodgkinen
dc.subject.meshMaleen
dc.subject.meshMiddle Ageden
dc.subject.meshSurvival Analysisen
dc.subject.meshVidarabine Phosphateen
dc.subject.meshWaldenstrom Macroglobulinemiaen
dc.titleMulticenter phase II study of fludarabine phosphate for patients with newly diagnosed lymphoplasmacytoid lymphoma, Waldenström's macroglobulinemia, and mantle-cell lymphoma.en
dc.typeArticleen
dc.contributor.departmentDepartment of Histopathology, St. Bartholomew's Hospital, London, England.en
dc.identifier.journalJournal of Clinical Oncologyen
html.description.abstractPURPOSE: Fludarabine phosphate (F-AMP) has significant activity in follicular lymphoma and in B-cell chronic lymphatic leukemia, where it has demonstrated high complete response (CR) rates. Lymphoplasmacytoid (LPC) lymphoma, Waldenstrom's macroglobulinemia (WM), and mantle-cell lymphoma (MCL) also present with advanced-stage disease and are incurable with standard alkylator-based chemotherapy. A phase II trial was undertaken to determine the activity of F-AMP in patients newly diagnosed with these diseases. PATIENTS AND METHODS: Between 1992 and 1996, 78 patients (aged 18 to 75 years) received intravenous F-AMP (25 mg/m2/d for 5 days, every 4 weeks) until maximum response, plus two further cycles as consolidation. The primary end point was response rate; secondary end points included time to progression (TTP), duration of response, and overall survival (OS). RESULTS: Forty-four (62%) of 71 assessable patients had a response to F-AMP (LPC lymphoma, 63%; WM, 79%; MCL, 41%); the CR rate was 15%. At a median follow-up of 1.5 years, 19 of 44 responding patients have had progression of lymphoma; the median duration of response was 2.5 years. The median survival has not yet been reached. There was no significant difference in the duration of response or OS between patients with different histologies; TTP was shorter in patients with MCL (P = .015). Myelosuppression was relatively common, and the treatment-related mortality (TRM) was 5%, mostly associated with pancytopenia and infection. CONCLUSION: Single-agent fludarabine phosphate is active in previously untreated LPC lymphoma and WM, with only moderate activity in MCL. However, the CR rate is low, and the TRM is relatively high. Its role in combination chemotherapy remains to be demonstrated.


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