Multicenter phase II study of fludarabine phosphate for patients with newly diagnosed lymphoplasmacytoid lymphoma, Waldenström's macroglobulinemia, and mantle-cell lymphoma.
AuthorsForan, James M
Johnson, Stephen A
Radford, John A
Norton, Andrew J
Tollerfield, Susan M
Wilson, Martin P
Lister, T Andrew
AffiliationDepartment of Histopathology, St. Bartholomew's Hospital, London, England.
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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.
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.
JournalJournal of Clinical Oncology
- Phase II trial of fludarabine monophosphate in patients with mantle-cell lymphomas.
- Authors: Decaudin D, Bosq J, Tertian G, Nedellec G, Bennaceur A, Venuat AM, Bayle C, Carde P, Bendahmane B, Hayat M, Munck JN
- Issue date: 1998 Feb
- Phase III intergroup study of fludarabine phosphate compared with cyclophosphamide, vincristine, and prednisone chemotherapy in newly diagnosed patients with stage III and IV low-grade malignant Non-Hodgkin's lymphoma.
- Authors: Hagenbeek A, Eghbali H, Monfardini S, Vitolo U, Hoskin PJ, de Wolf-Peeters C, MacLennan K, Staab-Renner E, Kalmus J, Schott A, Teodorovic I, Negrouk A, van Glabbeke M, Marcus R
- Issue date: 2006 Apr 1
- Fludarabine phosphate in chronic lymphoproliferative diseases. The French Group on CLL.
- Authors: Binet JL
- Issue date: 1993 Feb
- New initiatives with fludarabine monophosphate in hematologic malignancies.
- Authors: Keating MJ, O'Brien S, Robertson LE, Kantarjian H, Dimopoulos M, McLaughlin P, Cabanillas F, Gregoire V, Yang LY, Gandhi V
- Issue date: 1993 Oct
- Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with "low-grade" non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia.
- Authors: Foran JM, Oscier D, Orchard J, Johnson SA, Tighe M, Cullen MH, de Takats PG, Kraus C, Klein M, Lister TA
- Issue date: 1999 May