Journal of Clinical Oncology, Vol 17, Issue 2
(February), 1999: 546
© 1999 American Society for Clinical Oncology
Multicenter Phase II Study of Fludarabine Phosphate for Patients With Newly Diagnosed Lymphoplasmacytoid Lymphoma, Waldenström's Macroglobulinemia, and Mantle-Cell Lymphoma
James M. Foran,
Ama Z.S. Rohatiner,
Bertr Coiffier,
Tiziano Barbui,
Stephen A. Johnson,
Wolfgang Hiddemann,
John A. Radford,
Andrew J. Norton,
Susan M. Tollerfield,
Martin P. Wilson,
T. Andrew Lister
From the ICRF Medical Oncology Unit and Department of Histopathology, St. Bartholomew's Hospital, London, Department of Hematology, Taunton and Somerset Hospital, Taunton, CRC Department of Medical Oncology, Christie Hospital, Manchester, and Schering Health Care Limited, Burgess Hill, West Sussex, England; Department of Hematology, Centre Hospitalier Lyon Sud, Lyon, France; Divisione di Ematologia, Ospedali Riuniti, Bergamo, Italy; and Department of Hematology, Georg-August Universität, Göttingen, Germany.
Address reprint requests to J.M. Foran, MD, ICRF Medical Oncology Unit, Department of Medical Oncology, St. Bartholomew's Hospital, 45 Little Britain, 2nd Floor, London EC1A 7BE, England.
PURPOSE: 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, Waldenström'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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