Rituximab in Combination With Fludarabine Chemotherapy in Low-Grade or Follicular Lymphoma

  • M.S. Czuczman
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • A. Koryzna
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • A. Mohr
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • C. Stewart
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • K. Donohue
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • L. Blumenson
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • Z.P. Bernstein
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • P. McCarthy
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • A. Alam
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • F. Hernandez-Ilizaliturri
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • M. Skipper
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • K. Brown
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • A. Chanan-Khan
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • D. Klippenstein
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • P. Loud
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • M.K. Rock
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • M. Benyunes
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • A. Grillo-Lopez
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA
  • S.H. Bernstein
    From the Roswell Park Cancer Institute, Buffalo, NY; Berlex Laboratories, Richmond; Genentech Inc, San Francisco; and IDEC Pharmaceuticals, San Diego, CA

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<jats:sec><jats:title>Purpose</jats:title><jats:p> To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naïve or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m<jats:sup>2</jats:sup> administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m<jats:sup>2</jats:sup>/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> An overall response rate of 90% (80% complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-naïve and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88% of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15% incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma. </jats:p></jats:sec>

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