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Phase I trial of fludarabine and paclitaxel in non-hodgkin’s lymphoma

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Abstract

Fludarabine is an active agent in low-grade non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. Paclitaxel is also active in patients with refractory lymphoma, and preclinical data suggest an additive effect with fludarabine in vitro. We performed a phase I trial of fludarabine (25 mg/m2 d 1–3) plus a 3-h infusion of paclitaxel (125, 150, or 175 mg/m2) on d 3 every 28 d in 13 patients with non-Hodgkin’s lymphoma. The paclitaxel dose was escalated in cohorts of 3–4 patients using standard phase I design schema. Dose-limiting toxicity was defined as febrile neutropenia, platelet nadir less than 50,000/µL, or grade 3–4 nonhematologic toxicity.

Thirteen patients were accrued to the study, 8 of these 13 patients (62%) had received prior chemotherapy. At the 125-, 150-, and 175-mg/m2 dose levels of paclitaxel, dose-limiting toxicity occurred in 1/4, 0/4, and 0/4 patients, respectively. The single patient with dose-limiting toxicity had febrile neutropenia. Partial response occurred in two of eight patients with low-grade lymphoma and none of five patients with other types of lymphoma. A paclitaxel dose of 175 mg/m2 given as a 3-h infusion on d 3 in conjunction with fludarabine (25 mg/m2 d 1–3 every 4 wk) is a well-tolerated regimen for non-Hodgkin’s lymphoma. Further study will be required in order to determine whether the fludarabine-paclitaxel is more active than fludarabine alone in patients with low-grade lymphoma and chronic lymphocytic leukemia.

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Authors and Affiliations

  1. Department of Oncology, Montefiore Medical Center, Bronx, NY

    Joseph A. Sparano & Catherine Sarta

  2. OLM Cancer Center, New York Medical College, Bronx, NY

    Peter H. Wiernik

  3. Department of Medicine, Jacobi Medical Center, 1400 Pelham Parkway South, 10461, Bronx, NY

    Muhammad R. Abbasi M.D.

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  1. Muhammad R. Abbasi M.D.
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  2. Joseph A. Sparano
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  3. Catherine Sarta
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  4. Peter H. Wiernik
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Correspondence to Muhammad R. Abbasi M.D..

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Abbasi, M.R., Sparano, J.A., Sarta, C. et al. Phase I trial of fludarabine and paclitaxel in non-hodgkin’s lymphoma. Med Oncol 20, 53–58 (2003). https://doi.org/10.1385/MO:20:1:53

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  • DOI: https://doi.org/10.1385/MO:20:1:53

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