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Low-dose fludarabine and cyclophosphamide in elderly patients with B-cell chronic lymphocytic leukemia refractory to conventional therapy.
Haematologica. 2000 Dec; 85(12):1268-70.H

Abstract

BACKGROUND AND OBJECTIVES

In recent years fludarabine alone or in combination with other drugs has been reported to be effective in the treatment of B-cell chronic lymphocytic leukemia (B-CLL), both as first line and salvage therapy. Among the different combination regimens, the association of fludarabine and cyclophosphamide has shown a considerable therapeutic efficacy, although a relevant number of infectious complications have been described, particularly in elderly patients. The aim of this work was to evaluate the efficacy, the toxicity, and the incidence of infectious episodes of a regimen combining lower doses of fludarabine and cyclophosphamide in elderly patients with B-CLL refractory to conventional therapy.

DESIGN AND METHODS

Twenty patients with progressive B-CLL with a median age of 75 years (4 in stage B and 16 in stage C) and refractory to conventional therapy were enrolled in this study. The combination regimen was as follows: fludarabine 15 mg/m2/day i.v. [max 25 mg] and cyclophosphamide 200 mg/m2/day i.v. for four days.

RESULTS

All patients enrolled were evaluable for response. Three out of 20 (15%) patients achieved a complete remission (CR), 14/20 (70%) a partial response (PR) with an overall response rate (CR+PR) of 85%, according to National Cancer Institute-Working Group response criteria. Three patients were considered resistant. In four out of 20 patients (20%), a severe neutropenia (neutrophils < 0.5x10(9)/L) occurred and one of them developed an infectious complication which required treatment with systemic antibiotics and granulocyte colony- stimulating factor (G-CSF). Non-hematologic toxicity was negligible in all patients but one, who despite a adequate therapy with allopurinol and hydration, experienced a tumor lysis syndrome with transient but severe renal impairment.

INTERPRETATION AND CONCLUSIONS

The association of low-dose fludarabine and cyclophosphamide appeared to be effective in this subset of B-CLL patients, reproducing a similar overall response rate obtained with other fludarabine-based combination therapies. In addition, in this group of elderly patients, toxic side effects were negligible and infectious complications remarkably low.

Authors+Show Affiliations

Department of Hematology, A. Sclavo Hospital, via Tufi, 1 53100 Siena, Italy. marotta@unisi.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11114133

Citation

Marotta, G, et al. "Low-dose Fludarabine and Cyclophosphamide in Elderly Patients With B-cell Chronic Lymphocytic Leukemia Refractory to Conventional Therapy." Haematologica, vol. 85, no. 12, 2000, pp. 1268-70.
Marotta G, Bigazzi C, Lenoci M, et al. Low-dose fludarabine and cyclophosphamide in elderly patients with B-cell chronic lymphocytic leukemia refractory to conventional therapy. Haematologica. 2000;85(12):1268-70.
Marotta, G., Bigazzi, C., Lenoci, M., Tozzi, M., Bocchia, M., & Lauria, F. (2000). Low-dose fludarabine and cyclophosphamide in elderly patients with B-cell chronic lymphocytic leukemia refractory to conventional therapy. Haematologica, 85(12), 1268-70.
Marotta G, et al. Low-dose Fludarabine and Cyclophosphamide in Elderly Patients With B-cell Chronic Lymphocytic Leukemia Refractory to Conventional Therapy. Haematologica. 2000;85(12):1268-70. PubMed PMID: 11114133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose fludarabine and cyclophosphamide in elderly patients with B-cell chronic lymphocytic leukemia refractory to conventional therapy. AU - Marotta,G, AU - Bigazzi,C, AU - Lenoci,M, AU - Tozzi,M, AU - Bocchia,M, AU - Lauria,F, PY - 2000/12/13/pubmed PY - 2001/5/22/medline PY - 2000/12/13/entrez SP - 1268 EP - 70 JF - Haematologica JO - Haematologica VL - 85 IS - 12 N2 - BACKGROUND AND OBJECTIVES: In recent years fludarabine alone or in combination with other drugs has been reported to be effective in the treatment of B-cell chronic lymphocytic leukemia (B-CLL), both as first line and salvage therapy. Among the different combination regimens, the association of fludarabine and cyclophosphamide has shown a considerable therapeutic efficacy, although a relevant number of infectious complications have been described, particularly in elderly patients. The aim of this work was to evaluate the efficacy, the toxicity, and the incidence of infectious episodes of a regimen combining lower doses of fludarabine and cyclophosphamide in elderly patients with B-CLL refractory to conventional therapy. DESIGN AND METHODS: Twenty patients with progressive B-CLL with a median age of 75 years (4 in stage B and 16 in stage C) and refractory to conventional therapy were enrolled in this study. The combination regimen was as follows: fludarabine 15 mg/m2/day i.v. [max 25 mg] and cyclophosphamide 200 mg/m2/day i.v. for four days. RESULTS: All patients enrolled were evaluable for response. Three out of 20 (15%) patients achieved a complete remission (CR), 14/20 (70%) a partial response (PR) with an overall response rate (CR+PR) of 85%, according to National Cancer Institute-Working Group response criteria. Three patients were considered resistant. In four out of 20 patients (20%), a severe neutropenia (neutrophils < 0.5x10(9)/L) occurred and one of them developed an infectious complication which required treatment with systemic antibiotics and granulocyte colony- stimulating factor (G-CSF). Non-hematologic toxicity was negligible in all patients but one, who despite a adequate therapy with allopurinol and hydration, experienced a tumor lysis syndrome with transient but severe renal impairment. INTERPRETATION AND CONCLUSIONS: The association of low-dose fludarabine and cyclophosphamide appeared to be effective in this subset of B-CLL patients, reproducing a similar overall response rate obtained with other fludarabine-based combination therapies. In addition, in this group of elderly patients, toxic side effects were negligible and infectious complications remarkably low. SN - 0390-6078 UR - https://www.unboundmedicine.com/medline/citation/11114133/Low_dose_fludarabine_and_cyclophosphamide_in_elderly_patients_with_B_cell_chronic_lymphocytic_leukemia_refractory_to_conventional_therapy_ L2 - http://www.haematologica.org/cgi/pmidlookup?view=long&amp;pmid=11114133 DB - PRIME DP - Unbound Medicine ER -