Younger Patients Receiving FC May Not Need Anti-Infective Prophylaxis

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Br J Haematol. 2006 Nov 3; [Epub ahead of print]

Due to low infection rates no routine anti-infective prophylaxis is

required in younger patients with chronic lymphocytic leukaemia

during fludarabine-based first line therapy.

Eichhorst BF, Busch R, Schweighofer C, Wendtner CM, Emmerich B,

Hallek M; the German CLL Study Group (GCLLSG).

Department of Internal Medicine I, University of Cologne, Cologne,

Germany.

The impact of the combination therapy fludarabine plus

cyclophosphamide (FC) in comparison with fludarabine alone regarding

the incidence and severity of infections among previously untreated

patients with chronic lymphocytic leukaemia (CLL) was evaluated

within a multicentre phase III study.

A total of 375 patients, up to 65 years old, were randomised between

fludarabine or FC for first line therapy. No routine anti-infective

prophylaxis was provided. A total of 196 infectious episodes,

including 33 severe infections, were documented.

In the fludarabine arm, 32.9% of the patients developed an

infectious complication compared with 39.9% in the FC arm (P = 0.2).

No difference was observed in the rate of severe infections (Common

Toxicity Crtieria grades III and IV) between both treatment arms.

Dose reductions were performed more frequently in FC-treated

patients. Granulocyte colony-stimulating factor (G-CSF) was

administered due to leucopenia in 5% of all patients. A multivariate

regression model identified only elevated thymidine kinase, but not

the treatment arm, as a statistically independent risk factor for

infections.

In summary, FC was not associated with a higher rate of infections

compared with fludarabine alone. No routine antibiotic or virostatic

prophylaxis, or pre-emptive treatment with G-CSF, is necessary in

first line therapy with fludarabine-based regimens in younger

patients with CLL, if adequate dose reduction is performed.

The combination therapy FC is not associated with a higher rate of

infections compared with fludarabine alone. No routine antibiotic or

virostatic prophylaxis as well as pre-emptive treatment with G-CSF

is necessary in first line therapy with fludarabine-based regimen in

younger patients with CLL, if adequate dose reductions due to

cytopenia or previous infections are performed.

PMID: 17083342 [PubMed - as supplied by publisher]