Re: Another promising treatment

[Guest guest]

> This is a German paper from ASH - to the best of my knowledge, we have not

> heard much about EPIRUBICIN in this country -

>

>

> [1591] Fludarabine versus Fludarabine Plus Epirubicin in the Treatment of

> Chronic Lymphocytic Leukemia - Results of a Randomized Phase-III

Multicenter

> Study. Session Type: Poster Session 703-I

>

> Mathias J. Rummel, Heinold Gamm, s Rost, Ulrich von Gruenhagen,

> Wojatschek, Elke Jaeger, Stephan Stilgenbauer, Hartmut Doehner, Dieter

> Hoelzer, Lothar Bergmann Department for Hematology, University Clinic,

furt,

> Germany; University Clinic, Mainz; Staedtische Kliniken, Darmstadt;

> Schwerpunktpraxis, Cottbus; Kreiskrankenhaus am Plattenwald, Bad

Friedrichshall;

> Krankenhaus Nordwest, furt; University Clinic, Ulm

>

> Background: In our previous phase-II study using the combination of

> fludarabine plus epirubicin in previously untreated patients with CLL we

reached an

> overall response rate of 92% with a high rate of complete remissions of

40%.

> Aims: Based on these promising results we initiated a multicenter

randomized

> phase-III study to compare efficacy and toxicity of the combination

regimen

> fludarabine plus epirubicin versus monotherapy with fludarabine as

first-line therapy

> or therapy of first relapse. In addition, cytogenetic aberrations will be

> investigated in all patients to evaluate, if special chromosomal

abnormalities

> are associated with prognosis and response to fludarabine. Treatment

schedule:

> Fludarabine 25 mg/qm day 1-5, epirubicin 25 mg/qm day 4+5 for a maximum of

6

> cycles every four weeks. Results: 161 patients entered the study so far,

145 are

> evaluable for response. Cytogenetic aberrations are well balanced between

> both groups. The overall response rate (ORR) was 79% with a CR-rate of

18%. The

> ORR for patients treated with fludarabine and epirubicin was 87% compared

to

> patients treated with fludarabine monotherapy reaching an ORR of 73%. This

> difference is statistical different with a p-value of 0.037. Rates of

complete

> remissions are different in favor for combined treatment modality with a

> significance level of 0.0004. Patients treated with combination therapy

have a longer

> median duration of progression free survival with 30 months in comparison

to 20

> months for patients treated with fludarabine alone (p=0.11). There is a

trend

> for a longer median overall survival time, which is not yet reached for

> patients with combination therapy compared to the median survival time of

76 months

> for the monotherapy group, however this difference is not statistical

> different (p=0.10). Conclusions: From our results so far we can

corroborate the high

> activity of fludarabine in the treatment of CLL. It is of particular

interest

> if - with a longer follow-up period - the higher response rate of the

> combination therapy will translate in a longer duration of achieved

remissions and in

> a better overall survival.

> Abstract #1591 appears in Blood, Volume 102, issue 11, November 16, 2003

> Keywords: CLL|fludarabine|epirubicin

>

> Saturday, December 6, 2003 6:00 PM

>

> Poster Session: CLL: Therapy I (6:00 PM-7:30 PM)