Campath Effective in Advanced CLL

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[2971] Alemtuzumab Is Effective in Patients with Advanced,

Pretreated B-Cell Chronic Lymphocytic Leukemia: A Nationwide Study

of Routine Use in Austria. Session Type: Poster Session 222-III

Fiegl, s Falkner, Georg Hopfinger, Stefan Brugger,

August Zabernigg, Ferdinand Haslbauer, Johannes Andel, f Thaler,

Fridrik, Franz Bauer, Mian, Georg Tatzreiter, Niklas

Zojer, Dita Demirtas, Gerhard Postner, Jutta Auberger, Günther

Gastl, Greil Medical University of Innsbruck, Innsbruck,

Austria; Hanusch Hospital, Vienna, Austria; Hospital St. Pölten, St.

Pölten, Austria; General Hospital Kufstein, Kufstein, Austria; LKH

Voecklabruck, Voecklabruck, Austria; LKH Steyr, Steyr, Austria;

General Hospital Wels, Wels, Austria; General Hospital of Linz,

Linz, Austria; University of Graz, Graz, Austria; University

Hospital Salzburg, Salzburg, Austria; Danube Hospital, Vienna,

Austria; Wilhelminenspital, Vienna, Austria; Medical University of

Vienna, Vienna, Austria; Kaiser Franz f Spital, Vienna, Austria

It is often questionable as to whether or not therapeutic benefit

documented in prospective studies reflects that which is observed in

routine use. Four prospective studies have explored the efficacy of

alemtuzumab in heavily pretreated B-CLL patients, reporting response

rates (RR) between 33% to 55%, and median survival between 13-28

months.

Here, we report clinical outcomes after therapy with alemtuzumab of

106 consecutive, unselected B-CLL patients treated in 25 centers in

Austria. Seventy-two patients were male and 34 female, the median

age was 66 years (range, 46–88 years). The majority of patients had

advanced stage disease, with 58% having Rai stage IV disease. The

patients had received a median of 3 prior therapies (range, 1–11).

Alemtuzumab was administered according to guidelines, but in the

majority of cases, dosing was individualized, according to

tolerability, side effects, and economic considerations. Thus, the

median duration of therapy was 7 weeks (range, 2–24 weeks), and

median dose was only 390 mg (range, 11–1333 mg).

Therapeutic response was determined, strictly adhering to the NCI

criteria (duration of complete response [CR]/partial response

[PR]/stable disease [sD] & #8805;2 months; adequate radiologic studies of

all non-palpable manifestation; marrow for CR). CR, PR, and SD were

achieved in 5%, 17%, and 34% of patients (RR 22%). Progressive

disease occurred in 34%, and responses were not evaluable in 9%, due

to early death. In the 59 patients with overall CR/PR/SD, peripheral

blood responses were as follows: 63% CR, 25% PR, and 12% SD.

Survival times were encouraging and comparable with other studies.

The median survival for all patients was 19 months; 15 months for

fludarabine-refractory patients (n = 67) and 31 months for

fludarabine-sensitive patients (n = 24; P = 0.04).

Survival was dependent on response (P = 0.0001), the number of

previous therapy lines (0-3 vs >3; P = 0.0001), and the presence of

bulky disease (P = 0.005). Route of administration (IV: 49%; IV to

SC 38%; upfront SC 13%) did not influence outcome. Toxicities were

within the expected range, with grade 3/4 infections in 37% of

patients; grade 4 neutropenia and thrombocytopenia in 25% and 23% of

patients, CMV reactivation in 14% (CMV disease in 3%) of patients,

and early death (<2 months after last dose) in 12% of patients.

We conclude that in the routine clinical setting, alemtuzumab is a

safe and effective treatment with profound prolongation of survival

in pretreated B-CLL patients. This retrospective study is an

important contribution to continuous, nationwide quality control.