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Blood, 15 October 2000, Vol. 96, No. 8, pp. 2723-2729
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Cladribine with prednisone versus chlorambucil with prednisone as
first-line therapy in chronic lymphocytic leukemia: report of a
prospective, randomized, multicenter trial
Tadeusz Robak,
Jerzy Z. Blo ski,
Marek Kasznicki,
Maria Blasiska-Morawiec,
Euzebiusz Krykowski,
Anna Dmoszyska,
Halina Mrugala- piewak,
Aleksander B. Skotnicki,
Wieslaw Nowak,
Lech Konopka,
Bernadeta Ceglarek,
Stanislaw Maj,
Jadwiga Dwilewicz-Trojaczek,
Andrzej Hellmann,
Ignacy Urasiski,
Barbara Zdziarska,
Sabina Kotlarek-Haus,
Stanislaw Potoczek, and
Pawel Grieb
From the Department of Hematology, Medical University
of Lodz; Department of Hematology, Medical University, Lublin;
Department of Hematology, Jagiellonian University, Cracow; Institute of
Hematology and Transfusiology, Warsaw; Department of Hematology,
Medical Academy, Warsaw; Department of Hematology, University Medical
School of Gdansk; Department of Hematology, Pomeranian University of
Medicine, Szczecin; Department of Hematology, Medical University,
Wroclaw; Medical Research Center, Polish Academy of Sciences, Warsaw,
Poland.
The efficacy and toxicity of cladribine (2-CdA) + prednisone
(P) versus chlorambucil (Chl) + P were compared in previously untreated patients with progressive or symptomatic chronic lymphocytic leukemia (CLL) in a randomized, multicenter prospective trial. Eligible
patients were assigned to either 2-CdA 0.12 mg/kg per day in
2-hour infusions and P 30 mg/m2 per day for 5 consecutive
days or Chl 12 mg/m2 per day and P 30 mg/m2 per
day for 7 consecutive days. Three courses were administered at 28-day
intervals or longer if myelosuppression developed. The therapy was
finished if complete response (CR) was achieved. Of 229 available
patients 126 received 2-CdA+P and 103 received Chl+P as a first-line
treatment. CR and overall response rates were significantly higher in
the patients treated with 2-CdA+P (47% and 87%, respectively) than in
the patients treated with Chl+P (12% and 57%, respectively)
(P = .001). Progression-free survival was significantly
longer in the 2-CdA-treated group (P = .01), but
event-free survival was not statistically different. Thirteen percent
of patients were refractory to 2-CdA+P and 43% to Chl+P (P = .001). Drug-induced neutropenia was more frequently
observed during 2-CdA+P (23%) than Chl+P therapy (11%)
(P = .02), but thrombocytopenia occurred with similar
frequency in both groups (36% and 27%, respectively). Infections were
seen more frequently in the 2-CdA+P-treated group (56%) than in the
Chl+P-treated group (40%; P = .02). Death rates have so
far been similar in patients treated with 2-CdA (20%) and with Chl
(17%). The probability of overall survival calculated from
Kaplan-Meier curves at 24 months was also similar for both groups (78%
and 82%, respectively).
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