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Blood, 15 July 2006, Vol. 108, No. 2, pp. 473-479.
Prepublished online as a Blood First Edition Paper on March 21, 2006; DOI 10.1182/blood-2005-12-4828.
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CLINICAL TRIALS AND OBSERVATIONS
Cladribine alone and in combination with cyclophosphamide or cyclophosphamide plus mitoxantrone in the treatment of progressive chronic lymphocytic leukemia: report of a prospective, multicenter, randomized trial of the Polish Adult Leukemia Group (PALG CLL2)
Tadeusz Robak,
Jerzy Z. Blonski,
Joanna Gora-Tybor,
Krzysztof Jamroziak,
Jadwiga Dwilewicz-Trojaczek,
Agnieszka Tomaszewska,
Lech Konopka,
Bernadetta Ceglarek,
Anna Dmoszynska,
Malgorzata Kowal,
Janusz Kloczko,
Beata Stella-Holowiecka,
Kazimierz Sulek,
Malgorzata Calbecka,
Krystyna Zawilska,
Kazimierz Kuliczkowski,
Aleksander B. Skotnicki,
Krzysztof Warzocha,
Marek Kasznicki, and
the Polish Leukemia Group (PALG CLL2)
From the Department of Hematology, Medical University of Lodz; the Department of Hematology and Oncology, Medical University of Warsaw; the Institute of Hematology and Transfusiology, and the Department of Internal Medicine, Military Institute of Medicine, Warsaw; the Department of Hematology and Bone Marrow Transplantation, Medical University of Lublin; the Department of Hematology, Medical University, Bialystok; the Department of Hematology and Bone Marrow Transplantation, Medical University of Katowice; City Hospital, Torun; the Department of Hematology, Medical University of Poznan; the Department of Hematology, Medical University, Wroclaw; and the Department of Hematology, Jagiellonian University, Krakow, Poland.
In this prospective randomized trial, we compared the efficacy and toxicity of cladribine (2-CdA) alone to 2-CdA combined with cyclophosphamide (CC) or cyclophosphamide and mitoxantrone (CMC) in untreated progressive chronic lymphocytic leukemia (CLL). Study end points were complete response (CR), overall response, minimal residual disease (MRD), progression-free survival, overall survival, and toxicity. From January 1, 1998 to December 31, 2003, 508 patients from 15 hematology departments were randomized. Compared with 2-CdA, CMC induced higher CR rate (36% vs 21%, P = .004), and a trend for higher CR rate with CC was observed (29% vs 21%, P = .08). Furthermore, the percentage of patients who were in CR and were MRD negative was higher in CMC compared with 2-CdA (23% vs 14%, P = .042). There were no differences in overall response, progression-free survival, and overall survival among treatment groups. Grade 3/4 neutropenia occurred more frequently in CC (32%) and CMC (38%) than in 2-CdA (20%) (P = .01 and P = .004, respectively). Infections were more frequent in CMC compared with 2-CdA (40% vs 27%, P = .02). In conclusion, CMC used in first-line treatment of CLL results in a higher CR rate and suppresses MRD more efficiently than 2-CdA monotherapy, although associates with increased toxicity. No important differences in efficacy and toxicity were found between CC and 2-CdA regimens.
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