title: Cladribine with prednisone versus chlorambucil with prednisone as first-line therapy in chronic lymphocytic leukemia: report of a prospective, randomized, multicenter trial.
abstract: 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/m(2) per day for 5 consecutive days or Chl 12 mg/m(2) per day and P 30 mg/m(2) 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). (Blood. 2000;96:2723-2729)
authors.affiliation: Department of Hematology, Medical University of Lodz, Poland. robaktad@psk2.am.lodz.pl
authors.forename: T
authors.initials: T
authors.lastname: Robak
authors.forename: J Z
authors.initials: JZ
authors.lastname: Bloński
authors.forename: M
authors.initials: M
authors.lastname: Kasznicki
authors.forename: M
authors.initials: M
authors.lastname: Blasińska-Morawiec
authors.forename: E
authors.initials: E
authors.lastname: Krykowski
authors.forename: A
authors.initials: A
authors.lastname: Dmoszyńska
authors.forename: H
authors.initials: H
authors.lastname: Mrugala-Spiewak
authors.forename: A B
authors.initials: AB
authors.lastname: Skotnicki
authors.forename: W
authors.initials: W
authors.lastname: Nowak
authors.forename: L
authors.initials: L
authors.lastname: Konopka
authors.forename: B
authors.initials: B
authors.lastname: Ceglarek
authors.forename: S
authors.initials: S
authors.lastname: Maj
authors.forename: J
authors.initials: J
authors.lastname: Dwilewicz-Trojaczek
authors.forename: A
authors.initials: A
authors.lastname: Hellmann
authors.forename: I
authors.initials: I
authors.lastname: Urasiński
authors.forename: B
authors.initials: B
authors.lastname: Zdziarska
authors.forename: S
authors.initials: S
authors.lastname: Kotlarek-Haus
authors.forename: S
authors.initials: S
authors.lastname: Potoczek
authors.forename: P
authors.initials: P
authors.lastname: Grieb
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002699:Chlorambucil / Q000008:administration & dosage / Q000009:adverse effects; D017338:Cladribine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015994:Incidence; D007239:Infections / Q000453:epidemiology / Q000209:etiology; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000453:epidemiology; D011044:Poland / Q000453:epidemiology; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D012074:Remission Induction; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D002699:Chlorambucil; D017338:Cladribine; D011241:Prednisone