title: Comparison of cladribine plus prednisone with chlorambucil plus prednisone in patients with chronic lymphocytic leukemia. Final report of the Polish Adult Leukemia Group (PALG CLL1).
abstract: BACKGROUND
  We previously published an early report of a randomized, multicenter trial on the efficacy and toxicity of cladribine (2-CdA) + prednisone (P) compared with chlorambucil (Chl) + P in previously untreated patients with progressive or symptomatic chronic lymphocytic leukemia. Here we present the final report of this study.
  
  
  METHODS
  Of 229 patients, 126 received 2-CdA+P and 103 Chl+P. Patients with no response or progression after three courses or who relapsed earlier than 12 months after completing one treatment were switched to the other. Patients who relapsed later were retreated with the same schedule as before.
  
  
  RESULTS
  Thirty-three patients were retreated with 2-CdA+P and 19 with Chl+P. Overall response (and complete response) rates were 35% (6%) and 47% (16%), respectively. In 50 patients initially treated with Chl+P and then with 2-CdA+P, complete response (CR) was achieved in 12 (24%) and overall response (OR) in 32 (64%). In 28 patients originally treated with 2-CdA+P and then with Chl+P, CR in 1 (3%, p=0.01) and OR in 6 (21%, p=0.003) were obtained. We found no statistically significant difference in overall survival time in patients treated initially with 2-CdA+P and Chl+P aged 60 years (4.63 and 5.27 years, respectively, p=0.45), 60-70 years (3.29 and 3.14 years, p=0.79), and >70 years (1.53 and 1.93 years, p=0.11).
  
  
  CONCLUSIONS
  2-CdA+P is significantly more effective as a second-line treatment and re-treatment than Chl+P. However, we found a trend to longer survival in elderly patients treated with Chl+P.
authors.affiliation: Department of Hematology, Medical University of Łódź, Copernicus Memorial Hospital, Łódź, Poland. robaktad@csk.am.lodz.pl
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Robak
authors.forename: Jerzy Z
authors.initials: JZ
authors.lastname: Błoński
authors.forename: Marek
authors.initials: M
authors.lastname: Kasznicki
authors.forename: Joanna
authors.initials: J
authors.lastname: Góra-Tybor
authors.forename: Anna
authors.initials: A
authors.lastname: Dmoszyńska
authors.forename: Maria
authors.initials: M
authors.lastname: Wojtaszko
authors.forename: Aleksander B
authors.initials: AB
authors.lastname: Skotnicki
authors.forename: Wiesław
authors.initials: W
authors.lastname: Nowak
authors.forename: Andrzej
authors.initials: A
authors.lastname: Hellmann
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Lewandowski
authors.forename: Barbara
authors.initials: B
authors.lastname: Zdziarska
authors.forename: Lech
authors.initials: L
authors.lastname: Konopka
authors.forename: Bernadetta
authors.initials: B
authors.lastname: Ceglarek
authors.forename: Jadwiga
authors.initials: J
authors.lastname: Dwilewicz-Trojaczek
authors.forename: Piotr
authors.initials: P
authors.lastname: Boguradzki
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Kuliczkowski
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Sułek
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Warzocha
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002699:Chlorambucil / Q000008:administration & dosage; D017338:Cladribine / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D016019:Survival Analysis; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D002699:Chlorambucil; D017338:Cladribine; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone