title: Long-term results of the Polish Adult Leukemia Group PALG-CLL2 phase III randomized study comparing cladribine-based combinations in chronic lymphocytic leukemia.
abstract: Long-term outcomes following newer therapies for chronic lymphocytic leukemia (CLL) have rarely been reported. This article presents the results of the final analysis of the Polish Adult Leukemia Group PALG-CLL2 study performed 10 years from final patient enrollment. With the extended follow-up time, it was found that cladribine (2-CdA)-based combinations CMC (2-CdA, cyclophosphamide, mitoxantrone) and CC (2-CdA, cyclophosphamide) administered as first-line treatment of progressive CLL resulted in significantly longer progression-free survival, but similar overall survival compared to 2-CdA monotherapy. Furthermore, the risk of potentially fatal late adverse events including infections, autoimmune complications and, particularly, secondary neoplasms was comparable among patients treated with CMC, CC or 2-CdA. The results of our analysis support the importance of long-term outcome monitoring of randomized trials in CLL.
authors.affiliation: Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital , Lodz , Poland.
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Robak
authors.forename: Jerzy Z
authors.initials: JZ
authors.lastname: Blonski
authors.forename: Joanna
authors.initials: J
authors.lastname: Gora-Tybor
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Calbecka
authors.forename: Jadwiga
authors.initials: J
authors.lastname: Dwilewicz-Trojaczek
authors.forename: Piotr
authors.initials: P
authors.lastname: Boguradzki
authors.forename: Anna
authors.initials: A
authors.lastname: Dmoszynska
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Kowal
authors.forename: Janusz
authors.initials: J
authors.lastname: Kloczko
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Piszcz
authors.forename: Beata
authors.initials: B
authors.lastname: Stella-Holowiecka
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Sulek
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Kuliczkowski
authors.forename: Stanislaw
authors.initials: S
authors.lastname: Potoczek
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Warzocha
authors.forename: Ewa
authors.initials: E
authors.lastname: Lech-Maranda
authors.forename: Aleksander B
authors.initials: AB
authors.lastname: Skotnicki
authors.forename: Magdalena
authors.initials: M
authors.lastname: Piotrowska
authors.forename: Andrzej
authors.initials: A
authors.lastname: Moskwa
authors.forename: Krystyna
authors.initials: K
authors.lastname: Zawilska
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Jamroziak
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002423:Cause of Death; D017338:Cladribine / Q000009:adverse effects / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008942:Mitoxantrone / Q000009:adverse effects / Q000627:therapeutic use; D016609:Neoplasms, Second Primary; D016896:Treatment Outcome
chemical_list: D017338:Cladribine; D003520:Cyclophosphamide; D008942:Mitoxantrone