title: Treatment of chronic lymphocytic leukemia in early and stable phase of the disease: long-term results of a randomized trial.
abstract: In 1982 the IGCI CLL cooperative group decided to investigate the usefulness of treating, at diagnosis B-cell chronic lymphocytic leukemia (CLL) in early and stable phase of the disease. From January 1982 to December 1986, 148 patients were randomized either to receive immediate treatment with chlorambucil (CLB) or to defer therapy to the time of progression. The early and stable phase of the disease was defined by a total tumor mass (TTM) score < 9, the absence of anemia or thrombocytopenia and a doubling time > 12 months. The main end-point of the study was survival. At the last evaluation in April 1993, after a median follow-up of 75 months, no significant difference was found in overall survival between early vs. deferred treatment patients from every cause of death as well as from death due to CLL-related causes only. The same results were obtained when the patients in more favorable stages, such as Binet stage A and TTM < 4.5, were considered. Interestingly, the incidence of epithelial cancer was similar in the two groups. Early treatment was associated with a significantly better response and a lower progression rate. From this long-term experience, it can be concluded that immediate chemotherapy with CLB is not beneficial for CLL patients in early and stable phase of the disease in terms of survival.
authors.affiliation: Hematology Department, General Hospital USSL11, Reggio Calabria, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Brugiatelli
authors.forename: B
authors.initials: B
authors.lastname: Jaksic
authors.forename: A
authors.initials: A
authors.lastname: Planinc-Peraica
authors.forename: R
authors.initials: R
authors.lastname: Kusec
authors.forename: S
authors.initials: S
authors.lastname: Ostojic
authors.forename: V
authors.initials: V
authors.lastname: Callea
authors.forename: P
authors.initials: P
authors.lastname: Iacopino
authors.forename: F
authors.initials: F
authors.lastname: Morabito
authors.forename: C
authors.initials: C
authors.lastname: Stelitano
authors.forename: D
authors.initials: D
authors.lastname: Lutz
mesh_terms: D000368:Aged; D002423:Cause of Death; D002699:Chlorambucil / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D015996:Survival Rate; D013997:Time Factors
chemical_list: D002699:Chlorambucil