Effect of first-line treatment on second primary malignancies and Richter's transformation in patients with CLL

Leukemia. 2016 Oct;30(10):2019-2025. doi: 10.1038/leu.2016.113. Epub 2016 May 2.

Abstract

This study aimed to assess the frequency of and the contributing factors for second primary malignancies (SPMs) and Richter's transformations (RTs) following first-line treatment of chronic lymphocytic leukemia within four phase II/III trials of the GCLLSG evaluating fludarabine (F) vs F+cyclophosphamide (FC), chlorambucil vs F, FC without or with rituximab, and bendamustine+R (BR). Among 1458 patients, 239 (16.4%) experienced either an SPM (N=191) or a RT (N=75). Solid tumors (N=115; 43.2% of all second neoplasias) appeared most frequently, followed by RTs (N=75; 28.2%). Patients showed a 1.23-fold increased risk of solid tumors in comparison to the age-matched general population from the German cancer registry. Age>65 (hazard ratio (HR) 2.1; P<0.001), male sex (HR 1.7; P=0.01), co-morbidities (HR 1.6; P=0.01) and number of subsequent treatments⩾1 (HR 12.1; P<0.001) showed an independent adverse prognostic impact on SPM-free survival. Serum thymidine kinase>10 U/l at trial enrollment (HR 3.9; P=0.02), non-response to first-line treatment (HR 3.6; P<0.001) and number of subsequent treatments⩾1 (HR 30.2; P<0.001) were independently associated with increased risk for RT.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Bendamustine Hydrochloride / administration & dosage
  • Bendamustine Hydrochloride / therapeutic use
  • Case-Control Studies
  • Cell Transformation, Neoplastic / chemically induced*
  • Chlorambucil / administration & dosage
  • Chlorambucil / therapeutic use
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / therapeutic use
  • Disease-Free Survival
  • Female
  • Germany
  • Humans
  • Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy*
  • Leukemia, Lymphocytic, Chronic, B-Cell / mortality
  • Male
  • Middle Aged
  • Neoplasms, Second Primary / drug therapy*
  • Neoplasms, Second Primary / mortality
  • Registries
  • Risk Assessment
  • Risk Factors
  • Vidarabine / administration & dosage
  • Vidarabine / analogs & derivatives
  • Vidarabine / therapeutic use

Substances

  • Chlorambucil
  • Cyclophosphamide
  • Bendamustine Hydrochloride
  • Vidarabine
  • fludarabine