title: Low-dose fludarabine with or without darbepoetin alfa in patients with chronic lymphocytic leukemia and comorbidity: primary results of the CLL9 trial of the German CLL Study Group.
abstract: This study was planned as a phase 3 trial to investigate low-dose fludarabine with or without darbepoetin alfa in older patients with previously untreated or treated chronic lymphocytic leukemia (CLL) and comorbidity. Due to slow recruitment, the study was terminated prematurely after accrual of 97 patients who, on average, were 74 years old and had a cumulative illness rating scale (CIRS) total score of 5. We report toxicity and efficacy of the study treatment. Grade 3-5 neutropenia and infection were observed in 25% and 10% of patients, respectively. Response was seen in 73% (5% complete remissions). Median event-free and overall survival was 12.2 and 44.8 months, respectively. No differences in outcome were found for patients treated with versus without darbepoetin alfa. In subjects with progressive/recurrent CLL during or after study treatment, overall survival was similar for patients receiving chemotherapy versus chemoimmunotherapy as salvage treatment.
authors: a German CLL Study Group, Department I of Internal Medicine , Center of Integrated Oncology Cologne-Bonn, University Hospital Cologne , Cologne , Germany .|b Department of Geriatric Medicine , St. Marien Hospital , Cologne , Germany .
authors: Valentin
authors: V
authors: Goede
authors: c Institute of Medical Statistics and Epidemiology, Technical University of Munich , Munich , Germany .
authors: Raymonde
authors: R
authors: Busch
authors: a German CLL Study Group, Department I of Internal Medicine , Center of Integrated Oncology Cologne-Bonn, University Hospital Cologne , Cologne , Germany .
authors: Jasmin
authors: J
authors: Bahlo
authors: a German CLL Study Group, Department I of Internal Medicine , Center of Integrated Oncology Cologne-Bonn, University Hospital Cologne , Cologne , Germany .
authors: Viktoria
authors: V
authors: Chataline
authors: d Department of Hematology and Oncology , Caritas Hospital , Lebach , Germany .
authors: Stephan
authors: S
authors: Kremers
authors: e Private Oncology Practice , Leer , Germany .
authors: Lothar
authors: L
authors: Müller
authors: f Private Oncology Practice , Oldenburg , Germany .
authors: Daniel
authors: D
authors: Reschke
authors: g Private Oncology Practice , Würzburg , Germany .
authors: Rudolf
authors: R
authors: Schlag
authors: h Private Oncology Practice , Munich , Germany .
authors: Burkhard
authors: B
authors: Schmidt
authors: i Private Oncology Practice , Landshut , Germany .
authors: Ursula
authors: U
authors: Vehling-Kaiser
authors: j Department of Palliative Care Medicine , University Hospital Jena , Jena , Germany .
authors: Ulrich
authors: U
authors: Wedding
authors: k Department of Internal Medicine III , University of Ulm , Ulm , and.
authors: Stefan
authors: S
authors: Stilgenbauer
authors: a German CLL Study Group, Department I of Internal Medicine , Center of Integrated Oncology Cologne-Bonn, University Hospital Cologne , Cologne , Germany .|l Cologne Excellence Cluster on Cellular Stress Responses in Aging Associated Diseases (CECAD), University of Cologne , Cologne , Germany.
authors: Michael
authors: M
authors: Hallek
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D000068256:Darbepoetin alfa / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000068256:Darbepoetin alfa; D014740:Vidarabine; C024352:fludarabine
keywords: Chemotherapy; chronic lymphocytic leukemia; comorbidity; erythropoiesis-stimulating agents