5 research outputs found
Prognostische Bedeutung des Geriatrischen Assessments bei älteren Patienten mit chronischer lymphatischer Leukämie und Komorbidität
Bei der chronischen lymphatischen Leukämie (CLL) handelt es sich um ein niedrig-malignes Non-Hodgkin-Lymphom mit unbekannter Ätiologie und heterogenem Verlauf.
Die CLL tritt überwiegend bei Patienten im höheren Alter auf. Aufgrund der
demografischen Entwicklung ist in Zukunft mit einer weiteren Zunahme der CLL-Prävalenz und -Mortalität zu rechnen. In der CLL9-Studie der Deutschen CLL
Studiengruppe (DCLLSG) wurden erstmals die geriatrischen Parameter hinsichtlich
ihres prognostischen Wertes für das Therapieergebnis bei älteren komorbiden CLL-Patienten untersucht. Die geriatrischen Parameter wurden im Rahmen eines
prätherapeutischen mehrdimensionalen geriatrischen Assessments (GA) erhoben.
Dieses beinhaltete die obligate Erfassung der Komorbidität (CIRS: Cumulative Illness
Rating Scale) und, optional die Erfassung der Lokomotion (TUG-Test: Timed Up & Go-Test), der kognitiven Leistungsfähigkeit (DEMTECT-Test: Dementia Detection-Test)
sowie die Erfassung des funktionellen Status (IADL Index: Instrumental Activities of
Daily Living Index). Die 97 in die Studie aufgenommenen Patienten unterzogen sich
einer Therapie mit niedrig-dosiertem Fludarabin ± Darbopoetin alfa. 57 davon erhielten
ein vollständiges und 18 ein unvollständiges GA. Die gewonnenen Ergebnisse
unterlagen verschiedenen Limitationen, jedoch erwiesen sich bei der Auswertung der
Studiendaten schlechte TUG- und DEMTECT-Ergebnisse als prognostisch. Die
lokomotorischen und kognitiven Funktionen korrelierten stark mit einem kürzeren
Überleben. Die beobachtete prognostische Bedeutung erfordert weitere
Untersuchungen des geriatrischen Assessments bei CLL-Patienten, insbesondere im
Zusammenhang mit modernen Behandlungsmethode
Evaluation of geriatric assessment in patients with chronic lymphocytic leukemia: Results of the CLL9 trial of the German CLL study group
Multidimensional geriatric assessment (GA) has been demonstrated to predict outcomes in older patients with cancer. This study evaluated GA in a cohort of older patients with chronic lymphocytic leukemia (CLL). Seventy-five of 97 subjects with CLL who were enrolled in a clinical trial of the German CLL Study Group underwent GA prior to the start of study treatment (low-dose chemotherapy with fludarabine). GA included cumulative illness rating scale (CIRS), timed-up-and-go (TUG) test, dementia detection (DEMTECT) test and instrumental activities of daily living (IADL) index. There was little correlation between CIRS, TUG, DEMTECT or IADL results and treatment toxicity, feasibility or efficacy in this study. CIRS and IADL had no statistically significant impact on overall prognosis. However, under-performance in TUG or DEMTECT test was strongly associated with poor survival. The latter findings provide a rationale to further investigate geriatric assessment in CLL and in the context with other CLL treatments
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
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
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
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