Beeinflussung der Lebensqualität beim metastasierten kastrationsresistenten Prostatakarzinom – eine Übersicht

Zusammenfassung

Mit dem Auftreten von Metastasen verschlechtert sich zusehends auch die gesundheitsbezogene Lebensqualität von Karzinom-Patienten. Vor allem Fatigue, Schlafstörungen, Knochenschmerzen, Obstipation und andere krankheitsassoziierte Symptome belasten die Betroffenen sehr. Infolge der verbesserten Behandlungsmöglichkeiten und längeren Überlebenszeiten stellen auch Symptomkontrolle und Verbesserung der Lebensqualität wichtige Ziele der Tumortherapie dar. Bei Patienten mit metastasiertem kastrationsresistentem Prostatakarzinom (mCRPC) konnte für Abirateronacetat und Enzalutamid neben der signifikanten Überlebensverlängerung auch ein signifikanter Nutzen hinsichtlich mehrerer Parameter der Lebensqualität gezeigt werden.

Abstract

Health-related quality of life (HRQoL) deteriorates rapidly in patients with advanced-stage cancer, with patients seriously disturbed by fatigue, sleep disorders, bone pain, constipation and other disease related symptoms. As treatment and prognosis continues to improve, reducing symptoms and improving quality of life with minimum of toxicities have become important therapeutic goals. The effectiveness of abiraterone acetate and enzalutamide in both prolonging life and improving quality of life in asymptomatic or mildly symptomatic patients with metastatic castrations-resistant prostate cancer (mCRPC) has been clinically proven.

Schlüsselwörter

Fatigue - Lebensqualität - tumorassoziierte Fatigue - Prostatakarzinom - metastasiertes kastrationsresistentes Prostatakarzinom - mCRPC - Abirateronacetat - Enzalutamid - Docetaxel - Erstlinientherapie

Key words

fatigue - quality of life - cancer-related fatigue - prostate cancer - metastatic castration-resistant prostate cancer - mRCPC - abiraterone acetate - enzalutamide - docetaxel - first-line therapy

• Literatur

• 1 European Medicines Agency (EMA). Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life Measures in the Evaluation of Medicinal Products. 2005 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp (Zugriff am 18.12.2016)
• 2 The U.S. Food and Drug Administration (FDA). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm193282.pdf (Zugriff am 18.12.2016)
• 3 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Allgemeine Methoden 4. 2. 2014. https://www.iqwig.de/download/IQWiG_Methoden_Version_4-2.pdf (Zugriff am 18.12.2016)
• 4 Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF). Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms, Langversion 3.1, 2014 AWMF Registernummer: 034/022OL (Zugriff am: 18.12.2016). http://leitlinienprogramm-onkologie.de/Prostatakarzinom.58.0.html
• 5 Robert Koch-Institut (Hrsg) und die Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. Krebs in Deutschland 2011 / 2012. Berlin: 2015 10. Ausgabe.
• 6 Torvinen S. et al. Health-related quality of life in prostate cancer. Acta Oncol 2013; 52: 1094-1101
• 7 Scher HI. et al. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol 2016; 34: 1402-1418
• 8 Scher HI. et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008; 26: 1148-1159
• 9 Cookson MS. et al. Castration-resistant prostate cancer: AUA guideline amendment. J Urol 2015; 193: 491-499
• 10 Glaus A. et al. A qualitative study to explore the concept of fatigue/tiredness in cancer patients and in healthy individuals. Eur J Cancer Care (Engl) 1996; 5: 8-23
• 11 Stone P. et al. Cancer-related fatigue: inevitable, unimportant and untreatable? Results of a multi-centre patient survey. Cancer Fatigue Forum Ann Oncol 2000; 11: 971-975
• 12 Vogelzang NJ. et al. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol 1997; 34: 4-12
• 13 Curt GA. et al. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist 2000; 5: 353-360
• 14 Hofman M. et al. Cancer-related fatigue: the scale of the problem. Oncologist 2007; 12 (Suppl. 01) 4-10
• 15 Ryan CJ. et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castrationresistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2015; 16: 152-160
• 16 Beer TM. et al. Enzalutamide (ENZA) in men with chemotherapy-Naïve metastatic castration-resistant prostate cancer (mCRPC): Final analysis of the phase 3 PREVAIL study. J Clin Oncol 2015; 33: 5036 (Suppl; abstr)
• 17 Parker C. et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013; 369: 213-223
• 18 Basch E. et al. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol 2013; 14: 1193-1199
• 19 Ryan D. et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castrationresistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2015; 16: 152-160
• 20 Logothetis CJ. et al. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletalrelated events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol 2012; 13: 1210-1217
• 21 Sternberg CN. et al. Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy. Ann Oncol 2013; 24: 1017-1025
• 22 Loriot Y. et al. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol 2015; 16: 509-521
• 23 Parker C. et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013; 369: 213-223
• 24 Nilsson S. et al. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. J Clin Oncol 2013; 31: 19 (suppl 6; abstr)
• 25 Harland S. et al. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer 2013; 49: 3648-3657
• 26 Nilsson S. et al. Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study. Ann Oncol 2016; 27: 868-874
• 27 Tannock IF. et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351: 1502-1512
• 28 Berthold DR. et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol 2008; 26: 242-245
• 29 Al-Batran SE. et al. The impact of docetaxel-related toxicities on health-related quality of life in patients with metastatic cancer (Qoli-Tax). Ann Oncol 2015; 26: 1244-1248
• 30 Pilon D. et al. Assessment of central nervous system (CNS) and dose reduction events in patients treated with abiraterone acetate plus prednisone (AA+P) or enzalutamide (ENZ). J Clin Oncol 2016; 34: 5078 (suppl; abstr)
• 31 Parimi S. et al. Effects of abiraterone (ABI) and enzalutamide (ENZA) on cognitive impairment and depressive symptoms in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 2016; 34: 5059 (suppl; abstr)