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Der Onkologe

, Volume 25, Issue 2, pp 151–156 | Cite as

Lebensqualität bei Patientinnen mit Ovarialkarzinom

  • E. GreimelEmail author
  • V. Bjelic-Radisic
  • E. Nagele
  • B. Bliem
  • K. Tamussino
Psychoonkologie
  • 58 Downloads

Zusammenfassung

Fortschritte der chirurgischen und systemischen Therapien des Ovarialkarzinoms haben die Überlebenszeiten von Patientinnen verlängert und den Fokus auf deren Lebensqualität (LQ) erhöht. Die Berücksichtigung von Patient Reported Outcomes (PROs) als primäre oder sekundäre Endpunkte in klinischen Ovarialkarzinomstudien ist in den letzten Jahren deutlich angestiegen. Für die Messung von PROs stehen standardisierte Instrumente zur Verfügung, die speziell für Patientinnen mit Ovarialkarzinom entwickelt wurden. PRO-Instrumente sind mittels internetbasierter Erfassungsmethoden als ePROs verfügbar und weniger zeit- und kostenintensiv. Klinische Studienergebnisse mit PRO-Endpunkten haben in der Behandlung des Ovarialkarzinoms zur Veränderung des international anerkannten Therapiestandards geführt. Auf Grundlage der Daten wurden Carboplatin plus Paclitaxel weltweit als neuer Standard der Primärtherapie des fortgeschrittenen Ovarialkarzinoms festgelegt. Eine weitere Individualisierung der Therapie unter Berücksichtigung der LQ von Patientinnen konnte in der späten Rezidivsituation des Ovarialkarzinoms ermöglicht werden. Neben klinischen Studien finden PROs zunehmend auch in der klinischen Routine Eingang. Die Mehrheit onkologischer Patienten befürwortet die routinemäßige Erfassung der LQ. PRO-Daten geben wichtige Information über die subjektive Auswirkung der Erkrankung und der Therapie auf die LQ der Patientinnen, können für gemeinsame Therapieentscheidungen herangezogen werden und Behandlungsoptionen an die Bedürfnisse der Patientinnen anpassen.

Schlüsselwörter

Gynäkologische Tumoren „Patient reported outcomes“ Chemotherapie Klinischen Studien Lebensqualität 

Quality of life in patients with ovarian cancer

Abstract

Progress in surgical and systemic treatment for ovarian cancer has prolonged survival times of patients and changed the focus towards patients’ quality of life (QoL). The inclusion of patient-reported outcomes (PROs) as primary or secondary outcomes in clinical ovarian cancer studies has significantly increased in recent years. There are standardized instruments developed specifically for ovarian cancer patients to measure PROs. Web-based ePRO questionnaires are also available, saving time and expense. Results from clinical studies with PROs as the focus have led to a change in the international standardized therapy for ovarian cancer. Based on these data carboplatin/paclitaxel has become the new worldwide standard primary therapy for advanced ovarian cancer. A further individualization of treatment taking QoL of patients into account, could be made possible for late relapsed ovarian cancer. In addition to clinical trials, PROs are increasingly being used in routine clinical practice. The majority of cancer patients support the routine assessment of QoL. The PRO data provide important information about the subjective effect of the disease and the treatment on the QoL of patients. This information can then be used for clinical decision-making to select the best treatment option based on the needs of the patients.

Keywords

Gynecological tumors Patient-reported outcomes Chemotherapy Clinical trials Quality of life 

Notes

Einhaltung ethischer Richtlinien

Interessenkonflikt

E. Greimel, V. Bjelic-Radisic, E. Nagele, B. Bliem und K. Tamussino geben an, dass kein Interessenkonflikt besteht.

Dieser Beitrag beinhaltet keine von den Autoren durchgeführten Studien an Menschen oder Tieren.

Literatur

  1. 1.
    AMWF (2017) S3-Leitlinie Diagnostik, Therapie und Nachsorge maligner Ovarialtumoren. Version 2.1 - November 2017. Association of the Scientific Medical Societies of Germany, BerlinGoogle Scholar
  2. 2.
    Bordlein-Wahl I, Hilpert F, Kohlmann T (2009) Evaluating treatment from the point of view of the patient—PROs (patient-reported outcomes). Onkologie 32(Suppl 1):18–20CrossRefGoogle Scholar
  3. 3.
    Brundage M, Gropp M, Mefti F et al (2012) Health-related quality of life in recurrent platinum-sensitive ovarian cancer—results from the CALYPSO trial. Ann Oncol 23:2020–2027CrossRefGoogle Scholar
  4. 4.
    Calvert M, Blazeby J, Altman DG et al (2013) Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 309:814–822CrossRefGoogle Scholar
  5. 5.
    Du Bois A, Luck HJ, Meier W et al (2003) A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 95:1320–1329CrossRefGoogle Scholar
  6. 6.
    EMEA (2005) Regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. European Medicines Agency, London (Use CCfMPFH)Google Scholar
  7. 7.
    FDA (2006) Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Health Qual Life Outcomes. 4:79.  https://doi.org/10.1186/1477-7525-4-79
  8. 8.
    Friedlander M, Gebski V, Gibbs E et al (2018) Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol 19:1126–1134CrossRefGoogle Scholar
  9. 9.
    Friedlander M, Rau J, Lee CK et al (2018) Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters-patient-centered end points in trials of maintenance therapy. Ann Oncol 29:737–743CrossRefGoogle Scholar
  10. 10.
    Friedlander ML, Stockler M, O’connell R et al (2014) Symptom burden and outcomes of patients with platinum resistant/refractory recurrent ovarian cancer: a reality check: results of stage 1 of the gynecologic cancer intergroup symptom benefit study. Int J Gynecol Cancer 24:857–864CrossRefGoogle Scholar
  11. 11.
    Greimel E, Kristensen GB, Van Der Burg ME et al (2013) Quality of life of advanced ovarian cancer patients in the randomized phase III study comparing primary debulking surgery versus neo-adjuvant chemotherapy. Gynecol Oncol 131:437–444CrossRefGoogle Scholar
  12. 12.
    Greimel ER, Bjelic-Radisic V, Pfisterer J et al (2006) Randomized study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group comparing quality of life in patients with ovarian cancer treated with cisplatin/paclitaxel versus carboplatin/paclitaxel. J Clin Oncol 24:579–586CrossRefGoogle Scholar
  13. 13.
    Hagelstein V, Ortland I, Wilmer A et al (2016) Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Ann Oncol 27:2294–2299CrossRefGoogle Scholar
  14. 14.
    Hilarius DL, Kloeg PH, Gundy CM et al (2008) Use of health-related quality-of-life assessments in daily clinical oncology nursing practice: a community hospital-based intervention study. Cancer 113:628–637CrossRefGoogle Scholar
  15. 15.
    Joly F, Hilpert F, Okamoto A et al (2017) Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: recommendations on incorporating patient-reported outcomes in clinical trials in epithelial ovarian cancer. Eur J Cancer 78:133–138CrossRefGoogle Scholar
  16. 16.
    King MT, Stockler MR, O’connell RL et al (2018) Measuring what matters MOST: validation of the Measure of Ovarian Symptoms and Treatment, a patient-reported outcome measure of symptom burden and impact of chemotherapy in recurrent ovarian cancer. Qual Life Res 27:59–74CrossRefGoogle Scholar
  17. 17.
    Ledermann J, Harter P, Gourley C et al (2012) Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 366:1382–1392CrossRefGoogle Scholar
  18. 18.
    Mirza MR, Monk BJ, Herrstedt J et al (2016) Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med 375:2154–2164CrossRefGoogle Scholar
  19. 19.
    Oza AM, Matulonis UA, Malander S et al (2018) Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial. Lancet Oncol 19:1117–1125CrossRefGoogle Scholar
  20. 20.
    Pujade-Lauraine E, Ledermann JA, Selle F et al (2017) Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol 18:1274–1284CrossRefGoogle Scholar
  21. 21.
    Rochon J, Du Bois A, Lange T (2014) Mediation analysis of the relationship between institutional research activity and patient survival. BMC Med Res Methodol 14:9CrossRefGoogle Scholar
  22. 22.
    Sehouli J, Chekerov R, Reinthaller A et al (2016) Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabine plus carboplatin (GC) or pegylated liposomal doxorubicin plus carboplatin (PLDC): a randomized phase III trial of the NOGGO-AGO-Study Group-AGO Austria and GEICO-ENGOT-GCIG intergroup study (HECTOR). Ann Oncol 27:2236–2241CrossRefGoogle Scholar
  23. 23.
    Stark DP, Cook A, Brown JM et al (2017) Quality of life with cediranib in relapsed ovarian cancer: The ICON6 phase 3 randomized clinical trial. Cancer 123:2752–2761CrossRefGoogle Scholar
  24. 24.
    Vasey PA, Jayson GC, Gordon A et al (2004) Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst 96:1682–1691CrossRefGoogle Scholar
  25. 25.
    Velikova G, Booth L, Smith AB et al (2004) Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 22:714–724CrossRefGoogle Scholar
  26. 26.
    Vergote I, Trope CG, Amant F et al (2010) Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med 363:943–953CrossRefGoogle Scholar
  27. 27.
    Wilson MK, Friedlander ML, Joly F et al (2018) A systematic review of health-related quality of life reporting in ovarian cancer phase III clinical trials: room to improve. Oncologist 23:203–213CrossRefGoogle Scholar

Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2018

Authors and Affiliations

  • E. Greimel
    • 1
    Email author
  • V. Bjelic-Radisic
    • 2
  • E. Nagele
    • 1
  • B. Bliem
    • 1
  • K. Tamussino
    • 1
  1. 1.Universitätsklinik für Frauenheilkunde und GeburtshilfeMedizinische Universität GrazGrazÖsterreich
  2. 2.LandesfrauenklinikHelios Universitätsklinikum Wuppertal, Universität Witten/HerdeckeWuppertalDeutschland

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