The chief therapeutic goal in metastatic prostate cancer is prolongation of survival with good quality of life
. Quality of life (health-related) is often used as an endpoint parameter in phase III trials in metastatic prostate cancer, but the value of using HRQOL in this context has not been assessed to date.
In order to evaluate the role of HRQOL assessment in contemporary phase III trials in prostate cancer, we searched the PubMed database to identify publications presenting the results of these trials on systemic therapies for prostate cancer published between January 2000 and December 2015. The analysis was separately presented in ten leading journals. We searched for companion papers reporting on QOL separately.
We identified 84 studies which included a total of 57,193 patients in ten leading journals and 27 studies (7270 patients) in other journals. HRQOL parameters were described or mentioned in the main publication in 25 publications and four companions in total. There was no obvious trend in quality of life reported over two 8-year periods
. The explicit statistical comparisons were reported in 22/25 cases (88 %), with significant difference in only 10/25 (40 %) studies and in eight cases (80 %) was conducive to the examined arm. There was no significant association between improvements in HRQOL and improvements in overall survival (OS) or any other primary endpoint in the analyzed studies. Only one study was found which presented the difference in quality of life with no difference in the primary endpoint.
HRQOL is an indicator of benefit during treatment of patients with metastatic prostate cancer, but it is unlikely that HRQOL results can help clinicians choose between treatments given that they are not correlated with changes in OS or at other primary endpoints.
Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten
Mould, R. (2008). Cancer statistics overview with special reference to prostate, colon and rectum, lung, breast and cervix uteri.
Nowotwory Journal of Oncology,58, 213–220.
Wojciechowska, U., Didkowska, J., & Zatoński, W. (2012).
Nowotwory złośliwe w Polsce. Warszawa: Centrum Onkologii Instytut.
American Cancer Society. (2004).
Cancer facts and figures-2004 Atlanta. Atlanta: American Cancer Society.
The World Health Organization Quality of Life assessment. (1995). (WHOQOL): Position paper from the World Health Organization.
Social Science and Medicine,41, 1403–1409.
Greenfield, S., & Nelson, E. C. (1992). Recent developments and future issues in the use of health status assessment measures in clinical settings.
Medical Care,30, 23–41.
Michael, M., & Tannock, I. F. (1998). Measuring health-related quality of life in clinical trials that evaluate the role of chemotherapy in cancer treatment.
Canadian Medical Association Journal,158, 1727–1734.
Minasian, L. M., O’Mara, A. M., Reeve, B. B., et al. (2007). Health-related quality of life and symptom management research sponsored by the National Cancer Institute.
Journal of Clinical Oncology,25, 5128–5132.
Crook, J. M., O’Callaghan, C. J., Duncan, G., et al. (2012). Intermittent androgen suppression for rising PSA level after radiotherapy.
New England Journal of Medicine,367, 895–903.
Scher, H. I., Fizazi, K., Saad, F., et al. (2012). Increased survival with enzalutamide in prostate cancer after chemotherapy.
New England Journal of Medicine,367, 1187–1197.
Tannock, I. F., de Wit, R., Berry, W. R., et al. (2004). Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer.
New England Journal of Medicine,351, 1502–1512.
Loriot, Y., Miller, K., Sternberg, C. N., et al. (2015). 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 Oncology,16, 509–521.
Basch, E., Autio, K., Ryan, C. J., et al. (2013). 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 Oncology,14, 1193–1199.
Fosså, S. D., Slee, P. H., Brausi, M., et al. (2001). Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: A phase III study of the European organization for research and treatment of cancer genitourinary group.
Journal of Clinical Oncology,19, 62–71.
Harland, S., Staffurth, J., Molina, A., et al. (2013). Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy.
European Journal of Cancer,49, 3648–3657.
Cella, D., Ivanescu, C., Holmstrom, S., Bui, C. N., Spalding, J., & Fizazi, K. (2015). Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: Additional analyses from the AFFIRM randomized clinical trial.
Annals of Oncology,26, 179–185.
Nelson, J. B., Fizazi, K., Miller, K., et al. (2012). Phase 3, randomized, placebo-controlled study of zibotentan (ZD4054) in patients with castration-resistant prostate cancer metastatic to bone.
Abratt, R. P., Brune, D., Dimopoulos, M. A., et al. (2004). Randomised phase III study of intravenous vinorelbine plus hormone therapy versus hormone therapy alone in hormone-refractory prostate cancer.
Annals of Oncology,15, 1613–1621.
Shamash, J., Powles, T., Sarker, S. J., et al. (2011). A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: Immediate vs deferred Diethylstilbestrol.
British Journal of Cancer,104, 620–628.
Fizazi, K., Lesaunier, F., Delva, R., et al. (2012). A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: A planned analysis of response, toxicity and quality of life in the GETUG 12 trial.
European Journal of Cancer,48, 209–217.
Small, E. J., Meyer, M., Marshall, M. E., et al. (2000). Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: Results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone.
Journal of Clinical Oncology,18, 1440–1450.
Fizazi, K., Higano, C. S., Nelson, J. B., et al. (2013). Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer.
Journal of Clinical Oncology,31, 1740–1747.
Vitolins, M. Z., Griffin, L., Tomlinson, W. V., et al. (2013). Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.
Journal of Clinical Oncology,31, 4092–4098.
Brundage, M., Sydes, M. R., Parulekar, W. R., et al. (2015). Impact of radiotherapy when added to androgen-deprivation therapy for locally advanced prostate cancer: Long-term quality-of-life outcomes from the NCIC CTG PR3/MRC PR07 randomized trial.
Journal of Clinical Oncology,33, 2151–2157.
Ernst, D. S., Tannock, I. F., Winquist, E. W., et al. (2003). Randomized, double-blind, controlled trial of mitoxantrone/prednisone and clodronate versus mitoxantrone/prednisone and placebo in patients with hormone-refractory prostate cancer and pain.
Journal of Clinical Oncology,21, 3335–3342.
Saad, F., Gleason, D. M., Murray, R., et al. (2002). Zoledronic Acid Prostate Cancer Study Group. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma.
Journal of the National Cancer Institute,94, 1458–1468.
Fransson, P., Lund, J. A., Damber, J. E., et al. (2009). Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial.
Lancet Oncology,10, 370–380.
Denham, J. W., Wilcox, C., Joseph, D., et al. (2012). Quality of life in men with locally advanced prostate cancer treated with leuprorelin and radiotherapy with or without zoledronic acid (TROG 03.04 RADAR): secondary endpoints from a randomised phase 3 factorial trial.
Lancet Oncology,13, 1260–1270.
Goodwin, P. J., Black, J. T., Bordeleau, L. J., & Ganz, P. A. (2003). Health-related quality-of-life measurement in randomized clinical trials in breast cancer–taking stock.
Journal of the National Cancer Institute,95, 263–281.
Simes, R. J., Greatorex, V., & Gebski, V. J. (1998). Practical approaches to minimize problems with missing quality of life data.
Statistics in Medicine,17, 725–737.
Aaronson, N. K., Ahmedzai, S., Berman, B., et al. (1993). The Eurpean Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology.
Journal of the National Cancer Institute,85, 365–376.
Fayers, P., & Bottomley, A. (2002). Quality of life research within the EORTC—the EORTC QLQ-C30.
European Journal of Cancer,38, 125–133.
Cella, D. F., Tulsky, D. S., Gray, G., Sarafian, B., Linn, E., Bonomi, A., et al. (1993). The functional assessment of cancer therapy scale: Development and validation of the general measure.
Journal of Clinical Oncology,11, 570–579.
Esper, P., Mo, F., Chodak, G., Sinner, M., Cella, D., & Pienta, K. J. (1997). Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument.
King, M., Bell, M. L., Costa, D., Butow, P., & Oh, B. (2014). The quality of life questionnaire core 30 (QLQ-C30) and functional assessment of cancer-general (FACT-G) differ in responsiveness, relative efficiency, and therefore required sample size.
Journal of Clinical Epidemiology,67, 100–107.
Bottomley, A., & Aaronson, N. K. (2007). International perspective on health-related quality of-life research in cancer clinical trials: The European Organisation for Research and Treatment of Cancer experience.
Journal of Clinical Oncology,25, 5082–5086.
Adamowicz, K., Jassem, J., Katz, A., & Saad, E. D. (2012). Assessment of quality of life in advanced breast cancer. An overview of randomized phase III trials.
Cancer Treatment Reviews,38, 554–558.
Saad, E. D., Adamowicz, K., Katz, A., & Jassem, J. (2012). Assessment of quality of life in advanced non-small-cell lung cancer: An overview of recent randomized trials.
Cancer Treatment Reviews,38, 807–814.
Montazeri, A. (2008). Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007.
Journal of Experimental and Clinical Cancer Research,27, 32.
Dancey, J., Zee, B., Osoba, D., et al. (1997). Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group.
Quality of Life Research,6, 151–158.
Montazeri, A. (2009). Quality of life data as prognostic indicators of survival in cancer patients: An overview of the literature from 1982 to 2008.
Health Qual Life Outcomes,7, 102.
Van Steen, K., Curran, D., Kramer, J., et al. (2002). Multicollinearity in prognostic factor analyses using the EORTC QLQ-C30: Identification and impact on model selection.
Statistics in Medicine,21, 3865–3884.
Über diesen Artikel
Assessment of quality of life in advanced, metastatic prostate cancer: an overview of randomized phase III trials
Springer International Publishing
Quality of Life Research
An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation - Official Journal of the International Society of Quality of Life Research
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
Künstliche Intelligenz und ihre Auswirkung auf den Faktor Arbeit ist zum Modethema in der wirtschaftswissenschaftlichen Politikberatung avanciert. Studien, die alarmistisch die baldige Verdrängung eines Großteils konventioneller Jobprofile beschwören, leiden jedoch unter fragwürdiger Datenqualität und Methodik. Die Unternehmensperspektive zeigt, dass der Wandel der Arbeitswelt durch künstliche Intelligenz weitaus langsamer und weniger disruptiv ablaufen wird. Jetzt gratis downloaden!