How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials

作者: F. Bonnetain , C. Borg , R.R. Adams , J.A. Ajani , A. Benson

DOI: 10.1093/ANNONC/MDX191

关键词:

摘要: Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease clinical studies has been studied using overall survival and more recently tumor-based end points such as progression-free survival, measurements response to treatment. However, these seem not be relevant current situation if were no validated surrogate demonstrate efficacy. Appropriate, meaningful, primary patient-oriented patient-reported that adequately measure effects new therapeutic interventions are then crucial for advancement research colorectal complement results points. Health-related quality life (HRQoL) is effectively an evaluation its relationship health over time. HRQoL includes patient report at least way a affects physical, emotional social well-being. Over past few years, several phase III trials variety solid cancers have assessed incremental value addition traditional tumor results. could provide only complementary data outcomes, but also precise predictive prognostic value. This point useful both clinicians order achieve dogma precision medicine. The present article examines use trials, outlines importance assessment methods, analysis, presentation. Moreover, it discusses relevance including primary/co-primary support assess advanced setting.

参考文章(104)
Wendy L. Ward, Elizabeth A. Hahn, Fei Mo, Lesbia Hernandez, David S. Tulsky, David Cella, Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument Quality of Life Research. ,vol. 8, pp. 181- 195 ,(1999) , 10.1023/A:1008821826499
Jolie Ringash, Heather-Jane Au, Lillian L. Siu, Jeremy D. Shapiro, Derek J. Jonker, John R. Zalcberg, Malcolm J. Moore, Andrew Strickland, Rami Kotb, Mark Jeffery, Thierry Alcindor, Siobhan Ng, Muhammad Salim, Sabe Sabesan, Jay C. Easaw, Jenny Shannon, Fabyolla El-Tahche, Ian Walters, Dongsheng Tu, Christopher J. O'Callaghan, , , Quality of life in patients with K-RAS wild-type colorectal cancer: the CO.20 phase 3 randomized trial. Cancer. ,vol. 120, pp. 181- 189 ,(2014) , 10.1002/CNCR.28410
Roman Jaeschke, Joel Singer, Gordon H. Guyatt, Measurement of health status: Ascertaining the minimal clinically important difference Controlled Clinical Trials. ,vol. 10, pp. 407- 415 ,(1989) , 10.1016/0197-2456(89)90005-6
Dirk Arnold, Ullrich Graeven, Christian A. Lerchenmuller, Brigitta Killing, Reinhard Depenbusch, Claus-Christoph Steffens, Salah-Eddin Al-Batran, Thoralf Lange, Georg Dietrich, Jan Stoehlmacher, Andrea Tannapfel, Hans-Joachim Schmoll, Anke Reinacher-Schick, Susanna Hegewisch-Becker, Maintenance strategy with fluoropyrimidines (FP) plus Bevacizumab (Bev), Bev alone, or no treatment, following a standard combination of FP, oxaliplatin (Ox), and Bev as first-line treatment for patients with metastatic colorectal cancer (mCRC): A phase III non-inferiority trial (AIO KRK 0207). Journal of Clinical Oncology. ,vol. 32, pp. 3503- 3503 ,(2014) , 10.1200/JCO.2014.32.15_SUPPL.3503
Michelle Joy Naughton, Deborah Schrag, Alan Paul Venook, Donna Niedzwiecki, Roger T. Anderson, Heinz-Josef Lenz, Stephen S. Grubbs, Quality of life (QOL) and toxicity among patients in CALGB 80405. Journal of Clinical Oncology. ,vol. 31, pp. 3611- 3611 ,(2013) , 10.1200/JCO.2013.31.15_SUPPL.3611
Chantal Quinten, Francesca Martinelli, Corneel Coens, Mirjam A. G. Sprangers, Jolie Ringash, Carolyn Gotay, Kristin Bjordal, Eva Greimel, Bryce B. Reeve, John Maringwa, Divine E. Ediebah, Efstathios Zikos, Madeleine T. King, David Osoba, Martin J. Taphoorn, Henning Flechtner, Joseph Schmucker-Von Koch, Joachim Weis, Andrew Bottomley, , A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites Cancer. ,vol. 120, pp. 302- 311 ,(2014) , 10.1002/CNCR.28382
S Earlam, C Glover, C Fordy, D Burke, T G Allen-Mersh, Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases. Journal of Clinical Oncology. ,vol. 14, pp. 171- 175 ,(1996) , 10.1200/JCO.1996.14.1.171
D Osoba, G Rodrigues, J Myles, B Zee, J Pater, Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical Oncology. ,vol. 16, pp. 139- 144 ,(1998) , 10.1200/JCO.1998.16.1.139
Michelle K Wilson, Katherine Karakasis, Amit M Oza, Outcomes and endpoints in trials of cancer treatment: the past, present, and future. Lancet Oncology. ,vol. 16, ,(2015) , 10.1016/S1470-2045(14)70375-4