Quality of life assessment and reporting in colorectal cancer: A systematic review of phase III trials published between 2012 and 2018. (February 2020)

• Record Type: Journal Article
• Authors: Lombardi, Pasquale; Marandino, Laura; De Luca, Emmanuele; Zichi, Clizia; Reale, Maria Lucia; Pignataro, Daniele; Di Stefano, Rosario F.; Ghisoni, Eleonora; Mariniello, Annapaola; Trevisi, Elena; Leone, Gianmarco; Muratori, Leonardo; La Salvia, Anna; Sonetto, Cristina; Leone, Francesco; Aglietta, Massimo; Novello, Silvia; Scagliotti, Giorgio V.; Perrone, Francesco; Di Maio, Massimo
• Is Part Of: Critical reviews in oncology/hematology. Volume 146(2020)
• Publication Date: 2020-02
• Subjects: Health-related quality of life -- Colorectal cancer -- Endpoints -- Patient-reported outcomes -- Randomized controlled trials; Oncology -- Periodicals; Hematology -- Periodicals; 616.994
• DOI: 10.1016/j.critrevonc.2020.102877
• Languages: English
• ISSNs: 1040-8428

Abstract

Abstract: Background: In this study, our aim was to describe quality of life (QoL) prevalence and heterogeneity in QoL reporting in colorectal cancer phase III trials. Methods: We included all phase III trials evaluating anticancer drugs in colorectal cancer patients published between 2012 and 2018 by 11 major journals. Results: Out of the 67 publications identified, in 41 (61.2 %) QoL was not listed among endpoints. Out of 26 primary publications of trials including QoL among endpoints, QoL results were not reported in 10 (38.5 %). Overall, no QoL data were available in 51/67 (76.1 %) primary publications. In particular, in the metastatic setting, QoL data were not available in 12/18 (66.7 %) trials with primary endpoint overall survival, and in 20/29 (69.0 %) trials with other primary endpoints. Conclusions: QoL was absent in a high proportion of recently published phase III trials in colorectal cancer, even in trials of second or further lines, where attention to QoL should be particularly high.