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.

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

Lombardi P.;Marandino L.;De Luca E.;Zichi C.;Reale M. L.;Pignataro D.;Di Stefano R. F.;Ghisoni E.;Mariniello A.;Trevisi E.;Leone G.;Muratori L.;La Salvia A.;Sonetto C.;Aglietta M.;Novello S.;Scagliotti G. V.;Di Maio M.
2020-01-01

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.
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Colorectal cancer; Endpoints; Health-related quality of life; Patient-reported outcomes; Randomized controlled trials
Lombardi P.; Marandino L.; De Luca E.; Zichi C.; Reale M.L.; Pignataro D.; Di Stefano R.F.; Ghisoni E.; Mariniello A.; Trevisi E.; Leone G.; Muratori L.; La Salvia A.; Sonetto C.; Leone F.; Aglietta M.; Novello S.; Scagliotti G.V.; Perrone F.; Di Maio M.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1729963
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