TY - JOUR
T1 - Quality of life assessment and reporting in colorectal cancer
T2 - A systematic review of phase III trials published between 2012 and 2018
AU - Lombardi, Pasquale
AU - Marandino, Laura
AU - De Luca, Emmanuele
AU - Zichi, Clizia
AU - Reale, Maria Lucia
AU - Pignataro, Daniele
AU - Di Stefano, Rosario F.
AU - Ghisoni, Eleonora
AU - Mariniello, Annapaola
AU - Trevisi, Elena
AU - Leone, Gianmarco
AU - Muratori, Leonardo
AU - La Salvia, Anna
AU - Sonetto, Cristina
AU - Leone, Francesco
AU - Aglietta, Massimo
AU - Novello, Silvia
AU - Scagliotti, Giorgio V.
AU - Perrone, Francesco
AU - Di Maio, Massimo
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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.
KW - Colorectal cancer
KW - Endpoints
KW - Health-related quality of life
KW - Patient-reported outcomes
KW - Randomized controlled trials
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U2 - 10.1016/j.critrevonc.2020.102877
DO - 10.1016/j.critrevonc.2020.102877
M3 - Review article
AN - SCOPUS:85078561109
VL - 146
JO - Critical Reviews in Oncology/Hematology
JF - Critical Reviews in Oncology/Hematology
SN - 1040-8428
M1 - 102877
ER -