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

Pasquale Lombardi; Laura Marandino; Emmanuele De Luca; Clizia Zichi; Maria Lucia Reale; Daniele Pignataro; Rosario F. Di Stefano; Eleonora Ghisoni; Annapaola Mariniello; Elena Trevisi; Gianmarco Leone; Leonardo Muratori; Anna La Salvia; Cristina Sonetto; Francesco Leone; Massimo Aglietta; Silvia Novello; Giorgio V. Scagliotti; Francesco Perrone; Massimo Di Maio

doi:10.1016/j.critrevonc.2020.102877

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

Pasquale Lombardi, Laura Marandino, Emmanuele De Luca, Clizia Zichi, Maria Lucia Reale, Daniele Pignataro, Rosario F. Di Stefano, Eleonora Ghisoni, Annapaola Mariniello, Elena Trevisi, Gianmarco Leone, Leonardo Muratori, Anna La Salvia, Cristina Sonetto, Francesco Leone, Massimo Aglietta, Silvia Novello, Giorgio V. Scagliotti, Francesco Perrone, Massimo Di Maio

Istituto Nazionale Tumori Fondazione G. Pascale

Research output: Contribution to journal › Review article

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.

Original language	English
Article number	102877
Journal	Critical Reviews in Oncology/Hematology
Volume	146
DOIs	https://doi.org/10.1016/j.critrevonc.2020.102877
Publication status	Published - Feb 2020

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Keywords

Colorectal cancer
Endpoints
Health-related quality of life
Patient-reported outcomes
Randomized controlled trials

ASJC Scopus subject areas

Hematology
Oncology

Cite this

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. (2020). Quality of life assessment and reporting in colorectal cancer: A systematic review of phase III trials published between 2012 and 2018. Critical Reviews in Oncology/Hematology, 146, [102877]. https://doi.org/10.1016/j.critrevonc.2020.102877

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

In: Critical Reviews in Oncology/Hematology, Vol. 146, 102877, 02.2020.

Research output: Contribution to journal › Review article

Lombardi, P, Marandino, L, De Luca, E, Zichi, C, Reale, ML, Pignataro, D, Di Stefano, RF, Ghisoni, E, Mariniello, A, Trevisi, E, Leone, G, Muratori, L, La Salvia, A, Sonetto, C, Leone, F, Aglietta, M, Novello, S, Scagliotti, GV, Perrone, F & Di Maio, M 2020, 'Quality of life assessment and reporting in colorectal cancer: A systematic review of phase III trials published between 2012 and 2018', Critical Reviews in Oncology/Hematology, vol. 146, 102877. https://doi.org/10.1016/j.critrevonc.2020.102877

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. / Quality of life assessment and reporting in colorectal cancer : A systematic review of phase III trials published between 2012 and 2018. In: Critical Reviews in Oncology/Hematology. 2020 ; Vol. 146.

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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.",

keywords = "Colorectal cancer, Endpoints, Health-related quality of life, Patient-reported outcomes, Randomized controlled trials",

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doi = "10.1016/j.critrevonc.2020.102877",

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AU - Lombardi, Pasquale

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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

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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.

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10.1016/j.critrevonc.2020.102877