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

Franck Bonnetain*, C. Borg, R. R. Adams, J. A. Ajani, A. Benson, H. Bleiberg, B. Chibaudel, E. Diaz-Rubio, J. Y. Douillard, C. S. Fuchs, B. J. Giantonio, R. Goldberg, V. Heinemann, M. Koopman, R. Labianca, A. K. Larsen, T. Maughan, E. Mitchell, M. Peeters, C. J.A. Punt & 3 others H. J. Schmoll, C. Tournigand, A. de Gramont

*Corresponding author for this work

Research output: Contribution to journalReview article

5 Citations (Scopus)

Abstract

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

Original languageEnglish (US)
Pages (from-to)2077-2085
Number of pages9
JournalAnnals of Oncology
Volume28
Issue number9
DOIs
StatePublished - Jan 1 2017

Fingerprint

Colorectal Neoplasms
Quality of Life
Clinical Trials
Neoplasms
Disease-Free Survival
Survival
Precision Medicine
Therapeutic Uses
Health
Therapeutics
Research

Keywords

  • Clinical trial
  • Colorectal cancer
  • End point
  • Health-related quality of life
  • Longitudinal
  • Methodology

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Bonnetain, F., Borg, C., Adams, R. R., Ajani, J. A., Benson, A., Bleiberg, H., ... de Gramont, A. (2017). How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials. Annals of Oncology, 28(9), 2077-2085. https://doi.org/10.1093/annonc/mdx191
Bonnetain, Franck ; Borg, C. ; Adams, R. R. ; Ajani, J. A. ; Benson, A. ; Bleiberg, H. ; Chibaudel, B. ; Diaz-Rubio, E. ; Douillard, J. Y. ; Fuchs, C. S. ; Giantonio, B. J. ; Goldberg, R. ; Heinemann, V. ; Koopman, M. ; Labianca, R. ; Larsen, A. K. ; Maughan, T. ; Mitchell, E. ; Peeters, M. ; Punt, C. J.A. ; Schmoll, H. J. ; Tournigand, C. ; de Gramont, A. / How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials. In: Annals of Oncology. 2017 ; Vol. 28, No. 9. pp. 2077-2085.
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abstract = "Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease in clinical studies has been studied using overall survival and more recently tumor-based end points such as progression-free survival, measurements of response to treatment. However, these seem not to be the relevant clinical end points in current situation if such end points were no validated as surrogate of overall survival to demonstrate the clinical efficacy. Appropriate, meaningful, primary patient-oriented and patient-reported end points that adequately measure the effects of new therapeutic interventions are then crucial for the advancement of clinical research in metastatic colorectal cancer to complement the results of tumor-based end points. Healthrelated quality of life (HRQoL) is effectively an evaluation of quality of life and its relationship with health over time. HRQoL includes the patient report at least of the way a disease or its treatment affects its physical, emotional and social well-being. Over the past few years, several phase III trials in a variety of solid cancers have assessed the incremental value of HRQoL in addition to the traditional end points of tumor response and survival results. HRQoL could provide not only complementary clinical data to the primary outcomes, but also more precise predictive and prognostic value. This end point is useful for both clinicians and patients in order to achieve the dogma of precision medicine. The present article examines the use of HRQoL in phase III metastatic colorectal cancer clinical trials, outlines the importance of HRQoL assessment methods, analysis, and results presentation. Moreover, it discusses the relevance of including HRQoL as a primary/co-primary end point to support the progression-free survival results and to assess efficacy of treatment in the advanced disease setting.",
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Bonnetain, F, Borg, C, Adams, RR, Ajani, JA, Benson, A, Bleiberg, H, Chibaudel, B, Diaz-Rubio, E, Douillard, JY, Fuchs, CS, Giantonio, BJ, Goldberg, R, Heinemann, V, Koopman, M, Labianca, R, Larsen, AK, Maughan, T, Mitchell, E, Peeters, M, Punt, CJA, Schmoll, HJ, Tournigand, C & de Gramont, A 2017, 'How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials', Annals of Oncology, vol. 28, no. 9, pp. 2077-2085. https://doi.org/10.1093/annonc/mdx191

How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials. / Bonnetain, Franck; Borg, C.; Adams, R. R.; Ajani, J. A.; Benson, A.; Bleiberg, H.; Chibaudel, B.; Diaz-Rubio, E.; Douillard, J. Y.; Fuchs, C. S.; Giantonio, B. J.; Goldberg, R.; Heinemann, V.; Koopman, M.; Labianca, R.; Larsen, A. K.; Maughan, T.; Mitchell, E.; Peeters, M.; Punt, C. J.A.; Schmoll, H. J.; Tournigand, C.; de Gramont, A.

In: Annals of Oncology, Vol. 28, No. 9, 01.01.2017, p. 2077-2085.

Research output: Contribution to journalReview article

TY - JOUR

T1 - How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials

AU - Bonnetain, Franck

AU - Borg, C.

AU - Adams, R. R.

AU - Ajani, J. A.

AU - Benson, A.

AU - Bleiberg, H.

AU - Chibaudel, B.

AU - Diaz-Rubio, E.

AU - Douillard, J. Y.

AU - Fuchs, C. S.

AU - Giantonio, B. J.

AU - Goldberg, R.

AU - Heinemann, V.

AU - Koopman, M.

AU - Labianca, R.

AU - Larsen, A. K.

AU - Maughan, T.

AU - Mitchell, E.

AU - Peeters, M.

AU - Punt, C. J.A.

AU - Schmoll, H. J.

AU - Tournigand, C.

AU - de Gramont, A.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease in clinical studies has been studied using overall survival and more recently tumor-based end points such as progression-free survival, measurements of response to treatment. However, these seem not to be the relevant clinical end points in current situation if such end points were no validated as surrogate of overall survival to demonstrate the clinical efficacy. Appropriate, meaningful, primary patient-oriented and patient-reported end points that adequately measure the effects of new therapeutic interventions are then crucial for the advancement of clinical research in metastatic colorectal cancer to complement the results of tumor-based end points. Healthrelated quality of life (HRQoL) is effectively an evaluation of quality of life and its relationship with health over time. HRQoL includes the patient report at least of the way a disease or its treatment affects its physical, emotional and social well-being. Over the past few years, several phase III trials in a variety of solid cancers have assessed the incremental value of HRQoL in addition to the traditional end points of tumor response and survival results. HRQoL could provide not only complementary clinical data to the primary outcomes, but also more precise predictive and prognostic value. This end point is useful for both clinicians and patients in order to achieve the dogma of precision medicine. The present article examines the use of HRQoL in phase III metastatic colorectal cancer clinical trials, outlines the importance of HRQoL assessment methods, analysis, and results presentation. Moreover, it discusses the relevance of including HRQoL as a primary/co-primary end point to support the progression-free survival results and to assess efficacy of treatment in the advanced disease setting.

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

KW - Clinical trial

KW - Colorectal cancer

KW - End point

KW - Health-related quality of life

KW - Longitudinal

KW - Methodology

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U2 - 10.1093/annonc/mdx191

DO - 10.1093/annonc/mdx191

M3 - Review article

VL - 28

SP - 2077

EP - 2085

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

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