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Current Oncology
Volume 26
Issue 2
10.3747/co.26.4753
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Current Oncology is published by MDPI from Volume 28 Issue 1 (2021). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Multimed Inc..
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Article

What Is a Clinically Meaningful Survival Benefit in Refractory Metastatic Colorectal Cancer?

by
Y.J. Ko
1,
M. Abdelsalam
2,
P. Kavan
3,
H. Lim
4,
P.A. Tang
5,
M. Vincent
6,
R. Wong
7,
M. Kish
8 and
S. Gill
9,*
1
Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada
2
Division of Medical Oncology, Department of Medicine, Dalhousie University, Halifax, NS, Canada
3
Department of Oncology, McGill University, Montreal, QC, Canada
4
Division of Medical Oncology, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
5
Department of Oncology, Tom Baker Cancer Centre, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada
6
Division of Medical Oncology, London Regional Cancer Program, London, ON, Canada
7
CancerCare Manitoba, Department of Hemato-Oncology, University of Manitoba, Winnipeg, MB, Canada
8
Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada
9
BC Cancer, University of British Columbia, Vancouver, BC, Canada
*
Author to whom correspondence should be addressed.
Curr. Oncol. 2019, 26(2), 255-259; https://doi.org/10.3747/co.26.4753
Submission received: 4 January 2019 / Revised: 4 February 2019 / Accepted: 4 March 2019 / Published: 1 April 2019

Abstract

Assessment of the clinical benefit of cancer treatments can be highly subjective, influenced by both perspective and context. Such assessments are required in regulatory and policy decision-making, but consistency between jurisdictions is often lacking. Clear and consistent standards for determining when a treatment offers a meaningful benefit, relative to the current standard of care, can help to address issues of equity and transparency in health technology assessment. For metastatic colorectal cancer (MCRC), no standardized Canadian definition of clinically meaningful benefit has yet been proposed. Colorectal Cancer Canada therefore convened a group of medical oncologists expert in colorectal cancer to review the literature about clinical significance. The resulting consensus is intended to apply to any therapeutic agent being considered in the setting of chemotherapy-refractory MCRC. It was agreed that overall survival is the appropriate measure of clinical efficacy in chemorefractory MCRC. As quantitative targets for efficacy, an improvement of 2 months or more in median overall survival or a hazard ratio for survival of 0.75 or lower (or both) are proposed as the threshold for clinically meaningful benefit. That threshold could be influenced by a treatment’s effect on quality of life. Treatment toxicity is also relevant to the assessment of clinical benefit in this setting, specifically when significant differences in treatment tolerability are evident.
Keywords: colorectal cancer; metastatic; treatment-refractory disease; clinical significance; quality of life; patient functioning; treatment benefit; toxicity; tolerability colorectal cancer; metastatic; treatment-refractory disease; clinical significance; quality of life; patient functioning; treatment benefit; toxicity; tolerability

Share and Cite

MDPI and ACS Style

Ko, Y.J.; Abdelsalam, M.; Kavan, P.; Lim, H.; Tang, P.A.; Vincent, M.; Wong, R.; Kish, M.; Gill, S. What Is a Clinically Meaningful Survival Benefit in Refractory Metastatic Colorectal Cancer? Curr. Oncol. 2019, 26, 255-259. https://doi.org/10.3747/co.26.4753

AMA Style

Ko YJ, Abdelsalam M, Kavan P, Lim H, Tang PA, Vincent M, Wong R, Kish M, Gill S. What Is a Clinically Meaningful Survival Benefit in Refractory Metastatic Colorectal Cancer? Current Oncology. 2019; 26(2):255-259. https://doi.org/10.3747/co.26.4753

Chicago/Turabian Style

Ko, Y.J., M. Abdelsalam, P. Kavan, H. Lim, P.A. Tang, M. Vincent, R. Wong, M. Kish, and S. Gill. 2019. "What Is a Clinically Meaningful Survival Benefit in Refractory Metastatic Colorectal Cancer?" Current Oncology 26, no. 2: 255-259. https://doi.org/10.3747/co.26.4753

APA Style

Ko, Y. J., Abdelsalam, M., Kavan, P., Lim, H., Tang, P. A., Vincent, M., Wong, R., Kish, M., & Gill, S. (2019). What Is a Clinically Meaningful Survival Benefit in Refractory Metastatic Colorectal Cancer? Current Oncology, 26(2), 255-259. https://doi.org/10.3747/co.26.4753

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