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Clinical End Points and Relevant Clinical Benefits in Advanced Colorectal Cancer Trials

  • Therapeutic Approaches to Metastatic Colorectal Cancers (R Salazar, Section Editor)
  • Published:
Current Colorectal Cancer Reports

Abstract

Discussion of which variable represents the benefits derived from the adoption of a new treatment in a more reliable manner is of vital importance, both for the design of future clinical trials and for the interpretation of their results, and also to transfer them satisfactorily into clinical practice. Overall survival remains the end point which reflects the clinical benefit most clearly, followed by quality of life and patients’ reported outcomes. However, it may not always be feasible to choose overall survival as the primary end point. Must progression-free survival or other surrogate end points replace overall survival in some settings? In this review we highlight the flaws of the end points used in clinical trials and in the setting of advanced colorectal cancer. We also review the results of all recently reported randomized trials in the field, with a critical discussion of their clinical relevance and final recommendations to optimize the design of clinical trials.

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Acknowledgments

We thank Ron Clapp for his contribution to the editing of the manuscript.

Compliance with Ethics Guidelines

ᅟ

Conflict of Interest

Margarita García has received financial support through grants from Hoffman-La Roche (Madrid, Spain).

Valentín Navarro declares that he has no conflict of interest.

Ana Clopés has received financial support through grants from Roche, Merck Serono, and Amgen, and has also received non-financial support from Roche.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Authors and Affiliations

  1. Clinical Research Unit, Institut Català d’Oncologia—IDIBELL, Avinguda Gran Via de l’Hospitalet 199-203, L’Hospitalet de Llobregat, 08907, Barcelona, Spain

    Margarita García & Valentín Navarro

  2. Pharmacy Department, Institut Català d’Oncologia—IDIBELL, Avinguda Gran Via de l’Hospitalet 199-203, L’Hospitalet de Llobregat, 08907, Barcelona, Spain

    Ana Clopés

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  1. Margarita García
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  2. Valentín Navarro
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  3. Ana Clopés
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Correspondence to Margarita García.

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García, M., Navarro, V. & Clopés, A. Clinical End Points and Relevant Clinical Benefits in Advanced Colorectal Cancer Trials. Curr Colorectal Cancer Rep 10, 254–262 (2014). https://doi.org/10.1007/s11888-014-0227-4

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