Lost in the plot: missing visual elements in Kaplan-Meier plots of phase III oncology trials

Author:

Sherry Alexander D1ORCID,Msaouel Pavlos23ORCID,Kouzy Ramez1ORCID,Abi Jaoude Joseph14ORCID,Lin Timothy A5ORCID,Taniguchi Cullen M67ORCID,Fuller Clifton David1ORCID,Minsky Bruce6ORCID,Ludmir Ethan B168ORCID

Affiliation:

1. Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX , United States

2. Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center , Houston, TX , United States

3. Department of Translational Molecular Pathology, Division of Pathology/Lab Medicine, The University of Texas MD Anderson Cancer Center , Houston, TX , United States

4. Department of Radiation Oncology, Stanford University , Stanford, CA , United States

5. Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine , Baltimore, MD , United States

6. Department of Gastrointestinal Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX , United States

7. Department of Experimental Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX , United States

8. Department of Biostatistics, The University of Texas MD Anderson Cancer Center , Houston, TX , United States

Abstract

Abstract Missing visual elements (MVE) in Kaplan-Meier (KM) curves can misrepresent data, preclude curve reconstruction, and hamper transparency. This study evaluated KM plots of phase III oncology trials. MVE were defined as an incomplete y-axis range or missing number at risk table in a KM curve. Surrogate endpoint KM curves were additionally evaluated for complete interpretability, defined by (1) reporting the number of censored patients and (2) correspondence of the disease assessment interval with the number at risk interval. Among 641 trials enrolling 518 235 patients, 116 trials (18%) had MVE in KM curves. Industry sponsorship, larger trials, and more recently published trials were correlated with lower odds of MVE. Only 3% of trials (15 of 574) published surrogate endpoint KM plots with complete interpretability. Improvements in the quality of KM curves of phase III oncology trials, particularly for surrogate endpoints, are needed for greater interpretability, reproducibility, and transparency in oncology research.

Funder

Cancer Center Support

National Cancer Institute

National Institutes of Health

Publisher

Oxford University Press (OUP)

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