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Appropriate Analysis of Duration of Response Data in Cancer Trials

Appropriate Analysis of Duration of Response Data in Cancer Trials Letters founding (eg, from difference in cancer progression or greater co- scriptive and based on responders only. Without including data morbidity) by radiotherapy completion status when using date from nonresponders, this approach can result in biased infer- of last radiation dose as time zero. As suggested, we conducted ences about the DOR when, as in the present case, the cumu- Cox regression with radiotherapy modeled as a time-dependent lative response rates of the treatment groups are markedly im- exposure whereby patients who underwent radiotherapy were balanced. To this end, one could consider an ineffective classified as noncompleters until they received at least 45 Gy and treatment that only achieves response in patients with low dis- 25fractions,fromwhichpointtheywereclassifiedascompleters. ease burden at baseline and who were less likely to experi- Using this approach, the estimated aHR was 1.55 (95% CI, 1.13- ence progression. For this ineffective treatment, the median 2.14)—a result again nearly identical to our original analysis. DOR among the few responders might misleadingly appear im- Our final study design preferentially addressed potential pressive, yet most patients would not benefit. Even if we are confounding bias over immortal time bias. Based on the 3 aHRs interested in the DOR among responders http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Oncology American Medical Association

Appropriate Analysis of Duration of Response Data in Cancer Trials

JAMA Oncology , Volume 6 (12) – Dec 8, 2020

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Publisher
American Medical Association
Copyright
Copyright 2020 American Medical Association. All Rights Reserved.
ISSN
2374-2437
eISSN
2374-2445
DOI
10.1001/jamaoncol.2020.4657
Publisher site
See Article on Publisher Site

Abstract

Letters founding (eg, from difference in cancer progression or greater co- scriptive and based on responders only. Without including data morbidity) by radiotherapy completion status when using date from nonresponders, this approach can result in biased infer- of last radiation dose as time zero. As suggested, we conducted ences about the DOR when, as in the present case, the cumu- Cox regression with radiotherapy modeled as a time-dependent lative response rates of the treatment groups are markedly im- exposure whereby patients who underwent radiotherapy were balanced. To this end, one could consider an ineffective classified as noncompleters until they received at least 45 Gy and treatment that only achieves response in patients with low dis- 25fractions,fromwhichpointtheywereclassifiedascompleters. ease burden at baseline and who were less likely to experi- Using this approach, the estimated aHR was 1.55 (95% CI, 1.13- ence progression. For this ineffective treatment, the median 2.14)—a result again nearly identical to our original analysis. DOR among the few responders might misleadingly appear im- Our final study design preferentially addressed potential pressive, yet most patients would not benefit. Even if we are confounding bias over immortal time bias. Based on the 3 aHRs interested in the DOR among responders

Journal

JAMA OncologyAmerican Medical Association

Published: Dec 8, 2020

References