Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG-ACRIN E2805 trial

Caitlin C. Murphy; Hannah M. Fullington; David E. Gerber; Isaac Alex Bowman; Maneka Puligandla; Janice P. Dutcher; Robert S. DiPaola; Naomi B. Haas

doi:10.1002/cam4.4140

Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG-ACRIN E2805 trial

Caitlin C. Murphy, Hannah M. Fullington, David E. Gerber, Isaac Alex Bowman, Maneka Puligandla, Janice P. Dutcher, Robert S. DiPaola, Naomi B. Haas

Research output: Contribution to journal › Article › peer-review

Abstract

Background: As use of oral cancer therapies increases, patient adherence has become critical when evaluating the effectiveness of therapy. In a phase III trial for renal cell carcinoma, we: (a) characterized adherence to sorafenib, sunitinib, and/or placebo and (b) identified factors associated with non-adherence. Methods: ECOG-ACRIN E2805 was a double-blind, placebo-controlled, randomized trial comparing adjuvant sorafenib or sunitinib in patients with resected primary renal cell carcinoma at high risk for recurrence. We used patient-completed pill diaries to measure adherence as the number of pills taken divided by the number of pills prescribed. Log-binomial regression was used to identify correlates of non-adherence (<80% of prescribed pills reported as taken). Results: Mean adherence was 90.7% among those assigned to sunitinib (n = 613) and 84.8% among those assigned to sorafenib (n = 616). Among those assigned to placebo, mean adherence was 94.9% and 92.4% to sunitinib and sorafenib placebo, respectively. Non-adherence was associated with race/ethnicity (non-Hispanic Black: prevalence ratio [PR] 2.22, 95% CI 1.63, 3.01; Hispanic: PR 1.54, 95% CI 1.05, 2.26), high volume enrollment (≥10 patients: PR 1.30, 95% CI 1.03, 1.64), treatment group (sunitinib: PR 2.24, 95% CI 1.66, 3.02; sorafenib: PR 2.37, 95% CI 1.74, 3.22), and skin rash (PR 1.36, 95% CI 1.03, 1.80). Conclusion: Among patients participating in a randomized clinical trial, adherence to oral cancer therapies was lower compared to placebo. Adherence was also worse in racial/ethnic minorities, those experiencing toxicities, and high volume enrolling sites. Our findings highlight several challenges to address in clinical practice as use of oral therapies continues to increase. Clinical trial registration number: This trial is registered with ClinicalTrials.gov, number NCT00326898.

Original language	English
Pages (from-to)	5917-5924
Number of pages	8
Journal	Cancer Medicine
Volume	10
Issue number	17
DOIs	https://doi.org/10.1002/cam4.4140
State	Published - Sep 2021

Bibliographical note

Funding Information:
This study was conducted in part by the ECOG-ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under the Center for Translational Medicine’s award number KL2TR001103 and the National Cancer Institute of the National Institutes of Health under award numbers U10CA180820, U10CA180794, and UG1CA233302. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Mention herein of trade names, commercial products, or organizations does not imply endorsement by the US government. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Funding Information:
This study was conducted in part by the ECOG‐ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co‐Chairs). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under the Center for Translational Medicine’s award number KL2TR001103 and the National Cancer Institute of the National Institutes of Health under award numbers U10CA180820, U10CA180794, and UG1CA233302. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Mention herein of trade names, commercial products, or organizations does not imply endorsement by the US government. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Publisher Copyright:
© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Keywords

adherence
clinical trial
renal cell carcinoma

ASJC Scopus subject areas

Oncology
Radiology Nuclear Medicine and imaging
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/cam4.4140

Cite this

@article{379f7675f7044e52ab53f8ea644de4d2,

title = "Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG-ACRIN E2805 trial",

abstract = "Background: As use of oral cancer therapies increases, patient adherence has become critical when evaluating the effectiveness of therapy. In a phase III trial for renal cell carcinoma, we: (a) characterized adherence to sorafenib, sunitinib, and/or placebo and (b) identified factors associated with non-adherence. Methods: ECOG-ACRIN E2805 was a double-blind, placebo-controlled, randomized trial comparing adjuvant sorafenib or sunitinib in patients with resected primary renal cell carcinoma at high risk for recurrence. We used patient-completed pill diaries to measure adherence as the number of pills taken divided by the number of pills prescribed. Log-binomial regression was used to identify correlates of non-adherence (<80% of prescribed pills reported as taken). Results: Mean adherence was 90.7% among those assigned to sunitinib (n = 613) and 84.8% among those assigned to sorafenib (n = 616). Among those assigned to placebo, mean adherence was 94.9% and 92.4% to sunitinib and sorafenib placebo, respectively. Non-adherence was associated with race/ethnicity (non-Hispanic Black: prevalence ratio [PR] 2.22, 95% CI 1.63, 3.01; Hispanic: PR 1.54, 95% CI 1.05, 2.26), high volume enrollment (≥10 patients: PR 1.30, 95% CI 1.03, 1.64), treatment group (sunitinib: PR 2.24, 95% CI 1.66, 3.02; sorafenib: PR 2.37, 95% CI 1.74, 3.22), and skin rash (PR 1.36, 95% CI 1.03, 1.80). Conclusion: Among patients participating in a randomized clinical trial, adherence to oral cancer therapies was lower compared to placebo. Adherence was also worse in racial/ethnic minorities, those experiencing toxicities, and high volume enrolling sites. Our findings highlight several challenges to address in clinical practice as use of oral therapies continues to increase. Clinical trial registration number: This trial is registered with ClinicalTrials.gov, number NCT00326898.",

keywords = "adherence, clinical trial, renal cell carcinoma",

author = "Murphy, {Caitlin C.} and Fullington, {Hannah M.} and Gerber, {David E.} and Bowman, {Isaac Alex} and Maneka Puligandla and Dutcher, {Janice P.} and DiPaola, {Robert S.} and Haas, {Naomi B.}",

note = "Funding Information: This study was conducted in part by the ECOG-ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under the Center for Translational Medicine{\textquoteright}s award number KL2TR001103 and the National Cancer Institute of the National Institutes of Health under award numbers U10CA180820, U10CA180794, and UG1CA233302. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Mention herein of trade names, commercial products, or organizations does not imply endorsement by the US government. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Funding Information: This study was conducted in part by the ECOG‐ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co‐Chairs). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under the Center for Translational Medicine{\textquoteright}s award number KL2TR001103 and the National Cancer Institute of the National Institutes of Health under award numbers U10CA180820, U10CA180794, and UG1CA233302. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Mention herein of trade names, commercial products, or organizations does not imply endorsement by the US government. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Publisher Copyright: {\textcopyright} 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.",

year = "2021",

month = sep,

doi = "10.1002/cam4.4140",

language = "English",

volume = "10",

pages = "5917--5924",

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TY - JOUR

T1 - Adherence to oral therapies among patients with renal cell carcinoma

T2 - Post hoc analysis of the ECOG-ACRIN E2805 trial

AU - Murphy, Caitlin C.

AU - Fullington, Hannah M.

AU - Gerber, David E.

AU - Bowman, Isaac Alex

AU - Puligandla, Maneka

AU - Dutcher, Janice P.

AU - DiPaola, Robert S.

AU - Haas, Naomi B.

N1 - Funding Information: This study was conducted in part by the ECOG-ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under the Center for Translational Medicine’s award number KL2TR001103 and the National Cancer Institute of the National Institutes of Health under award numbers U10CA180820, U10CA180794, and UG1CA233302. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Mention herein of trade names, commercial products, or organizations does not imply endorsement by the US government. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Funding Information: This study was conducted in part by the ECOG‐ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co‐Chairs). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under the Center for Translational Medicine’s award number KL2TR001103 and the National Cancer Institute of the National Institutes of Health under award numbers U10CA180820, U10CA180794, and UG1CA233302. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Mention herein of trade names, commercial products, or organizations does not imply endorsement by the US government. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Publisher Copyright: © 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

PY - 2021/9

Y1 - 2021/9

N2 - Background: As use of oral cancer therapies increases, patient adherence has become critical when evaluating the effectiveness of therapy. In a phase III trial for renal cell carcinoma, we: (a) characterized adherence to sorafenib, sunitinib, and/or placebo and (b) identified factors associated with non-adherence. Methods: ECOG-ACRIN E2805 was a double-blind, placebo-controlled, randomized trial comparing adjuvant sorafenib or sunitinib in patients with resected primary renal cell carcinoma at high risk for recurrence. We used patient-completed pill diaries to measure adherence as the number of pills taken divided by the number of pills prescribed. Log-binomial regression was used to identify correlates of non-adherence (<80% of prescribed pills reported as taken). Results: Mean adherence was 90.7% among those assigned to sunitinib (n = 613) and 84.8% among those assigned to sorafenib (n = 616). Among those assigned to placebo, mean adherence was 94.9% and 92.4% to sunitinib and sorafenib placebo, respectively. Non-adherence was associated with race/ethnicity (non-Hispanic Black: prevalence ratio [PR] 2.22, 95% CI 1.63, 3.01; Hispanic: PR 1.54, 95% CI 1.05, 2.26), high volume enrollment (≥10 patients: PR 1.30, 95% CI 1.03, 1.64), treatment group (sunitinib: PR 2.24, 95% CI 1.66, 3.02; sorafenib: PR 2.37, 95% CI 1.74, 3.22), and skin rash (PR 1.36, 95% CI 1.03, 1.80). Conclusion: Among patients participating in a randomized clinical trial, adherence to oral cancer therapies was lower compared to placebo. Adherence was also worse in racial/ethnic minorities, those experiencing toxicities, and high volume enrolling sites. Our findings highlight several challenges to address in clinical practice as use of oral therapies continues to increase. Clinical trial registration number: This trial is registered with ClinicalTrials.gov, number NCT00326898.

AB - Background: As use of oral cancer therapies increases, patient adherence has become critical when evaluating the effectiveness of therapy. In a phase III trial for renal cell carcinoma, we: (a) characterized adherence to sorafenib, sunitinib, and/or placebo and (b) identified factors associated with non-adherence. Methods: ECOG-ACRIN E2805 was a double-blind, placebo-controlled, randomized trial comparing adjuvant sorafenib or sunitinib in patients with resected primary renal cell carcinoma at high risk for recurrence. We used patient-completed pill diaries to measure adherence as the number of pills taken divided by the number of pills prescribed. Log-binomial regression was used to identify correlates of non-adherence (<80% of prescribed pills reported as taken). Results: Mean adherence was 90.7% among those assigned to sunitinib (n = 613) and 84.8% among those assigned to sorafenib (n = 616). Among those assigned to placebo, mean adherence was 94.9% and 92.4% to sunitinib and sorafenib placebo, respectively. Non-adherence was associated with race/ethnicity (non-Hispanic Black: prevalence ratio [PR] 2.22, 95% CI 1.63, 3.01; Hispanic: PR 1.54, 95% CI 1.05, 2.26), high volume enrollment (≥10 patients: PR 1.30, 95% CI 1.03, 1.64), treatment group (sunitinib: PR 2.24, 95% CI 1.66, 3.02; sorafenib: PR 2.37, 95% CI 1.74, 3.22), and skin rash (PR 1.36, 95% CI 1.03, 1.80). Conclusion: Among patients participating in a randomized clinical trial, adherence to oral cancer therapies was lower compared to placebo. Adherence was also worse in racial/ethnic minorities, those experiencing toxicities, and high volume enrolling sites. Our findings highlight several challenges to address in clinical practice as use of oral therapies continues to increase. Clinical trial registration number: This trial is registered with ClinicalTrials.gov, number NCT00326898.

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KW - clinical trial

KW - renal cell carcinoma

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Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG-ACRIN E2805 trial

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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