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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\u2010adherence.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ECOG\u2010ACRIN E2805 was a double\u2010blind, placebo\u2010controlled, randomized trial comparing adjuvant sorafenib or sunitinib in patients with resected primary renal cell carcinoma at high risk for recurrence. We used patient\u2010completed pill diaries to measure adherence as the number of pills taken divided by the number of pills prescribed. Log\u2010binomial regression was used to identify correlates of non\u2010adherence (&lt;80% of prescribed pills reported as taken).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mean adherence was 90.7% among those assigned to sunitinib (n\u00a0=\u00a0613) and 84.8% among those assigned to sorafenib (n\u00a0=\u00a0616). Among those assigned to placebo, mean adherence was 94.9% and 92.4% to sunitinib and sorafenib placebo, respectively. Non\u2010adherence was associated with race\/ethnicity (non\u2010Hispanic 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 (\u226510 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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial registration number<\/jats:title><jats:p>This trial is registered with ClinicalTrials.gov, number NCT00326898.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.4140","type":"journal-article","created":{"date-parts":[[2021,8,18]],"date-time":"2021-08-18T09:37:58Z","timestamp":1629279478000},"page":"5917-5924","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG\u2010ACRIN E2805 trial"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9365-0691","authenticated-orcid":false,"given":"Caitlin C.","family":"Murphy","sequence":"first","affiliation":[{"name":"School of Public Health University of Texas Health Science Center at Houston (UTHealth) Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hannah M.","family":"Fullington","sequence":"additional","affiliation":[{"name":"Department of Population and Data Sciences University of Texas Southwestern Medical Center Dallas TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David E.","family":"Gerber","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine University of Texas Southwestern Medical Center Dallas TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0323-7049","authenticated-orcid":false,"given":"Isaac Alex","family":"Bowman","sequence":"additional","affiliation":[{"name":"Banner MD Anderson Cancer Center Gilbert AZ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maneka","family":"Puligandla","sequence":"additional","affiliation":[{"name":"Department of Data Sciences Dana\u2010Farber Cancer Institute Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janice P.","family":"Dutcher","sequence":"additional","affiliation":[{"name":"Cancer Research Foundation of New York Chappaqua NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert S.","family":"DiPaola","sequence":"additional","affiliation":[{"name":"College of Medicine University of Kentucky Lexington KY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naomi B.","family":"Haas","sequence":"additional","affiliation":[{"name":"Division of Hematology\u2010Oncology Perelman School of Medicine University of Pennsylvania Philadelphia PA 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