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 associa...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-09-01
|
| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.4140 |
| _version_ | 1818589764553539584 |
|---|---|
| author | Caitlin C. Murphy Hannah M. Fullington David E. Gerber Isaac Alex Bowman Maneka Puligandla Janice P. Dutcher Robert S. DiPaola Naomi B. Haas |
| author_facet | Caitlin C. Murphy Hannah M. Fullington David E. Gerber Isaac Alex Bowman Maneka Puligandla Janice P. Dutcher Robert S. DiPaola Naomi B. Haas |
| author_sort | Caitlin C. Murphy |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-16T09:45:50Z |
| format | Article |
| id | doaj.art-dba4739510324da8974b70634cac917c |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-12-16T09:45:50Z |
| publishDate | 2021-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-dba4739510324da8974b70634cac917c2022-12-21T22:36:11ZengWileyCancer Medicine2045-76342021-09-0110175917592410.1002/cam4.4140Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trialCaitlin C. Murphy0Hannah M. Fullington1David E. Gerber2Isaac Alex Bowman3Maneka Puligandla4Janice P. Dutcher5Robert S. DiPaola6Naomi B. Haas7School of Public Health University of Texas Health Science Center at Houston (UTHealth) Houston TX USADepartment of Population and Data Sciences University of Texas Southwestern Medical Center Dallas TX USADepartment of Internal Medicine University of Texas Southwestern Medical Center Dallas TX USABanner MD Anderson Cancer Center Gilbert AZ USADepartment of Data Sciences Dana‐Farber Cancer Institute Boston MA USACancer Research Foundation of New York Chappaqua NY USACollege of Medicine University of Kentucky Lexington KY USADivision of Hematology‐Oncology Perelman School of Medicine University of Pennsylvania Philadelphia PA USAAbstract 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.https://doi.org/10.1002/cam4.4140adherenceclinical trialrenal cell carcinoma |
| spellingShingle | Caitlin C. Murphy Hannah M. Fullington David E. Gerber Isaac Alex Bowman Maneka Puligandla Janice P. Dutcher Robert S. DiPaola Naomi B. Haas Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trial Cancer Medicine adherence clinical trial renal cell carcinoma |
| title | Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trial |
| title_full | Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trial |
| title_fullStr | Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trial |
| title_full_unstemmed | Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trial |
| title_short | Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trial |
| title_sort | adherence to oral therapies among patients with renal cell carcinoma post hoc analysis of the ecog acrin e2805 trial |
| topic | adherence clinical trial renal cell carcinoma |
| url | https://doi.org/10.1002/cam4.4140 |
| work_keys_str_mv | AT caitlincmurphy adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial AT hannahmfullington adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial AT davidegerber adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial AT isaacalexbowman adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial AT manekapuligandla adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial AT janicepdutcher adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial AT robertsdipaola adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial AT naomibhaas adherencetooraltherapiesamongpatientswithrenalcellcarcinomaposthocanalysisoftheecogacrine2805trial |