AI Article Synopsis

  • A phase III trial investigated patient adherence to oral cancer therapies (sorafenib and sunitinib) for renal cell carcinoma, using pill diaries to track pill intake and identify factors leading to non-adherence.
  • Overall adherence was high, with sunitinib patients averaging 90.7% and sorafenib patients 84.8%, while placebo groups had even higher rates of adherence.
  • Key factors for non-adherence included racial/ethnic background, treatment group, site enrollment volume, and experienced side effects like skin rash, emphasizing the need for better support in clinical practices.

Article 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419781PMC
http://dx.doi.org/10.1002/cam4.4140DOI Listing

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