Quality of life without toxicity or symptoms analysis of a randomized controlled clinical trial comparing efficacy of cabazitaxel versus docetaxel in recurrent head and neck cancer

Abstract

Background: This analysis was done with the aim to study the overall impact of docetaxel and cabazitaxel treatment using quality-adjusted time without symptoms and toxicity (QTWiST) analysis in head and neck cancer patients receiving second-line treatment. Methods: Overall survival (OS) was partitioned in three health states for QTWiST analysis. Toxicity (TOX) state was defined as the cumulative number of days spent in grade 3 or above toxicity postrandomization and before progression. TWiST state was defined as the cumulative number of days spent postrandomization and before progression without grade 3 or above toxicity. REL state was defined as the time spent in days postprogression till death. A threshold utility analysis was performed. Results: The restricted mean TOX state duration in cabazitaxel arm was 2.26 days (95% confidence interval [CI] 1.12–3.40) versus 1.54 days (95% CI 0.56–2.53 days) in docetaxel arm. In threshold utility analysis, the mean difference in QTWiST was in favor of docetaxel arm and ranged from −7.194 (utility for TOX) to −35.96. For any combination of utility score of REL >0, with any combination of utility score of TOX, the difference in mean QTWiST between the two arms was >14 days (i.e. >10% of OS), in favor of docetaxel arm which is considered clinically meaningful. Conclusion: Patients randomized to docetaxel arm had a higher QTWiST score than patients in cabazitaxel arm. There was a suggestion that docetaxel led to better quallity of life without toxicity or symptoms, which would require confirmation in a larger study.