QOL analysis of a phase II randomized controlled clinical trial comparing efficacy of cabazitaxel versus docetaxel as second line or above therapy in recurrent head and neck cancer

Abstract

Background: Cabazitaxel has shown activity in squamous cancer cell lines and in tax-ane resistant cell lines. We reported a randomized phase 2 study to evaluate the efficacy and safety of cabazitaxel against docetaxel in recurrent head and neck cancer, post first line treatment. The previously reported outcome of this study reported Docetaxel had a superior disease control rate at 6 weeks (52.3% versus 13.6%, p = 0.017) OS (155 vs 115 days) compared to cabazitaxel. In this analysis we planned to compare the QOL between the 2 arms. Methods: This was a phase 2 open-label, investigator-initiated, randomized controlled trial of Docetaxel (75 mg/m2) versus Cabazitaxel (20 mg/m2), in adult patients with head and neck cancer, ECOG performance status 0-2, with measurable disease, who have been exposed to at least one line of chemotherapy (CTRI/2015/06/005848). 1:1 central randomization was performed and chemotherapy was administered till progressive disease or until the patient had intolerable side effects, with a sample size of 92 (46 per group). EORTC C-30 was collected at baseline, day 1 of each cycle and at treatment completion. R statistical software was used for mixed ANOVA and time to deterioration analysis(QoLR package) Results: OoL analysis using mixed ANOVA did not find any difference in the score between the 2 arms at baseline and subsequent follow-up. However, time to deterioration analysis revealed superior outcomes for Docetaxel in terms of constipation, diarrhea, dyspnoea, nausea and vomiting, financial difficulties, cognitive function, social and emotional functioning. Global Health status was statistically significant in the docetaxel arm as compared to Cabazitaxel arm. Conclusions: Docetaxel is superior to Cabazitaxel in Global health status outcome in patients of head and neck cancers when analyzed using the time to deterioration analysis. There was no significant difference between the 2 arms when analyzed by mixed ANOVA.