Long-term outcomes of a randomized controlled clinical trial comparing the efficacy of cabazitaxel versus docetaxel as second-line or above therapy in recurrent head and neck cancer.

Abstract

e18008 Background: Long term outcomes (> 2 years or above) are rarely reported in studies with second line or beyond systemic therapies in head and neck squmouas cell carcinoma (HNSCC). Methods: Recurrent or relapsed adult HNSCC, with ECOG PS 0-2 who have been exposed to at least one line of chemotherapy were 1:1 randomized between Docetaxel (75 mg/m2) and Cabazitaxel (20 mg/m2). The chemotherapy was given till progression or development of intolerable side effects. The outcomes reported are long term overall survival(OS) and progression free survival (PFS) and factors impacting overall survival. Results: On the intention to treat analysis (n = 92), at the time of data censoring, 92 patients had died. The median overall survival was 112 days (95% CI 81 to 178 days) in the cabazitaxel arm versus 192 days (95% CI 153 to 259 days) in the Docetaxel arm (P = 0.048). In cabazitaxel arm, the one year OS was 6.5% (95% CI 1.6-16.06), 2 year OS was 2.17% (95% CI 0.17-9.95) and 3 years was 2.17% (95% CI 0.17-9.95). While the corresponding figures in the docetaxel arm were 21.7% (95% CI 11.23-34.46), 0% and 0%. The median progression-free survival was 21.0 days (95% CI 16.0-42.0 days) in the Cabazitaxel arm versus 57.5 days (95% CI 26.0-85.0 days) in the Docetaxel arm (P = 0.02). Among the tested factors age (p = 0.037) and site of primary(p = 0.023) had an impact on OS. Conclusions: In this phase 2 randomised study, cabazitaxel has inferior PFS and OS than docetaxel. Hence docetaxel remains the option of choice when cytotoxic chemotherapy needs to be used as second line or beyond setting in HNSCC. Clinical trial information: CTRI/2015/06/005848.