Results 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

Publication date: December 2017
Source:Oral Oncology, Volume 75
Author(s): Amit Joshi, Vijay Patil, Vanita Noronha, Sachin Dhumal, Nikhil Pande, Arun Chandrasekharan, Siddharth Turkar, Hollis DSouza, Sameer Shrirangwar, Abhishek Mahajan, Supreeta Arya, Shashikant Juvekar, Atanu BhattaCharjee, Kumar Prabhash
BackgroundCabazitaxel has shown activity in squamous cancer cell lines and in taxane resistant cell lines. Hence we planned a phase 2 study to evaluate the efficacy of cabazitaxel against Docetaxel in recurrent head and neck cancer, post first line treatment.MethodsThis was a phase 2, investigator initiated, randomized controlled trial of Docetaxel (75 mg/m²) versus Cabazitaxel (20 mg/m²), in patients with head and neck cancer with ECOG performance status 0–2 who have been exposed to at least one line of chemotherapy, involving a sample size of 92 (46 per group)(CTRI/2015/06/005848). Disease control rate at 6 weeks was assessed and compared using the chi-square test.ResultsThe disease control rate at 6 weeks was better in the Docetaxel arm over the cabazitaxel arm (52.3% versus 13.6%, p = 0.017). The median progression free survival was 21 days (95% CI 5.28 to 36.72 days) in the cabazitaxel arm versus 61 days (95% CI 21.39 to 100.60 days) in the Docetaxel arm (HR-1.455, 95% CI 0.919–2.304, p = 0.100). The median overall survival was 115 days (95% CI 74.04 to 155.95 days) in the cabazitaxel arm versus 155 days (95% CI 148.6 to 161.40 days) in the Docetaxel arm (HR-1.464, 95% CI 0.849–2.523, p = 0.170).ConclusionDocetaxel had a superior disease control rate at 6 weeks compared to cabazitaxel.



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