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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

In Oral Oncology.
By: Joshi A.
Contributor(s): Patil V | Noronha V | Dhumal S | Pande N | Chandrasekharan A | Turkar S | DSouza H | Shrirangwar S | Mahajan A | Arya S | Juvekar S | BhattaCharjee A | Prabhash K [Corresponding author].
Material type: materialTypeLabelArticlePublisher: 2017Description: .Subject(s): Cabazitaxel | Chemotherapy | Docetaxel | Head and neck cancer | Palliative | Second line In: Oral Oncology Vol. 75, p. 54-60Summary: BACKGROUND: Cabazitaxel 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. METHODS: This 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. RESULTS: The 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). CONCLUSION: Docetaxel had a superior disease control rate at 6 weeks compared to cabazitaxel
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Address for correspondence: kumarprabhashtmh@gmail.com.

BACKGROUND:
Cabazitaxel 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.

METHODS:
This 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.

RESULTS:
The 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).

CONCLUSION:
Docetaxel had a superior disease control rate at 6 weeks compared to cabazitaxel

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