The preliminary data of a study published in “BJU International” indicated that the addition of cabozantinib to docetaxel/prednisone is safe with possible improved efficacy. This multicentre phase 1/2 study was performed to explore the efficacy and safety of cabozantinib combined with docetaxel in 44 patients suffering from metastatic castration-resistant prostate cancer.
Investigators combined docetaxel (75 mg/m2 every three weeks with daily prednisone 10 mg) with the increasing dosages of daily cabozantinib (20, 40, and 60 mg). On the basis of the findings from the phase 1 study, the assessment was expanded into a randomized trial of docetaxel with prednisone plus the maximum tolerated dose of cabozantinib in comparison with docetaxel/prednisone alone.
A maximum tolerated dose of 40 mg cabozantinib plus docetaxel/prednisone was assessed. Palmar-plantar erythrodysesthesia and neutropenic fever were the dose-limiting toxicities. One subject died due to a thromboembolic event. Notably, three or more patients reported grade three or four myelosuppression, neuropathy, and hypophosphatemia.
In the phase I analysis, the overall survival time and the median time to progression were found to be 16.3 and 13.6 months respectively. In the phase II analysis (ended early due to inadequate accrual), the median time to progression and overall survival supported the combo in comparison with docetaxel/prednisone alone, as shown below:
|Combination group (n = 13)||Docetaxel/prednisone alone (n=12)|
|Median time to progression||21 months||6.6 months|
|Overall survival time||23.8 months||15.6 months|
Thus, in patients with metastatic castration-resistant prostate cancer, adding cabozantinib to docetaxel therapy is safe and also improves efficacy.
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|Original title of the article||Cabozantinib plus docetaxel and prednisone in metastatic castration resistant prostate cancer|
|Authors:||Ravi A Madan et al.|