The approval was based on the results of the phase 3 TROPIC clinical study, which involved 755 advanced hormone-refractory prostate cancer patients who were randomized to receive either cabazitaxel or mitoxantrone, both in combination with prednisone. Furthermore, all this patients must have failed docetaxel before enrollment.
The results indicated that cabazitaxel was able to significantly improve the median overall survival when compared with mitoxantrone (15.1 months with cabazitaxel and 12.7 months with mitoxantrone (P < .0001).
The tumor response rate was also higher in the cabazitaxel group than the mitoxantrone group (14.4% versus 4.4% respectively, P = .0005).
The most common adverse reactions were neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and alopecia.
To monitor the occurrence of neutropenia, frequent blood cell counts should be performed. Also, patients with neutrophil counts of 1500 cells/mm3 or less should not be given cabazitaxel.
This certainly is good news for patients with hormone and chemotherapy refractory prostate cancer patients. There is another drug to extend their life span.
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