Zeban in con.bination prednisone approved based on results frorn the Phase 3 TROPIC clinical study involving 755 patients rnHRPC previously treated writh a docetaxel—containing treatn-ment regirnen.
This trial dernonstrated a statistically significant 300/0 [HR=O.70 (950/0 CI: 0.59—0.83); P < O.OOO1] relative reduction in the risk Of death in r-nHRPC arnong patients taking Cabazitaxel in con.bination M.'ith prednisone cornpared an active chernotherapy regirnen consisting Of a standard dose ofn•itoxantrone and prednisone.
Median overall survival in the patients receiving Cabazitaxel plus prednisone 15.1 (14.1—16.3) rnonths cornpared to 12.7 (11.6 13.7) n•onths for patients receiving rnitoxantrone plus prednisone.
In the TROPIC Study? the I-nost con-unon (2 100/0) grade 1-4 adverse reactions anernra, leukopenia, neutropenia, thrornbocytopenia,
diarrhea, fatigue, nausea, vorniting, constipation, asthenia, abdoninal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and alopecia.
The I-nost cornrnon (2 50/0) grade 3-4 adverse reactions in patients received Cabazitaxel neutropenla, leukopenia, anernia, febrile neutropenia, diarrhea, fatigue, and asthenia.
Treatment discontinuations due to adverse drug reactions occurred in 180/0 Of patients A,vho received Cabazitaxel and 80/0 of patients received mitoxantrone.
The most comrnon adverse reactions leading to treatment discontinuation in the Cabazitaxel group were neutropenia and renal failure. Deaths due to causes other than disease progression 30 days of last study drug dose were reported in 18 (50/0) Cabazitaxel patients and three (less than 10/0) rnitoxantrone-treated patients.
The comrnon fatal adverse reactions in Cabazitaxel patients infections (n=5) and renal failure (n=4). One death was due to diarrhea—induced dehydration and electrolyte irnbalance.