Published in the Lancet in 2010, the TROPIC study showed that cabazitaxel plus prednisone (CbzP) improved survival compared with mitoxantrone plus prednisone (MP) in men with mCRPC who progressed after docetaxel-based therapy. Also, pain response rates and time to pain progression were similar when compared with MP. A total of 755 patients with mCRPC, who progressed during or after receiving docetaxel, were randomized to receive 10 mg of oral prednisone daily and either 12 mg/m2 of mitoxantrone or 25 mg/m2 of cabazitaxel every 3 weeks. Disease control was defined as complete response, partial response, or stable disease. Patients reported pain using the McGill-Melzack Present Pain Intensity (PPI) scale and analgesic consumption was used to derive the analgesic score (AS). Changes from baseline in ECOG PS and PPI score during treatment were also assessed. Area under the curve (AUC) for PPI and AS was calculated.
In the 405 evaluable patients, disease control rates were 61.7% with CbzP vs. 47.5% with MP (P=0.004). The median number of treatment cycles was higher in the CbzP group (6 vs. 4). Changes from baseline in performance status were evaluated in 357 CbzP and 364 MP patients; MP and PPI were assessed in 333 CbzP and 324 MP men. PS remained stable during treatment in most men (CbzP 79% vs. MP 78%), and respective rates of PS worsening or improvement was similar. PPI scores improved in 21% of men treated with CbzP and 18% with MP, whereas PPI score worsened in 32% of men in each group. Means of the AUC of PPI and AS were similar. The most common grade ≥3 toxicities were neutropenia (82% vs. 58%), febrile neutropenia (8% vs. 1%), and diarrhea (6% vs. <1%) in the CbzP vs. MP groups, respectively.
He concluded that despite longer treatment with cabazitaxel, PS remained stable and comparable during treatment and changes pain intensity and pain medication usage were similar with both agents.
Presented by Bertrand Tombal, MD, PhD, et al. at the 26th Annual European Association of Urology (EAU) Congress - March 18 - 21, 2011 - Austria Centre Vienna, Vienna, Austria