Background:
Cabazitaxel is a second-generation
taxane that is approved for use with concomitant low dose daily
prednisone in metastatic
castration resistant
prostate cancer (mCRPC) after
docetaxel failure. Since the role of daily
corticosteroids in improving
cabazitaxel efficacy or ameliorating its safety profile has not been adequately investigated so far, we compared outcomes of patients receiving
cabazitaxel with or without daily
corticosteroids in a retrospective single-Institution cohort of mCRPC patients. Patients and methods: Medical records of deceased patients with documented mCRPC treated with
cabazitaxel following prior
docetaxel between January, 2011 and January, 2017 were reviewed at the single participating center. Patients who were receiving daily doses of systemic
corticosteroids other than low dose daily
prednisone or
prednisolone (<= 10 mg a day) were excluded. The primary end point of this analysis was overall survival (OS). Secondary end-points were exposure to
cabazitaxel as well as incidence of grade 3-4 adverse events. Univariable and multivariable Cox proportional hazards regression was used to evaluate
prednisone use and other variables as potentially prognostic for overall survival. Results: Overall, among 91 patients, 57 patients received
cabazitaxel concurrently with low dose
prednisone and 34 patients did not receive concurrent
prednisone. The median overall survival of the population was 9.8 months (interquartile range, 9 to 14). Patients receiving
prednisone had an overall survival of 9 months (interquartile range, 8 to 12) vs.14 months (interquartile range, 9.4 to 16.7) for patients not treated with
prednisone. Approximately 45% of patients had a >30% PSA decline at 12 weeks.
Prednisone use was not significantly prognostic for overall survival or PSA decline ≥30% rates on regression analyses. Importantly, a >30% PSA decline at 12, but not at 3, 6, 9 weeks, was prognostic for improved survival at multivariate analysis Conclusions: The data presented here support the hypothesis that omitting daily
corticosteroids in
cabazitaxel-treated patients has no negative impact on either survival or safety profile. In the large prospective trial CABACARE,
cabazitaxel-treated patients will be randomized to receive or not receive daily
prednisone. The CABACARE (EudraCT n. 2016-003646-81) study is currently ongoing at University Federico II of Naples and at other multiple participating centers in Italy.