In a quality-of-life analysis from the phase IV CARD trial reported in The Lancet Oncology, Karim Fizazi, MD, and colleagues found that cabazitaxel was associated with improved pain response, time to pain progression, and time to symptomatic skeletal events vs abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer.
As previously reported, the CARD trial showed that cabazitaxel significantly improved radiographic progression-free survival and overall survival vs abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen signaling–targeted inhibitor.
Karim Fizazi, MD
Study Details
In the open-label trial, 255 patients were randomly assigned to receive either cabazitaxel at 25 mg/m2 every 3 weeks with prednisone at 10 mg daily and granulocyte colony-stimulating factor (n =129), or abiraterone at 1,000 mg once daily plus prednisone at 5 mg twice daily or enzalutamide at 160 mg daily (n = 126).
The current analysis included assessment of pain (using item 3 on the Brief Pain Inventory-Short Form [BPI-SF]), symptomatic skeletal events, and patient-reported outcomes using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and the EuroQoL-5 dimensions 5 level scale (EQ-5D-5L). Analyses were performed in the intention-to-treat population with a baseline and at least one postbaseline assessment.
Pain response was defined as at least a 30% decrease from baseline in average BPI-SF pain intensity score observed at two consecutive evaluations at least 3 weeks apart without an increased analgesic usage score. Pain progression was defined as at least a 30% increase from baseline in BPI-SF pain intensity score observed at two consecutive evaluations at least 3 weeks apart without at least a 30% increase or decrease in analgesic usage score.
Key Findings
Median follow-up was 9.2 months. Pain response was observed in 51 (46%) of 111 patients in the cabazitaxel group and in 21 (19%) of 109 patients in the abiraterone or enzalutamide group (P < .0001).
“Since cabazitaxel improved pain response, time to pain progression, time to symptomatic skeletal events, and EQ-5D-5L utility index, clinicians and patients with metastatic castration-resistant prostate cancer can be reassured that cabazitaxel will not reduce quality of life when compared with treatment with a second androgen signaling–targeted inhibitor.”— Karim Fizazi, MD
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At data cutoff, 25 (23%) of 111 patients treated with cabazitaxel had pain progression vs 27 (25%) of 109 treated with abiraterone or enzalutamide. The median time to pain progression was not reached (95% confidence interval [CI] = not estimable–not estimable) with cabazitaxel and 8.5 months (95% CI = 4.9 months–not estimable) with abiraterone or enzalutamide (hazard ratio [HR] = 0.55, 95% CI = 0.32–0.97, P = .035).
Symptomatic skeletal events were observed in 24 (19%) of 129 patients in the cabazitaxel group and 35 (28%) of 126 patients in the abiraterone or enzalutamide group. Median time to symptomatic skeletal events was not reached (95% CI = 20.0 months–not estimable) with cabazitaxel and 16.7 months (95% CI = 10.8 months–not estimable) with abiraterone or enzalutamide (HR = 0.59, 95% CI = 0.35–1.01, P = .050). Denosumab or bisphosphonates were used by 21% of patients in the cabazitaxel group vs 37% of the abiraterone or enzalutamide group.
FACT-P total score deterioration was observed in 32 (30%) of 108 patients receiving cabazitaxel and 33 (29%) of 114 patients receiving abiraterone or enzalutamide. The median time to FACT-P deterioration was 14.8 months (95% CI = 6.3 months–not estimable) with cabazitaxel and 8.9 months (95% CI = 6.3–not estimable) with abiraterone or enzalutamide (HR = 0.72, 95% CI = 0.44–1.20, P = .21).
Changes from baseline in EQ-5D-5L utility index score were significantly in favor of cabazitaxel (P =.030), but no difference was observed between groups for change from baseline in EQ-5D-5L visual analog scale (P = .060).
The investigators concluded, “Since cabazitaxel improved pain response, time to pain progression, time to symptomatic skeletal events, and EQ-5D-5L utility index, clinicians and patients with metastatic castration-resistant prostate cancer can be reassured that cabazitaxel will not reduce quality of life when compared with treatment with a second androgen signaling–targeted inhibitor.”
Dr. Fizazi, of Institut Gustave Roussy and University of Paris Saclay, Villejuif, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by Sanofi. For full disclosures of the study authors, visit thelancet.com.
