(Prostate Cancer) Is Cabazitaxel + Carboplatin Effective?

(Prostate Cancer) Is Cabazitaxel + Carboplatin Effective?

(Prostate Cancer) Is Cabazitaxel + Carboplatin Effective?

• October 15, 2019
• Read time: 2 minutes

On September 9, 2019, Paul G Corn published results in the medical journal Lancet Oncology titled "Efficacy and safety assessment of cabazitaxel plus carboplatin in previously treated, metastatic, castration-resistant prostate cancer patients: Phase 1/2 clinical trial results."

This trial was a randomized, open-label Phase 1/2 clinical trial that randomized previously treated, metastatic, castration-resistant prostate cancer patients (N=160) in a 1:1 ratio to receive either cabazitaxel plus carboplatin (20-25mg/m2 cabazitaxel plus 3-4mg/mL carboplatin every 21 days) or cabazitaxel monotherapy (25mg/m2 cabazitaxel every 21 days). The primary endpoint for Phase 1 was maximum tolerated dose, and for Phase 2 was progression-free survival.

This trial was initiated because the efficacy of concurrent taxane chemotherapy in metastatic castration-resistant prostate cancer patients had only been confirmed in single-arm trials, not yet in randomized trials.

Trial results were as follows. In Phase 1, no dose-limiting toxicity was observed in the primary endpoint, determining the optimal dose as 25mg/m2 cabazitaxel plus 3-4mg/mL carboplatin. Grade 3 adverse events included anemia (2), fatigue (1), thrombocytopenia (1), hypomagnesemia (1), diarrhea (1), hypokalemia (1), anorexia (1), and dehydration (1). No Grade 4 adverse events occurred.

In Phase 2, the median progression-free survival was: cabazitaxel plus carboplatin group 7.3 months versus cabazitaxel monotherapy group 4.5 months. The cabazitaxel plus carboplatin group showed a 31% risk of disease progression with a hazard ratio of 0.69, demonstrating significant improvement.

Regarding safety, the most frequent Grade 3-5 adverse events in Phase 2 included: fatigue—cabazitaxel plus carboplatin 20% (N=16) versus cabazitaxel monotherapy 9% (N=7); anemia—cabazitaxel plus carboplatin 23% (N=19) versus cabazitaxel monotherapy 9% (N=3); neutropenia—cabazitaxel plus carboplatin 16% (N=13) versus cabazitaxel monotherapy 4% (N=3); thrombocytopenia—cabazitaxel plus carboplatin 14% (N=11) versus cabazitaxel monotherapy 1% (N=1). No patients died from adverse events.

Based on Phase 1/2 clinical trial results, Paul G Corn concluded that previously treated, metastatic, castration-resistant prostate cancer patients receiving cabazitaxel plus carboplatin demonstrated significant improvement in progression-free survival. Although the incidence of adverse events was higher than with monotherapy, patients tolerated the adverse effects.

【Important Note】 Medical Supporter's translations of overseas clinical trial data and pharmaceutical information are not intended to encourage participation in clinical trials or use of new drugs. The translated information is for reference only and not intended as medication guidelines. Please discuss with healthcare professionals and refer to the original text below the article for accurate information.

Data Source: Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1–2 trial (Lancet Oncol. 2019 Sep 9. pii: S1470-2045(19)30408-5. doi: 10.1016/S1470-2045(19)30408-5.)

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