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A lower dose of cabazitaxel works nearly as well and causes far fewer serious side effects, which is why most men now start on the lower dose.
PROSELICA randomised 1,200 men with metastatic castration-resistant prostate cancer after docetaxel to cabazitaxel 20 mg/m2 (598) or 25 mg/m2 (602), stratified by ECOG performance status, measurability of disease and region. Non-inferiority required the upper bound of the hazard ratio confidence interval for the lower dose to stay below 1.214, which corresponds to keeping at least half the survival advantage cabazitaxel had over mitoxantrone in TROPIC.
Median overall survival was 13.4 months at 20 mg/m2 and 14.5 months at 25 mg/m2, hazard ratio 1.024 with an upper bound of 1.184: non-inferiority was met.
The efficacy secondary endpoints favoured the higher dose. PSA response occurred in 29.5 percent at 20 mg/m2 against 42.9 percent at 25 mg/m2 (nominal p<0.001), and median time to PSA progression was 5.7 against 6.8 months, hazard ratio 1.195 (95 percent confidence interval 1.025 to 1.393). Health-related quality of life did not differ.
The safety endpoint is why the trial changed practice: grade 3 or 4 treatment-emergent adverse events occurred in 39.7 percent at 20 mg/m2 against 54.5 percent at 25 mg/m2. For an older or frailer man the lower dose is the reasonable default, and the trade-off, a poorer PSA response for a substantially lower chance of a serious event, is one worth stating to him.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,200 enrolled.
Upper bound of the confidence interval 1.184, below the non-inferiority margin of 1.214.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Cabazitaxel 20 mg/m2 | 598 | 13.4 months | 1.024 | - | link |
| Cabazitaxel 25 mg/m2 | 602 | 14.5 months | ||||
| Grade 3 or 4 treatment-emergent adverse events | Cabazitaxel 20 mg/m2 | 598 | 39.7% | - | - | link |
| Cabazitaxel 25 mg/m2 | 602 | 54.5% | ||||
| PSA response | Cabazitaxel 20 mg/m2 | 598 | 29.5% | - | <0.001 nominal | link |
| Cabazitaxel 25 mg/m2 | 602 | 42.9% |
Shares FIRSTANA, TROPIC, PSA50 / PSA90 response, What follows what in castration-resistant prostate cancer.
Shares PSA50 / PSA90 response, CARD, What follows what in castration-resistant prostate cancer, Quality of life and patient-reported outcomes (QoL, PRO).
Shares TROPIC, Cabazitaxel, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares PSA50 / PSA90 response, Prednisone, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.
Shares PSA50 / PSA90 response, What follows what in castration-resistant prostate cancer, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares PSA50 / PSA90 response, CARD, Cabazitaxel, What follows what in castration-resistant prostate cancer.
Shares Quality of life and patient-reported outcomes (QoL, PRO), Prednisone, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.
Shares PSA50 / PSA90 response, What follows what in castration-resistant prostate cancer, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.