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Adding an endothelin blocker to chemotherapy changed nothing, not survival, not progression, not pain.
SWOG S0421 randomised 994 men with metastatic castration-resistant prostate cancer and bone metastases to docetaxel with atrasentan 10 mg daily or placebo for up to 12 cycles, with the option to continue the study drug for up to 52 weeks in the absence of progression. It was halted early for futility at a planned interim analysis in April 2011.
Median progression-free survival was 9.2 months (95 percent confidence interval 8.5 to 9.9) with atrasentan and 9.1 months (8.4 to 10.2) with placebo, hazard ratio 1.02 (0.89 to 1.16, p=0.81). Median overall survival was 17.8 months (16.4 to 19.8) against 17.6 months (16.4 to 20.1), hazard ratio 1.04 (0.90 to 1.19, p=0.64). Grade 3 or greater toxicity occurred in 278 of 492 men (57 percent) with atrasentan and 294 of 486 (60 percent) with placebo, p=0.22, and three deaths in the atrasentan group and seven in the placebo group were judged possibly or probably due to protocol treatment.
The separately published patient-reported outcomes reinforce the null: clinically meaningful pain palliation in 44.0 percent with atrasentan against 41.7 percent with placebo (p=0.70), functional status improvement in 28.7 against 24.2 percent (p=0.13), and no difference over time in Brief Pain Inventory worst pain scores (0.13 points, p=0.23).
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.
994 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Docetaxel with atrasentan | 498 | 17.8 months | 1.04 (0.9 to 1.19) | 0.64 | link |
| Docetaxel with placebo | 496 | 17.6 months | ||||
| Progression-free survival (median)primary | Docetaxel with atrasentan | 498 | 9.2 months | 1.02 (0.89 to 1.16) | 0.81 | link |
| Docetaxel with placebo | 496 | 9.1 months |
Shares READY, TAX 327, Prostate cancer programmes that failed, and what each failure taught, Castration-resistant prostate cancer (CRPC).
Shares TAX 327, SWOG Cancer Research Network, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares TAX 327, Prostate cancer programmes that failed, and what each failure taught, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares READY, Prostate cancer programmes that failed, and what each failure taught, Bone metastases and skeletal-related events, Castration-resistant prostate cancer (CRPC).
Shares Prostate cancer programmes that failed, and what each failure taught, Quality of life and patient-reported outcomes (QoL, PRO), Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares TAX 327, Castration-resistant prostate cancer (CRPC), Docetaxel, Metastatic castration-resistant prostate cancer.
Shares Prostate cancer programmes that failed, and what each failure taught, Bone metastases and skeletal-related events, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.
Shares Prostate cancer programmes that failed, and what each failure taught, Bone metastases and skeletal-related events, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.