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Adding the anti-angiogenic antibody bevacizumab to chemotherapy delayed progression and shrank more tumours, but men did not live longer and four times as many died of the treatment.
CALGB 90401 randomly assigned 1,050 men with chemotherapy-naive progressive metastatic castration-resistant prostate cancer to docetaxel and prednisone with bevacizumab 15 mg/kg every 3 weeks or placebo.
Median overall survival was 22.6 months with bevacizumab against 21.5 months without, hazard ratio 0.91 (95 percent confidence interval 0.78 to 1.05, stratified log-rank p=0.181). Median progression-free survival was better with bevacizumab, 9.9 against 7.5 months (stratified log-rank p<0.001), as was objective response, 49.4 against 35.5 percent (p=0.0013).
The harm is in the safety table. Grade 3 or greater treatment-related toxicity occurred in 75.4 percent with bevacizumab against 56.2 percent (p at most 0.001), and treatment-related deaths in 4.0 against 1.2 percent (p=0.005).
An intervention that improves progression-free survival and objective response while quadrupling the treatment-related death rate and not extending life is the clearest possible argument against reading those endpoints as proxies for benefit. Bevacizumab is not used in prostate cancer.
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.
1,050 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Docetaxel, prednisone and bevacizumab | - | 22.6 months | 0.91 (0.78 to 1.05) | 0.181 | link |
| Docetaxel and prednisone | - | 21.5 months | ||||
| Progression-free survival (median) | Docetaxel, prednisone and bevacizumab | - | 9.9 months | - | <0.001 | link |
| Docetaxel and prednisone | - | 7.5 months | ||||
| Treatment-related deaths | Docetaxel, prednisone and bevacizumab | - | 4% | - | 0.005 | link |
| Docetaxel and prednisone | - | 1.2% |
Shares TAX 327, Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares READY, TAX 327, Prostate cancer programmes that failed, and what each failure taught, Castration-resistant prostate cancer (CRPC).
Shares COMET-1, Prostate cancer programmes that failed, and what each failure taught, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.
Shares Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares Prednisone, Docetaxel, Metastatic castration-resistant prostate cancer, Cytotoxic chemotherapy.
Shares Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.