A drug aimed at the tissue around the tumour delayed progression on scans by two and a half months, and the men who took it lived, if anything, slightly less long.
10TASQ10 randomly assigned 1,245 men with chemotherapy-naive metastatic castration-resistant prostate cancer and bone metastases 2:1 to tasquinimod (832) or placebo (413). Median age was 71, 77.3 percent had a Karnofsky performance status of 90 percent or more and 21.1 percent had visceral metastases.
Estimated median radiographic progression-free survival by central review was 7.0 months (95 percent confidence interval 5.8 to 8.2) with tasquinimod and 4.4 months (3.5 to 5.5) with placebo, hazard ratio 0.64 (0.54 to 0.75, p<0.001). Median overall survival was 21.3 months (19.5 to 23.0) with tasquinimod and 24.0 months (21.4 to 26.9) with placebo, hazard ratio 1.10 (0.94 to 1.28, p=0.25).
Grade 3 or worse adverse events were more frequent with tasquinimod (42.8 against 33.6 percent), the commonest being anaemia, fatigue and cancer pain.
Tasquinimod and orteronel are the pair that should be quoted whenever radiographic progression-free survival is proposed as a registrational endpoint in prostate cancer. Both moved it a long way. Neither moved survival, and one moved it in the wrong direction.
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.
1,245 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival (median)primary | Tasquinimod | 832 | 7 months | 0.64 (0.54 to 0.75) | <0.001 | link |
| Placebo | 413 | 4.4 months | ||||
| Overall survival (median) | Tasquinimod | 832 | 21.3 months | 1.1 (0.94 to 1.28) | 0.25 | link |
| Placebo | 413 | 24 months |
Shares COMET-1, Prostate cancer programmes that failed, and what each failure taught, Bone metastases and skeletal-related events, 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 ELM-PC 4, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer, 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.
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 Bone metastases and skeletal-related events, Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer, 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.