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Adding chemotherapy to hormone therapy and radiotherapy for the most aggressive localised prostate cancer improved four-year survival from 89 to 93 percent.
RTOG 0521 enrolled 612 men with high-risk non-metastatic prostate cancer between 2005 and 2009; 563 were evaluable. Median PSA was 15.1 ng/mL, 53 percent had a Gleason score of 9 to 10 and 27 percent had cT3 to cT4 disease. Men were randomised to standard long-term androgen suppression with radiotherapy, with or without adjuvant docetaxel.
At a median 5.7 years, 4-year overall survival was 89 percent (95 percent confidence interval 84 to 92) without chemotherapy and 93 percent (90 to 96) with it, hazard ratio 0.69 (90 percent confidence interval 0.49 to 0.97, one-sided p=0.034). There were 59 deaths without chemotherapy and 43 with it, and fewer of those deaths were from prostate cancer (23 against 16). The 6-year rate of distant metastasis was 14 percent without and 9.1 percent with chemotherapy, hazard ratio 0.60 (0.37 to 0.99, two-sided p=0.044), and 6-year disease-free survival was 55 against 65 percent, hazard ratio 0.76 (0.58 to 0.99, p=0.043).
Treatment was well tolerated in both arms. The authors framed the result carefully, as an option to be discussed with selected men rather than a new standard, and it has not displaced abiraterone, which the STAMPEDE high-risk non-metastatic comparison later showed improves metastasis-free survival with a hazard ratio of 0.53.
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.
612 randomised.
Confidence interval is 90 percent, as prespecified.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 4 yearsprimary | Androgen suppression, radiotherapy and docetaxel | - | 93% | 0.69 (0.49 to 0.97) | 0.034 one-sided | link |
| Androgen suppression and radiotherapy | - | 89% | ||||
| Distant metastasis at 6 years | Androgen suppression, radiotherapy and docetaxel | - | 9.1% | 0.6 (0.37 to 0.99) | 0.044 | link |
| Androgen suppression and radiotherapy | - | 14% |
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