I have been involved with the Scandinavian Prostate Cancer Group and about twenty years ago we were planning to have adjuvant studies because it was known that in colorectal and breast cancer adjuvant chemotherapy is beneficial. Then we started two studies, 12 and13, and I was the PI of the 13 where we included patients with high risk or intermediate risk prostate cancer who received radical radiotherapy and also LHRH analogues for nine months. After radiotherapy they were randomised either to surveillance or six cycles of docetaxel normal dose.

What were the results of this study?

The primary endpoint was biochemical recurrence free survival and it was presented five years ago in GU ASCO. There was no gain with docetaxel. 30% of the patients had PSA recurrence. The secondary aims were quality of life and overall survival. The quality of life results which are also published showed that at the time with docetaxel the quality of life of patients were statistically worse than those in follow-ups but after one year they were at the same level.

Now I am going to present the over ten year survival results. The median survival of the surveillance group was around 14.5 years and it’s not yet reached in the docetaxel group. However, there was not a statistically significant gain from docetaxel. Patients with high Gleason group, 8 or more, tended to have better survival, when they received docetaxel but the group was so small that it was not statistically significant.

So the main conclusion is that there is no benefit to the patients to give six cycles of docetaxel and we need better markers to select patients for this type of trials for treatments.

What is the clinical significance of these results, and what is next for this study?

The clinical significance is that it was the first long-term follow-up in this kind of adjuvant trial. Of course, before that it was discussed with the patients about the harms and benefits of docetaxel in some cases but now I think it’s over.