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CD 3, Tracks 11, 13

DR LOVE: Dan, can you review the clinical trials of docetaxel in patients with metastatic disease?

DR PETRYLAK: Two randomized trials published in 2004 established docetaxel-based therapy as the standard of care for hormone-refractory metastatic prostate cancer (Tannock 2004; Petrylak 2004).

In SWOG-S9916, a combination of docetaxel plus estramustine was compared to mitoxantrone and prednisone (Petrylak 2004). The other study (TAX-327) compared either weekly or every three-week docetaxel with prednisone to mitoxantrone and prednisone (Tannock 2004).

The consistency of the data in terms of survival is remarkable. SWOG-S9916 demonstrated a two-month difference in median overall survival and a 20 percent reduction in the rate of death in favor of the docetaxel-containing regimen (Petrylak 2004).

TAX-327 demonstrated a 24 percent reduction in the risk of death and a two-month difference in median survival in favor of the patients treated with every three-week docetaxel (Tannock 2004).

Also important are the quality-of-life improvements seen in TAX-327. Using the FACT-P score, there was an improvement in the quality-of-life parameters in favor of both weekly and every three-week docetaxel compared to mitoxantrone/prednisone, even though weekly docetaxel did not show a survival benefit (Tannock 2004).

In SWOG-S9916, we found that, except for nausea, there were similar quality-of-life improvements with docetaxel/estramustine compared to mitoxantrone/prednisone. This seems to be a comparable regimen in terms of quality of life (Berry 2006).

DR EISENBERGER: In TAX-327, a little less than 50 percent of patients had major pain relief. It is fascinating that when we evaluated the most powerful endpoint to correlate with survival, it was not PSA decline. Rather, it was actually pain relief.

DR SCHELLHAMMER: My impression is that the patients are getting better, with minimal side effects and toxicity, with docetaxel-based chemotherapy. In the big world of chemotherapy, docetaxel seems to be tolerated remarkably well.

DR LOVE: Len, what is your impression of how urologists view chemotherapy for patients with prostate cancer?

DR GOMELLA: I believe this is determined by the attitude of your local medical oncologist. At our institution, they are big believers in second- and third-line hormonal therapy before they commit someone to chemotherapy. If you send a patient with hormone-refractory prostate cancer to a medical oncologist in our local community, they go right to chemotherapy.

DR KEANE: I have five or six patients who have received chemotherapy. It is remarkable how much better the patients seemed after receiving a course of docetaxel.

A lot of people in the community still live by the old paradigm that chemotherapy is the last resort and can’t be used until you have tried everything else. I don’t think that holds true anymore, and I think we need to bring medical oncologists into the treatment of prostate cancer earlier and earlier.

DR ZELEFSKY: Dan, is bone pain recognized to be much improved with docetaxel?

DR PETRYLAK: You do see a difference in the bone pain response rates between SWOG-S9916 and TAX-327. It is superior with docetaxel/prednisone when compared to mitoxantrone/prednisone (Tannock 2004), but it is the same in SWOG-S9916 for docetaxel/estramustine compared to mitoxantrone/prednisone (Petrylak 2004). I wonder, if we had prednisone in the regimen, whether there would been a higher rate of pain improvement.

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