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Clinical Practice Guidelines for the management of locally advanced ...

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hydrocortisone respectively. Tannock et al documented that treatment with mitoxantrone resulted in a<br />

significant improvement in pain, quality <strong>of</strong> life and PSA response. There was no survival benefit<br />

although this was not a study endpoint. Kant<strong>of</strong>f et al reported similar outcomes.<br />

Subsequently, two pivotal large multicentre phase III studies 14,20 have demonstrated a survival benefit<br />

while maintaining improvements in quality <strong>of</strong> life <strong>for</strong> patients receiving docetaxel-based<br />

chemo<strong>the</strong>rapy <strong>for</strong> <strong>the</strong>ir CRPC. These two studies <strong>for</strong>m <strong>the</strong> basis <strong>for</strong> <strong>the</strong> current standard <strong>of</strong> care in<br />

Australia, docetaxel chemo<strong>the</strong>rapy <strong>for</strong> CRPC.<br />

Tannock et al (TAX 327 study) enrolled 1006 patients who were randomly assigned to docetaxel<br />

30mg/m 2 weekly <strong>for</strong> five <strong>of</strong> every six weeks, docetaxel 75mg/m 2 every three weeks or mitoxantrone<br />

12mg/m 2 every three weeks. 14 All patients received 5mg bd <strong>of</strong> prednisolone. GnRH was continued.<br />

The majority <strong>of</strong> patients were Karn<strong>of</strong>sky per<strong>for</strong>mance score >70 and nearly half were asymptomatic.<br />

Up to ten cycles were planned <strong>for</strong> mitoxantrone and <strong>the</strong> three-weekly docetaxel group where median<br />

cycles completed were 5 and 9.5 respectively. Median survival was superior in <strong>the</strong> three-weekly<br />

docetaxel arm compared with mitoxantrone arm (18.9 months and 16.5 months; p=0.009). Threeweekly<br />

docetaxel also led to better pain control (35% versus 22%; p = 0.01), improvement in quality<br />

<strong>of</strong> life (22% improvement versus 13 % improvement; p=0.005) and PSA decline <strong>of</strong> >50% (48% vs<br />

32% P

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