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Table 4 Mitoxantrone and anthracycline trials.

From: Non-hormonal systemic therapy in men with hormone-refractory prostate cancer and metastases: a systematic review from the Cancer Care Ontario Program in Evidence-based Care's Genitourinary Cancer Disease Site Group

Trial

N randomized/evaluable

Treatment arms (dose) and schedule

Duration

Berry, 2002 [69]

120/119

mitoxantrone (12 mg/m2) iv q 3 wks prednisone (5 mg) po twice daily

6 cycles

  

prednisone (5 mg) po twice daily

 

Kantoff, 1999 [70]

242/242

mitoxantrone (14 mg/m2) iv q 3 wks hydrocortisone (40 mg) po daily (two divided doses)

hydrocortisone to progression or treatment failure

  

hydrocortisone (40 mg) po daily (two divided doses)

 

Tannock, 1996 [71]

161/161

mitoxantrone (12 mg/m2) iv q 3 wks prednisone (5 mg) po twice daily

mitoxantrone to dose of 140 mg/m2, continuing on prednisone

  

prednisone (5 mg) po twice daily

 

Weissbach, 1998 [88]

NR/175

epirubicin (25 mg/m2) iv q mo

NR

  

EMP (560 mg) daily

 
  

mitomycin C (10 mg/m2) iv q mo

 

Anderström, 1995 [72]

149/145

epirubicin (20 mg/m2) iv q wk MPA (500 mg) po twice daily

epirubicin to dose of 1000 mg/m2, MPA to progression

  

EMP (12 mg/kg) po daily (two divided doses)

 

Laurie, 1992* [73]

145/142

In combination: 5-FU (600 mg/m2) iv q 4–5 wks doxorubicin (30 mg/m2) iv q 4–5 wks mitomycin-C (10 mg/m2) iv q 4–5 wks†

to progression

  

In sequence: 5-FU (500 mg/m2) iv q 5 wk doxorubicin (50 mg/m2) iv q 3–4 wk mitomycin-C (12.5 mg/m2) iv q 4 wk

 

Saxman, 1992 [74]

103/103

cyclophosphamide (500mg/m2)‡ iv q 3 wks doxorubicin (50mg/m2)‡ iv q 3 wks methotrexate (40mg/m2)‡ iv q 3 wks

to progression, doxorubicin not to exceed dose of 450mg/m2

  

cyclophosphamide (1000 mg/m2)§iv q 3 wks

 

Murphy, 1988 [75]

180/152

doxorubicin (50 mg/m2) iv q 3 wks cyclophosphamide (500 mg/m2) iv q 3 wks

to progression

  

cisplatin (50 mg/m2) iv q 3 wks 5-FU (500 mg/m2) iv q 3 wks cyclophosphamide (500 mg/m2) iv q 3 wks

 
  

methotrexate (100 mg/m2) iv (2 divided doses) q 2 wks

 

Stephens, 1984 [76]

158/137

doxorubicin (40 mg/m2)¶iv q 3 wks cyclophosphamide (200 mg/m2)¶iv q 3 wks

doxorubicin to dose of 450 mg/m2, continuing on cyclophosphamide or hydroxyurea to progression

  

hydroxyurea (3600 mg/m2) po twice q wk

 
  1. *This trial was terminated early due to declining patient accrual ; †after three courses, mitomycin-C was only given with every other course; ‡patients who had received prior radiation therapy were give cyclophosphamide, doxorubicin, and methotrexate at doses of 400 mg/m2, 40 mg/m2, and 32 mg/m2, respectively; §patients who had received prior radiation therapy were given cyclophosphamide at a dose of 800 mg/m2; ¶patients older than 65 years and with prior bone irradiation, and marrow invasion with tumor were deemed poor risk and were randomized to a reduced dose of doxorubicin (20 mg/m2) and cyclophosphamide (100 mg/m2).
  2. Abbreviations: 5-FU – 5- fluorouracil; EMP – estramustine phosphate; iv – intravenous; m2 - meters squared; mg – milligrams; mo – month; MPA – medroxyprogesterone; N – number; po – per oral; q – every; wk(s) – week(s)
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