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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)