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

Table 9 Non-cytotoxic trials: survival outcomes.

Trial	Treatment arms	Overall survival			Progression-free survival or TTP or FFS
		N	Median (mo)	Statistical comparison	N	Median (mo)	Statistical comparison
Carducci, 2004 [85]	Atrasentan	NR			408	NR	HR for TTP = 1.14 (95% CI, 0.98–1.34) p = 0.091
	placebo				401
Carducci, 2003 [79]	atrasentan 10 mg	NR			89	6.5	p = 0.13 (TTP)
	atrasentan 2.5 mg				95	6.4	p = 0.29 (TTP)
	placebo				104	4.9	NA
Small, 2003 [86]	APC8015	NR			82	NR	HR for TTP = 1.39 (95% CI, 0.95–2.04) p = 0.085
	placebo				45
Small, 2002 [81]	suramin (3.192 g/m²)	128	16	p = 0.49	128	NR	p = NS
	suramin (5.320 g/m²)	124	14		124
	suramin (7.661 g/m²)	120	13		120
Ahmann, 2001 [87]	prinomastat (5 mg) mitoxantrone prednisone	134	15.1	p = NS	134	6	p = NS
	prinomastat (10 mg) mitoxantrone prednisone	134	14.7		134	4.7
	mitoxantrone prednisone placebo	138	14.8		138	6
Small, 2000 [82]	suramin hydrocortisone	228	10.2	p = NS	228	NR	RR for TTP = 1.51 (95% CI, 1.22–1.85) p = 0.0003
	placebo hydrocortisone	230	10		230
Debruyne, 1998 [83]	liarozole	160	10.3	p = 0.52 HR = 0.74* (95% CI, 0.56–0.99) p = 0.039	160	4.9	p = NS
	CPA	161	10.3		161	4.6

*Adjusted for performance status, hemoglobin, baseline PSA, alkaline phosphatase, and duration of response.
Abbreviations: CI – confidence interval; CPA – cyproterone acetate; DES – diethylstilbestrol; FFS – failure-free survival; HR – hazard ratio; m² - meters squared; mg – milligrams; mo – months; N – number; NA – not applicable; NR – not reported; NS – non-significant; RR – relative risk; TTP – time-to-progression.

ISSN: 1471-2407