Toremifene in the treatment of breast cancer

Table 2 Non-randomized clinical trials (case reports or series with fewer than 10 patients excluded)

Ref.	Pts	Studytype	Diagnosis	Treatment	Results
Asaishi et al[68], 1993	51 women	Not stated	Advanced breast cancer refractory to TAM		CR + PR	SD > 6 mo	Median duration of response	Median duration of SD > 6 mo
				TOR 120 mg	11.8%	15.7%	127 d	238.5 d
Gams et al[69], 2002	102 women peri- or post-menopausal women	Pr	Advanced breast cancer refractory to TAM		OR		SD
				TOR 200 mg	5%		23%
					(TTF 10.9 mo)		(TTF 7.8 mo)
Pyrhönen et al[70], 1994	50 Women	Pr	Advanced breast cancer refractory to TAM		RR	Mixed response	SD
				TOR 240 mg	4%	6%	18% < 5 mo 26% > 5 mo
					Hietanne et al[71], 1997	73 post-menopausal women	Pr	Advanced breast cancer		OR (CR + PR)	NC	PD
TOR 240 mg	59%	29%	12%
Yamamoto et al[72], 2005	10 Women	RA	Metastatic breast cancer		OR	CB	Media TTP	Median OS
				TOR 120 mg	30%	70%	9 mo	21.5 mo
Ohtake et al[73], 2009	12 post-menopausal women who had failed AI therapy	RA	Advanced/recurrent breast cancer		CR	CB	Mean TTP
				TOR 120 mg	16.70%	58.30%	33.8 wk
Okita et al[74], 2009	15 women	Pr	Metastatic breast cancer		CR	PR	No change	Stable > 6 mo	PD	Mean TTF
				TOR 120 mg	0%	6.7%	66.7%,	26.7%	26.7%	2.7 mo
				Paclitaxel 80 mg/m2 on 5 d
Koyama et al[75], 2011	19 postmenopausal women	RA	Advanced or metastatic breast cancer		OR	CB
				TOR 120 mg	36.8% (1 CR, 6 PR 6)	47.4%
Gu et al[40], 2012	810 pre-menopausal women	RA	Early invasive breast cancer (adjuvant treatment)		5-yr OS	DFS
				TOR 60 mg	100%	97.2%
				TAM 20 mg	98.4 (ns)%	90.4% (P = 0.022)
Sawaki et al[76], 2012	13 post-menopausal women	Pr	Adjuvant aromatase inhibitor resistant metastatic breast cancer		CR	SD	PD	CB	PFS
				TOR 120 mg	7.7%	53.8%	38.5%	46.2%	5.9 mo
Tokura et al[77], 2012	18 women	Pr	Advanced/recurrent breast cancer		CB	PD	Media PFS
				TOR 120 mg	58%	22%	5.5 mo
					(5 PR, 5 long SD)
Koike et al[78], 2013	21	Pr	Recurrent or metastatic breast cancer		CR	PR/SD
					(12 wk)	(12 wk)
				TOR 120 mg	0%	21.1%/47.4%
Ogata et al[79], 2013	23 women	Pr	Recurrent breast cancer who were receiving or had received adjuvant aromatase inhibitor therapy		PR	SD	CB	Median TTP
				TOR 120 mg	13%	62%	78.30%	8.1 mo
Qin et al[41], 2013	1847 pre-menopausal women	RA	Operable breast cancer (adjuvant treatment)		DFS	5-Yr DFS	5-Yr OS
				TOR 60 mg	10.3 yr	87%	94.3%
				TAM 20 mg	10.3 yr	85%	93.5%

DB: Double blind; CR: Complete response; PR: Partial response; SD: Stable disease; LSD: Long stable disease; TOR: Toremifene; TAM: Tamoxifen; DFS: Disease-free survival; OS: Overall survival; (O)RR: (Objective) response rate; CB: Clinical benefit; DFS: Disease-free survival; PFS: Progression-free survival; R: Randomized; OL: Open label; UC: Uncontrolled; RA: Retrospective analysis; CC: Case control; Pr: Prospective; CS: Cohort study; AIU: Aromatase inhibitor; TTP: Time to progression.