Table 1 Selected studies of endocrine therapy in metastatic breast cancer

III^a

Tamoxifen

156 premenopausal + postmenopausal (24%)

RR: 16%

POA 74181/74185 [77]

TTP: 6.7 months

5-year PFS: 8%

OS: 27.2 months

III

Tamoxifen vs. BSO [10]

53 premenopausal (21%)

CR: 0% vs. 15%

PR: 31% vs. 20%

TTP: 160 vs. 144 days

OS: 749 vs. 722 days

III

BSO/RT vs. goserelin vs. BSO/RT + tamoxifen vs. tamoxifen + goserelin [11]

85 perimenopausal (33%)

RR: 47% vs. 27% vs. 11% vs. 45%

OS: 37 (ovarian) vs. 36 months (goserelin)

III

Buserelin vs. tamoxifen vs. buserelin + tamoxifen EORTC 10881 [78]

161 premenopausal (52%)

RR: 34% vs. 28% vs. 48%

PFS: 6.3 vs. 5.6 months. vs. 9.7 months^b

OS: 2.5 vs. 2.9 vs. 3.7 years^b

Meta

LHRH agonist vs.

LHRH + tamoxifen [12]

506 premenopausal (22%)

RR: 30% vs. 39%^b

PFS HR: 0.70^b

OS HR: 0.78^b

III

Fulvestrant 500 mg every 30 days vs. fulvestrant 250 mg every 30 days

736 postmenopausal

RR: 9% vs. 10%

PFS HR: 0.80^b

CONFIRM [15]

OS: 25.1 vs. 22.8 months

III

Fulvestrant 250 mg every 30 days vs. tamoxifen 20 mg by mouth every day [79]

587 postmenopausal (20%)

RR: 33% vs. 31%

TTP: 8.2 vs. 8.3 (estrogen receptor/progesterone receptor-positive)

OS: 39.3 vs. 40.7 months

III

Fulvestrant vs. anastrozole

205 postmenopausal

CBR: 73% vs. 67%

FIRST [17]

TTP: not reached vs. 12.5 months^b

III

Anastrozole tamoxifen vs. tamoxifen anastrozole

60 postmenopausal (20%)

TTP: 28.2 vs. 19.5 months^c

TARGET/SAKK 21/95 [80]

OS: 69.7 vs. 59.3 months

III

Letrozole vs. tamoxifen

977 postmenopausal

TTP: 42 vs. 21 weeks^b

LILBCG [81]

III

Exemestane vs. megestrol [23]

769 postmenopausal

TTP: 20 vs. 17 weeks^b

OS: not reached vs. 123.4 weeks^b

III

Exemestane vs. tamoxifen

371 postmenopausal (6.5%)

RR: 46% vs. 31%^b

EORTC [22]

PFS: 9.9 vs. 5.8 months^b but NS after 47 months follow-up

OS HR: 1.13

III

Anastrozole vs. exemestane [24]

130 postmenopausal

Insufficient accrual

RR: 16% vs. 16%

TTP: 3.71 vs. 4.24 months

OS: 33.3 vs. 30.5 months

II

Megestrol [25]

73

CR: 0%

PR: 4% for median of 9 months Median 8 months of stabilization in 48%

III

Tamoxifen vs. megestrol

182 premenopausal + postmenopausal (17%)

RR: 17% vs. 34%^b

POA [82]

TTF: 5.5 vs. 6.3 months

OS: 23.8 vs. 33 months

III

Vorozole vs.

megestrol [18]

452 postmenopausal (15%)

RR: 10% vs. 7% Duration response: 18.2 vs. 12.5 months

TTP: 2.6 vs. 3.3 months

OS: 26.3 vs. 28.8 months

II

Estradiol 30 mg by mouth every day vs. estradiol 6 mg by mouth every day [26]

66 postmenopausal

CBR: 28% vs. 29%