Tailored Therapy Based on Molecular Characteristics in Endometrial Cancer

Table 1

Hormonal therapy in advanced or recurrent endometrial cancer.

Study	Design	No. of patients	Treatment	Primary end point	Results
Monotherapy
Antiestrogen therapy
Quinn and Campbell [69]	Case series	49	Tamoxifen 40 mg	RR	RR 20%; Median survival of responder 34 mths
Thigpen et al. [70]	Prospective	68	Tamoxifen 40 mg	RR	RR 10% (90% CI 5.7-17.9); Median PFS 1.9 mths; (90% CI 7-10.1)
McMeekin et al. [71]	Phase 2, open label	29	Arzoxifene 20 mg	RR	RR 31% (CI 25-51); Median PFS 3.7 mths; (CI 1.9-6.6)
Emons et al. [73]	Phase 2	35	Fulvestrant 250 mg	RR	RR 11.4%; TTP 2.3 mths; (95% CI 2.5-6.6)
Covens et al. [72]	Phase 2	53	Fulvestrant 250 mg	RR	In ER-positive patients; RR 16%; Median PFS 10 mths; Median OS 26 mths
Rose et al. [66]	Phase 2	23	Anastrozole 1 mg	RR	RR 9% (90% CI 3-23)
Ma et al. [67]	Phase 2	32	Letrozole 2.5 mg	RR	RR 9.4% (95% CI 2-25)
Lindemann et al. [68]	Phase 2, open label	51	Exemestane 25 mg	RR	In ER-positive patients; RR 10%; Median PFS 3.8 mths; (95% CI 0.7-6.9)
					Median OS 13.3 mths; (95% CI 7.7-18.9)
Progestin therapy
Thigpen et al. [64]	Prospective	299	MPA 200 mg vs. MPA 1 g	RR	Low-dose group; RR 25%; Median PFS 3.2 mths; Median OS 11.1 mths
					High-dose group; RR 15%; Median PFS 2.5 mths; Median OS 7 mths
Lentz et al. [65]	Phase 2	54	MA 800 mg	RR	RR 24%; Median PFS, 2.5 mths; Median OS 7.6 mths
Combination therapy
Tamoxifen/progestational agents
Pandya et al. [59]	Phase 2, randomized	42	MA 320 mg vs. tamoxifen 20 mg & MA 160 mg	RR survival	MA group; RR 20%; Median OS 12 mths; Tamoxifen & MA group; RR 19%; Median OS 8.6 mths
Whitney et al. [60]	Phase 2	58	Tamoxifen 40 mg & MPA 200 mg/day/alternating weekly	RR	RR 33% (95% CI 21-46); Median PFS 3 mths; Median OS 13 mths
Fiorica et al. [61]	Phase 2	56	MA 160 mg altering with tamoxifen 40 mg	RR	RR 27% (90% CI 17-38)
Hormonal agents/mTOR inhibitor
Fleming et al. [62]	Phase 2, randomized	71	Temsirolimus 25 mg vs. Temsirolimus 25 mg & MA 160 mg altering with tamoxifen 40 mg	RR	Temsirolimus group; RR 22%
					Combination group; RR 14%
Slomovitz et al. [63]	Phase 2	35	Everolimus 10 mg & letrozole 2.5 mg	CBR	CBR 40%; RR 32%

No.: number; RR: response rate; mths: months; CI: confidence interval; PFS: progression-free survival; TTP: time to progression; ER: estrogen receptor; OS: overall survival; MPA: medroxyprogesterone acetate; MA: megestrol acetate; CBR: clinical benefit rate (complete response+partial response+stable disease ≥ 16 weeks).