Comparative Treatment Patterns and Outcomes of Fulvestrant versus Everolimus Plus Exemestane for Postmenopausal Metastatic Breast Cancer Resistant to Aromatase Inhibitors in Real-World Experience

Figures & data

Table 1 Baseline Characteristics of Patients, According to Treatment Choices

Characteristics	FUL N=124 n (%)	EVE-EXE N=44 n (%)	P values
Median age (range)	58.1 (34–85)	53.4 (24–67)	0.013*
De novo stage IV breast cancer	8 (6.5)	3 (6.8)	0.787
Menopausal status
Postmenopausal	105 (84.7)	37 (84.1)	0.926
Premenopausal	19 (15.3)	7 (15.9)
Disease free interval (months)
<12	9 (7.8)	4 (9.8)	0.852
12–24	18 (15.5)	5 (12.2)
>24	89 (76.7)	32 (78.0)
Number of metastatic sites
1	38 (30.6)	5 (11.4)	0.002*
2	46 (37.1)	12 (27.2)
≥3	40 (32.3)	27 (61.4)
Metastatic sites
Visceral	75 (60.5)	36 (81.8)	0.010*
Liver	31 (25.0)	20 (45.5)	0.011*
Lung	55 (44.4)	24 (54.5)	0.245
Bone only	19 (15.3)	3 (6.8)	0.197
Lines of endocrine therapy
1	19 (15.3)	4 (9.0)	0.272
2	59 (47.6)	18 (41.0)
≥3	46 (37.1)	22 (50.0)
Endocrine sensitivity
Primary resistant	35 (28.2)	10 (22.7)	0.762
Secondary resistant	83 (63.0)	32 (72.7)
Sensitive	6 (4.8)	2 (4.5)
Lines of metastatic chemotherapy
0	60 (48.4)	12 (27.3)	0.039*
1	25 (20.2)	8 (18.2)
2	20 (16.1)	14 (31.8)
≥3	19 (15.3)	10 (22.7)

Note: *P<0.05.

Abbreviations: FUL, fulvestrant; EVE-EXE, everolimus plus exemestane.

Table 2 Baseline Characteristics After Propensity-Score Matching

Characteristics	FUL N=88 n (%)	EVE-EXE N=44 n (%)	P values
Median age (range)	56.3 (34–72)	53.4 (24–67)	0.102
De novo stage IV breast cancer	6 (6.8)	3 (6.8)	0.714
Menopausal status
Postmenopausal	77 (87.5)	37 (84.1)	0.591
Premenopausal	11 (12.5)	7 (15.9)
Disease free interval (months)
< 12	6 (7.3)	4 (9.8)	0.898
12–24	10 (12.2)	5 (12.2)
>24	66 (80.5)	32 (78.0)
Number of metastatic sites
1	12 (13.6)	5 (11.4)	0.166
2	37 (42.0)	12 (27.2)
≥3	39 (44.3)	27 (61.4)
Metastatic sites
Visceral	69 (78.4)	36 (81.8)	0.647
Liver	30 (34.1)	20 (45.5)	0.205
Lung	49 (55.7)	24 (54.5)	0.901
Bone only	4 (4.5)	3 (6.8)	0.686
Lines of endocrine therapy
1	9 (10.2)	4 (9.0)	0.760
2	41 (46.6)	18 (41.0)
≥3	38 (43.2)	22 (50.0)
Endocrine sensitivity
Primary resistant	25 (28.4)	10 (22.7)	0.727
Secondary resistant	58 (65.9)	32 (72.7)
Sensitive	5 (5.7)	2 (4.5)
Lines of metastatic chemotherapy
0	29 (33.0)	12 (27.3)	0.484
1	22 (25.0)	8 (18.2)
2	18 (20.5)	14 (31.8)
≥3	19 (21.6)	10 (22.7)

Abbreviations: FUL, fulvestrant; EVE-EXE, everolimus plus exemestane.

Figure 1 Kaplan–Meier curves for progression-free survival before and after matching. (A) For patients before matching. (B) For patients after matching.

Abbreviations: FUL, fulvestrant; EVE-EXE, everolimus plus exemestane; HR, hazard ratio; CI, confidence interval.

Figure 2 Forest plot of progression-free survival in FUL and EVE-EXE arms after matching.

Abbreviations: FUL, fulvestrant; EVE-EXE, everolimus plus exemestane; DFI, disease-free survival; HR, hazard ratio; CI, confidence interval.

Figure 3 Kaplan–Meier curves for progression-free survival in multiple metastatic sites subgroup.

Abbreviations: FUL, fulvestrant; EVE-EXE, everolimus plus exemestane; HR, hazard ratio; CI, confidence interval.

Table 3 Drug-Related AEs

AE	FUL (n=124)		EVE-EXE (n=44)
	Any Grade (%)	Grade 3/4 (%)	Any Grade (%)
Hematologic
Anemia	2 (1.6)	0	6 (13.6)	1 (2.7)
Thrombocytopenia	0	0	5 (11.4)	2 (4.5)
Leukopenia	0	0	2 (4.5)	0
Non-Hematologic
Stomatitis	0	0	25 (56.8)	5 (11.4)
Fatigue	2 (1.6)	0	11 (25)	1 (2.3)
Infection	0	0	11 (25)	2 (4.5)
Rash	0	0	8 (18.2)	2 (2.4)
Edema	1 (0.9)	0	6 (13.6)	0
Cough	0	0	6 (13.6)	0
Diarrhea	0	0	5 (11.4)	0
Non-infectious pneumonitis	0	0	5 (11.4)	0
Pyrexia	0	0	4 (9.1)	0
Anorexia	0	0	4 (9.1)	0
Hypertension	0	0	3 (6.8)	1 (2.3)
Weight loss	0	0	2 (4.5)	0
Joint disorders	6 (5.0)	0	0	0
Injection site reactions	5 (4.0)	0	0	0
Gastrointestinal disturbances	3 (2.4)	0	0	0
Hot flashes	2 (1.6)	0	0	0
Biological events			0	0
Hyperglycemia	2 (2.7)	0	10 (22.7)	0
ALT increased	6 (8.2)	0	7 (15.9)	1 (2.3)
AST increased	6 (8.2)	0	7 (15.9)	0
Hyperlipidemia	0	0	4 (9.1)	0

Abbreviations: AE, adverse events; FUL, fulvestrant; EVE-EXE, everolimus plus exemestane; ALT, alanine aminotransferase; AST, aspartate aminotransferase.