Introduction
Methods
Patients
Study Design
Study Assessments
Statistical Analysis
Results
Characteristic | EVE+EXE (n = 485), % | PBO+EXE (n = 239), % |
---|---|---|
Median age, years (range) | 62 (34–93) | 61 (28–90) |
Race | ||
White | 74 | 78 |
Asian | 20 | 19 |
Black | 3 | 1 |
Other | 3 | 2 |
ECOG performance status 0 | 60 | 59 |
Visceral disease | 58 | 59 |
Measurable diseasea
| 70 | 68 |
Metastatic site | ||
Lung | 30 | 33 |
Liver | 33 | 30 |
Bone | 77 | 77 |
Prior therapy | ||
Setting of most recent treatment | ||
Adjuvant | 21 | 16 |
Advanced/metastatic disease | 79 | 84 |
LET or ANA as most recent treatment | 74 | 75 |
Tamoxifen | 47 | 50 |
Fulvestrant | 17 | 16 |
Chemotherapy (any setting) | 69 | 65 |
Chemotherapy for metastatic BC | 26 | 26 |
Radiotherapy | 70 | 69 |
Number of prior therapiesb
| ||
1 or 2 | 46 | 47 |
≥3 | 54 | 53 |
Efficacy
PFS interim (7-month follow-up) | PFS update (12-month follow-up) | PFS final (18-month follow-up) | |
---|---|---|---|
Cutoff date | Feb 11, 2011 | Jul 8, 2011 | Dec 15, 2011 |
OS events, n
EVE vs PBO, % of events | 83 10.6 vs 13.0 | 137 17.3 vs 22.7 | 200 25.4 vs 32.2 |
Δ OS events, % of events | 2.4 | 5.4 | 6.8 |
Response | Local assessment | Central assessment | ||
---|---|---|---|---|
EVE+EXE (n = 485) | PBO+EXE (n = 239) | EVE+EXE (n = 485) | PBO+EXE (n = 239) | |
Best overall response (%) | ||||
Complete response (CR) | 0.6 | 0 | 0 | 0 |
Partial response (PR) | 12.0 | 1.7 | 12.6 | 2.1 |
Stable disease (SD) | 71.3 | 59.0 | 73.4 | 62.8 |
Progressive disease | 10.1 | 32.6 | 5.8 | 23.4 |
Unknown | 6.0 | 6.7 | 8.2 | 11.7 |
ORR (CR or PR), % | 12.6* | 1.7 | 12.6 | 2.1 |
95% CI for ORR | 9.8–15.9 | 0.5–4.2 | 9.8–15.9 | 0.7–4.8 |
CBR (CR+PR+SD ≥ 24 weeks), % | 51.3* | 26.4 | 49.9 | 22.2 |
95% CI for CBR | 46.8–55.9 | 20.9–32.4 | 45.4–54.4 | 17.1–28.0 |
Safety
AE (preferred term) | EVE+EXE (n = 482), % | PBO+EXE (n = 238), % | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Grade | Grade | |||||||||
All | 1 | 2 | 3 | 4 | All | 1 | 2 | 3 | 4 | |
Stomatitis | 59 | 29 | 22 | 8 | 0 | 12 | 9 | 2 | <1 | 0 |
Rash | 39 | 29 | 9 | 1 | 0 | 7 | 5 | 2 | 0 | 0 |
Fatigue | 37 | 18 | 14 | 4 | <1 | 27 | 16 | 10 | 1 | 0 |
Diarrhea | 34 | 26 | 6 | 2 | <1 | 19 | 14 | 4 | <1 | 0 |
Nausea | 31 | 21 | 9 | <1 | <1 | 29 | 21 | 7 | 1 | 0 |
Decreased appetite | 31 | 19 | 10 | 1 | 0 | 13 | 8 | 4 | <1 | 0 |
Weight decreased | 28 | 10 | 16 | 1 | 0 | 7 | 3 | 5 | 0 | 0 |
Cough | 26 | 21 | 4 | <1 | 0 | 12 | 8 | 3 | 0 | 0 |
Dysgeusia | 22 | 18 | 4 | 0 | 0 | 6 | 6 | 0 | 0 | 0 |
Dyspnea | 22 | 10 | 6 | 5 | <1 | 11 | 8 | 2 | <1 | <1 |
Headache | 23 | 17 | 6 | <1 | 0 | 15 | 13 | 2 | 0 | 0 |
Arthralgia | 21 | 15 | 5 | <1 | 0 | 17 | 11 | 5 | <1 | 0 |
Peripheral edema | 21 | 14 | 6 | 1 | 0 | 6 | 5 | <1 | <1 | 0 |
Anemia | 21 | 4 | 10 | 7 | <1 | 5 | 2 | 2 | <1 | <1 |
Epistaxis | 17 | 16 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
Vomiting | 17 | 11 | 6 | <1 | <1 | 13 | 9 | 3 | <1 | 0 |
Pyrexia | 16 | 13 | 3 | <1 | 0 | 7 | 5 | <1 | <1 | 0 |
Pneumonitis | 16 | 7 | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
Constipation | 15 | 11 | 2 | <1 | 0 | 13 | 8 | 5 | <1 | 0 |
Back pain | 15 | 10 | 5 | <1 | 0 | 11 | 5 | 3 | 2 | 0 |
Pruritus | 13 | 11 | 2 | <1 | 0 | 5 | 3 | 2 | 0 | 0 |
Insomnia | 14 | 10 | 4 | <1 | 0 | 8 | 6 | 3 | 0 | 0 |
Asthenia | 14 | 7 | 5 | 2 | <1 | 4 | 3 | <1 | <1 | 0 |
AST increased | 14 | 6 | 5 | 3 | <1 | 5 | 2 | 2 | 1 | 0 |
Hyperglycemia | 14 | 4 | 5 | 5 | <1 | 2 | <1 | <1 | <1 | 0 |
ALT increased | 12 | 5 | 4 | 3 | <1 | 5 | <1 | 2 | 2 | 0 |
Dry mouth | 11 | 10 | 1 | 0 | 0 | 7 | 7 | <1 | 0 | 0 |
Alopecia | 10 | 9 | 1 | 0 | 0 | 5 | 5 | 0 | 0 | 0 |
Nasopharyngitis | 10 | 9 | 1 | 0 | 0 | 9 | 7 | 2 | 0 | 0 |
Pain in extremity | 10 | 6 | 3 | <1 | 0 | 12 | 5 | 5 | 2 | 0 |
Urinary tract infection | 10 | 3 | 7 | <1 | 0 | 2 | <1 | 2 | 0 | 0 |
GGT increase | 10 | 2 | 2 | 5 | 2 | 9 | <1 | <1 | 5 | 2 |