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BOLERO-2

Baseline patient characteristics were well balanced between the 2 treatment arms

BASELINE PATIENT CHARACTERISTICS1,2
Characteristic AFINITOR + exemestane (n=485) Placebo + exemestane (n=239)
Median age (range), years 62 (34-93) 61 (28-90)
Race* White 74% 78%
Asian 20% 19%
No adjuvant therapy 31% 31%
Visceral disease 58% 59%
Measurable disease 70% 68%
Metastatic site Lung 30% 33%
Liver 33% 30%
Bone 77% 77%
Number of metastatic sites 1 32% 29%
2 31% 34%
≥3 36% 37%
ECOG performance status 0 60% 59%
1 36% 35%
2 2% 3%
~59%of patients had visceral disease1‡
69%of patients had ≥2 sites of metastatic involvement1
21%of patients had bone-only metastases1
*Race was determined by self-report.
All other patients had at least 1 mainly lytic bone lesion.
AFINITOR is indicated for the treatment of hormone receptor–positive, HER2/neu-negative advanced breast cancer, in
combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a nonsteroidal aromatase inhibitor.
Abbreviations:
ABC, advanced breast cancer; BOLERO-2, Breast Cancer Trials of Oral Everolimus-2; HR+, hormone receptor-positive; ECOG, Eastern Cooperative Oncology Group.
References:
  1. Yardley DA, Noguchi S, Pritchard KI, et al. Everolimus plus exemestane in postmenopausal patients with HR+ breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013;30(10):870-884.
  2. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366(6):520-529.