Table 2.
Responses to everolimus plus exemestane in the full analysis set and by prior therapy
| All patients in the FAS (N = 281) | Prior exemestane | Prior chemotherapy | |||
|---|---|---|---|---|---|
| No (n = 190) | Yes (n = 91) | No (n = 130) | Yes (n = 151) | ||
| Week 24 | |||||
| ORR24w, 1 n (%) [95% CI] | 25 (8.9) [5.8–12.9] | 17 (8.9) [5.3–13.9] | 8 (8.8) [3.9–16.6] | 15 (11.5) [6.6–18.3] | 10 (6.6) [3.2–11.8] |
| CR | 1 (0.4) | 1 (0.5) | 0 | 0 | 1 (0.7) |
| PR | 24 (8.5) | 16 (8.4) | 8 (8.8) | 15 (11.5) | 9 (6.0) |
| SD | 69 (24.6) | 47 (24.7) | 22 (24.2) | 40 (30.8) | 29 (19.2) |
| PD | 105 (37.4) | 72 (37.9) | 33 (36.3) | 41 (31.5) | 64 (42.4) |
| Unknown 2 | 82 (29.2) | 54 (28.4) | 28 (30.8) | 34 (26.2) | 48 (31.8) |
| Week 48 | |||||
| ORR48w, 1 n (%) [95% CI] | 29 (10.3) [7.0–14.5] | 21 (11.1) [7.0–16.4] | 8 (8.8) [3.9–16.6] | 17 (13.1) [7.8–20.1] | 12 (7.9) [4.2–13.5] |
| CR | 1 (0.4) | 1 (0.5) | 0 | 0 | 1 (0.7) |
| PR | 28 (10.0) | 20 (10.5) | 8 (8.8) | 17 (13.1) | 11 (7.3) |
| SD | 72 (25.6) | 47 (24.7) | 25 (27.5) | 40 (30.8) | 32 (21.2) |
| PD | 112 (39.9) | 77 (40.5) | 35 (38.5) | 44 (33.8) | 68 (45.0) |
| Unknown 2 | 68 (24.2) | 45 (23.7) | 23 (25.3) | 29 (22.3) | 39 (25.8) |
Responses were evaluated using Response Evaluation Criteria In Solid Tumors version 1.1, assessed by local radiology review.
1
Rate of patients with best overall response of CR or PR.
2
Included in calculation of ORR (not regarded as responders).
Abbreviations: CI: confidence interval; CR: complete response; FAS: full analysis set; ORR: overall response rate; PD: progressive disease; PR; partial response; SD: stable disease.