Table 5.
Best Overall Response in Patients with Measurable and Non-measurable Disease by Response Evaluation Criteria in Solid Tumours v1.1.
| Best Overall Response a | Letrozole Part A, n (%) | Anastrozole Part B, n (%) | Tamoxifen Part C, n (%) | Exemestane Part D, n (%) | Parts A–Dn (%) |
|---|---|---|---|---|---|
| All patients (N) | 20 | 16 | 16 | 15 | 67 |
| CR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 1 (1.5) |
| PR | 2 (10.0) | 3 (18.8) | 3 (18.8) | 5 (33.3) | 13 (19.4) |
| SD | 10 (50.0) | 11 (68.8) | 9 (56.3) | 5 (33.3) | 35 (52.2) |
| Progressive disease | 2 (10.0) | 1 (6.3) | 3 (18.8) | 2 (13.3) | 8 (11.9) |
| Not assessed | 6 (30.0) | 1 (6.3) | 1 (6.3) | 2 (13.3) | 10 (14.9) |
| Objective response rate (CR + PR) | 2 (10.0) | 3 (18.8) | 3 (18.8) | 6 (40.0) | 14 (20.9) |
| Disease control rate (CR + PR + SD) | 12 (60.0) | 14 (87.5) | 12 (75.0) | 11 (73.3) | 49 (73.1) |
| Clinical benefit rate (CR + PR + SD≥24 weeks) | 8 (40.0) | 13 (81.3) | 12 (75.0) | 9 (60.0) | 42 (62.7) |
| Measurable disease (N) | 9 | 9 | 8 | 10 | 36 |
| CR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 1 (2.8) |
| PR | 2 (22.2) | 3 (33.3) | 3 (37.5) | 5 (50.0) | 13 (36.1) |
| SD | 4 (44.4) | 4 (44.4) | 2 (25.0) | 1 (10.0) | 11 (30.6) |
| Progressive disease | 2 (22.2) | 1 (11.1) | 3 (37.5) | 1 (10.0) | 7 (19.4) |
| Not assessed | 1 (11.1) | 1 (11.1) | 0 (0.0) | 2 (20.0) | 4 (11.1) |
| Objective response rate (CR + PR) | 2 (22.2) | 3 (33.3) | 3 (37.5) | 6 (60.0) | 14 (38.9) |
| Disease control rate (CR + PR + SD) | 6 (66.7) | 7 (77.8) | 5 (62.5) | 7 (70.0) | 25 (69.4) |
| Clinical benefit rate (CR + PR + SD≥24 weeks) | 3 (33.3) | 6 (66.7) | 5 (62.5) | 6 (60.0) | 20 (55.6) |
| PFS [at 6 months, % (95% CI)] | 76.2 (42.7, 91.7) | 86.7 (56.4, 96.5) | 73.3 (43.6, 89.1) | 75.2 (40.7, 91.4) | 77.9 (64.3, 86.8) |
| Median PFS, months (95% CI) | 28.5 (2.1, NE) | 32.0 (9.7, NE) | 18.4 (2.1, NE) | 34.3 (5.6, NE) | 25.4 (18.0, 35.8) |
CI, confidence interval; CR, complete response; N, number of patients in population; n, number of patients in the category; NE, not estimable; PFS, progression free survival; PR, partial response; SD, stable disease.
a
Response according to Response Evaluation Criteria in Solid Tumours version 1.1.