Table 5 WHO tumor response status (n, %) in the ITT and PP populations at Months 4 and 8 and Individual End of letrozole treatment
Intent-to-treat population, N = 29 | Per-protocol population, N = 25 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Month 4 | Month 8 | Individual End | Month 4 | Month 8 | Individual End | |||||||
Tumor response | Clinical tumor assessment | Clinical tumor assessment | ||||||||||
complete response | 1 | (3.5%) | 1 | (3.5%) | 2 | (6.9%) | 1 | (4.0%) | 1 | (4.0%) | 2 | (8.0%) |
partial response | 15 | (51.7%) | 6 | (20.7%) | 19 | (65.5%) | 14 | (56.0%) | 3 | (12.0%) | 16 | (64.0%) |
no change (stable disease) | 5 | (17.2%) | 1 | (3.5%) | 4 | (13.8%) | 3 | (12.0%) | 0 | (0.0%) | 3 | (12.0%) |
progressive disease | 2 | (6.9%) | 0 | (0.0%) | 3 | (10.3%) | 2 | (8.0%) | 0 | (0.0%) | 3 | (12.0%) |
Missing observations | 6 | (20.7%) | 21 | (72.4%) | 1 | (3.5%) | 5 | (20.0%) | 21 | (84.0%) | 1 | (4.0%) |
Tumor response | Mammography | Mammography | ||||||||||
complete response | 0 | (0.0%) | 0 | (0.0%) | 0 | (0.0%) | 0 | (0.0%) | 0 | (0.0%) | 0 | (0.0%) |
partial response | 7 | (24.1%) | 2 | (6.9%) | 7 | (24.1%) | 5 | (20.0%) | 1 | (4.0%) | 5 | (20.0%) |
no change (stable disease) | 11 | (37.9%) | 1 | (3.5%) | 13 | (44.8%) | 10 | (40.0%) | 0 | (0.0%) | 11 | (44.0%) |
progressive disease | 1 | (3.5%) | 0 | (0.0%) | 1 | (3.5%) | 1 | (4.0%) | 0 | (0.0%) | 1 | (4.0%) |
Missing observations | 10 | (34.5%) | 26 | (89.7%) | 8 | (27.6%) | 9 | (36.0%) | 24 | (96.0%) | 8 | (32.0%) |
Tumor response | Breast ultrasound | Breast ultrasound | ||||||||||
complete response | 1 | (3.5%) | 1 | (3.5%) | 2 | (6.9%) | 1 | (4.0%) | 1 | (4.0%) | 2 | (8.0%) |
partial response | 13 | (44.8%) | 5 | (17.2%) | 16 | (55.2%) | 11 | (44.0%) | 2 | (8.0%) | 13 | (52.0%) |
no change (stable disease) | 6 | (20.7%) | 1 | (3.5%) | 8 | (27.6%) | 5 | (20.0%) | 1 | (4.0%) | 7 | (28.0%) |
progressive disease | 1 | (3.5%) | 0 | (0.0%) | 1 | (3.5%) | 1 | (4.0%) | 0 | (0.0%) | 1 | (4.0%) |
Missing observations | 8 | (27.6%) | 22 | (75.9%) | 2 | (6.9%) | 7 | (28.0%) | 21 | (84.0%) | 2 | (8.0%) |