Table 3 Unadjusted patient-reported outcomes by study arm and age group at baseline and 18-months post-enrollment.
Patient-reported outcome measure | Baseline | 18 months | ||||||
|---|---|---|---|---|---|---|---|---|
TH | T-DM1 | TH | TDM1 | |||||
≤50 | >50 | ≤50 | >50 | ≤50 | >50 | ≤50 | >50 | |
FACT-B (total) - mean (SD) | ||||||||
n | 30 | 51 | 93 | 188 | 31 | 48 | 92 | 188 |
FACT-B total score | 115.06 (20.58) | 116.53 (20.07) | 122.25 (14.40) | 128.35 (13.63) | 114.59 (24.57) | 119.69 (23.00) | 126.20 (13.46) | 126.38 (16.72) |
Physical well-being | 25.57 (3.82) | 26.02 (3.26) | 26.14 (2.62) | 26.69 (3.07) | 23.84 (5.24) | 23.58 (4.83) | 25.77 (2.74) | 25.21 (3.93) |
Social/family well-being | 23.89 (6.13) | 24.64 (4.11) | 24.98 (4.85) | 25.88 (3.94) | 21.90 (7.37) | 24.34 (6.07) | 24.81 (3.80) | 24.77 (5.47) |
Emotional well-being | 16.83 (4.63) | 17.42 (4.46) | 19.00 (3.46) | 19.69 (2.95) | 18.41 (4.62) | 19.46 (4.80) | 20.42 (3.30) | 20.76 (2.86) |
Functional well-being | 20.03 (5.41) | 20.35 (6.30) | 20.03 (5.41) | 23.68 (4.48) | 21.34 (7.13) | 22.37 (6.01) | 23.88 (4.49) | 23.43 (5.35) |
Breast cancer subscale | 28.73 (6.68) | 28.26 (7.00) | 28.73 (6.68) | 32.33 (4.57) | 28.18 (7.70) | 30.06 (6.13) | 31.34 (4.81) | 32.08 (5.15) |
RSCL - mean (SD) | ||||||||
n | 30 | 51 | 92 | 188 | 31 | 47 | 91 | 186 |
Physical symptom distress | 30.61 (7.31) | 30.96 (6.83) | 28.95 (4.95) | 27.80 (5.09) | 32.10 (8.97) | 32.50 (7.97) | 30.36 (5.97) | 31.29 (7.60) |
Psychological distress | 14.73 (5.13) | 14.80 (4.99) | 12.65 (4.23) | 10.93 (3.23) | 12.23 (4.33) | 11.13 (4.70) | 10.14 (3.83) | 9.73 (3.22) |
Activity level | 30.92 (2.30) | 30.82 (2.72) | 30.36 (4.01) | 31.24 (1.94) | 31.41 (1.46) | 30.34 (3.69) | 31.61 (1.82) | 30.75 (3.61) |
Overall valuation of life | 1.81 (1.04) | 2.14 (1.53) | 1.82 (0.95) | 1.48 (0.72) | 2.00 (1.41) | 2.10 (1.30) | 1.64 (0.89) | 1.71 (0.94) |
WPAI:SHP - mean (SD) | ||||||||
n | 30 | 50 | 91 | 188 | 31 | 44 | 91 | 184 |
Percentage employed - (n, %) | 20 (67%) | 24 (48%) | 75 (83%) | 99 (53%) | 24 (77%) | 21 (48%) | 76 (84%) | 91 (48%) |
% work time missed due to breast cancer | 29.05 (38.63) | 17.02 (25.19) | 34.56 (41.48) | 14.92 (28.28) | 6.11 (21.11) | 2.22 (5.09) | 3.53 (14.45) | 2.53 (12.58) |
% impairment at work due to breast cancer | 14.67 (19.95) | 24.21 (29.12) | 19.62 (26.19) | 5.60 (10.79) | 7.39 (18.15) | 8.24 (15.51) | 3.53 (9.58) | 2.44 (7.35) |
% overall work impairment due to breast cancer | 27.01 (27.13) | 32.78 (31.53) | 29.26 (32.91) | 14.61 (22.17) | 9.30 (19.09) | 9.96 (17.25) | 5.47 (12.91) | 3.72 (10.42) |
% activity impairment due to breast cancer | 23.45 (27.68) | 18.98 (24.94) | 21.41 (27.40) | 10.82 (18.92) | 12.67 (26.38) | 16.19 (28.71) | 6.44 (16.44) | 7.43 (16.53) |
APA - (n, %) | ||||||||
n | 29 | 49 | 93 | 183 | 31 | 44 | 88 | 177 |
Any hair loss | 1 (3%) | 5 (10%) | 3 (3%) | 15 (8%) | 3 (10%) | 9 (20%) | 12 (14%) | 23 (13%) |
PNQ - (n, %) | ||||||||
n | 30 | 51 | 92 | 182 | 31 | 48 | 92 | 189 |
Any moderate, moderate-severe or severe neuropathy | 3 (10%) | 1 (2%) | 7 (8%) | 3 (2%) | 8 (26%) | 19 (40%) | 9 (10%) | 39 (21%) |
