Introduction
Patients and methods
Patients
Treatment regimens
Points of assessment
Procedure
Instruments
Statistical considerations
Sample size and power
- a high score for a symptom scale represents a high level of symptoms or problems
- a high score for a functional scale represents a high level of functioning
- a high score for the global health status/QoL represents high quality of life.
Response rates and missing data
Main analysis and statistical model
Results
Characteristic | Treatment group, no. (%) | |
---|---|---|
Experimental group (tailored dose-dense chemotherapy) n = 384 | Standard group (standard chemotherapy) n = 396 | |
Age, median [min–max] | 51.9 [24.7–64.8] | 50.0 [21.4–65.9] |
Type of surgery | ||
Mastectomy | 234 (61) | 237 (60) |
Breast-conserving surgery | 150 (39) | 150 (40) |
Tumour size, cm | ||
≤ 2 | 158 (41) | 158 (40) |
> 2 to 5 | 196 (51) | 215 (54) |
> 5 | 30 (8) | 23 (6) |
Positive nodes, no. | ||
0 | 22 (6) | 17 (4) |
1–3 | 236 (62) | 233 (59) |
4–9 | 87 (23) | 110 (28) |
> 9 | 39 (10) | 36 (9) |
Tumour grade | ||
1 | 29 (8) | 24 (6) |
2 | 151 (39) | 171 (43) |
3 | 201 (52) | 201 (51) |
Missing | 3 (1) | 0 (0) |
Hormone receptor status | ||
ER or PR positive | 297 (77) | 298 (75) |
ER and PR negative | 86 (23) | 98 (25) |
Missing | 1 (0) | 0 (0) |
HER2 status | ||
Negative | 313 (82) | 312 (79) |
Positive | 71 (19) | 84 (21) |
Ki-67 positive cells, IHC | ||
≤20 | 150 (39) | 155 (39) |
> 20 | 197 (51) | 200 (51) |
Missing | 37 (10) | 41 (10) |
HRQoL differences between the randomization groups over time
Pre-selected scales | At end of treatment (4 months) | At first follow-up visit (8 months) | Test for interaction‡ | ||||||
---|---|---|---|---|---|---|---|---|---|
EORTC subscales | Experimental group Mean (SD) | Standard group Mean (SD) | MD# (99% CI) | P | Experimental group Mean (SD) | Standard group Mean (SD) | MD# (99% CI) | P | P |
EORTC QLQ-C30 | |||||||||
Global health status | 41.0 (21.4) | 55.2 (21.0) | − 14 (− 18 to − 10)M | < 0.001 | 66.6 (18.8) | 67.6 (19.7) | − 1 (− 5 to 3) | 0.570 | < 0.001 |
Physical functioning | 64.9 (21.5) | 73.6 (18.9) | − 9 (− 12 to − 6)S | < 0.001 | 82.2 (16.6) | 84.4 (14.6) | − 3 (− 6 to 1) | 0.031 | < 0.001 |
Role functioning | 33.2 (29.2) | 47.8 (30.9) | − 15 (− 20 to − 9)M | < 0.001 | 64.3 (29.6) | 69.1 (28.3) | − 5 (− 10 to 1)S | 0.028 | < 0.001 |
Emotional functioning | 68.3 (22.3) | 69.9 (22.6) | − 2 (− 6 to 3) | 0.307 | 73.3 (21.4) | 72.0 (23.6) | 2 (− 3 to 6) | 0.353 | 0.055 |
Social functioning | 50.1 (27.9) | 59.9 (25.4) | − 10 (− 15 to − 5)M | < 0.001 | 74.4 (25.0) | 77.4 (23.5) | − 3 (− 7 to 2) | 0.160 | < 0.001 |
Fatigue | 61.3 (25.6) | 49.1 (25.3) | 12 (8 to 17)M | < 0.001 | 34.4 (23.1) | 32.0 (22.7) | 3 (− 2 to 7) | 0.157 | < 0.001 |
EORTC QLQ− BR23 | |||||||||
Body image | 56.7 (28.8) | 56.7 (29.5) | 0 (− 5 to 5) | 0.896 | 70.1 (25.5) | 68.9 (28.0) | 2 (− 3 to 7) | 0.414 | 0.884 |
Sexual functioning | 10.2 (15.9) | 15.1 (18.7) | − 5 (− 9 to − 1)S | 0.001 | 20.9 (21.3) | 24.3 (21.1) | − 3 (− 7 to 1) | 0.045 | 0.057 |
Systemic therapy | 52.2 (18.2) | 40.7 (19.2) | 12 (9 to 14)M | < 0.001 | 19.9 (14.1) | 17.2 (13.9) | 3 (0 to 5) | 0.024 | < 0.001 |
Breast symptoms | 13.3 (14.9) | 13.5 (15.0) | 0 (− 4 to 3) | 0.785 | 22.7 (19.7) | 21.8 (19.1) | 0 (− 3 to 4) | 0.762 | 0.904 |
Arm symptoms | 12.0 (16.4) | 13.8 (16.5) | − 2 (− 5 to 2) | 0.194 | 24.2 (21.2) | 22.5 (19.8) | 2 (− 2 to 6) | 0.182 | 0.077 |