Table 2.
Adjusted EORTC QLQ-C30 and EORTC QLQ-BR23 mean function and symptom scores (95% CI), at early postoperative measurement and at one-year follow-up in the SLNB + ALND versus the SLNB only group.
| Early postoperative measurement |
1-year follow-up |
|||||||
|---|---|---|---|---|---|---|---|---|
| SLNB + ALND (N = 457) | SLNB only (N = 503) | Mean difference | P* | SLNB + ALND (N = 475) | SLNB only (N = 501) | Mean difference | P* | |
| EORTC QLQ-C30 version 3.0 | ||||||||
| Global health/QoL | 65.0 (63.0, 67.1) | 68.3 (66.3, 70.2) | 3.2 (0.6, 5.9) | .017 | 73.8 (71.2, 76.4) | 74.4 (72.0, 77.0) | 0.8 (−1.9, 3.4) | .307 |
| Function subscales | ||||||||
| Physical function | 82.5 (80.9, 84.1) | 82.9 (81.4, 84.4) | 0.4 (−1.6, 2.5) | .684 | 83.6 (81.4, 85.7) | 84.2 (82.1, 86.3) | 0.6 (−1.6, 2.9) | .568 |
| Role function | 65.0 (62.1, 67.9) | 70.5 (67.7, 73.2) | 5.5 (1.7, 9.3) | .005 | 81.0 (77.9, 84.1) | 83.6 (80.6, 86.5) | 2.6 (−0.6, 5.8) | .108 |
| Emotional function | 70.5 (68.2, 72.8) | 73.3 (71.1, 75.5) | 2.8 (−0.1, 5.8) | .060 | 78.3 (75.6, 80.9) | 80.9 (78.3, 83.5) | 2.6 (−0.1, 5.4) | .061 |
| Cognitive function | 81.6 (79.5, 83.7) | 82.8 (80.9, 84.8) | 1.2 (−1.5, 3.9) | .373 | 80.4 (77.6, 83.1) | 82.4 (79.7, 85.0) | 2.0 (−0.8, 4.8) | .167 |
| Social function | 78.4 (76.1, 80.7) | 81.6 (79.4, 83.8) | 3.2 (0.2, 6.2) | .034 | 83.2 (80.2, 86.1) | 85.9 (83.0, 88.8) | 2.8 (−0.3, 5.8) | .076 |
| Symptom subscales/items | ||||||||
| Fatigue | 35.6 (33.3, 37.9) | 33.3 (31.1, 35.5) | −2.3 (−5.3, 0.71) | .136 | 30.5 (27.6, 33.5) | 27.5 (24.6, 30.3) | - 3.0 (−6.1, 0.0) | .052 |
| Nausea/vomiting | 5.7 (4.5, 6.9) | 5.7 (4.6, 6.9) | 0.0 (−1.5, 1.6) | .976 | 4.4 (3.1, 5.7) | 3.2 (1.9, 4.4) | - 1.3 (−2.6, 0.1) | .072 |
| Pain | 30.3 (28.0, 32.7) | 22.3 (20.0, 24.5) | −8.1 (−11.1, −5.1) | <.001 | 21.6 (18.7, 24.5) | 15.9 (13.1, 18.7) | −5.7 (−8.7, −2.7) | <.001 |
| Dyspnoea | 12.8 (10.7, 15.0) | 14.0 (11.9, 16.0) | 1.2 (−1.7, 4.0) | .420 | 21.6 (18.4, 24.9) | 18.5 (15.3, 21.6) | −3.2 (−6.5, 0.2) | .061 |
| Insomnia | 33.0 (29.9, 33.9) | 31.0 (28.1, 33.9) | −2.0 (−5.9, 2.0) | .327 | 33.7 (29.7, 37.7) | 28.4 (24.6, 32.2) | −5.3 (−9.4, −1.2) | .011 |
| Appetite loss | 14.1 (12.0, 16.3) | 11.2 (9.1, 13.2) | −3.0 (−5.8, −0.2) | .036 | 8.7 (6.2, 11.2) | 9.3 (7.0, 11.8) | 0.7 (−1.9, 3.2) | .620 |
| Constipation | 13.2 (11.0, 15.5) | 12.0 (9.9, 14.2) | −1.2 (−4.1, 1.7) | .419 | 11.2 (8.4, 14.0) | 10.9 (8.2, 13.6) | −0.3 (−3.2, 2.6) | .850 |
| Diarrhoea | 7.5 (5.8, 9.2) | 8.5 (6.8, 10.1) | 1.0 (−1.3, 3.2) | .400 | 8.2 (5.9, 10.4) | 7.1 (4.9, 9.2) | −1.1 (−3.4, 1.2) | .348 |
| Financial difficulties | 9.0 (6.7, 11.4) | 10.0 (7.7, 12.2) | 0.9 (−2.1, 4.0) | .560 | 10.4 (7.5, 13.4) | 8.2 (5.4, 11.0) | −2.3 (−5.3, 0.8) | .141 |
| EORTC QLQ-BR23 | ||||||||
| Function subscales/items | ||||||||
| Body image | 80.9 (78.6, 83.2) | 81.4 (79.2, 83.6) | 0.5 (−2.5, 3.5) | .759 | 77.4 (74.1, 80.8) | 79.2 (75.9, 82.4) | 1.7 (−1.7, 5.2) | .323 |
| Future perspective | 46.3 (43.2, 49.4) | 50.0 (47.0, 53.0) | 3.7 (−0.4, 7.8) | .078 | 56.0 (52.2, 59.7) | 58.3 (54.6, 61.9) | 2.3 (−1.6, 6.2) | .247 |
| Sexual function | 18.1 (15.9, 20.3) | 15.3 (13.2, 17.4) | −2.8 (−5.6, −0.0) | .049 | 18.0 (15.0, 20.9) | 19.2 (16.4, 22.1) | 1.2 (−1.8, 4.3) | .423 |
| Sexual enjoyment | 60.5 (55.9, 65.2) | 62.5 (57.8, 67.1) | 1.9 (−4.3, 8.2) | .539 | 60.0 (53.7, 66.4) | 61.4 (55.0, 67.7) | 1.3 (−5.1, 7.7) | .686 |
| Symptom subscales/items | ||||||||
| Systemic therapy side effects | 15.3 (13.8, 16.8) | 15.1 (13.7, 16.5) | −0.2 (−2.1, 1.7) | .846 | 21.1 (19.1, 23.0) | 19.0 (17.1, 20.9) | −2.1 (−4.1, 0.0) | .047 |
| Upset by hair loss | 60.2 (49.9, 70.5) | 54.2 (45.3, 63.2) | −5.9 (−18.4, 6.5) | .348 | 42.7 (31.1, 54.3) | 49.8 (39.2, 60.3) | 7.0 (−5.1, 19.2) | .255 |
| Arm symptoms | 25.0 (23.1, 26.9) | 14.2 (12.4, 15.9) | −10.8 (−13.3, −8.4) | <.001 | 23.2 (20.7, 25.7) | 11.0 (8.6, 13.4) | −12.2 (−14.8, −9.6) | <.001 |
| Breast symptoms | 30.4 (28.4, 32.3) | 27.2 (25.3, 29.1) | −3.2 (−5.7, −0.7) | .014 | 22.9 (20.5, 25.2) | 16.2 (13.9, 18.4) | −6.7 (−9.1, −4.3) | <.001 |
Adjusted means from participants who had responded to the questionnaire at least once. Early postoperative measurement: adjusted means for country. 1-year follow-up: adjusted means for country and inclusion of axillary level 1 in CTV. *ANOVA F-test. P ≤ .0017 is considered statistically significant. Global health and QoL: the higher score the better HRQoL. Function scales: the higher score the better function. Symptom scales: the higher score the worse symptom.