Table 2.
Acute and late toxicities related to radiation. Data are number (percentage), unless otherwise specified
| MRLN sparing RT (n=282) | Standard RT (n=282) | P value for events grade ≥1 | P value for events grade ≥3 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||||
| Any acute toxicities | |||||||||||
| Dermatitis | 106 (37.6) | 41 (14.5) | 3 (1.1) | 0 | 127 (45.0) | 30 (10.6) | 3 (1.1) | 1 (0.4) | 0.35* | >0.99* | |
| Mucositis | 55 (19.5) | 106 (37.6) | 28 (9.9) | 2 (0.7) | 34 (12.1) | 144 (51.1) | 43 (15.2) | 4 (1.4) | 0.001* | 0.04* | |
| Dry mouth | 88 (31.2) | 98 (34.8) | 2 (0.7) | 0 | 88 (31.2) | 106 (37.6) | 4 (1.4) | 0 | 0.36* | 0.68* | |
| Dysphagia | 34 (12.1) | 34 (12.1) | 4 (1.4) | 0 | 51 (18.1) | 39 (13.8) | 9 (3.2) | 0 | 0.01* | 0.16* | |
| Weight loss | 100 (35.5) | 31 (11.0) | 1 (0.4) | 0 | 63 (22.3) | 95 (33.7) | 5 (1.8) | 0 | 0.009* | 0.22* | |
| Trismus | 0 | 0 | 0 | 0 | 0 | 1 (0.4) | 0 | 0 | >0.99† | — | |
| Subcutaneous soft tissue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | — | — | |
| Any late toxicities‡ | |||||||||||
| Skin | 63 (22.6) | 8 (2.9) | 0 | 0 | 56 (20.0) | 22 (7.9) | 0 | 0 | 0.52* | — | |
| Neck tissue damage | 48 (17.2) | 22 (7.9) | 0 | 0 | 52 (18.6) | 20 (7.1) | 4 (1.4) | 0 | 0.58* | 0.13* | |
| Dysphagia | 51 (18.3) | 15 (5.4) | 1 (0.4) | 0 | 71 (25.4) | 24 (8.6) | 1 (0.4) | 0 | 0.008* | >0.99* | |
| Hoarseness | 2 (0.7) | 0 | 0 | 0 | 4 (1.4) | 0 | 0 | 0 | 0.68* | — | |
| Dry mouth | 116 (41.6) | 66 (23.7) | 8 (2.9) | 0 | 112 (40.0) | 72 (25.7) | 16 (5.7) | 0 | 0.39* | 0.10* | |
| Trismus | 11 (3.9) | 3 (1.1) | 0 | 0 | 13 (4.6) | 6 (2.1) | 0 | 0 | 0.38* | — | |
| Auditory/hearing | 108 (38.7) | 21 (7.5) | 4 (1.4) | 0 | 107 (38.2) | 40 (14.3) | 8 (2.9) | 0 | 0.07* | 0.25* | |
| Temporal lobe injury | 18 (6.5) | 1 (0.4) | 0 | 0 | 24 (8.6) | 0 | 0 | 0 | 0.43* | — | |
Safety analyses were done in the safety population, comprising all patients who commenced the randomly assigned treatment. MRLN=medial retropharyngeal lymph node; RT=radiotherapy.
*
P values were calculated by χ² tests.
†
P values were calculated by Fisher’s exact tests.
‡
Three patients in the MRLN sparing RT group and two patients in the standard RT group were lost to follow-up or died within three months after RT and thus the late toxicity analysis included 279 patients in the MRLN sparing RT group and 280 patients in the standard RT group.