Table 2.
Characteristics | All patients (N=536), n (%) | Training set (n=402), n (%) | Testing set (n=134), n (%) | |||||
Group 2: Post– induction chemotherapy– decision features (after D1a and before D2b) | ||||||||
|
Prescribed chemotherapy | |||||||
|
|
None | 342 (63.8) | 250 (62.2) | 92 (68.7) | |||
|
|
Doublet | 41 (7.6) | 32 (8) | 9 (6.7) | |||
|
|
Triplet | 143 (26.7) | 111 (27.6) | 32 (23.9) | |||
|
|
Quadruplet | 7 (1.3) | 7 (1.7) | 0 (0) | |||
|
|
Not otherwise specified | 3 (0.6) | 2 (0.5) | 1 (0.7) | |||
|
Chemotherapy modification | 85 (15.9) | 65 (16.2) | 20 (14.9) | ||||
|
Chemotherapy modification type | |||||||
|
|
No dose adjustment | 451 (84.1) | 336 (83.6) | 115 (85.8) | |||
|
|
Dose modified | 21 (3.9) | 16 (4) | 5 (3.7) | |||
|
|
Dose delayed | 10 (1.9) | 9 (2.2) | 1 (0.7) | |||
|
|
Dose cancelled | 18 (3.4) | 13 (3.2) | 5 (3.7) | |||
|
|
Dose delayed and modified | 6 (1.1) | 5 (1.2) | 1 (0.7) | |||
|
|
Regimen modification | 29 (5.4) | 22 (5.5) | 7 (5.2) | |||
|
|
Unknown | 1 (0.2) | 1 (0.2) | 0 (0) | |||
|
Dose-limiting toxicity | 95 (17.7) | 73 (18.2) | 22 (16.4) | ||||
|
Dose-limiting toxicity g rade (also included for dermatological, neurological, gastrointestinal, hematological, nephrological, vascular, and infection [pneumonia]) | |||||||
|
|
0 | 446 (83.2) | 334 (83.1) | 112 (83.6) | |||
|
|
1 | 7 (1.3) | 6 (1.5) | 1 (0.7) | |||
|
|
2 | 33 (6.2) | 26 (6.5) | 7 (5.2) | |||
|
|
3 | 41 (7.6) | 29 (7.2) | 12 (9) | |||
|
|
4 | 9 (1.7) | 7 (1.7) | 2 (1.5) | |||
|
Imaging (yes) | 194 (36.2) | 152 (37.8) | 42 (31.3) | ||||
|
Complete response, primary (1c, as opposed to 0d) | 84 (15.7) | 67 (16.7) | 17 (12.7) | ||||
|
Complete response, nodal (1) | 16 (3) | 14 (3.5) | 2 (1.5) | ||||
|
Parietal response, primary (1) | 89 (16.6) | 70 (17.4) | 19 (14.2) | ||||
|
Parietal response, nodal (1) | 156 (29.1) | 125 (31.1) | 31 (23.1) | ||||
|
Stable disease, primary (1) | 11 (2.1) | 8 (2) | 3 (2.2) | ||||
|
Stable disease, nodal (1) | 10 (1.9) | 6 (1.5) | 4 (3) | ||||
Group 3: Post–concurrent chemotherapy –decision features (after D2 and before D3e) | ||||||||
|
Concurrent chemotherapy regimen | |||||||
|
|
None | 126 (23.5) | 89 (22.1) | 37 (27.6) | |||
|
|
Platinum based | 257 (47.9) | 198 (49.3) | 59 (44) | |||
|
|
Cetuximab based | 129 (24.1) | 95 (23.6) | 34 (25.4) | |||
|
|
Other | 24 (4.5) | 20 (5) | 4 (3) | |||
|
Concurrent chemotherapy modification (1) | 99 (18.5) | 77 (19.2) | 22 (16.4) | ||||
|
Complete response, primary 2 (1) | 450 (84.1) | 336 (83.8) | 114 (85.1) | ||||
|
Complete response, nodal 2 (1) | 247 (46.1) | 186 (46.3) | 61 (45.5) | ||||
|
Parietal response, primary 2 (1) | 77 (14.4) | 58 (14.4) | 19 (14.2) | ||||
|
Parietal response, nodal 2 (1) | 257 (47.9) | 191 (47.5) | 66 (49.3) | ||||
|
Stable disease, primary 2 (1) | 2 (0.4) | 2 (0.5) | 0 (0) | ||||
|
Stable disease, nodal 2 (1) | 10 (1.9) | 6 (1.5) | 4 (3) | ||||
|
Dose-limiting toxicity 2 (also included for dermatological, neurological, gastrointestinal, hematological, nephrological, vascular, and other) | 102 (19) | 80 (19.9) | 22 (16.4) | ||||
Group 4: Primary outcomes after D3 | ||||||||
|
Four-year overall survival (alive) | 457 (85.3) | 344 (85.6) | 113 (84.3) | ||||
|
Feeding tube 6 months (yes) | 98 (18.3) | 77 (19.2) | 21 (15.7) | ||||
|
Aspiration rate after therapy (yes) | 98 (18.3) | 79 (19.7) | 19 (14.2) | ||||
|
Dysphagia (yes) | 154 (28.7) | 122 (30.3) | 32 (23.9) |
aD1: decision 1 (induction chemotherapy or not).
bD2: decision 2 (concurrent chemotherapy or radiotherapy alone).
cThe patient survived for at least four years after the treatment ended.
dAll other events.
eD3: decision 3 (neck dissection or not).