Table 3.
Acute and chronic side-effects.
| Acute toxicities # | Cisplatin (n = 56) | Nedaplatin (n = 33) | Lobaplatin (n = 52) |
P value (≥grade 1) |
P value (≥grade 3) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade2 | Grade3 | Grade4 | Grade1 | Grade2 | Grade3 | Grade4 | Grade1 | Grade2 | Grade3 | Grade4 | |||
| Digestive tract | ||||||||||||||
| Nausea | 2 (4%) |
31 (55%) |
21 (38%) |
2 (4%) |
14 (42%) |
18 (55%) |
1 (3%) |
0 | 32 (62%) |
19 (37%) |
1 (2%) |
0 | <0.001* | <0.001 |
| Vomiting | 13 (23%) |
28 (50%) |
13 (23%) |
0 | 24 (73%) |
2 (6%) |
0 | 0 | 29 (56%) |
4 (8%) |
0 | 0 | <0.001 | <0.001※ |
| Diarrhea | 1 (2%) |
0 | 0 | 0 | 1 (3%) |
0 | 0 | 0 | 1 (2%) |
0 | 0 | 0 | 1.000※ | - |
| Dry mouth | 9 (16%) |
47 (84%) |
0 | 0 | 17 (52%) |
16 (48%) |
0 | 0 | 26 (50%) |
26 (50%) |
0 | 0 | <0.001* | - |
| Oral mucositis | 5 (9%) |
36 (64%) |
15 (27%) |
0 | 18 (55%) |
11 (33%) |
3 (9%) |
1 (3%) |
21 (40%) |
27 (52%) |
4 (8%) |
0 | <0.001* | 0.021 |
| Hematological | ||||||||||||||
| Leucopenia | 9 (16%) |
32 (57%) |
9 (16%) |
0 | 8 (24%) |
18 (55%) |
2 (6%) |
0 | 8 (15%) |
19 (37%) |
12 (23%) |
0 | 0.135 | 0.117 |
| Anemia | 37 (66%) |
7 (13%) |
4 (7%) |
0 | 27 (82%) |
0 | 1 (3%) |
0 | 35 (67%) |
8 (15%) |
2 (4%) |
0 | 1.000※ | 0.695※ |
| Thrombocytopenia | 7 (13%) |
2 (4%) |
1 (2%) |
0 | 12 (36%) |
3 (9%) |
0 | 0 | 19 (37%) |
9 (17%) |
2 (4%) |
0 | <0.001 | 0.615※ |
| Neutropenia | 16 (29%) |
16 (29%) |
5 (9%) |
1 (2%) |
6 (18%) |
8 (24%) |
1 (3%) |
0 (%) |
8 (15%) |
14 (27%) |
3 (6%) |
2 (4%) |
0.081 | 0.471※ |
| Lymphocytopenia | 0 | 7 (13%) |
37 (66%) |
12 (21%) |
0 | 4 (12%) |
27 (82%) |
2 (6%) |
0 | 4 (8%) |
39 (75%) |
9 (17%) |
- | 0.733※ |
| Febrile neutropenia | 0 | 0 | 5 (9%) |
0 | 0 | 0 | 1 (3%) |
0 | 0 | 0 | 5 (10%) |
0 | - | 0.571※ |
| Infection | 0 | 0 | 6 (11%) |
0 | 0 | 0 | 2 (6%) |
0 | 0 | 0 | 7 (13%) |
0 | - | 0.612※ |
| Aminotransferase increase | 5 (9%) |
1 (2%) |
0 | 0 | 3 (9%) |
1 (3%) |
0 | 0 | 8 (15%) |
0 | 0 | 0 | 0.769※ | - |
| Creatinine increase | 9 (16%) |
0 | 1 (2%) |
0 | 3 (9%) |
0 | 0 | 0 | 1 (2%) |
0 | 0 | 0 | 0.019※ | - |
| Dermatitis | 22 (39%) |
27 (48%) |
7 (13%) |
0 | 24 (73%) |
5 (15%) |
3 (9%) |
1 (3%) |
47 (90%) |
3 (6%) |
2 (4%) |
0 | <0.001* | 0.218※ |
| Late toxicities # ξ | ||||||||||||||
| Chronic otitis media | 40 (71%) |
9 (16%) |
0 | 0 | 20 (61%) |
4 (12%) |
1 (3%) |
0 | 32 (62%) |
8 (15%) |
0 | 0 | 0.263 | - |
| Hearing impairment | 22 (39%) |
1 (2%) |
0 | 0 | 14 (42%) |
1 (3%) |
0 | 0 | 11 (21%) |
5 (10%) |
0 | 0 | 0.342 | - |
| Trismus | 1 (2%) |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) |
0 | 0 | 0 | 1.000※ | - |
| Crannial nerve disorder | 1 (2%) |
0 | 0 | 0 | 4 (12%) |
0 | 0 | 0 | 2 (4%) |
0 | 0 | 0 | 0.097※ | - |
| Dysphagia | 1 (2%) |
0 | 0 | 0 | 1 (3%) |
0 | 0 | 0 | 3 (6%) |
0 | 0 | 0 | 0.636※ | |
| Radiation-induced encephalopathy | 1 (2%) |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) |
0 | 0 | 0 | 1.000※ | - |
| Superficial soft tissue fibrosis | 10 (18%) |
0 | 0 | 0 | 5 (15%) |
0 | 0 | 0 | 4 (8%) |
0 | 0 | 0 | 0.277※ | - |
# According to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
*≥
grade 2.
ξ
Adverse events which arised 90 days after chemoradiotherapy are defined as late toxicities.
※
Fisher’s exact probability method.