Table 4.
Adjuvant treatment-related adverse events
| Toxicity | Toxicity | CTCAE v5 grade | Whole population (n = 55) | Withheld pembrolizumab (n = 27) | Concomitant pembrolizumab (n = 28) | P value | Power | w | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| After radiotherapy | Radiodermitis | 1 | 37 | 67.27 % | 19 | 70.37% | 18 | 64.29% | .461 | 0.23 | 0.21 |
| 2 | 9 | 16.36 % | 3 | 11.11% | 6 | 21.43% | |||||
| 3 | 1 | 1.82% | 1 | 3.7% | 0 | 0% | |||||
| 4 | 0 | 0% | 0 | 0% | 0 | 0% | |||||
| Asthenia | 1 | 22 | 40% | 10 | 37.04% | 12 | 42.86% | .614 | 0.12 | 0.15 | |
| 2 | 4 | 7.27% | 1 | 3.7% | 3 | 10.71% | |||||
| 3+ | 0 | 0% | 0 | 0% | 0 | 0% | |||||
| Pain | 1 | 10 | 18.18 % | 7 | 25.93% | 3 | 10.71% | .364 | 0.28 | 0.42 | |
| 2 | 0 | 0% | 0 | 0% | 0 | 0% | |||||
| 3 | 1 | 1.82% | 0 | 0% | 1 | 3.57% | |||||
| 4 | 0 | 0% | 0 | 0% | 0 | 0% | |||||
| Myocarditis | 1+ | 0 | 0% | 0 | 0% | 0 | 0% | NA | NA | NA | |
| Dyspnea | 1 | 3 | 5.45% | 0 | 0% | 3 | 10.71% | 1.000 | 0.28 | 0.42 | |
| 2 | 1 | 1.82% | 0 | 0% | 1 | 3.57% | |||||
| 3+ | 0 | 0% | 0 | 0% | 0 | 0% | |||||
| Cough | 1 | 4 | 7.27% | 2 | 7.41% | 2 | 7.14% | 1.000 | NA | NA | |
| 2+ | 0 | 0% | 0 | 0% | 0 | 0% | |||||
| Odynophagia | 1 | 3 | 5.45% | 2 | 7.41% | 1 | 3.57% | 1.000 | 0.07 | 0.17 | |
| 2 | 2 | 3.64% | 1 | 3.7% | 1 | 3.57% | |||||
| 3+ | 0 | 0% | 0 | 0% | 0 | 0% | |||||
| Lymphoedema | 1 | 5 | 9.09% | 3 | 11.11% | 2 | 7.14% | 1.000 | NA | NA | |
| 2+ | 0 | 0% | 0 | 0% | 0 | 0% | |||||
Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; NA = not applicable; w = effect size.
P values were calculated with Fisher's exact test. Posthoc power analyses were additionally performed.