Table 2.
Grade 3 and 4 AEs observed during neoadjuvant treatment (N=37)
| Adverse event |
Arm A: CRT+pembrolizumab (n=24) |
Arm B: CRT (n=13) |
||
| Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
| Gastrointestinal | ||||
| Diarrhea | 2 | 0 | 0 | 0 |
| Nausea | 1 | 0 | 0 | 0 |
| Hepatic | ||||
| Transaminitis | 1* | 0 | 0 | 0 |
| Hematologic | ||||
| Lymphocyte count decreased | 7 | 0 | 4 | 0 |
| Leukemia | 0 | 1† | 0 | 0 |
| Metabolic/nutrition | ||||
| Hypophosphatemia | 1 | 0 | 0 | 0 |
| Musculoskeletal | ||||
| Myalgia | 1 | 0 | 0 | 0 |
| Arthralgia | 1 | 0 | 0 | 0 |
9 Patients had a grade 3 or 4 AE; some patients had more than one.
*Attributed “probably” to CRT+pembrolizumab, thus qualifying as a dose-limiting toxicity.
†Attributed to chemotherapy.
AE, adverse event; CRT, chemoradiotherapy.