Table 2 Adverse events during Neoadjuvant Pembrolizumab plus Chemoradiotherapy and after surgery

From: Preoperative pembrolizumab (anti-PD-1 antibody) combined with chemoradiotherapy for esophageal squamous cell carcinoma: a phase 1/2 trial (PALACE-2)

Events

n (%)

Events of any grade during neoadjuvant therapy (n = 140)

 

 Blood and lymphatic system disorders

 

 Lymphopenia

119 (85.0)

 Leukopenia

101 (72.1)

 Anemia

80 (57.1)

 Thrombocytopenia

64 (45.7)

 Decreased neutrophil count

47 (33.6)

 Immune-related events

 

 Pneumonitis

4 (2.9)

 Myocarditis

1 (0.7)

 Hepatitis

1 (0.7)

 Pancreatitis

1 (0.7)

 Toxic epidermal necrolysis

1 (0.7)

 Gastrointestinal disorders

 

 Nausea

19 (13.6)

 Esophagitis

16 (11.4)

 Vomiting

12 (8.6)

 Constipation

8 (5.7)

 Diarrhea

6 (4.3)

 Esophageal hemorrhage

3 (2.1)

 Skin and subcutaneous tissue disorders

 

 Alopecia

24 (17.1)

 Rash

8 (5.7)

 Dermatitis

7 (5.0)

 General disorders

 

 Fatigue

22 (15.7)

Events of grade ≥ 3 during neoadjuvant therapy (n = 140)

 

 Blood and lymphatic system disorders

 

 Lymphopenia

104 (74.3)

 Leukopenia

4 (2.9)

 Anemia

1 (0.7)

 Thrombocytopenia

2 (1.4)

 Decreased neutrophil count

2 (1.4)

 Immune-related events

 

 Pneumonitis

4 (2.9)

 Myocarditis

1 (0.7)

 Hepatitis

1 (0.7)

 Pancreatitis

1 (0.7)

 Toxic epidermal necrolysis

1 (0.7)

 Gastrointestinal disorders

 

 Esophageal hemorrhage

2 (1.4)

Postoperative events (n = 125)

 

 Pneumonia

27 (21.6)

 Hoarseness

21 (16.8)

 Anastomotic leakage

14 (11.2)

 Chylothorax

4 (3.2)

 Postoperative intrathoracic hemorrhage

2 (1.6)

 Gastrointestinal fistula

1 (0.8)

 Wound infection

1 (0.8)

 Tracheoesophageal fistula

1 (0.8)

 Cholecystitis

1 (0.8)

  1. AEs were evaluated and recorded according to the CTCAE version 5.0