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Table 3 Frequent and Severe Adverse Events (CTCAE version 3.0)

From: A phase ΙI study of five peptides combination with oxaliplatin-based chemotherapy as a first-line therapy for advanced colorectal cancer (FXV study)

FOLFOX (n = 89), FOLFOX + Bev (n = 4), XELOX + Bev (n = 1)
  HLA-A*2402-matched (n = 50) HLA-A*2402-unmatched (n = 46)
FOLFOX (n = 48), XELOX (n = 2) FOLFOX (n = 41) + Bev (n = 4), XELOX + Bev (n = 1)
Adverse Event 1 2 3 4 5 1 2 3 4 5
No % No % No % No % No % No % No % No % No % No %
Hand-foot syndrome 0 0 0 0 1 2 0 0 0 0 1 2 0 0 1 2 0 0 0 0
Allergy 4 8 3 6 2 4 0 0 0 0 3 7 4 9 0 0 0 0 0 0
Mucositis 2 4 1 2 1 2 0 0 0 0 2 4 0 0 0 0 0 0 0 0
Nausea/vomiting 5 10 1 2 2 4 0 0 0 0 6 13 2 4 1 2 0 0 0 0
Neurologic toxicity 15 30 10 20 4 8 0   0 0 17 37 10 22 5 11 1 2 0 0
Anorexia 10 20 3 6 4 8 0 0 0 0 10 22 4 9 2 4 0 0 0 0
Diarrhea 3 6 6 12 2 4 0 0 0 0 3 7 0 0 1 2 0 0 0 0
Fatigue/Asthenia 5 10 1 2 2 4 0 0 0 0 5 11 1 2 1 2 0 0 0 0
Fever 2 4 0 0 0 0 0 0 0 0 3 7 2 4 0 0 0 0 0 0
Injection site reaction 18 36 18 36 9 18 0 0 0 0 20 43 17 37 3 13 0 0 0 0
Interstitial pneumonia 0 0 0 0 4 8 0 0 2 4 0 0 0 0 4 9 0 0 1 2
Neutropenia 5 10 10 20 10 20 1 2 0 0 8 17 14 30 2 4 1 2 0 0
Leukopenia 10 20 12 24 1 2 0 0 0 0 12 26 9 20 2 4 0 0 0 0
Thrombocytopenia 17 34 3 6 0 0 0 0 0 0 20 43 2 4 0 0 0 0 0 0
Bilirubin 2 4 2 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
AL-P 11 22 1 2 1 2 0 0 0 0 10 22 1 2 0 0 0 0 0 0
Creatinine 3 6 1 2 0 0 0 0 0 0 1 2 0 0 0 0 0 0 0 0
Hemoglobin 11 22 5 10 0 0 0 0 0 0 13 28 7 15 0 0 0 0 0 0
Embolism 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0 0
AST/ALT 12 24 0 0 1 2 0 0 0 0 6 13 1 2 0 0 0 0 0 0
  1. No gastrointestinal perforation nor bleeding wound healing complication was observed. FOLFOX, infusional fluorouracil, leucovorin, and oxaliplatin; XELOX, capecitabine and oxaliplatin; Bev, bevacizumab; AL-P, alkaline phosphatese; AST, aspartete aminotransfarase; ALT, alanine aminotransferase; CTCAE, the Common Terminology Criteria for Adverse Event version 3.0; HLA, Human leukocyte antigen.