Table 2

Potential drug-related adverse events among 16 evaluable patients with desmoid tumors treated on the DART immunotherapy protocol (nivolumab plus ipilimumab)

Desmoid tumor (n=16)Any gradeGrades 3–4Grade 5
Any16 (100.0%)8 (50.0%)0 (0.0%)
Serious7 (43.8%)7 (43.8%)0 (0.0%)
Led to discontinuation7 (43.8%)6 (37.5%)0 (0.0%)
Led to death0 (0.0%)0 (0.0%)0 (0.0%)
>10% of patients
Symptoms/conditions
 Fatigue7 (43.8%)0 (0.0%)0 (0.0%)
 Nausea6 (37.5%)1 (6.3%)0 (0.0%)
 Hypothyroidism5 (31.3%)0 (0.0%)0 (0.0%)
 Adrenal insufficiency4 (25.0%)1 (6.3%)0 (0.0%)
 Diarrhea4 (25.0%)1 (6.3%)0 (0.0%)
 Hyperthyroidism4 (25.0%)1 (6.3%)0 (0.0%)
 Headache4 (25.0%)0 (0.0%)0 (0.0%)
 Abdominal pain3 (18.8%)0 (0.0%)0 (0.0%)
 Cough3 (18.8%)0 (0.0%)0 (0.0%)
 Rash maculo-papular3 (18.8%)0 (0.0%)0 (0.0%)
 Anemia2 (12.5%)0 (0.0%)0 (0.0%)
 Arthralgia2 (12.5%)0 (0.0%)0 (0.0%)
 Chills2 (12.5%)0 (0.0%)0 (0.0%)
 Constipation2 (12.5%)0 (0.0%)0 (0.0%)
 Hypophysitis2 (12.5%)0 (0.0%)0 (0.0%)
 Myalgia2 (12.5%)0 (0.0%)0 (0.0%)
 Neck pain2 (12.5%)0 (0.0%)0 (0.0%)
 Pruritus2 (12.5%)0 (0.0%)0 (0.0%)
 Vomiting2 (12.5%)0 (0.0%)0 (0.0%)
Laboratory abnormalities
 Lymphocyte count decreased3 (18.8%)0 (0.0%)0 (0.0%)
 White blood cell decreased2 (12.5%)0 (0.0%)0 (0.0%)
Immune mediated14 (87.5%)5 (31.3%)0 (0.0%)
 Hypothyroidism5 (31.3%)0 (0.0%)0 (0.0%)
 Adrenal insufficiency4 (25.0%)1 (6.3%)0 (0.0%)
 Diarrhea4 (25.0%)1 (6.3%)0 (0.0%)
 Hyperthyroidism4 (25.0%)1 (6.3%)0 (0.0%)
 Rash maculo-papular3 (18.8%)0 (0.0%)0 (0.0%)
 Arthralgia2 (12.5%)0 (0.0%)0 (0.0%)
 Pruritus2 (12.5%)0 (0.0%)0 (0.0%)
 Lipase increased1 (6.3%)1 (6.3%)0 (0.0%)
 Pneumonitis1 (6.3%)1 (6.3%)0 (0.0%)
 Alanine aminotransferase increased1 (6.3%)0 (0.0%)0 (0.0%)
 Aspartate aminotransferase increased1 (6.3%)0 (0.0%)0 (0.0%)
 Serum amylase increased1 (6.3%)0 (0.0%)0 (0.0%)

  • DART, Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors.