Table 2.
Summary of most common treatment-related adverse events of all grades across 15 prospective studies with complete results.
| Trials | Tumor | Patient number | Included TRAE | Regimen | Leukopenia | Anemia | Neutropenia | Nausea | Fatigue | ALT elevation | AST elevation | Decreased appetite/Anorexia | Thrombocytopenia | Rash/Skin reaction | Vomiting | Hypothyroidism | Fever | Constipation | Diarrhea | Creatine kinase elevation | Pruritus | Hyponatremia | Hyperglycemia | Myalgia | Proteinuria | Peripheral neuropathy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03946917 (79) | CRC | 39 | All | Toripalimab plus regorafenib | 0.0% | 5.1% | 2.6% | 0.0% | 10.3% | 0.0% | 0.0% | 5.1% | 10.3% | 30.8% | 0.0% | 2.6% | 20.5% | 0.0% | 17.9% | 0.0% | 2.6% | 0.0% | 0.0% | 12.8% | 2.6% | 0.0% |
| PICC (77) (Combination) | CRC | 17 | All | Toripalimab plus celecoxib (neoadjuvant) | 0.0% | 0.0% | 0.0% | 6.0% | 12.0% | 6.0% | 18.0% | 0.0% | 0.0% | 6.0% | 0.0% | 6.0% | 0.0% | 0.0% | 0.0% | 0.0% | 12.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| PICC (77) (Monotherapy) | CRC | 17 | All | Toripalimab monotherapy (neoadjuvant) | 0.0% | 0.0% | 0.0% | 18.0% | 24.0% | 6.0% | 12.0% | 6.0% | 0.0% | 18.0% | 0.0% | 0.0% | 6.0% | 0.0% | 0.0% | 0.0% | 18.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| NCT02915432 (64) (Cohort 1) | GC | 58 | All (>5%) | Toripalimab monotherapy | 8.6% | 12.1% | 1.7% | 5.2% | 10.3% | 8.6% | 10.3% | 5.2% | 6.9% | 8.6% | 5.2% | 12.1% | 5.2% | 0.0% | 5.2% | 0.0% | 10.3% | 0.0% | 0.0% | 0.0% | 8.6% | 0.0% |
| NCT02915432 (64) (Cohort 2) | GC | 18 | All (>10%) | Toripalimab plus CapeOx | 38.9% | 27.8% | 38.9% | 50.0% | 16.7% | 16.7% | 33.3% | 27.8% | 22.2% | 22.2% | 38.9% | 0.0% | 11.1% | 16.7% | 27.8% | 0.0% | 22.2% | 0.0% | 0.0% | 0.0% | 22.2% | 0.0% |
| NCT03013101 (22) | Melanoma | 128 | All (>5%) | Toripalimab montherapy | 20.3% | 0.0% | 17.2% | 0.0% | 14.8% | 31.3% | 22.7% | 10.2% | 7.0% | 23.4% | 0.0% | 27.3% | 6.3% | 0.0% | 0.0% | 25.8% | 0.0% | 0.0% | 30.5% | 5.5% | 0.0% | 0.0% |
| NCT03086174 (23) | Mucosal melanoma | 33 | All (>15%) | Toripalimab plus axitinib | 27.3% | 21.2% | 24.2% | 21.2% | 48.5% | 42.4% | 33.3% | 24.2% | 0.0% | 36.4% | 0.0% | 51.5% | 0.0% | 0.0% | 60.6% | 36.4% | 0.0% | 0.0% | 33.3% | 0.0% | 57.6% | 0.0% |
| NCT03167853 (97) | NEN | 40 | All (≥10%) | Toripalimab monotherapy | 15.0% | 22.5% | 10.0% | 15.0% | 20.0% | 32.5% | 37.5% | 10.0% | 0.0% | 17.5% | 0.0% | 0.0% | 12.5% | 0.0% | 12.5% | 25.0% | 25.0% | 15.0% | 35.0% | 0.0% | 40.0% | 0.0% |
| POLARIS-02 (101) | NPC | 190 | All (≥5%) | Toripalimab monotherapy | 10.0% | 15.3% | 5.3% | 0.0% | 13.2% | 13.7% | 15.3% | 0.0% | 0.0% | 6.3% | 0.0% | 23.7% | 9.5% | 0.0% | 0.0% | 0.0% | 8.4% | 0.0% | 0.0% | 0.0% | 12.6% | 0.0% |
| NCT03854838 (105) | NPC | 25 | All | Toripalimab plus IMRT | 16.0% | 0.0% | 8.0% | 76.0% | 88.0% | 20.0% | 12.0% | 0.0% | 4.0% | 40.0% | 8.0% | 32.0% | 4.0% | 0.0% | 4.0% | 20.0% | 32.0% | 0.0% | 36.0% | 16.0% | 0.0% | 0.0% |
| JUPITER-02 (107) (Toripalimab group) | NPC | 146 | All (≥10%) | Toripalimab plus GP | 91.1% | 88.4% | 85.6% | 69.2% | 35.6% | 36.3% | 37.7% | 53.4% | 63.0% | 27.4% | 67.1% | 30.8% | 30.8% | 39.0% | 30.1% | 17.8% | 16.4% | 25.3% | 0.0% | 23.3% | 0.0% | 30.1% |
| JUPITER-02 (107) (Placebo group) | NPC | 143 | All (≥10%) | Placebo plus GP | 94.4% | 94.4% | 93.0% | 83.2% | 35.7% | 39.9% | 30.8% | 58.7% | 62.2% | 21.7% | 65.7% | 16.8% | 21.7% | 44.8% | 23.1% | 23.8% | 7.0% | 36.4% | 0.0% | 26.6% | 0.0% | 28.7% |
| NCT03301688 (40) | NSCLC | 41 | All | Toripalimab monotherapy | 2.4% | 0.0% | 0.0% | 4.9% | 2.4% | 7.3% | 12.2% | 0.0% | 0.0% | 14.6% | 0.0% | 7.3% | 0.0% | 0.0% | 0.0% | 0.0% | 2.4% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| NeoTPD01 (50) | NSCLC | 33 | All | Toripalimab plus chemotherapy (neoadjuvant) | 0.0% | 51.6% | 6.1% | 30.3% | 15.2% | 0.0% | 0.0% | 12.1% | 15.2% | 18.2% | 3.0% | 18.2% | 0.0% | 0.0% | 3.0% | 0.0% | 3.0% | 0.0% | 0.0% | 15.1% | 0.0% | 15.1% |
| NCT03513666 (46) | NSCLC | 40 | All | Toripalimab plus chemotherapy | 82.5% | 67.5% | 70.0% | 47.5% | 25.0% | 50.0% | 52.5% | 37.5% | 47.5% | 15.0% | 17.5% | 0.0% | 10.0% | 27.5% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| NCT02857166 (19) | ST | 25 | All | Toripalimab monotherapy | 4.0% | 0.0% | 0.0% | 8.0% | 64.0% | 4.0% | 4.0% | 16.0% | 0.0% | 24.0% | 0.0% | 12.0% | 4.0% | 0.0% | 12.0% | 0.0% | 12.0% | 0.0% | 0.0% | 0.0% | 16.0% | 0.0% |
| NCT02836834 (21) | ST | 33 | All (≥10%) | Toripalimab monotherapy | 30.0% | 18.0% | 18.0% | 0.0% | 18.0% | 18.0% | 21.0% | 0.0% | 0.0% | 21.0% | 0.0% | 0.0% | 30.0% | 0.0% | 0.0% | 3.0% | 15.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| NCT02836795 (20) | ST | 36 | All (≥20%) | Toripalimab monotherapy | 25.0% | 33.3% | 0.0% | 0.0% | 22.2% | 22.2% | 25.0% | 22.2% | 0.0% | 44.4% | 0.0% | 0.0% | 38.9% | 0.0% | 0.0% | 0.0% | 25.0% | 0.0% | 58.3% | 0.0% | 50.0% | 0.0% |
CRC, colorectal cancer; GC, gastric cancer; NEN, neuroendocrine neoplasms; NPC, nasopharyngeal carcinoma; NSCLC, non-small cell lung cancer; ST, solid tumors; TRAE, treatment-related adverse events; CapeOx, capecitabine and oxaliplatin; IMRT, intensity-modulated radiotherapy; GP, gemcitabine and platinum; ALT, alanine aminotransferase; AST, aspartate aminotransferase.