Table 1.
The incidence of ICI treatment-related AEs in GI cancers.
| Study | ICIs | Cancer type | Decreased appetite (%) | Nausea (%) | Diarrhea (%) | Colitis (%) | Others (%) |
|---|---|---|---|---|---|---|---|
| CheckMate 14221 | Nivo (3)a, n = 74 | CRC | – | 9.5 | 21.6 | 1.4 | 4.1 (Stomatitis) |
| 2.7 (Abdominal pain) | |||||||
| 1.4 (Esophagitis) | |||||||
| 1.4 (Gastritis) | |||||||
| KEYNOTE-01222 | Pembro, n = 39 | GC | 12.8 | – | – | – | – |
| KEYNOTE-059 cohort 123 | Pembro, n = 259 | GC | 7.3 | 6.9 | 6.6 | 2.3 | – |
| ATTRACTION-224 | Nivo, n = 330 | GC, EGJ | 4.8 | 4.2 | 7.0 | 0.6 | – |
| Placebo, n = 163 | 4.3 | 2.5 | 1.9 | 0.0 | – | ||
| CheckMate 03225 | Nivo (3)a, n = 59 | GC, EC, EGJ | 15.3 | – | 15.3 | – | – |
| Nivo (3)a + Ipi (1)a, n = 52 | 5.8 | – | 9.6 | – | – | ||
| Nivo (1)a + Ipi (3)a, n = 49 | 10.2 | – | 30.6 | – | – | ||
| Desai et al 201726 | BGB-A317, n = 55 | GC, EC | – | 16.4 | – | 1.8 | 14.5 (Dysphagia) |
| KEYNOTE-02827 | Pembro, n = 23 | EC | 13.0 | – | – | – | – |
| Kudo et al 201728 | Nivo, n = 65 | ESCC | 9.2 | – | 13.8 | – | 1.5 (Constipation) |
| Ralph et al 201031 | Treme, n = 18 | GC, EAC | – | 16.7 | 27.8 | 5.6 | – |
| KEYNOTE-059 cohort 232 | Pembro+5-FU/CAPE + CDDP, n = 25 | GC | – | – | – | 4.0 | – |
| Moehler et al 201633 | Ipi, n = 57 | GC, EGJ | – | – | 24.6 | – | – |
| CheckMate 14234 | Nivo (3)a + Ipi (1)a, n = 30 | CRC | – | 20.0 | 43.3 | – | – |
| Nivo (3)a + Ipi (1)a, n = 10 | – | 20.0 | 20.0 | – | 10.0 (Vomiting) | ||
| Nivo (1)a + Ipi (3)a, n = 10 | – | 30.0 | 40.0 | – | 30.0 (Vomiting) |
ICI: immune-checkpoint inhibitor; AE: adverse event; GI: gastrointestinal; Pembro: pembrolizumab; Nivo: nivolumab; Ipi: ipilimumab; Treme: tremelimumab; 5-FU: 5-fluorouracil; CAPE: capecitabine; CDDP: cisplatin; CRC: colorectal cancer; GC: gastric cancer; EGJ: esophagogastric junction; EC: esophageal carcinoma; EAC: esophageal adenocarcinoma; ESCC: esophageal squamous-cell carcinoma; −: not applicable.
a
The number in the parenthesis indicated the dose of Nivo or Ipi: “3” represented “3 mg/kg” and “1” represented “1 mg/kg”.