Table 4.
Focus on specific AEs
| Study | N | Fatigue/general weakness |
Nausea |
Diarrhea |
Neutropenia |
Anemia |
Peripheral neuropathy/neurotoxicity |
Pneumonitis |
Stomatitis/mucositis/mucosal inflammation |
PPE/HFS |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All gr | Gr ≥3 | All gr | Gr ≥3 | All gr | Gr ≥3 | All gr | Gr ≥3 | All gr | Gr ≥3 | All gr | Gr ≥3 | All gr | Gr ≥3 | All gr | Gr ≥3 | All gr | Gr ≥3 | ||
| Shitara Int J Clin Oncol 2020 (JACOB subgroup analysis)30 |
40 | 35% | 2.5% | 60% | 10% | 37.5% | 5% | 52.5% | 30% | NR | NR | 17.5% | 0% | NR | NR | 50% | 2.5% | 62.5% | 0% |
| Liu Cancer Commun 2019 (JACOB subgroup analysis)31 |
80 | 20% | 1.3% | 61.3% | 2.5% | 16.3% (10% tx related) | 1.3% | 65% | 30% | 53.8% | 22.5% | NR | NR | NR | NR | 8.8% | 1.3% | 20% | 7.5% |
| Tabernero Lancet Oncol 2018 (JACOB)32 |
388 | 31% | 4% | 57% | 5% | 35% | 6% | 52% | 28% | 39% | 17% | 7% | 0% | 4% | 2% | 18% | 2% | 25% | 3% |
| Shah J Clin Oncol 2017 (HELOISE)28 |
124 | 15.3% | NR | 41.9% | NR | 16.9% | NR | 46.8% | NR | 32.3% | NR | NR | NR | NR | NR | NR | NR | 9.7% | NR |
| Sawaki Gastric Cancer 2012 (ToGA subgroup analysis)29 |
51 | 61% | 8% | 86% | 14% | 45% | 8% | 59% | 35% | 29% | 25% | 31% | 2% | NR | NR | 57% | 0% | 41% | 0% |
| Bang Lancet6 2010 (ToGA) |
294 | 35% | 4% | 67% | 7% | 37% | 9% | 53% | 27% | 28% | 12% | NR | NR | NR | NR | 24% (stomatitis) 13% (mucosal inflammation) |
1% (stomatitis) 2% (mucosal inflammation) |
26% | 1% |
| Yuki Cancer Chemother Pharmacol 2020 (KSCC/HGCSG/CCOG/Perseus 1501B)27 |
39 | 62% | 5% | 59% | 8% | 51% | 8% | 74% | 10% | 97% | 13% | 82% | 5% | 3% | 3% | 49% | 0% | 41% | 0% |
| Rivera Cancer Chemother Pharmacol 2019 (HERXO)33 |
45 | 73% (tx related) | 16% (tx related) | 47% (tx related) | 20% (tx related) | 53% (tx related) | 27% (tx related) | 22% (tx related) | 2% (tx related) | 38% (tx related) | 2% (tx related) | 78% (tx related) | 2% (tx related) | NR | NR | 13% (tx related) | 2% (tx related) | 13% (tx related) | 2% (tx related) |
| Takahari Gastric Cancer 2019 (HIGHSOX)34 |
75 | 57% (tx related) | 3% (tx related) | 65% (tx related) | 4% (tx related) | 52% (tx related) | 7% (tx related) | 79% (tx related) | 11% (tx related) | 96% (tx related) | 7% (tx related) | 84% (tx related) | 16% (tx related) | NR | NR | 25% (tx related) | 1% (tx related) | NR | NR |
| Miura Gastric Cancer 2018 (WJOG7212G/T-SPACE)35 |
44 | 75% | 14% | 61% | 11% | 50% | 11% | 66% | 30% | 86% | 18% | NR | NR | NR | NR | 46% | 5% | 18% | 0% |
| Ryu Eur J Cancer 201526 |
55 | 55% | 5% | 55% | 2% | 38% | 2% | 56% | 18% | 96% | 11% | 71% | 11% | NR | NR | 22% | 2% | 33% | 2% |
| Kurokawa Br J Cancer 2014 (HERBIS-1)23 |
53 | 64% | 4% | 62% | 2% | 40% | 8% | 60% | 36% | 66% | 15% | 11% | 0% | NR | NR | 32% | 2% | NR | NR |
| Gong BMC Cancer 2016 (CGOG1001)36 |
51 | 10% | 2% | 55%a | 4%a | 22% | 4% | 65% | 14% | 49% | 6% | 14% | 4% | NR | NR | NR | NR | 37% | 4% |
| Oh Cancer Chemother Pharmacol 201925 |
123 | 11% | 0% | 19% | 3% | NR | NR | NR | NR | 3% | 0% | 11% | 1% | NR | NR | 11% | 1% | 11% | 0% |
| Okita Tohoku J Exp Med 201837 |
28 | 42.9% | 14.3% | 32.1% | 3.6% | 17.9% | 3.6% | 57.1% | 28.6% | 75% | 21.4% | 14.3% | 3.6% | NR | NR | 21.4% | 0% | 32.1% | 14.3% |
| Okita Tohoku J Exp Med 201837 |
30 | 43.3% | 10% | 36.7% | 10% | 26.7% | 6.7% | 56.7% | 26.7% | 86.7% | 23.3% | 13.3% | 0% | NR | NR | 16.7% | 0% | 23.3% | 0% |
| Soularue Bull Cancer 201519 |
34 | NR | NR | 47% | 3% | 32% | 0% | 29% | 9% | 59% | 3% | 97% | 18% | NR | NR | 32% | 0% | 32% | 3% |
| Kim BMC Cancer 202120 |
47 | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Dijksterhuis Int J Cancer 202022 |
71 | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Li Clin Transl Oncol 201821 |
75 | 27% | 1% | 29% | 5% | 13% | 1% | 60% | 15% | 24% | 4% | 27% | 3% | NR | NR | 5% | 1% | NR | NR |
| Janjigian Lancet Oncol 202015 |
37 | 86% | 0% | 84% | 5% | 73% | 3% | 19% | 0% | 81% | 11% | 97% | 0% | NR | NR | 38% | 5% | 22% | 0% |
| Lee AACR 2021, Abstr. CT174 (HCRN GI17-319)24 |
18 | NR | NR | NR | NR | NR | NR | NR | 28% | NR | 11% | NR | NR | NR | NR | NR | NR | NR | NR |
| Rha ASCO 2020, Abstr. 303117 Rha ASCO GI 2021, Abstr. 218 (PANTHERA)16 |
43 | 18.6% | 2.3% | 32.6% | 0% | 30.2% | 2.3% | 46.5% | 41.8% | 32.6% | 16.3% | 18.6% | 0% | NR | NR | 23.3% | 2.3% | 23.3% | 0% |
| Janjigian ASCO 2021, Abstr. 4013 (KEYNOTE-811)14 |
216 (placebo) | 20% | 3% | 44% | 6% | 44% | 8% | 25% | 7% | 44% | 9% | 19% | 1% | 1% | 0% | NR | NR | NR | NR |
| 217 (pembro) | 24% | 4% | 49% | 5% | 53% | 7% | 24% | 7% | 41% | 9% | 23% | 3% | 5% | 1% | NR | NR | NR | NR | |
AE, adverse event; gr, grade; HFS, hand-foot syndrome; NR, not reported; pembro, pembrolizumab; PPE, palmar-plantar erythrodysesthesia; ToGA, Trastuzumab for Gastric Cancer; tx, treatment.
a
Preferred term is nausea/vomiting.