Table 1.
Characteristics of the included clinical trials in the systematic review
| Author, year | Study type | Trial No. | Country | Intervention | Subjects | Sample size, n | Age, years median (range) | Female, n | ECOG status | ILD/pneumonitis, n (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| Modi (2020) [9] | Open-label, single-arm, multicenter, phase II | NCT03248492 | International | T-DXd 5.4 mg/kg q3w | Previously treated, ERBB2(+) breast CA | 184 | 55 (28–96) | 184 |
0: 102 1: 81 2: 1 |
25 (13.59) |
| Cortes (2021) [8] | Open-label, randomized, multicenter, phase III | NCT03529110 | International | T-DXd, NR dose | Previously treated, ERBB2(+) breast CA | 257 | 54 (20–83) | NR | NR | 27 (10.51) |
| Modi (2020) [10] | Open-label, single-arm, multicenter, phase Ib | NCT03248492 | USA and Japan | T-DXd 5.4 or 6.4 mg/kg q3w | Previously treated, ERBB2(+) breast CA | 54 | 56.6 (33–75) | NR |
0: 36 1: 18 2: 0 |
8 (14.81) |
| Chang (2019) [11] | Open-label, single-arm, multicenter, phase I | NCT03368196 | Taiwan | T-DXd 6.4 mg/kg q3w | Breast CA | 12 | 55 (36–69) | 12 | NR | 0 |
| Tamura (2019) [12] | Open-label, single-arm, multicenter, phase I | NCT02564900 | USA and Japan | T-DXd 5.4 or 6.4 mg/kg q3w | Previously treated, ERBB2(+) breast CA | 115 | 55 (47–66) | 114 |
0: 72 1: 43 2: 0 |
13 (11.30) |
| Yamashita (2020) [13] | Open-label, single-arm, multicenter, phase I | NCT03366428 | Japan | T-DXd 6.4 mg/kg q3w | Advanced ERBB2(+) or low breast CA | 51 | 56 (31–79) | 51 | NR | 1 (1.96) |
| Bartsch (2021) [7] | Open-label, single-arm, single center, phase II | NCT04752059 | Austria | T-DXd, NR dose | Previously treated, ERBB2(+), breast CA with brain mets | 10 | 48.5 (NR) | NR | NR | 0 |
| Shitara (2020) [14] | Open-label, randomized, multicenter, phase II | NCT03329690 | Japan and South Korea | T-DXd 6.4 mg/kg q3w | Previously treated, ERBB2(+) gastric/GEJ CA | 125 | 65 (34–82) | 30 |
0: 62 1: 63 2: 0 |
12 (9.60) |
| Van Cutsem (2021) [15] | Open-label, single arm, multicenter, phase II | NCT04014075 | International | T-DXd 6.4 mg/kg q3w | Previously treated, ERBB2(+) gastric/GEJ CA | 79 | 61 (20–78) | NR | NR | 6 (7.59) |
| Shitara (2019) [16] | Open-label, single-arm, multicenter, phase I | NCT02564900 | USA and Japan | T-DXd 5.4 or 6.4 mg/kg q3w | Previously treated, ERBB2(+) gastric/GEJ CA | 44 | 68 (62.5–72) | 12 |
0: 32 1: 12 2: 0 |
1 (2.27) |
| Siena (2021) [17] | Open-label, single arm, multicenter, phase II | NCT03384940 | International | T-DXd 6.4 mg/kg q3w | Previously treated, ERBB2(+) colorectal CA | 78 | 58.5 (50–60)a | 37 |
0: 49 1: 28 2: 1 |
5 (6.41) |
| Hasegawa (2021) [19] | Open-label, single-arm, multicenter, phase II | STATICE trial, NCCH1615 | Japan | T-DXd 6.4 mg/kg q3w | Previously treated, ERBB2(+) uterine carcinosarcoma | 34 | NR | 34 | NR | 9 (26.47) |
| Li (2022) [20] | Open-label, single-arm, multicenter, phase II | NCT03505710 | International | T-DXd 6.4 mg/kg q3w | Previously treated, ERBB2(+) NSCLC | 91 | 60 (29–88) | 60 |
0: 23 1: 68 2: 0 |
24 (26.37) |
| Tsurutani (2020) [18] | Open-label, single-arm, multicenter, phase I | NCT02564900 | USA and Japan | T-DXd 6.4 mg/kg q3w | Previously treated, ERBB2(+) non-breast or gastric solid tumors | 59 | 58 (23–83) | 31 |
0: 29 1: 31 2: NR |
5 (8.47) |
CA cancer, ECOG Eastern Cooperative Oncology Group, ERBB2 human epidermal growth factor receptor 2, GEJ gastroesophageal junction, ILD interstitial lung disease, mets metastasis, NR not reported, NSCLC non-small cell lung cancer, q3w every 3 weeks, T-DXd trastuzumab deruxtecan
aAge is the median (interquartile range)