Table 1.
Baseline characteristics of included studies
| Study | Design | n | Population | Intervention | Dose, mg/kg | Primary endpoint | Median follow-up, months (range) |
|---|---|---|---|---|---|---|---|
| DESTINY-01, 2019 | Non-RCT, phase II | 184 | HER2+, after T-DM1 | T-DXda | 5.4 | PFS | 11.1 (0.7-19.9) |
| DESTINY-02, 2022 | RCT, phase III | 608 | HER2+, after T-DM1 | T-DXd versus TPC | 5.4 | PFS | T-DXd: 21.5 (0.1-45.6); TPC: 18.6 (0-45.7) |
| DESTINY-03, 2022 | RCT, phase III | 524 | HER2+, after T&T | T-DXd versus T-DM1 | 5.4 | PFS | T-DXd: 28.4 (0-46.9); T-DM1: 26.5 (0-45.0) |
| DESTINY-04, 2022 | RCT, phase III | 713 | HER2-low, >1 line | T-DXd versus PCC | 5.4 | PFS | 18.4 (17.7-18.9) |
| DESTINY-07, 2022 | Non-RCT, phase Ib/II | 55 | HER2+, 1st line | T-DXd versus T-DXd + P | 5.4 | Safety and tolerability | 10.0 (NA) |
| TUXEDO-1, 2022 | Non-RCT, phase II | 15 | HER2+, with brain metastasis | T-DXda | 5.4 | ORR-IC | 12 (8-NA) |
| DEBBRAH, 2022 | Non-RCT, phase II | 21 | HER2+, with brain metastasis | T-DXdb | 5.4 | 16 weeks PFS, cohort 1/ORR-IC, cohorts 2 and 3 | 8.4 (1.4-12.6) |
| DAISY, 2021 | Non-RCT, phase II | 186 | HER2+, HER2-low and HER2−, >1 line | T-DXda | 5.4 | BOR | 10.1 (9.2-11.1) |
| Modi et al., 20209 | Non-RCT, phase I | 54 | HER2-low, >1 line | T-DXda | 5.4 (n = 21) 6.4 (n = 33) |
Safety and preliminary activity | NA |
| Shimomura et al., 202312 | Non-RCT, phase I | 51 | 92.2% HER2-low, >2 lines | T-DXda | 6.4 | QT/QTc interval and pharmacokinetics | NA |
| Tamura et al., 201910 | Non-RCT, phase I | 274 | HER2+, after T-DM1 | T-DXda | 5.4 (n = 49) 6.4 (n = 66) |
Safety and preliminary activity | 9.9 (6.9-14.3) |
| DE-REAL, 2023 | Retrospective cohort | 143 | HER2+ | T-DXda | 5.4 | PFS | 12 (1-31) |
| Nakajima et al., 202226 | Retrospective cohort | 22 | HER2+ | T-DXda | NA | PFS | 10.1 (8.4-12.0) |
| TREX-Old, 2023 | Retrospective cohort | 27 | HER2+ | T-DXda | 5.4 | PFS | 9.5 (1-29) |
| ROSET-BM, 2022 | Retrospective cohort | 104 | HER2+ | T-DXda | 5.4 | PFS | 11.2 |
BOR, best overall response; HER2, human epidermal growth factor receptor 2; n, number of patients; NA, not available; ORR-IC, intracranial objective response rate; P, pertuzumab; PCC, physician’s choice of chemotherapy; PFS, progression-free survival; RCT, randomized controlled trial; T-DXd, trastuzumab deruxtecan; T&T, trastuzumab and a taxane; TPC, treatment of physician’s choice.
a
Single-arm study.
b
Multicohort study.