China Oncology ›› 2024, Vol. 34 ›› Issue (2): 143-150.doi: 10.19401/j.cnki.1007-3639.2024.02.002
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Received:
2024-01-25
Revised:
2024-02-18
Online:
2024-02-29
Published:
2024-03-14
Contact:
JIANG Zefei
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ZHANG Siyuan, JIANG Zefei. Important research progress in clinical practice for advanced breast cancer in 2023[J]. China Oncology, 2024, 34(2): 143-150.
Tab. 1
Large-scale clinical study on immunotherapy for TNBC"
Item | TORCHLIGHT (n= 531) | KEYNOTE-355 (n = 847) | IMpassion130 (n = 902) | IMpassion131 (n = 943) | BEGONIA Arm 7 | |||||
---|---|---|---|---|---|---|---|---|---|---|
Treatment | Toripalimab + nab-paclitaxelvs placebo + nab-paclitaxel | Pembrolizumab + chemotherapy vsplacebo + chemotherapy | Atezolizumab + nab-paclitaxel vsplacebo + nab-paclitaxel | Atezolizumab + paclitaxel vsplacebo + paclitaxel | Dato-DXd + durvalumab | |||||
Previously untreated or no more than one previous systemic chemotherapy regimen | Completion of treatment with curative inten t≥6 months prior to first disease recurrence | No prior therapy for advanced setting (prior RT or CT in curative setting allowed if ≥12 months DFI) | No prior therapy for advanced setting (prior RT or CT in curative setting allowed if ≥12 months DFI) | No prior treatment for stage Ⅳ TNBC or 212 months since prior taxane therapy | ||||||
PD-L1 IHC staining assay | JS311 | 22C3 | SP142 | SP142 | SP263, 22C3 | |||||
End points | PFS | PFS, OS | PFS, OS | PFS | PFS, OS and DoR | |||||
Grouping | ITT | PD-L1+ (CPS≥1) | ITT | PD-L1+ | ITT | PD-L1+ SP142 IC≥1% | ITT | PD-L1+ SP142 IC≥1% | Regardless of PD-L1 expression level | |
CPS≥10 | CPS≥1 | |||||||||
mPFS | 8.4 vs6.9 | 8.4 vs 5.6 | 7.5vs5.6 | 9.7 vs5.6 | 7.6 vs5.6 | 7.2 vs5.5 | 7.5 vs5.0 | 5.7 vs5.6 | 6.0 vs5.7 | 13.8 |
mOS | 33.1 vs23.5 | 32.8 vs19.5 | 17.2vs15.5 | 23.0 vs16.1 | 17.6 vs16.0 | 21.0 vs18.7 | 25.4 vs17.9 | 19.2 vs22.8 | 22.1 vs28.3 | |
Domestic indications | Submitted the first-line indication application for advanced triple-negative breast cancer in May 2023 | Unapproved | Unapproved | Negative result |
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