Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial
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Discussion
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Implication
Randomized trial reveals traditional chemotherapy outperforms targeted conjugate for pathological response in HER2-positive breast cancer, highlighting trade-offs between efficacy and safety.
Key Points
- To determine whether replacing standard systemic chemotherapy with the targeted antibody-drug conjugate trastuzumab emtansine plus pertuzumab improves pathological complete response rates in early-stage HER2-positive breast cancer.
- Randomized, open-label, multicentre, phase 3 trial (NCT02131064) across international clinical sites evaluating neoadjuvant therapy in 444 patients with HER2-positive breast cancer.
- Participants were randomly assigned to receive either intravenous trastuzumab emtansine plus pertuzumab (n=223) or standard chemotherapy consisting of docetaxel, carboplatin, and trastuzumab plus pertuzumab (n=221).
- The primary endpoint was pathological complete response (ypT0/is, ypN0) assessed locally in tumor tissue resected during surgery 14 days to 6 weeks after finishing neoadjuvant therapy.
- Pathological complete response was achieved in 44.4% (99/223) of patients receiving trastuzumab emtansine plus pertuzumab compared with 55.7% (123/221) receiving standard chemotherapy plus dual HER2 blockade (absolute difference -11.3 percentage points, 95% CI -20.5 to -2.0; p=0.016).
- Grade 3-4 adverse events occurred in 13% (29/223) of patients in the targeted conjugate group versus 64% (141/219) in the standard chemotherapy group.
- Serious adverse events were reported in 5% (11/223) of patients receiving the targeted conjugate compared to 29% (63/219) of patients receiving standard chemotherapy, with neutropenia and febrile neutropenia being the most frequent severe events in the chemotherapy arm.
Cite This Study
Hurvitz et al. (2017) studied this question.