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KRISTINE tested whether an antibody-drug conjugate could replace chemotherapy before surgery in HER2-positive breast cancer and found it could not: fewer tumours disappeared and more grew before the operation.
KRISTINE, trial NCT02131064 sponsored by Roche and Genentech and published in the Lancet Oncology in 2018, randomised 444 patients with stage II or III HER2-positive breast cancer to six cycles of trastuzumab emtansine plus pertuzumab or to docetaxel, carboplatin, trastuzumab and pertuzumab before surgery. Pathological complete response was 44.4 percent with the antibody-drug conjugate against 55.7 percent with chemotherapy, and although the conjugate arm had fewer severe side effects and better quality of life, 15 patients in that arm had locoregional progression before surgery against none with chemotherapy. The three-year follow-up in 2019 showed worse event-free survival with the conjugate driven by those pre-surgical progressions, while invasive disease-free survival after surgery was similar. The trial is the standard warning against replacing chemotherapy with an antibody-drug conjugate on the basis of response rates alone, a lesson revisited when DESTINY-Breast11 kept a chemotherapy phase after trastuzumab deruxtecan.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
444 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete response (breast and axilla)primary | Trastuzumab emtansine + pertuzumab | 223 | 44.4% | - | 0.016 | link |
| Docetaxel, carboplatin, trastuzumab, pertuzumab | 221 | 55.7% |
Shares HER2, HER2-positive breast cancer, Antibody-drug conjugate (ADC) and the tag failure.
Shares Roche / Genentech and the tag failure.
Shares HER2 and the tag failure.
Shares Roche / Genentech and the tag failure.
Shares HER2 and the tag failure.
Shares Roche / Genentech and the tag failure.
Shares Carboplatin and the tag failure.
Shares Antibody-drug conjugate (ADC) and the tag failure.