Switching to an ADC after surgery when pre-surgery treatment left cancer behind halved the risk of recurrence and improved survival.
KATHERINE, trial NCT01772472 sponsored by Roche and Genentech and reported in 2018, showed that switching to the antibody-drug conjugate trastuzumab emtansine after surgery, when pre-surgery treatment left HER2-positive cancer behind, halved the risk of recurrence and improved survival. It randomised 1,486 women with residual invasive disease after neoadjuvant therapy to fourteen cycles of T-DM1 or trastuzumab, met its primary invasive disease-free survival endpoint with a large effect that held at seven years, and showed an overall survival benefit. It was superseded rather than replicated, since DESTINY-Breast05 showed trastuzumab deruxtecan beats T-DM1 in the same population, and whether any patient still needs T-DM1 is the open question.
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.
1,486 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 3-year invasive disease-free survivalprimary | T-DM1 | 743 | 88.3% | 0.5 (0.39 to 0.64) | <0.001 | link |
| Trastuzumab | 743 | 77% | ||||
| Overall survival (7-year) | T-DM1 | - | 89.1% | 0.66 (0.51 to 0.87) | - | link |
| Trastuzumab | - | 84.4% |
Shares Trastuzumab emtansine, Early HER2-positive breast cancer, Trastuzumab, HER2-positive breast cancer.
Shares Trastuzumab emtansine, Early HER2-positive breast cancer, Trastuzumab, HER2-positive breast cancer.
Shares Trastuzumab emtansine, Early HER2-positive breast cancer, Pathologic complete response (pCR), Trastuzumab.
Shares KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment, Early HER2-positive breast cancer, Pathologic complete response (pCR), HER2-positive breast cancer.
Shares Trastuzumab emtansine, Early HER2-positive breast cancer, HER2-positive breast cancer, Antibody-drug conjugate (ADC).
Shares Trastuzumab emtansine, Early HER2-positive breast cancer, HER2-positive breast cancer, Antibody-drug conjugate (ADC).
Shares Inflammatory breast cancer, Trastuzumab emtansine, Early HER2-positive breast cancer, HER2-positive breast cancer.
Shares Charles E. Geyer Jr., NSABP Foundation, Early HER2-positive breast cancer, Trastuzumab.