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ATEMPT tested whether a year of the antibody-drug conjugate T-DM1 could replace chemotherapy plus trastuzumab for the smallest HER2-positive breast cancers; almost no one relapsed on T-DM1, but it was not less toxic overall, so it is an alternative rather than a replacement.
The APT trial had shown that paclitaxel plus trastuzumab cures almost all node-negative HER2-positive tumours of 3 cm or less. ATEMPT randomised 497 patients with stage I HER2-positive breast cancer three to one to 17 cycles of trastuzumab emtansine or to the APT regimen. The co-primary endpoints were invasive disease-free survival with T-DM1 and a comparison of clinically relevant toxicities.
Three-year invasive disease-free survival with T-DM1 was very high, but the rate of clinically relevant toxicity was similar in the two arms, so the toxicity endpoint was not met; T-DM1 caused more thrombocytopenia and liver enzyme rises, paclitaxel more neuropathy and alopecia. T-DM1 is now listed as an alternative adjuvant option for stage I disease, especially for patients who wish to avoid chemotherapy side effects.
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.
512 enrolled.
95% CI 96.3 to 99.3 · 95% CI 88.9 to 98.8
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 3 years (registry results)primary | Trastuzumab emtansine | - | 97.8% | - | - | link |
| Paclitaxel + trastuzumab | - | 93.4% |
Shares Trastuzumab emtansine, Roche / Genentech, Paclitaxel / nab-paclitaxel, Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Early HER2-positive breast cancer, Trastuzumab, Roche / Genentech, HER2-positive breast cancer and the tag subtype-trials.
Shares HER2-positive breast cancer, Antibody-drug conjugate (ADC), Breast cancer (all types) and the tag subtype-trials.
Shares Trastuzumab, HER2-positive breast cancer, Breast cancer (all types) and the tag subtype-trials.
Shares Paclitaxel / nab-paclitaxel, Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Trastuzumab emtansine, Trastuzumab and the tag subtype-trials.
Shares Trastuzumab, Paclitaxel / nab-paclitaxel, Breast cancer (all types) and the tag subtype-trials.
Shares HER2-positive breast cancer, Breast cancer (all types) and the tag subtype-trials.