Dose-dense neoadjuvant bi-weekly nab-paclitaxel followed by epirubicin-cyclophosphamide versus bi-weekly docetaxel followed by epirubicin-cyclophosphamide in patients with HR+/HER2- early breast cancer: a multicentre, randomised, phase III trial.
Mingkun Zhang, Yuan Qin, Junhao Wan et al.
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In 30 seconds
This multicentre, randomised phase III trial at three hospitals in China compared dose-dense neoadjuvant nab-paclitaxel with docetaxel, each followed by epirubicin-cyclophosphamide, in patients with early HR+/HER2− breast cancer. Among 388 participants, residual cancer burden (RCB) 0/I was more frequent with nab-paclitaxel: 20.1% (95% CI 14.41-26.72) versus 11.34% (95% CI 6.92-15.81; P = 0.018). Five-year disease-free and overall survival did not differ significantly between groups. Grade 3/4 adverse-event rates were similar, although high-grade peripheral sensory neuropathy occurred only with nab-paclitaxel.
Key findings
- RCB 0/I occurred in 20.1% with nab-paclitaxel versus 11.34% with docetaxel (P = 0.018).
- pCR rates were 15.98% versus 10.31%, respectively; the difference was not statistically significant (P = 0.098).
- Five-year DFS was 90.21% versus 87.11% (P = 0.656), and five-year OS was 96.34% versus 95.31% (P = 0.274).
- Grade 3/4 adverse events occurred in 30% versus 38%; grade 3/4 peripheral sensory neuropathy occurred only in the nab-paclitaxel group.
Why it matters
The trial provides comparative evidence that, in early HR+/HER2− breast cancer, a dose-dense nab-paclitaxel regimen can increase the proportion achieving RCB 0/I relative to dose-dense docetaxel. The absence of a significant survival difference means the pathological response result should not be interpreted as evidence of improved long-term outcomes. The neuropathy finding is relevant when weighing regimen tolerability.
What to keep in mind
The reported five-year survival comparisons showed no significant difference; the abstract does not establish a survival benefit from the higher RCB 0/I rate.