Info

🌱 來自: Chemotherapy regimens for NAV or ADJ use in HR positive and TNBC-of-localized breast cancer

ABC trial

Anthracyclines in Early Breast Cancer: The ABC Trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology)

Comparison of Docetaxel and Cyclophosphamide (TC) with Taxane and Cyclophosphamide (TaxAC) Regimens in Early Breast Cancer: A Joint Efficacy Analysis of Three Randomized Trials

1. Design:
   • Phase: III
   • Multi-center, randomized trials
   • Women were randomly assigned to either TC or TaxAC regimens
   • Joint efficacy analysis of TC versus TaxAC regimens was planned before any analysis of individual trials
   • Invasive disease-free survival (IDFS) was the primary end point
   • Prespecified interim monitoring plan was to report for futility if the HR was > 1.18 when 334 IDFS events were observed
   • Patients who received TC6 plus bevacizumab on NSABP B-46-I/USOR 07132 were not included
2. Number of patients:
   • 2,125 patients received TC6 regimens
   • 2,117 patients received TaxAC regimens
3. Patient characteristics:
   • Patients with high-risk human epidermal growth factor receptor 2-negative breast cancer
4. Agent:
   • TC or TaxAC regimens
5. Treatment line: Adjuvant treatment for early breast cancer

Endpoint	TC6	TaxAC	P-value
Invasive Disease-Free Survival (IDFS)	88.2%	90.7%	0.04

8. Other findings in this trial:
   • The HR for TC6 versus TaxAC was 1.202 (95% CI, 0.97 to 1.49), which triggered early reporting for futility.
   • Tests for treatment interaction by protocol, hormone receptor status, and nodal status were negative.
9. Summary: The TaxAC regimens were found to be superior to the TC6 regimen in improving IDFS in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer. The trial did not report any significant differences in PFS, OS, or RR between the two regimens.