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. 2020 Aug;32(4):485-496.
doi: 10.21147/j.issn.1000-9604.2020.04.06.

Dose-dense paclitaxel plus carboplatin vs. epirubicin and cyclophosphamide with paclitaxel as adjuvant chemotherapy for high-risk triple-negative breast cancer

Affiliations

Dose-dense paclitaxel plus carboplatin vs. epirubicin and cyclophosphamide with paclitaxel as adjuvant chemotherapy for high-risk triple-negative breast cancer

Qing Li et al. Chin J Cancer Res. 2020 Aug.

Abstract

Objective: The objective of this open-label, randomized study was to compare dose-dense paclitaxel plus carboplatin (PCdd) with dose-dense epirubicin and cyclophosphamide followed by paclitaxel (ECdd-P) as an adjuvant chemotherapy for early triple-negative breast cancer (TNBC).

Methods: We included Chinese patients with high recurrence risk TNBC who underwent primary breast cancer surgery. They were randomly assigned to receive PCdd [paclitaxel 150 mg/m2 on d 1 and carboplatin, the area under the curve, (AUC)=3 on d 2] or ECdd-P (epirubicin 80 mg/m2 divided in 2 d and cyclophosphamide 600 mg/m2 on d 1 for 4 cycles followed by paclitaxel 175 mg/m2 on d 1 for 4 cycles) every 2 weeks with granulocyte colony-stimulating factor (G-CSF) support. The primary endpoint was 3-year disease-free survival (DFS); the secondary endpoints were overall survival (OS) and safety.

Results: The intent-to-treat population included 143 patients (70 in the PCdd arm and 73 in the ECdd-P arm). Compared with the ECdd-P arm, the PCdd arm had significantly higher 3-year DFS [93.9% vs. 79.1%; hazard ratio (HR)=0.310; 95% confidence interval (95% CI), 0.137-0.704; log-rank, P=0.005] and OS (98.5% vs. 92.9%; HR=0.142; 95% CI, 0.060-0.825; log-rank, P=0.028). Worse neutropenia (grade 3/4) was found in the ECdd-P than the PCdd arm (47.9% vs. 21.4%, P=0.001).

Conclusions: PCdd was superior to ECdd-P as an adjuvant chemotherapy for early TNBC with respect to improving the 3-year DFS and OS. PCdd also yielded lower hematological toxicity. Thus, PCdd might be a preferred regimen for early TNBC patients with a high recurrence risk.

Keywords: Triple-negative breast cancer; carboplatin; dose-dense adjuvant chemotherapy; paclitaxel.

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Figures

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1
Flow diagram of study design. ECdd-P, dose-dense epirubicin and cyclophosphamide followed by paclitaxel; PCdd, dose-dense paclitaxel plus carboplatin.
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2
Kaplan-Meier plot of disease-free survival (DFS). Cross marks indicate censored observations. Data for the intention-to-treat population. Hazard ratio (HR), 0.310, 95% confidence interval (95% CI), 0.137−0.704; Log-rank P=0.005; ECdd-P, dose-dense epirubicin and cyclophosphamide followed by paclitaxel; PCdd, dose-dense paclitaxel plus carboplatin.
3
3
Kaplan-Meier plot of overall survival (OS). Cross marks indicate censored observations. Data for the intention-to-treat population. Hazard ratio (HR), 0.142, 95% confidence interval (95% CI), 0.060−0.825, Log-rank P=0.028; ECdd-P, dose-dense epirubicin and cyclophosphamide followed by paclitaxel; PCdd, dose-dense paclitaxel plus carboplatin.
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Subgroup analyses of disease-free survival (DFS). The analyses of two arm patients were stratified for modified intention-to-treat population in clinically relevant subgroups. ECdd-P, dose-dense epirubicin and cyclophosphamide followed by paclitaxel; PCdd, dose-dense paclitaxel plus carboplatin; SCI, surgery-chemotherapy interval; HR, hazard ratio; 95% CI, 95% confidence interval.

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