What is the clinical evidence from this study?

Study design: Cohort. Population: Stages II and III breast cancer (n=304). Intervention: Pegylated Liposomal Doxorubicin (PLD) vs. Epirubicin. Primary outcome: 5-year Disease-Free Survival (DFS) (HR 0.52, 95% CI 0.30-0.92, p=0.0227).

January 2, 2024Open Access

The survival benefit of Pegylated Liposomal Doxorubicin-Based Neoadjuvant Chemotherapy in the management of breast cancer

Key Result

Pegylated liposomal doxorubicin-based neoadjuvant chemotherapy significantly reduced the risk of disease recurrence by 48% (HR 0.52) compared to epirubicin-based therapy in patients with stage II-III breast cancer.

Study Design

Type

Cohort (n=304)

Multicenter

Structured PICO

Does Pegylated Liposomal Doxorubicin-based neoadjuvant chemotherapy improve overall and disease-free survival compared to epirubicin-based therapy in patients with stage II-III breast cancer?

Population

304 patients with stage II-III breast cancer who received neoadjuvant chemotherapy, followed for a median of 58 months.

Exposure

Pegylated Liposomal Doxorubicin (PLD) 40 mg/m² plus cyclophosphamide 600 mg/m² on day 1 of a 21-day cycle, followed by 4 cycles of docetaxel 85 mg/m² on day 1 of a 21-day cycle.

Comparator

Epirubicin 90-100 mg/m² plus cyclophosphamide, followed by docetaxel (mirroring the PLD protocol).

Outcome

Overall survival (OS) and disease-free survival (DFS)hard clinical

PLD-based neoadjuvant chemotherapy significantly improves disease-free and overall survival compared to epirubicin in stage II-III breast cancer, without increasing cardiotoxicity.

Main Result

Hazard Ratio: 0.52 (95% CI 0.3–0.92)

Absolute Event Rate: 84.5% vs 72.9%

p-value: p=0.0227

Limitations

Retrospective design
Lack of prospective randomization
Small sample size
All patients enrolled were Chinese, making conclusions potentially inapplicable to other ethnicities

Abstract

Abstract Purpose This study aims to evaluate the short-term outcomes and prognosis and the cardiac safety of PLD-based neoadjuvant chemotherapy (NAC) compared to epirubicin-based therapy in breast cancer treatment. Methods 304 patients diagnosed with stages II and III breast cancer were enrolled including 97 cases treated with PLD and 207 controls treated with epirubicin in neoadjuvant chemotherapy. The effectiveness of the anti-breast cancer treatment was evaluated using overall survival (OS) and disease-free survival (DFS) metrics, while cardiac toxicity was measured through the left ventricular ejection fraction (LVEF) and electrocardiogram (ECG) assessments. Results The 5-year DFS and OS rates in the PLD group were 84.5% and 88.7% (with 15 recurrences and 11 deaths), while in the control group, these rates were 72.9% and 79.2% (with 56 recurrences and 43 deaths). Regarding cardiac toxicity, there was no significant difference in ECG abnormalities or left ventricular ejection fraction (LVEF) decline between the two groups. Conclusion The study suggests that PLD-based neoadjuvant chemotherapy may provide substantial benefits in terms of DFS and OS, along with a safe cardiac toxicity profile, in patients with stage II-III breast cancer.

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