43P - Efficacy and safety of paclitaxel liposomes in combination with anti-HER-2 targeted drugs as first-line rescue therapy for HER-2-positive locally advanced or metastatic breast cancer: A retrospective, real-world study based on the Cancer Database of China National Cancer Center (NCC)

Background

Paclitaxel liposomes use liposomal phospholipid bilayer as drug carrier, which can reduce the risk of serious allergic reactions and other adverse reactions while ensuring efficacy. The aim of this study is to explore the efficacy and safety of paclitaxel liposomes in combination with anti-HER-2 drugs in real-world settings in China.

Methods

This was a retrospective, single-arm, real-world study based on data from the Cancer Database of China NCC. It enrolled patients with HER 2-positive locally advanced or relapsed metastatic breast cancer who received paclitaxel liposomes in combination with anti-HER-2 targeted drugs as first-line rescue therapy between January, 2013, and May, 2023. Baseline characteristics, treatment regimens, efficacy, and safety data were collected for these patients. The primary endpoints were real-world progression-free survival (rwPFS), overall survival (OS). The secondary endpoints included rwORR, rwCBR, mTTP, mTTF and safety.

Results

526 patients were enrolled. Among the 443 patients available for follow-up of PFS and OS at the median follow-up time of 27.4 months, the mPFS was 19.4 (95% CI: 16.3, 22.0) months. The 1-, 2-, 3-, and 5-year PFS rates were 69.1%, 40.7%, 27.1%, and 12.0%, respectively. The mOS was 72.8 months (95% CI: 57.7-NE), and the 1-, 2-, 3-, and 5-year OS rates were 97.3%, 86.5%, 77.1%, and 58.1%, respectively. The rwORR was 55.9% and the rwCBR was 94.7%. The mTTP was 23.9 months (95% CI: 20.7-29.3), and the mTTF was 15.0 months (13.9-17.0 months). The incidences of adverse events related to paclitaxel liposomes occurred and documented in the medical records were 34.8% for myelosuppression, 18.4% for gastrointestinal reactions, 4.6% for fluid retention, 3.8% for alopecia, 3.4% for liver toxicity, 3.0% for neurotoxicity, 2.1% for allergic reactions.

Conclusions

Paclitaxel liposomes in combination with multiple anti-HER-2 targeted drugs are effective and safe as the first-line rescue regimen for HER-2 positive locally advanced or metastatic breast cancer in China.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Nanjing Luye Pharmaceutical Co. Ltd.

Disclosure

All authors have declared no conflicts of interest.