Paclitaxel liposome with anti–HER-2 drugs as first-line therapy for recurrent/metastatic HER-2–positive breast cancer: a real-world study

Background Clinical evidence for the use of paclitaxel liposome combined with anti–HER-2 drugs as first-line salvage treatment for HER-2–positive advanced breast cancer (BC) remains limited. Methods In this retrospective, single-arm, real-world study, patients with HER-2–positive advanced BC who received paclitaxel liposome combined with anti–HER-2 agents as first-line salvage therapy between January 2013 and December 2022 were identified from the National Cancer Center Oncology Information Database. The primary outcomes were real-world progression-free survival (rwPFS) and overall survival (OS). Results A total of 526 eligible patients were included, with a median age of 53.0 years; 296 (56.3%) were hormone receptor (HR)–positive. Treatment regimens mainly included paclitaxel liposome plus trastuzumab (53.2%), paclitaxel liposome plus trastuzumab and pertuzumab (32.1%), and paclitaxel liposome plus trastuzumab and tyrosine kinase inhibitors (TKIs) (11.0%). Median follow-up was 856 days. The overall median rwPFS and OS were 22.1 months (95% CI, 20.0 to 25.7) and 57.9 months (95% CI, 52.2 to 62.9), respectively. The overall rwORR was 55.9%, and rwDCR was 94.7%. Among HR + and HR–subgroups, median rwPFS was 24.5 months (95% CI, 20.8 to 28.7) and 17.7 months (95% CI, 14.7 to 21.8), respectively; mOS was 60.5 months (95% CI, 50.7 to not reached) and 53.5 months (95% CI, 49.9 to 63.3), respectively. Common adverse events included myelosuppression, gastrointestinal reactions, hepatic dysfunction, and neurotoxicity. Conclusions In real-world setting, paclitaxel liposome combined with various anti–HER-2 drugs demonstrated favorable effect and safety in patients with HER-2–positive advanced BC, regardless of HR status. Trial registration Registered on ClinicalTrials.gov under NCT06481553 on July 01, 2024 (retrospectively registered; https://clinicaltrials.gov/study/NCT06481553 ).