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Nanoparticle-based Drug Delivery / Cancer Treatment and Pharmacology / HER2/EGFR in Cancer Research · Journal article
Holistic Integrative Oncology · August 11, 2026
Encouraging direction, but not yet definitive.
This retrospective real-world cohort of 526 patients with HER-2–positive advanced breast cancer treated with paclitaxel liposome plus anti-HER-2 agents achieved a median progression-free survival of 22.1 months and overall survival of 57.9 months, with an objective response rate of 55.9%. The results are consistent across hormone receptor subgroups and suggest clinical efficacy in a contemporary population, but the lack of a randomized comparator limits ability to establish whether this combination is superior to other first-line approaches.
Retrospective cohort study (real-world evidence). Patients with HER-2–positive recurrent/metastatic breast cancer; median age 53.0 years; 296 (56.3%) hormone receptor–positive; treated in a real-world oncology setting. Intervention: Paclitaxel liposome combined with anti-HER-2 drugs: paclitaxel liposome plus trastuzumab (53.2%), paclitaxel liposome plus trastuzumab and pertuzumab (32.1%), or paclitaxel liposome plus trastuzumab and tyrosine kinase inhibitors (11.0%). n = 526. National Cancer Center (country not explicitly stated in abstract, but registry name suggests South Korea or similar jurisdiction).
Median real-world progression-free survival 22.1 months (95% CI, 20.0 to 25.7) Median overall survival 57.9 months (95% CI, 52.2 to 62.9) Overall objective response rate 55.9% and disease control rate 94.7%
Specific toxicity rates and grades not quantified in abstract
These findings suggest paclitaxel liposome combined with anti-HER-2 agents (trastuzumab, pertuzumab, or TKIs) is a feasible first-line regimen for HER-2–positive advanced breast cancer with substantial response and survival. However, without a randomized comparator, clinicians should interpret this as supporting evidence within existing treatment paradigms rather than as a basis for changing standard-of-care choices.
Real-world retrospective cohort with substantial sample size and mature follow-up reporting clinically relevant survival outcomes, but lacks randomized control and prospective design needed for practice-changing or strong evidence.
As stated by the source record.
Quoted from the source exactly as published.
These findings suggest paclitaxel liposome combined with anti-HER-2 agents (trastuzumab, pertuzumab, or TKIs) is a feasible first-line regimen for HER-2–positive advanced breast cancer with substantial response and survival. However, without a randomized comparator, clinicians should interpret this as supporting evidence within existing treatment paradigms rather than as a basis for changing standard-of-care choices.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Abstract 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 ).
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