In a significant advancement for gastric cancer treatment, oral Liporaxel has demonstrated superior survival benefits compared to its intravenous (IV) counterpart in a large-scale phase 3 clinical trial. The findings, presented at the 2025 Gastrointestinal Cancers Symposium, mark a potential paradigm shift in second-line therapy for advanced gastric cancer.
Survival Benefits and Efficacy Outcomes
The trial, involving 536 patients equally randomized between oral and IV formulations, achieved its primary endpoint of non-inferior progression-free survival (PFS). Patients receiving oral Liporaxel showed a median PFS of 3.02 months, comparable to 2.89 months in the IV group. More notably, the oral formulation demonstrated superior overall survival (OS) with a median of 9.13 months, representing a significant 2.59-month improvement over the IV group's 6.54 months.
Enhanced Safety Profile
The oral solution of Liporaxel exhibited a more favorable safety profile compared to IV administration. Key safety findings include:
- Lower incidence of all-grade neuropathy (22.3% vs 38.7%)
- Reduced occurrence of alopecia, fatigue, and musculoskeletal disorders
- No hypersensitivity reactions without premedication
- Comparable rates of grade 5 treatment-related adverse events (1.5% vs 1.1%)
The most significant grade 3 or higher adverse events included neutrophil count decrease (47.9% oral vs 54.5% IV), white blood cell count decrease (41.5% vs 35.3%), and anemia (16.6% vs 10.9%).
Trial Design and Patient Population
Dr. Jin Li of Tongji University Shanghai East Hospital led this multicenter trial across 53 Chinese centers. The study focused on patients with unresectable, recurrent, or metastatic gastric cancer who had progressed following first-line therapy with fluoropyrimidine or fluoropyrimidine plus platinum-based treatments.
Treatment protocols included:
- Oral group: 200 mg/m² twice daily on days 1, 8, and 15 of a 28-day cycle
- IV group: 175 mg/m² on day 1 of a 21-day cycle
Clinical Implications
This breakthrough represents the world's first successfully developed oral formulation of paclitaxel, addressing several limitations of IV administration, including:
- Reduced need for hospital visits
- Elimination of vehicle-led safety risks
- No requirement for premedication
- Shorter administration time
The results support oral Liporaxel as a viable second-line treatment option for advanced gastric cancer, potentially offering patients a more convenient and equally effective alternative to traditional IV therapy.
