Among patients with advanced gastric cancer, second-line therapy of Liporaxel (oral paclitaxel) demonstrated non-inferiority of progression-free survival (PFS) compared with the intravenous (IV); however, Liporaxel showed superiority in overall survival (OS) versus IV Liporaxel, according to data from a phase 3 clinical trial presented in a poster at the 2025 Gastrointestinal Cancers Symposium.
In total, 268 patients received the oral solution of Liporaxel and 268 the IV formulation of the agent, between April 22, 2019 and January 31, 2022. The study met non-inferiority criteria for PFS, with a median PFS of 3.02 months in the oral Liporaxel group compared with 2.89 months in the IV group.
Furthermore, with a primary analysis cut-off of February 15, 2023, OS showed superiority of the Liporaxel oral solution, with a median OS of 9.13 months versus 6.54 in the IV group, showing a 2.59-month improvement.
Regarding safety, the oral solution of Liporaxel was clinically manageable and had a favorable safety profile versus the IV formulation, supporting Liporaxel oral solution as a second-line treatment option for gastric cancer, authors wrote.
Glossary:
Blind independent review committee (BIRC): a group of independent medical experts who review patient data from a clinical trial without knowing which treatment group the patient belongs to, allowing for a less biased assessment of the study's end points.
Category 1 preferred regimen: a treatment plan designated by the National Comprehensive Cancer Network guidelines as the most preferred option based on high-level evidence.
ECOG performance status: a widely used medical scale to assess a patient's functional ability and level of activity by evaluating their ability to perform daily tasks and care for themselves.
Intravenous (IV): a medical procedure that involves inserting a needle or tube into a vein.
Progression-free survival (PFS): a measure in clinical trials that indicates the length of time a patient lives with a disease without it worsening or progressing.
Non-inferiority: when a new treatment is not worse than a standard treatment.
Overall survival (OS): the amount of time a patient lives after being diagnosed with a disease or starting treatment.
“[Liporaxel] oral solution demonstrated non-inferiority in PFS and superiority in OS compared [with Liporaxel] IV, with clinically manageable and favorable safety profile,” Dr. Jin Li, of the Department of Medical Oncology, Tongji University Shanghai East Hospital, and co-authors, wrote in the abstract describing their poster presentation.
Although IV Liporaxel is a category 1 preferred regimen in the second-line treatment of gastric cancer, there remains unmet needs with this treatment approach including vehicle-led safety risk, long time injection, premedication or frequent hospital visits. However, the oral solution of Liporaxel—the world's first successfully developed oral formulation of the agent, according to the abstract—may serve as an alternative to investigate this new formulation of the standard of care approach. Investigators sought to investigate Liporaxel oral solution versus Liporaxel IV as a second-line monotherapy in order to establish non-inferiority in efficacy and comparable safety profile for patients with gastric cancer.
Investigators conducted this clinical trial at 53 centers in China, evaluating patients with unresectable, recurrent or metastatic gastric cancer which had progressed following treatment with fluoropyrimidine- or fluoropyrimidine plus platinum-based first-line therapy. Eligible participants were stratified by gastrectomy, ECOG performance status and prior chemotherapy. Patients were randomly assigned 1:1 to receive an oral solution of Liporaxel at 200 milligrams per square meter (mg/m2) twice daily on days 1, 8 and 15 of a 28-day cycle or IV Liporaxel at 175mg/m2 on day 1 of a 21-day cycle.
The co-primary end points of the trial were PFS assessed by BIRC and OS, according to the abstract.
Treatment-related side effects in the oral administration group had a lower incidence of all-grade neuropathy versus the IV group (22.3% versus 38.7%); alopecia, fatigue, musculoskeletal and connective tissue disorders all occurred at a lower incidence in the oral group, and no hypersensitivity occurred without premedication. The authors of the abstract noted that the most common grade 3 or higher treatment-related side effects were neutrophil count decrease (oral group, 47.9%; IV, 54.5%), white blood cell count decrease (41.5%; 35.3%) and anemia (16.6%; 10.9%). Although grade 5 treatment-related side effects were rare, they had comparable rates across both groups (1.5%; 1.1%).
Reference:
Li J, Huang M, Deng T, et al. Paclitaxel oral solution versus paclitaxel injection as a second-line therapy in advanced gastric cancer: A randomized, open-label, non-inferiority phase 3 trial. J Clin Oncol. suppl.442.
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