Matching-Adjusted Indirect Comparison of Oral Paclitaxel (Liporaxel®) Versus Weekly Intravenous Paclitaxel in Advanced Gastric Cancer.

PURPOSE: Intravenous (IV) paclitaxel is widely used in the treatment of advanced gastric cancer. Liporaxel® is the first orally administered paclitaxel formulation and demonstrated non-inferiority to paclitaxel administered every 3 weeks in the phase III DREAM trial. As no head-to-head trial has compared Liporaxel® with the widely used weekly paclitaxel regimen in gastric cancer, this study aimed to compare their relative efficacy.

MATERIALS AND

METHODS

This study utilized individual patient data from the DREAM trial and aggregate data for the weekly paclitaxel regimen from a systematic literature review. Given the absence of a common comparator, an unanchored matching-adjusted indirect comparison (MAIC) was performed for progression-free survival (PFS) and overall survival (OS) with weighting based on common and extended variables. Primary and sensitivity analyses were performed according to the effective sample size (ESS).

RESULTS

Matching was performed across 5 studies. Despite a reduction in the ESS, baseline patient characteristics remained similarly distributed after matching. In the two studies included in the primary analysis, the adjusted hazard ratios from the unanchored MAIC, based on common variables, were 0.95 (95% confidence interval [CI], 0.72-1.26) and 1.03 (95% CI, 0.81-1.29) for PFS, and 0.94 (95% CI, 0.69-1.28) and 1.06 (95% CI, 0.84-1.34) for OS. The results obtained using the extended variables and sensitivity analyses were consistent with the primary analysis.

CONCLUSIONS

The efficacy of Liporaxel® and the weekly IV paclitaxel regimen were comparable. This finding supports the previously established non-inferiority evidence and suggests Liporaxel® as a valid treatment option for advanced gastric cancer.