Multicenter phase II study on the efficacy of an oral nutritional supplement containing eicosapentaenoic acid in advanced gastric cancer patients with cachexia.

Abstract

Background: Cachexia is a common complication in advanced gastric cancer (AGC). Eicosapentaenoic acid (EPA) may ameliorate cachexia. This single-arm, phase II study assessed the potential benefit of an oral nutritional supplement containing EPA (ONS-EPA) for cachexia in AGC patients.

Methods: Chemotherapy-naive AGC patients with cachexia, defined by serum albumin < 3.5 g/dl and C-reactive protein ≥ 0.5 mg/dl, were included. Patients received an EPA-enriched supplement (Prosure^®, 1.056 g EPA/pack) twice daily during first-line chemotherapy. The primary endpoint was time to treatment failure (TTF) in patients adhering to ≥ 25% of the planned ONS-EPA dose in the first two weeks (per-protocol set, PPS). Secondary analyses evaluated adherence impact on treatment outcomes.

Results: Of 72 enrolled patients, 65 were evaluated. Median adherence was 42.8%. Median TTF in the PPS group was 4.8 months (95% CI 3.6-5.5), below the pre-set 4-month threshold. The PPS group had a higher proportion of patients who improved their nutritional and inflammatory status during treatment, along with better TTF and overall survival (OS) compared to those with poor adherence. Adjusted median TTF was 4.6 vs. 2.5 months (hazard ratio: 0.56; 95% CI 0.28-1.12, p = 0.105).

Conclusions: Although the primary endpoint was not achieved, the study suggests that ONS-EPA may benefit AGC patients with cachexia.