一项关于含二十碳五烯酸的口服营养补充剂对晚期胃癌恶病质患者疗效的多中心II期研究。
Multicenter phase II study on the efficacy of an oral nutritional supplement containing eicosapentaenoic acid in advanced gastric cancer patients with cachexia.
作者信息
Kawabata Ryohei, Nishikawa Kazuhiro, Kawase Tomono, Kawada Junji, Kimura Yutaka, Kashima Yasushige, Ueda Shugo, Takeno Atsushi, Shimomura Kazuhiro, Imamura Hiroshi
机构信息
Department of Surgery, Sakai City Medical Center, 1-1-1, Ebaraji-cho, Nishi-ku, Sakai, Osaka, 5938304, Japan.
Department of Surgery, Osaka Rosai Hospital, Sakai, Japan.
出版信息
Gastric Cancer. 2025 Mar 19. doi: 10.1007/s10120-025-01605-x.
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.
背景
恶病质是晚期胃癌（AGC）的常见并发症。二十碳五烯酸（EPA）可能改善恶病质。这项单臂II期研究评估了含EPA的口服营养补充剂（ONS-EPA）对AGC患者恶病质的潜在益处。
方法
纳入未接受过化疗、血清白蛋白<3.5g/dl且C反应蛋白≥0.5mg/dl定义为恶病质的AGC患者。患者在一线化疗期间每日两次接受富含EPA的补充剂（Prosure，每包含1.056g EPA）。主要终点是在前两周内坚持服用≥25%计划剂量的ONS-EPA的患者的治疗失败时间（TTF）（符合方案集，PPS）。二次分析评估依从性对治疗结果的影响。
结果
72例入组患者中，65例接受评估。中位依从率为42.8%。PPS组的中位TTF为4.8个月（95%CI 3.6-5.5），低于预设的4个月阈值。与依从性差的患者相比，PPS组在治疗期间营养和炎症状态改善的患者比例更高，TTF和总生存期（OS）也更好。调整后的中位TTF为4.6个月对2.5个月（风险比：0.56；95%CI 0.28-1.12，p=0.105）。
结论
尽管未达到主要终点，但该研究表明ONS-EPA可能使有恶病质的AGC患者获益。
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