胃癌胃切除术后口服营养补充剂的长期影响:多中心、开放标签、随机对照试验的生存分析。
Long-Term Effects of Oral Nutritional Supplements After Gastrectomy for Gastric Cancer: A Survival Analysis from a Multicenter, Open-Label, Randomized Controlled Trial.
发表日期:2024 Jul 10
作者:
Takeshi Omori, Kazuyoshi Yamamoto, Yukinori Kurokawa, Yasuhiro Miyazaki, Kazumasa Fujitani, Ryohei Kawabata, Hiroshi Imamura, Atsushi Takeno, Yoshitomo Yanagimoto, Tsuyoshi Takahashi, Takuro Saito, Hidetoshi Eguchi, Yuichiro Doki
来源:
ANNALS OF SURGICAL ONCOLOGY
摘要:
胃癌胃切除术后体重减轻(WL)与辅助化疗依从性降低和生存受损有关。本研究探讨了胃切除术后 3 个月服用口服营养补充剂 (ONS) 对辅助化疗依从性和生存结果的影响。这项大规模、多中心、开放标签、随机对照试验纳入了 1,003 名接受根治性治疗的胃癌患者。胃切除术。患者被分配到对照组(n = 503)或ONS组(n = 500)。在 ONS 组中,胃切除术后 3 个月内,除了常规饮食外,还建议每天摄入 400 kcal ONS。比较两组辅助化疗依从性及生存结局。与对照组相比,ONS组胃切除术后3个月WL显着降低(分别为8.6±6.1% vs 7.2±5.7%,P=0.0004)。对照组和 ONS 组在辅助化疗的诱导率(分别为 84.9 vs. 82.8%,P = 0.614)或术后 3 个月的继续率(分别为 75.3 vs. 76.6%,P = 0.809)方面没有差异。口服营养补充剂 3 个月没有显示出生存益处;对照组3年和5年总生存率(OS)分别为91.3%和87.6%,ONS组分别为89.6%和86.4%,差异无统计学意义(P = 0.548)。亚组分析无法检测到 ONS 给药增加 OS 的人群。胃切除术后 3 个月给予 ONS 与辅助化疗依从性增加或预后改善无关。© 2024。外科肿瘤学会。
Weight loss (WL) after gastrectomy for gastric cancer is associated with both decreased compliance with adjuvant chemotherapy and impaired survival. This study examined the effects of administering oral nutritional supplements (ONS) for 3 months after gastrectomy in terms of compliance with adjuvant chemotherapy and survival outcomes.This large-scale, multicenter, open-label, randomized controlled trial enrolled 1,003 gastric cancer patients undergoing curative gastrectomy. Patients were assigned to the control group (n = 503) or ONS group (n = 500). In the ONS group, 400 kcal/day of ONS was recommended in addition to a regular diet for 3 months after gastrectomy. Compliance with adjuvant chemotherapy and survival outcomes were compared between the two groups.Compared with the control group, the ONS group showed significantly decreased WL at 3 months after gastrectomy (8.6 ± 6.1 vs. 7.2 ± 5.7%, respectively, P = 0.0004). The control and ONS groups did not differ regarding the induction rate of adjuvant chemotherapy (84.9 vs. 82.8%, respectively, P = 0.614) or the continuation rate at 3 months postoperatively (75.3 vs. 76.6%, respectively, P = 0.809). Oral nutritional supplements for 3 months showed no survival benefit; the 3- and 5-year overall survival (OS) rates were 91.3% and 87.6% in the control group and 89.6% and 86.4% in the ONS group, respectively, indicating no significant difference (P = 0.548). Subgroup analysis could not detect a population in which ONS administration increased OS.Administration of ONS for 3 months after gastrectomy was not associated with increased compliance with adjuvant chemotherapy or with improved prognosis.© 2024. Society of Surgical Oncology.