Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.
Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.
JAMA Surg. 2019 Dec 1;154(12):1093-1101. doi: 10.1001/jamasurg.2019.3473.
Laparoscopic distal gastrectomy and neoadjuvant chemotherapy are increasingly used to treat locally advanced gastric cancer. However, the safety and efficacy of the laparoscopic procedure after neoadjuvant chemotherapy remain unclear.
To evaluate the short-term outcomes of patients with locally advanced gastric cancer who received either laparoscopic distal gastrectomy or open distal gastrectomy.
DESIGN, SETTING, AND PARTICIPANTS: Between April 23, 2015, and November 16, 2017, a phase 2, open-label, noninferiority randomized clinical trial was conducted at the Gastrointestinal Cancer Center of Peking University Cancer Hospital and Institute in Beijing, China. Patients (n = 96) between 18 and 80 years of age with locally advanced gastric cancer (cT2-4aN+M0) who were receiving neoadjuvant chemotherapy were enrolled and randomized. An as-treated population and a modified intention-to-treat (mITT) population were defined for the data analysis.
Patients were randomized to undergo either laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy or open distal gastrectomy (ODG) with D2 lymphadenectomy.
The primary end point was 3-year recurrence-free survival rate. Secondary end points were surgical radicality, 30-day postoperative morbidity and mortality, 2-week postoperative recovery indexes, and adjuvant chemotherapy completion status.
In total, 95 patients were eligible for as-treated analyses (LADG: 45, of whom 13 were female [29%], with a median [interquartile range (IQR)] age of 59 [52-65] years; ODG: 50, of whom 16 were female [32%], with a median [IQR] age of 61 [55-64] years) and mITT analyses (LADG: 47, of whom 14 were female [30%], with a median [IQR] age of 59 [52-65] years; ODG: 48, of whom 15 were female [31%], with a median [IQR] age of 61 [55-64] years). In the as-treated analyses, the LADG group had a significantly lower postoperative complication rate than the ODG group (20% vs 46%; P = .007). The postoperative visual analog scale score for pain was 1.2 units lower on postoperative day 2 only in the LADG group (95% CI, -2.1 to -0.3; P = .008). Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%]; P = .04). The mITT analyses showed similar results to as-treated analyses.
This trial found that LADG appears to offer the benefits of better postoperative safety and adjuvant chemotherapy tolerance compared with ODG for patients with locally advanced gastric cancer who received neoadjuvant chemotherapy.
ClinicalTrials.gov identifier: NCT02404753.
腹腔镜远端胃切除术和新辅助化疗越来越多地用于治疗局部晚期胃癌。然而，新辅助化疗后腹腔镜手术的安全性和疗效仍不清楚。
评估接受腹腔镜远端胃切除术或开放远端胃切除术的局部晚期胃癌患者的短期结局。
设计、地点和参与者：2015 年 4 月 23 日至 2017 年 11 月 16 日，在中国北京北京大学肿瘤医院和研究所的胃肠癌中心进行了一项 2 期、开放标签、非劣效性随机临床试验。纳入了年龄在 18 至 80 岁之间、接受新辅助化疗的局部晚期胃癌（cT2-4aN+M0）患者，并进行了随机分组。为数据分析定义了按治疗人群和改良意向治疗（mITT）人群。
患者被随机分配接受腹腔镜辅助远端胃切除术（LADG）联合 D2 淋巴结清扫术或开放远端胃切除术（ODG）联合 D2 淋巴结清扫术。
主要终点是 3 年无复发生存率。次要终点是手术根治性、30 天术后发病率和死亡率、2 周术后恢复指标以及辅助化疗完成情况。
共有 95 例患者符合按治疗方案分析（LADG：45 例，其中 13 例为女性[29%]，中位[四分位距（IQR）]年龄为 59[52-65]岁；ODG：50 例，其中 16 例为女性[32%]，中位[IQR]年龄为 61[55-64]岁）和 mITT 分析（LADG：47 例，其中 14 例为女性[30%]，中位[IQR]年龄为 59[52-65]岁；ODG：48 例，其中 15 例为女性[31%]，中位[IQR]年龄为 61[55-64]岁）。按治疗方案分析，LADG 组的术后并发症发生率明显低于 ODG 组（20%比 46%；P=0.007）。仅在 LADG 组，术后第 2 天的视觉模拟评分法（VAS）疼痛评分低 1.2 分（95%CI，-2.1 至-0.3；P=0.008）。LADG 组的辅助化疗完成情况更好（调整优势比，4.39；95%CI，1.63-11.80；P=0.003），且因不良反应终止辅助化疗的可能性更小（10[22%]比 21[42%]；P=0.04）。mITT 分析结果与按治疗方案分析相似。
本试验发现，与接受新辅助化疗的局部晚期胃癌患者相比，LADG 似乎具有更好的术后安全性和辅助化疗耐受性优势。
ClinicalTrials.gov 标识符：NCT02404753。
