Department of Surgery "Pietro Valdoni", "Sapienza" University of Rome, Rome, Italy.
Department of Surgery "Pietro Valdoni", "Sapienza" University of Rome, Rome, Italy
In Vivo. 2019 Nov-Dec;33(6):2065-2070. doi: 10.21873/invivo.11705.
BACKGROUND/AIM: A prospective randomized open label parallel trial, comparing the quality of life (QoL) after endoscopic placement of a self-expandable metal stent or primary tumor resection, in patients with stage IV colorectal cancer was performed.
Thirty-three patients affected with stage IV colorectal cancer and unresectable metastases were randomly assigned into two groups: Group 1 (16 patients), that underwent self-expandable metal stent positioning and Group 2 (17 patients), in which primary tumor resection was performed. Karnofsky performance scale and QoL assessment using the EQ-5D-5L™ questionnaire was administered before treatment and thereafter at 1, 3 and 6 months.
At 1 month, index values showed a statistically significant deterioration of the QoL in patients of Group 2 when compared to those of Group 1 (p=0.001; 95%CI=0.065-0.211) whereas, at 6 months, index values showed a statistically significant deterioration of the QoL in patients of Group 1 (p<0.025; 95%CI=0.017-0.238).
QoL in patients affected with stage IV colorectal cancer has a bimodal fluctuation pattern: at 1-month it was better in patients that received stent, but at 6-months it was significantly better in patients submitted to surgical resection.
背景/目的:本研究开展了一项前瞻性随机开放标签平行试验,比较了内镜放置自膨式金属支架与原发肿瘤切除治疗 IV 期结直肠癌患者的生活质量(QoL)。
33 例 IV 期结直肠癌伴不可切除转移患者被随机分为两组:组 1(16 例)行自膨式金属支架定位,组 2(17 例)行原发肿瘤切除。治疗前及治疗后 1、3 和 6 个月分别采用 Karnofsky 表现量表和 EQ-5D-5L™问卷评估 QoL。
1 个月时,与组 1 相比,组 2 患者的 QoL 指数显著恶化(p=0.001;95%CI=0.065-0.211),而 6 个月时,组 1 患者的 QoL 指数显著恶化(p<0.025;95%CI=0.017-0.238)。
IV 期结直肠癌患者的 QoL 呈双峰波动模式:1 个月时,接受支架治疗的患者 QoL 更好,但 6 个月时,接受手术切除的患者 QoL 显著更好。