Fast-track multidisciplinary treatment versus conventional treatment for colorectal cancer: a multicenter, open-label randomized controlled study
Fast-track multidisciplinary treatment versus conventional treatment for colorectal cancer: a multicenter, open-label randomized controlled study
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结直肠癌的快速多学科治疗与常规治疗：一项多中心、开放标签随机对照研究
DOI：
10.1186/s12885-019-6188-x
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发表时间：
2019-10-23
期刊：
影响因子：
3.8
通讯作者：
Ding, Ke-Feng
中科院分区：
文献类型：
--
作者：
Li, Jun;Kong, Xiang-Xing;Ding, Ke-Feng
背景腹腔镜手术、快速围手术期治疗和XELOX化疗是缩短肿瘤患者住院时间的有效策略。本试验旨在阐明快速通道多学科治疗（FTMDT）模式在中国结直肠癌患者中与传统手术联合化疗相比的安全性和有效性。方法采用2 × 2平衡因子设计，在6家医院进行前瞻性随机对照研究。1组（FTMDT）患者接受快速通道围手术期治疗和XELOX辅助化疗。2组（常规治疗）患者接受常规围手术期治疗和mFOLFOX6辅助化疗。亚组1a和2a为腹腔镜手术，亚组1b和2b为开放手术。主要终点是治疗期间的总住院时间。结果共374例患者被随机分为4个亚组，最终分析342例患者，其中1a亚组87例，1b亚组85例，2a亚组86例，2b亚组84例。组1总住院时间短于组2[13天，（IQR， 11 ~ 17天）vs. 23.5天（IQR， 15 ~ 42天），P= 0.0001]。与2组比较，1组手术费用低，住院并发症少，恢复快（p < 0.05）。1a亚组术后恢复快于1b亚组（p < 0.05）。组1和组2的5年总生存率无差异[87.1% (95% CI, 80.7 ~ 91.5%) vs. 87.1% (95% CI, 80.8 ~ 91.4%)，P= 0.7420]。结论结合腹腔镜手术、快速通道治疗和XELOX化疗的FTMDT模式是促进我国结直肠癌患者康复的优势模式。试验注册：clinicaltrials .gov: NCT01080547，于2010年3月4日注册。
BackgroundLaparoscopic surgery, fast-track perioperative treatment and XELOX chemotherapy are effective strategies for shortening the duration of hospital stay for cancer patients. This trial aimed to clarify the safety and efficacy of the fast-track multidisciplinary treatment (FTMDT) model compared to conventional surgery combined with chemotherapy in Chinese colorectal cancer patients.MethodsThis trial was a prospective randomized controlled study with a 2 × 2 balanced factorial design and was conducted at six hospitals. Patients in group 1 (FTMDT) received fast-track perioperative treatment and XELOX adjuvant chemotherapy. Patients in group 2 (conventional treatment) received conventional perioperative treatment and mFOLFOX6 adjuvant chemotherapy. Subgroups 1a and 2a had laparoscopic surgery and subgroups 1b and 2b had open surgery. The primary endpoint was total length of hospital stay during treatment.ResultsA total of 374 patients were randomly assigned to the four subgroups, and 342 patients were finally analyzed, including 87 patients in subgroup 1a, 85 in subgroup 1b, 86 in subgroup 2a, and 84 in subgroup 2b. The total hospital stay of group 1 was shorter than that of group 2 [13 days, (IQR, 11–17 days) vs. 23.5 days (IQR, 15–42 days),P= 0.0001]. Compared to group 2, group 1 had lower surgical costs, fewer in-hospital complications and faster recovery (allP< 0.05). Subgroup 1a showed faster surgical recovery than that of subgroup 1b (allP< 0.05). There was no difference in 5-year overall survival between groups 1 and 2 [87.1% (95% CI, 80.7–91.5%) vs. 87.1% (95% CI, 80.8–91.4%),P= 0.7420].ConclusionsThe FTMDT model, which integrates laparoscopic surgery, fast-track treatment, and XELOX chemotherapy, was the superior model for enhancing the recovery of Chinese patients with colorectal cancer.Trial registrationClinicalTrials.gov: NCT01080547 , registered on March 4, 2010.