全程新辅助治疗局部进展期直肠癌疗效和安全性的Meta分析

doi:10.3877/cma.j.issn.2095-3224.2021.02.011

目的

比较全程新辅助治疗（TNT）和新辅助放化疗（nCRT）治疗中低位局部进展期直肠癌的疗效和安全性。

方法

全面检索中文数据库（中国知网、万方、中国生物医学文献数据库）和英文数据库（PubMed、Embase）公开发表的有关TNT和nCRT治疗局部进展期直肠癌疗效和安全性的临床研究。随机对照研究的质量评价采用Cochrane协作网提供的偏倚评价工具，非随机对照研究质量评价选择Newcastle-Ottawa量表。采用RevMan 5.3软件对TNT和nCRT组的pCR率、肿瘤降期率、R0切除率、保肛率、3/4级急性毒性反应发生率、围手术期并发症率、局部复发和远处转移率以及生存预后等进行Meta分析。

结果

最终纳入研究14项，其中6项为随机对照研究。共纳入病例3 797例，TNT组1 865例，nCRT组1 932例。两组基线资料具有可比性。Meta分析结果表明，TNT组的pCR率（OR=1.57，95%CI：1.30~1.90，P＜0.00001）、T分期降期率（OR=2.16，95%CI：1.63~2.57，P＜0.00001）和R0切除率（OR=1.42，95%CI：1.09~1.85，P=0.009）均显著高于nCRT组。两组3/4级急性毒性反应发生率和围手术期并发症率差异无统计学意义。TNT组的5年OS（HR=0.84，95%CI：0.69~1.02，P=0.08）和DFS（HR=0.94，95%CI：0.03~1.39，P=0.74）与nCRT组相近。

结论

与nCRT相比，尽管TNT未显著改善5年OS和DFS，但明显提高了肿瘤的pCR率、降期率和R0切除率。

关键词: 直肠肿瘤, 全程新辅助治疗, 新辅助放化疗, 局部进展期直肠癌, 疗效, 安全性, Meta分析

Objective

To evaluate the efficacy and safety of total neoadjuvant therapy for locally advanced rectal cancer.

Methods

A systemic search of CNKI, WanFang, CBM, PubMed and Embase was conducted for the studies that compared the efficacy of TNT and nCRT for rectal cancer. The quality evaluation of randomized controlled trials was based on the Cochrane's risk of bias tool, while non-randomized trials were assessed using Newcastle-Ottawa Scale. RevMan 5.3 software was used for meta-analisis, and the rate of pCR, T-downstaging, R0 resection and sphincter preservation rate, grade 3/4 acute toxicity during treatment, perioperative complications and survival benefits were compared between the two groups.

Results

A total of 14 studies was included with the amount of 3 797 patients, 1 865 and 1 932 in TNT group and nCRT group respectively. Meta analysis revealed that, a significant difference existed in the rate of pCR (OR=1.57,95%CI:1.30~1.90, P＜0.00001), T-downstaging (OR=2.16,95%CI:1.63~2.57, P＜0.00001) and R0 resection (OR=1.42,95%CI:1.09~1.85, P=0.009). There was no significant difference in the rate of perioperative complication and acute toxicity between the two groups. The 5-OS and 5-DFS were comparable between TNT group and nCRT group, indicating that TNT showed no survival benefits on rectal cancer patients.

Conclusion

Compared to nCRT, though no significant improvement in OS and DFS, the rate of pCR, tumor downstaging and R0 resection rate was improved in TNT group.

Key words: Rectal neoplasms, Total neoadjuvant therapy, Neoadjuvant chemoradiotherapy, Locally advanced rectal cancer, Efficacy, Safety, Meta-analysis

图1 纳入研究流程图

表1 纳入研究一般特征

作者	发表年份	国家	研究类型	总样本量	样本量		纳入研究质量评价
作者	发表年份	国家	研究类型	总样本量	TNT	nCRT	纳入研究质量评价
Garcia^[9]	2015	美国	前瞻性研究	259	199	60	6
翟志伟^[11]	2020	中国	回顾性研究	134	79	55	6
Cercek^[12]	2018	美国	回顾性研究	628	308	320	8
Markovina^[13]	2017	美国	前瞻性研究	138	69	69	6
Zhu^[14]	2019	美国	回顾性研究	1079	372	707	8
Fernandez^[15]	2015	美国	随机对照研究	103	54	49	－
Maréchal^[18]	2012	比利时	随机对照研究	57	28	29	－
Calvo^[19]	2014	西班牙	回顾性研究	335	207	128	7
Bhatti^[20]	2015	巴基斯坦	回顾性研究	154	93	61	7
Bujko^[21]	2016	波兰	随机对照研究	515	261	254	－
Kim^[22]	2018	韩国	随机对照研究	110	54	56	－
Liang^[23]	2019	中国	前瞻性研究	156	76	80	5
Moore^[24]	2017	澳大利亚	随机对照研究	49	25	24	－
李雷蕾^[25]	2017	中国	随机对照研究	80	40	40	－

表1 纳入研究一般特征

作者	发表年份	国家	研究类型	总样本量	样本量		纳入研究质量评价
作者	发表年份	国家	研究类型	总样本量	TNT	nCRT	纳入研究质量评价
Garcia^[9]	2015	美国	前瞻性研究	259	199	60	6
翟志伟^[11]	2020	中国	回顾性研究	134	79	55	6
Cercek^[12]	2018	美国	回顾性研究	628	308	320	8
Markovina^[13]	2017	美国	前瞻性研究	138	69	69	6
Zhu^[14]	2019	美国	回顾性研究	1079	372	707	8
Fernandez^[15]	2015	美国	随机对照研究	103	54	49	－
Maréchal^[18]	2012	比利时	随机对照研究	57	28	29	－
Calvo^[19]	2014	西班牙	回顾性研究	335	207	128	7
Bhatti^[20]	2015	巴基斯坦	回顾性研究	154	93	61	7
Bujko^[21]	2016	波兰	随机对照研究	515	261	254	－
Kim^[22]	2018	韩国	随机对照研究	110	54	56	－
Liang^[23]	2019	中国	前瞻性研究	156	76	80	5
Moore^[24]	2017	澳大利亚	随机对照研究	49	25	24	－
李雷蕾^[25]	2017	中国	随机对照研究	80	40	40	－

表2 TNT组和nCRT组放化疗方案及具体剂量

作者	TNT			nCRT
作者	IT/CT	化疗方案	剂量	放疗方案	同步化疗方案
Garcia^[9]	CT	mFOFLOX	5-FU 400 mg/m²；LV 200 mg/m²；OX 85 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²
翟志伟^[11]	CT	CAPEOX	CAP 1 000 mg/m²; OX 130 mg/m ²	50.4 Gy/28 f	CAP 850 mg/m²
Cercek^[12]	IT	mFOFLOX	5-FU 400 mg/m²；LV 200 mg/m²；OX 85 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²/CAP 850 mg/m²
Markovina^[13]	IT	mFOFLOX	5-FU/LV/OX	45.0 Gy/25 f	5-FU/CAP
Zhu^[14]	IT	FOFLOX/CAPEOX	－	45.0 Gy/25 f 50.4 Gy/25~28 f	－
Fernandez^[15]	IT	CAPEOX	CAP/ OX	45.0 Gy/25 f	CAP
Maréchal^[18]	IT	mFOFLOX	5-FU 400 mg/m²；LV 400 mg/m²；OX 100 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²
Calvo^[19]	IT	mFOFLOX	5-FU 400 mg/m²；LV 200 mg/m²；OX 85 mg/m²	45.0 Gy/25 f	5-FU 425 mg/m²
Bhatti^[20]	IT	CAPEOX	CAP 1 000 mg/m²; OX 130 mg/m²	50.4 Gy/25~28 f	CAP 825 mg/m²
Bujko^[21]	CT	mFOFLOX	5-FU/LV/OX	50.4 Gy/25~28 f	5-FU 325 mg/m²/LV 20 mg/m²
Kim^[22]	CT	CAPEOX	CAP 1 700 mg/m²; OX 100 mg/m²	50.4 Gy/25~28 f	CAP
Liang^[23]	CT	CAPEOX FOFLOX	CAP 1 000 mg/m²; OX 130 mg/m² 5-FU 400 mg/m²; LV 400 mg/m²;OX 85 mg/m²	50.4 Gy/25~28 f	CAP 825 mg/m²
Moore^[24]	CT	5-FU/LV	5-FU 450 mg/m²; LV 50 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²
李雷蕾^[25]	CT	FOFLOX	5-FU 400 mg/m²; LV 200 mg/m²;OX 85 mg/m²	50.4 Gy/25~28 f	5-FU 225 mg/m²

表2 TNT组和nCRT组放化疗方案及具体剂量

作者	TNT			nCRT
作者	IT/CT	化疗方案	剂量	放疗方案	同步化疗方案
Garcia^[9]	CT	mFOFLOX	5-FU 400 mg/m²；LV 200 mg/m²；OX 85 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²
翟志伟^[11]	CT	CAPEOX	CAP 1 000 mg/m²; OX 130 mg/m ²	50.4 Gy/28 f	CAP 850 mg/m²
Cercek^[12]	IT	mFOFLOX	5-FU 400 mg/m²；LV 200 mg/m²；OX 85 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²/CAP 850 mg/m²
Markovina^[13]	IT	mFOFLOX	5-FU/LV/OX	45.0 Gy/25 f	5-FU/CAP
Zhu^[14]	IT	FOFLOX/CAPEOX	－	45.0 Gy/25 f 50.4 Gy/25~28 f	－
Fernandez^[15]	IT	CAPEOX	CAP/ OX	45.0 Gy/25 f	CAP
Maréchal^[18]	IT	mFOFLOX	5-FU 400 mg/m²；LV 400 mg/m²；OX 100 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²
Calvo^[19]	IT	mFOFLOX	5-FU 400 mg/m²；LV 200 mg/m²；OX 85 mg/m²	45.0 Gy/25 f	5-FU 425 mg/m²
Bhatti^[20]	IT	CAPEOX	CAP 1 000 mg/m²; OX 130 mg/m²	50.4 Gy/25~28 f	CAP 825 mg/m²
Bujko^[21]	CT	mFOFLOX	5-FU/LV/OX	50.4 Gy/25~28 f	5-FU 325 mg/m²/LV 20 mg/m²
Kim^[22]	CT	CAPEOX	CAP 1 700 mg/m²; OX 100 mg/m²	50.4 Gy/25~28 f	CAP
Liang^[23]	CT	CAPEOX FOFLOX	CAP 1 000 mg/m²; OX 130 mg/m² 5-FU 400 mg/m²; LV 400 mg/m²;OX 85 mg/m²	50.4 Gy/25~28 f	CAP 825 mg/m²
Moore^[24]	CT	5-FU/LV	5-FU 450 mg/m²; LV 50 mg/m²	45.0 Gy/25 f	5-FU 225 mg/m²
李雷蕾^[25]	CT	FOFLOX	5-FU 400 mg/m²; LV 200 mg/m²;OX 85 mg/m²	50.4 Gy/25~28 f	5-FU 225 mg/m²

图2 纳入随机对照研究的质量评价表

图3 TNT和nCRT组急性3/4级毒性反应的比较分析

图4 TNT和nCRT组围手术期并发症的比较分析

图5 TNT和nCRT组pCR率的比较分析

图6 TNT和nCRT组肿瘤T分期降期率的比较分析

图7 TNT和nCRT组R0切除率的比较分析

图8 TNT和nCRT组保肛率的比较分析

图9 TNT和nCRT组局部复发情况的比较分析

图10 TNT和nCRT组远处转移情况的比较分析

图11 TNT和nCRT组5年OS比较分析

图12 TNT和nCRT组5年DFS比较分析

图13 纳入研究的发表偏移情况（pCR）

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A meta-analysis of efficacy and safety on total neoadjuvant therapy for locally advanced rectal cancer

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A meta-analysis of efficacy and safety on total neoadjuvant therapy for locally advanced rectal cancer