Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer

DU Meilu; HOU Fenggang; ZHU Guanghui; SHI Qi; HAN Susu; YANG Yi; JIA Jianing; YIN Xiaoling; ZHAO Gang

doi:10.16306/j.1008-861x.2023.04.002

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Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer

Clinical Research | 更新时间：2023-08-04

- Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer
- Academic Journal of Shanghai University of Traditional Chinese Medicine Vol. 37, Issue 4, Pages: 9-21(2023)
- 作者机构：
  
  1.上海中医药大学附属市中医医院（上海　200071）
  2.上海中医药大学附属曙光医院（上海　201203）
- 作者简介：
- 基金信息：
- DOI：10.16306/j.1008-861x.2023.04.002
  CLC：
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杜美璐,侯风刚,朱光辉等.中药维持治疗对晚期大肠癌患者生存期的影响[J].上海中医药大学学报,2023,37(04):9-21.

DU Meilu,HOU Fenggang,ZHU Guanghui,et al.Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2023,37(04):9-21.
杜美璐,侯风刚,朱光辉等.中药维持治疗对晚期大肠癌患者生存期的影响[J].上海中医药大学学报,2023,37(04):9-21. DOI： 10.16306/j.1008-861x.2023.04.002.

DU Meilu,HOU Fenggang,ZHU Guanghui,et al.Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2023,37(04):9-21. DOI： 10.16306/j.1008-861x.2023.04.002.

摘要

目的,2,评估晚期大肠癌（ACC）患者一线化疗后中药参与维持治疗的临床疗效，为中药干预ACC维持治疗提供循证依据。,方法,2,采用回顾性队列研究设计，收集ACC患者的临床资料，根据维持治疗期间是否服用中药将患者分为干预组和对照组。对照组患者给予西医常规维持治疗，干预组患者在对照组治疗基础上加服中药治疗。采用倾向性评分匹配（PSM）进一步平衡组间协变量，以无进展生存期（PFS）、总生存期（OS）为结局指标，并分析中药对口服氟尿嘧啶类药物维持治疗和观察策略维持治疗方案的影响。,结果,2,共纳入850例ACC患者，PSM后纳入670例患者，包括干预组335例、对照组335例。干预组和对照组患者的中位PFS分别为10个月（95%,CI, 8.05~11.95）和7个月（95%,CI, 6.15~7.85），进展或死亡风险比（,HR,）为0.75（95%,CI, 0.64~0.88，,P,=0.000）；干预组和对照组患者的中位OS分别为32个月（95%,CI, 26.15~37.85）和21个月（95%,CI, 17.24~24.76），死亡,HR,为0.62（95%,CI, 0.53~0.73，,P,=0.000）。采用口服氟尿嘧啶类药物维持治疗的患者，干预组和对照组的中位PFS分别为13个月和10个月（,HR,=0.80， 95%,CI, 0.61~1.06，,P,=0.098），中位OS分别为31个月和22个月（,HR,=0.65， 95%,CI, 0.52~0.81，,P,=0.000）；采用观察策略维持治疗的患者，干预组和对照组的中位PFS分别为10个月和6个月（,HR,=0.78， 95%,CI, 0.63~0.96，,P,=0.013），中位OS分别为27个月和17个月（,HR,=0.65， 95%,CI, 0.52~0.81，,P,=0.000）。,结论,2,一线化疗后含中药的维持治疗方案可延长ACC患者的PFS和OS，同时，中药可延长采用氟尿嘧啶类药物维持治疗患者的OS，并对采用观察策略维持治疗患者的PFS和OS均有延长作用。

Abstract

Objective： To evaluate the clinical efficacy of maintenance therapy involved in Chinese medicine in patients with advanced colorectal cancer （ACC） after first-line chemotherapy， in order to provide an evidence-based basis for Chinese medicine intervention in ACC maintenance therapy.,Methods,2,A retrospective cohort study design was applied. The clinical data of ACC patients were collected， and the patients were divided into the intervention group and control group according to whether taking Chinese medicine during the maintenance therapy. The patients in the control group were given conventional maintenance therapy with western medicine， and the patients in the intervention group were given Chinese medicine orally based on the treatment of the control group. Propensity score matching （PSM） was used to further balance the covariates between the two groups， the progression-free survival （PFS） and overall survival （OS） were taken as outcome indicators， and the influences of Chinese medicine on oral fluorouracil maintenance therapy and the observation strategy maintenance therapy were analyzed.,Results,2,A total of 850 patients with ACC were included， and 670 patients were included after PSM and divided into the intervention group （335 cases） and the control group （335 cases）. The median PFS was 10 months （95%,CI, 8.05~11.95） in the intervention group and 7 months （95%,CI, 6.15~7.85） in the control group， with a hazard ratio（,HR,） of 0.75 （95%,CI, 0.64~0.88， ,P,=0.000） for progression or death. The median OS was 32 months （95%,CI, 26.15~37.85） in the intervention group and 21 months （95%,CI, 17.24~24.76） in the control group， with a ,HR, of 0.62 （95%,CI, 0.53~0.73， ,P,=0.000） for death. In patients treated with oral fluorouracil maintenance therapy， the median PFS was 13 months in the intervention group and 10 months in the control group （,HR,=0.80， 95%,CI, 0.61~1.06， ,P,=0.098）， and the median OS was 31 months in the intervention group and 22 months in the control group （,HR,=0.65， 95%,CI, 0.52~0.81， ,P,=0.000）. In patients treated with observation strategy maintenance therapy， the median PFS was 10 months in the intervention group and 6 months in the control group （,HR,=0.78， 95%,CI, 0.63~0.96， ,P,=0.013）， and the median OS was 27 months in the intervention group and 17 months in the control group （,HR,=0.65， 95%,CI, 0.52~0.81， ,P,=0.000）.,Conclusion,2,Maintenance therapy containing Chinese medicine after first-line chemotherapy can prolong the PFS and OS in patients with ACC， meanwhile Chinese medicine can prolong the OS in patients treated with fluorouracil maintenance therapy and prolong the PFS and OS in patients treated with observation strategy maintenance therapy.

关键词

晚期大肠癌维持治疗中药无进展生存期总生存期

Keywords

advanced colorectal cancermaintenance treatmentChinese medicineprogression-free survivaloverall survival

references

VAN CUTSEM E， OLIVEIRA J； ESMO Guidelines Working Group. Advanced colorectal cancer： ESMO clinical recommendations for diagnosis， treatment and follow-up［J］. Ann Oncol， 2009， 20（Suppl 4）： 61-63.

HOCHSTER H S， GROTHEY A， HART L， et al. Improved time to treatment failure with an intermittent oxaliplatin strategy： results of CONcePT［J］. Ann Oncol， 2014， 25（6）： 1172-1178.

SONBOL M B， MOUNTJOY L J， FIRWANA B， et al. The Role of Maintenance Strategies in Metastatic Colorectal Cancer： A Systematic Review and Network Meta-analysis of Randomized Clinical Trials［J］. JAMA Oncol， 2020， 6（3）： e194489.

CREMOLINI C， ANTONIOTTI C， LONARDI S， et al. Activity and Safety of Cetuximab Plus Modified FOLFOXIRI Followed by Maintenance With Cetuximab or Bevacizumab for RAS and BRAF Wild-type Metastatic Colorectal Cancer： A Randomized Phase 2 Clinical Trial［J］. JAMA Oncol， 2018， 4（4）： 529-536.

NOEPEL-DUENNEBACKE S， ARNOLD D， HERTEL J， et al. Impact of the localization of the primary tumor and RAS/BRAF mutational status on maintenance strategies after first-line oxaliplatin， fluoropyrimidine， and bevacizumab in metastatic colorectal cancer： results from the AIO 0207 trial［J］. Clin Colorectal Cancer， 2018， 17（4）： e733-e739.

TOURNIGAND C， CERVANTES A， FIGER A， et al. OPTIMOX1： a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer—a GERCOR study［J］. J Clin Oncol， 2006， 24（3）： 394-400.

MAUGHAN T S， JAMES R D， KERR D J， et al. Comparison of intermittent and continuous palliative chemotherapy for advanced colorectal cancer： a multicenter randomised trial［J］. Lancet， 2003， 361（9356）： 457-464.

SOBRERO A， DAMIANI A. Maintenance therapy in advanced colorectal cancer， yes or no？ Ask the laboratory［J］. Ann Oncol， 2017， 28（9）： 2043-2044.

BENSON A B， VENOOK A P， AL-HAWARY M M， et al. Colon Cancer， Version 2.2021， NCCN Clinical Practice Guidelines in Oncology［J］. J Natl Canc Netw， 2021， 19（3）： 329-359.

XU R H， SHEN L， LI J， et al. Expert consensus on maintenance treatment for metastatic colorectal cancer in China［J］. Chin J Cancer， 2016， 35： 13.

MARTÍN-RICHARD M， TOBEÑA M. First-Line Maintenance Treatment in Metastatic Colorectal Cancer （mCRC）： Quality and Clinical Benefit Overview［J］. J Clin Med， 2021， 10（3）： 470.

MA H， WU X， TAO M， et al. Efficacy and safety of bevacizumab-based maintenance therapy in metastatic colorectal cancer： A meta-analysis［J］. Medicine （Baltimore）， 2019， 98（50）： 18227.

CHIBAUDEL B， MAINDRAULT-GOEBEL F， LLEDO G， et al. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer？ The GERCOR OPTIMOX2 Study［J］. J Clin Oncol， 2009， 27（34）： 5727-5733.

GENG R， WANG G， QIU L， et al. Metronomic capecitabine as maintenance treatment after first line induction with XELOX for metastatic colorectal cancer patients［J］. Medicine （Baltimore）， 2020， 99（51）： e23719.

ZHU Y， YU J， ZHANG K， et al. Network Pharmacology Analysis to Explore the Pharmacological Mechanism of Effective Chinese Medicines in Treating Metastatic Colorectal Cancer using Meta-Analysis Approach［J］. Am J Chin Med， 2021， 49（8）： 1839-1870.

GE L， WANG Y F， TIAN J H， et al. Network meta-analysis of Chinese herb injections combined with FOLFOX chemotherapy in the treatment of advanced colorectal cancer［J］. J Clin Pharm Ther， 2016， 41（4）： 383-391.

郝捷，李进，马军，等. 中国临床肿瘤学会（CSCO）常见恶性肿瘤诊疗指南2020［M］. 北京：人民卫生出版社， 2020： 433-446.

HAO J， LI J， MA J， et al. Chinese Society of Clinical Oncology （CSCO） Guidelines for Diagnosis and Treatment of Common Malignancies， 2020［M］. Beijing： People's Medical Publishing House， 2020： 433-446.

周岱翰. 中医肿瘤学［M］. 广州：广东高等教育出版社， 2007： 213-215.

ZHOU D H. Chinese Medical Oncology［M］. Guangzhou： Guangdong Higher Education Press， 2007： 213-215.

KARNOFSKY D A， ABELMANN W H， CRAVER L F， et al. The Use of the Nitrogen Mustards in the Palliative Treatment of Carcinoma-with Particular Reference to Bronchogenic Carcinoma［J］. Cancer， 1948， 1（4）： 634-656.

SCHWARTZ L H， LITIÈRE S， DE VRIES E， et al. RECIST 1.1-Update and clarification： From the RECIST committee［J］. Eur J Cancer， 2016， 62： 132-137.

刘见荣，徐燕丰，可飞，等. 抑癌方对结肠癌转移潜能及血管生成拟态的影响［J］. 辽宁中医杂志， 2014， 41（3）： 574-576.

LIU J R， XU Y F， KE F， et al. Effects of Yiai Decoction on Metastatic Potential and Vasculogenic Mimicry of Colon Cancer Cells［J］. Liaoning Journal of Traditional Chinese Medicine， 2014， 41（3）： 574-576.

任明名，顾立梅，杨文娟，等. 国医大师周仲瑛从湿热瘀毒、脾气亏虚论治结直肠癌经验［J］. 中华中医药杂志， 2022， 37（8）： 4488-4492.

REN M M，GU L M， YANG W J， et al. Experience of TCM master ZHOU Zhong-ying in the treatment of colorectal cancer from damp-heat stasis toxin and spleen qi deficiency［J］. China Journal of Traditional Chinese Medicine and Pharmacy， 2022， 37（8）： 4488-4492.

张彦博，刘宣，季青，等. 健脾解毒方联合化疗治疗转移性结直肠癌临床研究［J］. 中华中医药杂志， 2015， 30（6）： 2090-2093.

ZHANG Y B， LIU X， JI Q， et al. Clinical research on treating metastatic colorectal cancer with Jianpi Jiedu Decoction and chemotherapy［J］. China Journal of Traditional Chinese Medicine and Pharmacy， 2015， 30（6）： 2090-2093.

MODEST D P， RIVERA F， BACHET J B， et al. Panitumumab-based maintenance after oxaliplatin discontinuation in metastatic colorectal cancer： A retrospective analysis of two randomised trials［J］. Int J Cancer， 2019， 145（2）： 576-585.

LUO H Y， LI Y H， WANG W， et al. Single-agent capecitabine as maintenance therapy after induction of XELOX （or FOLFOX） in first-line treatment of metastatic colorectal cancer： randomized clinical trial of efficacy and safety［J］. Ann Oncol， 2016， 27（6）： 1074-1081.

ZHOU M， FU L， ZHANG J. Who will benefit more from maintenance therapy of metastatic colorectal cancer？［J］. Oncotarget， 2017， 9（15）： 12479-12486.

AUBER M L， WEN S， HOBBS G， et al. Capecitabine as Maintenance Therapy for High-Risk， Resected Colorectal Cancer［J］. Gastrointest Tumors， 2021， 8（2）： 81-86.

HU H， LIU X， CAI W， et al. A Retrospective Exploration of Targeted Maintenance Therapy in Advanced Colorectal Cancer： Based on the Background of Chinese Patient Assistance Program［J］. Front Oncol， 2020， 10： 522.

ZHANG Y， CHEN Z， LI J. The current status of treatment for colorectal cancer in China： A systematic review［J］. Medicine （Baltimore）， 2017， 96（40）： e8242.

HONG X C， LIANG Q L， LUO X B， et al. Clinical study of XiangShaLiuJunZi decoction combined with S-1 as maintenance therapy for stage Ⅲ or Ⅳ gastric carcinoma and colorectal carcinoma［J］. Medicine （Baltimore）， 2020， 99（19）： e20081.

XU R， LI Y， LUO H. Continuing single agent capecitabin as maintenance therapy after induction of XELOX （or FOLFOX） in first line treatment of metastatic colorectal cancer［J］. J Clin Oncol， 2015， 33（1）： 2580.

SALVATORE L， BRIA E， SPERDUTI I， et al. Bevacizumab as maintenance therapy in patients with metastatic colorectal cancer： A meta-analysis of individual patients' data from 3 phase Ⅲ studies［J］. Cancer Treat Rev， 2021， 97： 102202.

ZHAO L， WANG J， LI H， et al. Meta-analysis comparing maintenance strategies with continuous therapy and complete chemotherapy-free interval strategies in the treatment of metastatic colorectal cancer［J］. Oncotarget， 2016， 7（22）： 33418-33428.

YALCIN S， USLU R， DANE F， et al. Bevacizumab + capecitabine as maintenance therapy after initial bevacizumab + XELOX treatment in previously untreated patients with metastatic colorectal cancer： phase Ⅲ ‘Stop and Go’ study results—a Turkish Oncology Group Trial［J］. Oncology， 2013， 85（6）： 328-335.

ADAMS R A， MEADE A M， MADI A， et al. Toxicity associated with combination oxaliplatin plus fluoropyrimidine with or without cetuximab in the MRC COIN trial experience［J］. Br J Cancer， 2009， 100（2）： 251-258.

PIETRANTONIO F， MORANO F， CORALLO S， et al. Maintenance Therapy With Panitumumab Alone vs Panitumumab Plus Fluorouracil-Leucovorin in Patients With RAS Wild-Type Metastatic Colorectal Cancer： A Phase 2 Randomized Clinical Trial［J］. JAMA Oncol， 2019， 5（9）： 1268-1275.

SHI M， MA T， XI W， et al. A study of capecitabine metronomic chemotherapy is non-inferior to conventional chemotherapy as maintenance strategy in responders after induction therapy in metastatic colorectal cancer［J］. Trials， 2020， 21（1）： 249.

李泓佳，石齐，李文，等. 健脾除湿、祛瘀解毒中药联合化疗对晚期大肠癌的疗效及安全性评估［J］.肿瘤研究与临床， 2016， 28（4）： 256-261.

LI H J， SHI Q， LI W， et al. Efficacy and safety assessment on herbs invigorating spleen and removing dampness， blood stasis and toxin combined with chemotherapy in the treatment of advanced colorectal cancer［J］. Cancer Research and Clinic， 2016， 28（4）： 256-261.

陈文婷，任建琳，侯风刚，等. 健脾补肾复方联合化疗治疗大肠癌患者疗效指标的系统评价［J］. 辽宁中医杂志， 2015， 42（7）： 1162-1166.

CHEN W T， REN J L， HOU F G， et al. Clinical Effects of Colorectal Cancer Patients Receiving Jianpibushen Compound Recipe Combined with Chemotherapy： A Systematic Review［J］. Liaoning Journal of Traditional Chinese Medicine， 2015， 42（7）： 1162-1166.

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