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Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

BACKGROUND: Huangci Granule is a traditional Chinese medicine for treating metastatic colorectal cancer (mCRC). OBJECTIVE: To evaluate the efficacy and safety of Huangci Granule combination with chemotherapy and cetuximab (CET) or bevacizumab (BV) for treating mCRC. METHODS: We performed a randomize...

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Autores principales: Liu, Ningning, Wu, Chaojun, Jia, Ru, Cai, Guoxiang, Wang, Yan, Zhou, Lihong, Ji, Qing, Sui, Hua, Zeng, Puhua, Xiao, Haijuan, Liu, Huaimin, Huo, Jiege, Feng, Yuanyuan, Deng, Wanli, Li, Qi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7187887/
https://www.ncbi.nlm.nih.gov/pubmed/32372960
http://dx.doi.org/10.3389/fphar.2020.00478
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author Liu, Ningning
Wu, Chaojun
Jia, Ru
Cai, Guoxiang
Wang, Yan
Zhou, Lihong
Ji, Qing
Sui, Hua
Zeng, Puhua
Xiao, Haijuan
Liu, Huaimin
Huo, Jiege
Feng, Yuanyuan
Deng, Wanli
Li, Qi
author_facet Liu, Ningning
Wu, Chaojun
Jia, Ru
Cai, Guoxiang
Wang, Yan
Zhou, Lihong
Ji, Qing
Sui, Hua
Zeng, Puhua
Xiao, Haijuan
Liu, Huaimin
Huo, Jiege
Feng, Yuanyuan
Deng, Wanli
Li, Qi
author_sort Liu, Ningning
collection PubMed
description BACKGROUND: Huangci Granule is a traditional Chinese medicine for treating metastatic colorectal cancer (mCRC). OBJECTIVE: To evaluate the efficacy and safety of Huangci Granule combination with chemotherapy and cetuximab (CET) or bevacizumab (BV) for treating mCRC. METHODS: We performed a randomized, controlled, and double-blind trial and recruited patients with mCRC who were planned to undergo chemotherapy combined with CET or BV. The treatment group was treated with Huangci Granule, while the control group was treated with placebo. Continuous treatment until disease progression, death, intolerable toxicity or up to 6 months. The primary endpoint was progression-free survival (PFS), and the secondary endpoint was quality of life and safety. RESULT: 320 patients were randomly assigned to receive treatment, including 200 first-line patients and 120 second-line patients. In the first-line treatment, the median PFS was 9.59 months (95% CI, 6.94–13.25) vs 6.89 months (95% CI, 4.99–9.52) in treatment group and control group (HR, 0.69; 95% CI, 0.50–0.97; P = 0.027). Chinese medicine was an independent factor affecting the PFS. In the second-line treatment, the median PFS was 6.51 months (95% CI, 4.49–9.44) vs 4.53 months (95% CI, 3.12–6.57) in the treatment group and control group (HR, 0.65; 95% CI, 0.45–0.95; P = 0.020). Compared with the control group, “role function,” “social function,” “fatigue,” and “appetite loss” were significantly improved in the treatment (P < 0.05) and drug related grades 3 to 4 adverse events were less. CONCLUSION: Huangci Granule combined with chemotherapy and CET or BV can prolong the PFS of mCRC, improve the quality of life, reduce adverse reactions, and have good safety.
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spelling pubmed-71878872020-05-05 Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Liu, Ningning Wu, Chaojun Jia, Ru Cai, Guoxiang Wang, Yan Zhou, Lihong Ji, Qing Sui, Hua Zeng, Puhua Xiao, Haijuan Liu, Huaimin Huo, Jiege Feng, Yuanyuan Deng, Wanli Li, Qi Front Pharmacol Pharmacology BACKGROUND: Huangci Granule is a traditional Chinese medicine for treating metastatic colorectal cancer (mCRC). OBJECTIVE: To evaluate the efficacy and safety of Huangci Granule combination with chemotherapy and cetuximab (CET) or bevacizumab (BV) for treating mCRC. METHODS: We performed a randomized, controlled, and double-blind trial and recruited patients with mCRC who were planned to undergo chemotherapy combined with CET or BV. The treatment group was treated with Huangci Granule, while the control group was treated with placebo. Continuous treatment until disease progression, death, intolerable toxicity or up to 6 months. The primary endpoint was progression-free survival (PFS), and the secondary endpoint was quality of life and safety. RESULT: 320 patients were randomly assigned to receive treatment, including 200 first-line patients and 120 second-line patients. In the first-line treatment, the median PFS was 9.59 months (95% CI, 6.94–13.25) vs 6.89 months (95% CI, 4.99–9.52) in treatment group and control group (HR, 0.69; 95% CI, 0.50–0.97; P = 0.027). Chinese medicine was an independent factor affecting the PFS. In the second-line treatment, the median PFS was 6.51 months (95% CI, 4.49–9.44) vs 4.53 months (95% CI, 3.12–6.57) in the treatment group and control group (HR, 0.65; 95% CI, 0.45–0.95; P = 0.020). Compared with the control group, “role function,” “social function,” “fatigue,” and “appetite loss” were significantly improved in the treatment (P < 0.05) and drug related grades 3 to 4 adverse events were less. CONCLUSION: Huangci Granule combined with chemotherapy and CET or BV can prolong the PFS of mCRC, improve the quality of life, reduce adverse reactions, and have good safety. Frontiers Media S.A. 2020-04-21 /pmc/articles/PMC7187887/ /pubmed/32372960 http://dx.doi.org/10.3389/fphar.2020.00478 Text en Copyright © 2020 Liu, Wu, Jia, Cai, Wang, Zhou, Ji, Sui, Zeng, Xiao, Liu, Huo, Feng, Deng and Li http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Liu, Ningning
Wu, Chaojun
Jia, Ru
Cai, Guoxiang
Wang, Yan
Zhou, Lihong
Ji, Qing
Sui, Hua
Zeng, Puhua
Xiao, Haijuan
Liu, Huaimin
Huo, Jiege
Feng, Yuanyuan
Deng, Wanli
Li, Qi
Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_fullStr Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full_unstemmed Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_short Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_sort traditional chinese medicine combined with chemotherapy and cetuximab or bevacizumab for metastatic colorectal cancer: a randomized, double-blind, placebo-controlled clinical trial
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7187887/
https://www.ncbi.nlm.nih.gov/pubmed/32372960
http://dx.doi.org/10.3389/fphar.2020.00478
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