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

cetuximab (CET) or bevacizumab (BV) metastatic colorectal cancer progression-free survival quality of life traditional Chinese medicine

Journal

Frontiers in pharmacology
ISSN: 1663-9812
Titre abrégé: Front Pharmacol
Pays: Switzerland
ID NLM: 101548923

Informations de publication

Date de publication:
2020
Historique:
received: 18 11 2019
accepted: 26 03 2020
entrez: 7 5 2020
pubmed: 7 5 2020
medline: 7 5 2020
Statut: epublish

Résumé

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

Sections du résumé

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

Identifiants

pubmed: 32372960
doi: 10.3389/fphar.2020.00478
pmc: PMC7187887
doi:

Types de publication

Journal Article

Langues

eng

Pagination

478

Informations de copyright

Copyright © 2020 Liu, Wu, Jia, Cai, Wang, Zhou, Ji, Sui, Zeng, Xiao, Liu, Huo, Feng, Deng and Li.

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Auteurs

Ningning Liu (N)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Chaojun Wu (C)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Ru Jia (R)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Guoxiang Cai (G)

Department of Colorectal Cancer Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.

Yan Wang (Y)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Lihong Zhou (L)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Qing Ji (Q)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Hua Sui (H)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Puhua Zeng (P)

Cancer Research Institute, Hunan Academy of Traditional Chinese Medicine, Changsha, China.

Haijuan Xiao (H)

Department of Oncology, Hospital Affiliated to Shaanxi University of Chinese Medicine, Xianyang, China.

Huaimin Liu (H)

Department of Integrated Chinese and Western Medicine, Henan Provincial Cancer Hospital, Affiliated Tumor Hospital of Zhengzhou University, Zhengzhou, China.

Jiege Huo (J)

Department of Oncology, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.

Yuanyuan Feng (Y)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Wanli Deng (W)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Qi Li (Q)

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Academy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Classifications MeSH