Evidence map›Paper›PMID 33747930›Full record

ArticleFrontiers in oncology2021

Effect of PRM1201 Combined With Adjuvant Chemotherapy on Preventing Recurrence and Metastasis of Stage III Colon Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Ru Jia, Ningning Liu, Guoxiang Cai, Yun Zhang, Haijuan Xiao, Lihong Zhou, Qing Ji, Ling Zhao, Puhua Zeng, Huaimin Liu and 15 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Ru JiaDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Ningning LiuDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Guoxiang CaiDepartment of Colorectal Cancer Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Yun ZhangDepartment of Gastrointestinal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Haijuan XiaoDepartment of Oncology, Hospital Affiliated to Shaanxi University of Chinese Medicine, Xianyang, China.
Lihong ZhouDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Qing JiDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Ling ZhaoAcademy of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Puhua ZengDepartment of Medical Oncology, Hunan University of Chinese Medicine Integrated Chinese and Western Medicine Affiliated Hospital, Changsha, China.
Huaimin LiuDepartment of Integrated Chinese and Western Medicine, Henan Cancer Hospital, Zhengzhou, China.
Jiege HuoDepartment of Oncology, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
Xiaoqiang YueDepartment of Traditional Chinese Medicine, Changzheng Hospital, Naval Medical University, Shanghai, China.
Yi ZhangDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Chaojun WuDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Xiaoting SunDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Yuanyuan FengDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Hongjie LiuDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Hui LiuDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Zhifen HanDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Youying LaiDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Yanbo ZhangDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Gang HanDepartment of Gastrointestinal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Hangjun GongDepartment of Gastrointestinal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Yan WangDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Qi LiDepartment of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemotherapy is the standard adjuvant treatment for colon cancer. Chinese herbal formula PRM1201 improves the efficacy of chemotherapy when used in combination with Cetuximab or Bevacizumab in patients with metastatic colorectal cancer. This study aims to explore the benefits of treatment with chemotherapy plus PRM1201 in the postoperative adjuvant setting.

methodsIn this parallel-group study, patients who had undergone curative resection for stage III colon cancer were randomly assigned to receive adjuvant chemotherapy (FOLFOX q2w for 6 months, or CapeOx q3w for 6 months) plus PRM1201 (chemo+PRM1201 group) or adjuvant chemotherapy plus placebo (chemo+placebo group). The primary endpoint was disease-free survival (DFS), and the secondary endpoints were quality of life (QOL) and toxicity.

resultsA total of 370 patients were randomly assigned to chemotherapy plus PRM1201 group (n = 184) and chemotherapy plus placebo group (n = 186). Up to October 30, 2019, 96 events of recurrence, metastasis, or death had been reported, of which 38 events were in the group of chemotherapy plus PRM1201 and 58 events in the chemo+placebo group. The 3-year DFS rate was 77.1 and 68.6% in the chemo+PRM1201 and chemo+placebo group, respectively (hazard ratio [HR], 0.63; 95% CI, 0.42 to 0.94). The QOL of patients in the chemo+PRM1201 group were significantly improved in terms of global quality of life, physical functioning, role functioning, emotional functioning, fatigue, and appetite loss. The incidence of grade 3 or 4 treatment-related adverse event (TRAEs) were similar between the two arms.

conclusionsChemotherapy in combination with PRM1201 improved the adjuvant treatment of colon cancer. PRM1201 can be recommended as an effective option in clinical practice. CLINICAL

trial registrationChinese Clinical Trials Registry, identifier ChiCTR-IOR-16007719.

Indexed as

cancer recurrence and metastasisChinese herbal medicineclinical trialcolon cancerdisease-free survival

Identifiers

PMID33747930
PMCPMC7968418

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