Evidence map›Paper›PMID 30774373›Full record

ArticleOncoTargets and therapy2019

Efficacy and safety of nivolumab for metastatic biliary tract cancer.

Miaomiao Gou, Yong Zhang, Haiyan Si, Guanghai Dai

Registry-linked trialAbstract read
In one paragraph

Article in OncoTargets and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03982680 (Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma), which is not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
–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.

NCT03982680 phase2unknown statusnot on this map

Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma

TypeinterventionalSponsorJiangmen Central HospitalRan2019 to 2021Enrolled30ConditionsAdvanced CholangiocarcinomaArmsToripalimab, Gemcitabine, 5- fluorine pyrimidine
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  10. The microbiome, gastrointestinal cancer, and immunotherapy.Journal of gastroenterology and hepatology · 2022
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  17. Targeting cancer stem cells in cholangiocarcinoma (Review).International journal of oncology · 2020
    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

4 authors.

Miaomiao GouDepartment of Medical Oncology, Chinese People's Liberation Army General Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.
Yong ZhangDepartment of Medical Oncology, Chinese People's Liberation Army General Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.
Haiyan SiDepartment of Medical Oncology, Chinese People's Liberation Army General Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.
Guanghai DaiDepartment of Medical Oncology, Chinese People's Liberation Army General Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePD-1 inhibitors have improved efficacy in many cancers. There are currently no reports of the use of PD-1 inhibitors, such as nivolumab, for metastatic biliary tract cancer (mBTC). This study reviewed the efficacy and safety of nivolumab for mBTC with the aim of exploring ways to improve efficacy and survival.

methodsThirty patients with mBTC were voluntarily treated with nivolumab at the PLA General Hospital. Nivolumab 3 mg/kg was administered. Progression-free survival (PFS) and overall survival were evaluated by Kaplan-Meier and univariate and multivariate analyses were carried out for clinical characteristics. Objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (AEs) were also evaluated.

resultsThe median treatment cycle is four cycles. One case was complete response, 5 cases partial response, 12 cases stable, and 12 cases progression. ORR was 20%, DCR was 60%, and PFS was 3.1 months (95% CI: 2.13-4.06). The AEs of nivolumab monotherapy were fatigue (three cases), fever (two cases), hypothyroidism (one case), skin reaction (one case), and liver injury (one case). Nivolumab combined with chemotherapy related grade 1-2 hematologic toxicity were leukopenia (five cases) and thrombocytopenia (two cases), and grade 3-4 were leukopenia (three cases). Non-hematologic toxicity grade 1-2 were nausea and vomiting (four cases), fatigue (four cases), fever (three cases), peripheral neurotoxicity (three cases), and hypothyroidism (one case). Univariate analysis showed that PFS of nivolumab combined with chemotherapy was statistically significant compared with that of nivolumab monotherapy (4.1 vs 2.3 months,

conclusionThe safety of nivolumab in mBTC is controllable. Further selection of superior populations is needed to improve the efficacy of nivolumab in mBTC.

Indexed as

metastatic biliary tract cancernivolumabPD-1PD-L1

Identifiers

PMID30774373
PMCPMC6355165

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.