Evidence map›Paper›PMID 40495210›Full record

SynthesisWorld journal of surgical oncology2025

PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone as the first line treatment for advanced biliary tract cancer: a pooled analysis of KEYNOTE-966 and TOPAZ-1 trails.

Jiashou Wang, Yun Xu, Bo Hong, Qingjian Hou, Wenying Chen, Wenxiong Zhang, Wen Zheng

Abstract readMeta-AnalysisComparative StudyReview
In one paragraph

Synthesis in World journal of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 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.

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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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

7 authors.

Jiashou WangDepartment of Interventional Diagnosis and Treatment, Shangrao People's Hospital, Shangrao, 334000, China.
Yun XuDepartment of Oncology, Shangrao People's Hospital, No. 86 Shuyuan Road, Xinzhou District, Shangrao, 334000, China.
Bo HongDepartment of General Surgery, Shangrao People's Hospital, Shangrao, 334000, China.
Qingjian HouDepartment of Oncology, Shangrao People's Hospital, No. 86 Shuyuan Road, Xinzhou District, Shangrao, 334000, China.
Wenying ChenDepartment of Oncology, Shangrao People's Hospital, No. 86 Shuyuan Road, Xinzhou District, Shangrao, 334000, China.
Wenxiong ZhangDepartment of Thoracic Surgery, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, 330006, China.
Wen ZhengDepartment of Oncology, Shangrao People's Hospital, No. 86 Shuyuan Road, Xinzhou District, Shangrao, 334000, China. Zhengwen_1150@163.com.

Funding

Science and Technology Plan Project of Jiangxi Provincial Health Commission 202410952
6 · The paper itself

Abstract

backgroundThe efficacy of PD-1/PD-L1 inhibitors plus chemotherapy (PIC) as a first-line treatment for advanced biliary tract cancer (BTC) remains controversial, given inconsistent findings regarding survival benefits and safety concerns. This meta-analysis systematically evaluates the safety and efficacy of PIC versus chemotherapy alone, aiming to provide more definitive guidance for BTC treatment decisions.

methodsTo identify phase 3 randomized controlled trials (RCTs) comparing PIC with chemotherapy alone in patients with advanced BTC, a comprehensive literature search was conducted across six databases. Primary outcomes were overall survival (OS) and progression-free survival (PFS), while secondary outcomes included response rates and adverse events (AEs).

resultsTwo phase 3 RCTs (KEYNOTE-966 and TOPAZ-1) involving 1,754 patients met the inclusion criteria. Findings demonstrated that the PIC group had significantly improved OS (hazard ratio [HR]: 0.76 [0.66, 0.87]) and PFS (HR: 0.76 [0.66, 0.87]). The mOS (MD: 1.70 [1.51, 1.90] months) and mPFS (MD: 1.20 [0.61, 1.79] months) were also higher in the PIC group. OS and PFS advantages for the PIC group were confirmed across most subgroups. In the first two years of treatment, survival rates (OS and PFS) and extended duration of response in the PIC group increased over time. Both groups showed comparable total AEs, treatment-related AEs, ORR, and DCR. However, the PIC group had significantly higher rates of immune-related AEs (irAEs) and grade 3-5 irAEs.

conclusionsPIC is associated with improved OS and PFS in advanced BTC compared to chemotherapy alone, though the elevated risk of irAEs calls for careful monitoring.

trial registrationPROSPERO ID: CRD42024611835. PROSPERO link:  https://www.crd.york.ac.uk/PROSPERO/view/CRD42024611835 .

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiliary Tract NeoplasmsImmune Checkpoint InhibitorsProgrammed Cell Death 1 ReceptorClinical Trials, Phase III as TopicHumansPrognosisProgression-Free SurvivalRandomized Controlled Trials as TopicSurvival RateB7-H1 AntigenCD274 protein, humanImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 ReceptorBiliary tract cancerChemotherapyMeta-analysisPD-1/PD-L1 inhibitorsRandomized controlled trials

Identifiers

PMID40495210
PMCPMC12150578

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.