Evidence map›Paper›PMID 42366316›Full record

SynthesisClinical & experimental metastasis2026

Safety evaluation of TOPAZ-1 and KEYNOTE-966 regimens in metastatic biliary tract cancer: a systematic review and meta-analysis.

Elsa Vitale, Lorenza Maistrello, Francesco Ciccimarra, Deniz Can Guven, Taha Koray Sahin, Fernando Sabino Marques Monteiro, Raffaele de Luca, Matteo Scaramuzzi, Sabina Delcuratolo, Oronzo Brunetti and 2 more

Abstract readSystematic ReviewMeta-AnalysisReview
PubMed Publisher
In one paragraph

Synthesis in Clinical & experimental metastasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Elsa VitaleDirectorate of Health Professions and Nursing, ASL Bari, Bari, Italy.
Lorenza MaistrelloIRCCS San Camillo Hospital, Venice, Italy.
Francesco CiccimarraS.S.D. C.O.r.O. Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124, Bari, Italy.
Deniz Can GuvenDepartment of Medical Oncology, Hacettepe University, Ankara, Turkey.
Taha Koray SahinDepartment of Medical Oncology, Hacettepe University, Ankara, Turkey.
Fernando Sabino Marques MonteiroHospital Israelita Albert Einstein, São Paulo, SP, Brazil.
Raffaele de LucaHepato-Biliary-Pancreatic and Robotic Surgery Unit, Department of Surgical Oncology, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Matteo ScaramuzziHepato-Biliary-Pancreatic and Robotic Surgery Unit, Department of Surgical Oncology, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Sabina DelcuratoloScientific Directorate, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Oronzo BrunettiS.S.D. C.O.r.O. Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124, Bari, Italy.
Alessandro RizzoS.S.D. C.O.r.O. Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124, Bari, Italy. rizzo.alessandro179@gmail.com.
Giovanni BrandiDepartment of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The addition of immunotherapy to chemotherapy has improved prognosis of metastatic biliary tract cancer (BTC). The present systematic review aimed to assess frequency of treatment-emergent adverse events (TEAEs) among metastatic BTC patients receiving first-line immune checkpoint inhibitors (ICIs) plus chemotherapy in the two practice-changing TOPAZ-1 and KEYNOTE-966 clinical trials. The present systematic review and meta-analysis was recorded in the PROSPERO register with no. CRD420251137398. Incidence of TEAEs in patients receiving ICIs plus chemotherapy and in patients treated with placebo plus chemotherapy was collected. A total of two studies were included in these analyses including 1754 patients, comprising 1743 observations and 193 events for Grade 1/2 and 650 events for Grade ≥ 3. The risk of several TEAEs did not significantly differ between patients receiving chemoimmunotherapy versus those treated with chemotherapy alone. The present meta-analysis further confirms the tolerable safety profile of TOPAZ-1 and KEYNOTE-966 regimens as first-line therapy in advanced BTC. Future research should focus on identifying risk factors for TEAEs and develop prophylactic strategies to mitigate this risk without blunting antitumor efficacy. By improving our understanding and management of TEAEs, we might maximize the clinical benefits of ICIs and minimize harm, ultimately enhance clinical outcomes for BTC patients.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsImmune Checkpoint InhibitorsHumansNeoplasm MetastasisImmune Checkpoint InhibitorsBiliary tract cancerChemotherapyCholangiocarcinomaImmune checkpoint inhibitorsMeta-analysisSafetySystematic review

Identifiers

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Registered trials

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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.