Evidence map›Paper›PMID 36627145›Full record

Trial reportJournal for immunotherapy of cancer2023

New prognostic model in patients with advanced urothelial carcinoma treated with second-line immune checkpoint inhibitors.

Aristotelis Bamias, Axel Merseburger, Yohann Loriot, Nicholas James, Ernest Choy, Daniel Castellano, F Lopez-Rios, Fabio Calabrò, Mario Kramer, Guillermo de Velasco and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02928406 (An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
6.7field-weighted citation impact, top 3% of its field
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.

NCT02928406 phase3completednot on this map

An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

TypeinterventionalSponsorHoffmann-La RocheRan2016 to 2022Enrolled1,004ConditionsUrinary Tract CancerArmsAtezolizumab
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

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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

13 authors at 8 institutions in 6 countries.

Aristotelis BamiasSecond Propaedeutic Department of Internal Medicine, National and Kapodistrian University of Athens, Chaidari, Greece abamias@med.uoa.gr.ORCID 0000-0002-5996-7262
Axel MerseburgerUniversity Clinic Schleswig-Holstein-Lubeck, Lübeck, Germany.
Yohann LoriotInstitut Gustave-Roussy, Villejuif, France.
Nicholas JamesRoyal Marsden Hospital NHS Trust, London, UK.
Ernest ChoyCardiff University, Cardiff, UK.
Daniel CastellanoHospital Universitario 12 de Octubre, Madrid, Spain.
F Lopez-RiosHospital Universitario HM Sanchinarro, Madrid, Spain.
Fabio CalabròGU Oncology Unit, San Camillo Forlanini Hospital, Roma, Italy.
Mario KramerUniversity Clinic Schleswig-Holstein-Lubeck, Lübeck, Germany.
Guillermo de VelascoHospital Universitario 12 de Octubre, Madrid, Spain.
Roubini ZakopoulouUniversity of Athens, Athens, Greece.
Kimon TzannisNational and Kapodistrian University of Athens, Athens, Greece.
Cora N SternbergHematology and Oncology Englander Institute for Precision Medicine Weill Cornell Medicine, New York, New York, USA.
National and Kapodistrian University of Athens · GRHospital Universitario 12 De Octubre · ESCardiff University · GBCarlo Forlanini Hospital · ITCornell University · USHospital Universitario HM Sanchinarro · ESInstitut Gustave Roussy · FRRoyal Marsden Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBellmunt Risk Score, based on Eastern Cooperative Oncology Group (ECOG) performance status (PS), hemoglobin levels and presence of liver metastases, is the most established prognostic algorithm for patients with advanced urothelial cancer (aUC) progressing after platinum-based chemotherapy. Nevertheless, existing algorithms may not be sufficient following the introduction of immunotherapy. Our aim was to develop an improved prognostic model in patients receiving second-line atezolizumab for aUC.

methodsPatients with aUC progressing after cisplatin/carboplatin-based chemotherapy and enrolled in the prospective, single-arm, phase IIIb SAUL study were included in this analysis. Patients were treated with 3-weekly atezolizumab 1200 mg intravenously. The development and internal validation of a prognostic model for overall survival (OS) was performed using Cox regression analyses, bootstrapping methods and calibration.

resultsIn 936 patients, ECOG PS, alkaline phosphatase, hemoglobin, neutrophil-to-lymphocyte ratio, liver metastases, bone metastases and time from last chemotherapy were identified as independent prognostic factors. In a 4-tier model, median OS for patients with 0-1, 2, 3-4 and 5-7 risk factors was 18.6, 10.4, 4.8 and 2.1 months, respectively. Compared with Bellmunt Risk Score, this model provided enhanced prognostic separation, with a c-index of 0.725 vs 0.685 and increment in c-statistic of 0.04 (p<0.001). Inclusion of PD-L1 expression did not improve the model.

conclusionsWe developed and internally validated a prognostic model for patients with aUC receiving postplatinum immunotherapy. This model represents an improvement over the Bellmunt algorithm and could aid selection of patients with aUC for second-line immunotherapy. TRIAL REGISTRATION NUMBER: NCT02928406.

Indexed as

Carcinoma, Transitional CellUrinary Bladder NeoplasmsUrologic NeoplasmsHemoglobinsHumansImmune Checkpoint InhibitorsPrognosisProspective StudiesHemoglobinsImmune Checkpoint InhibitorsImmunotherapyUrinary Bladder Neoplasms

Identifiers

PMID36627145
PMCPMC9835946
OpenAlexW4313990830

What OpenQuestion holds

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LicenceCC BY-NC
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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.