Evidence map›Paper›PMID 33984672›Full record

Trial reportESMO open2021

SAUL, a single-arm study of atezolizumab for chemotherapy-pretreated locally advanced or metastatic carcinoma of the urinary tract: outcomes by key baseline factors, PD-L1 expression and prior platinum therapy.

A Bamias, A S Merseburger, Y Loriot, N James, E Choy, D Castellano, F Lopez-Rios, F Calabrò, M Kramer, G de Velasco and 3 more

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

Trial report in ESMO open, 2021. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.5field-weighted citation impact, top 19% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. 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

13 authors at 9 institutions in 7 countries.

A BamiasSecond Propaedeutic Department of Internal Medicine, ATTIKON University Hospital, National & Kapodistrian University of Athens, Athens, Greece. Electronic address: abamias@med.uoa.gr.
A S MerseburgerDepartment of Urology, University Clinic Schleswig-Holstein-Lu¨beck, Lu¨beck, Germany.
Y LoriotDepartment of Cancer Medicine, Institut Gustave Roussy, Villejuif, France.
N JamesInstitute of Cancer Research, The Royal Marsden Hospital NHS Foundation Trust, London.
E ChoyCREATE Centre, Division of Infection and Immunity, Cardiff University, Cardiff, UK.
D CastellanoMedical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
F Lopez-RiosPathology Laboratory of Therapeutic Targets, HM Sanchinarro University Hospital, Madrid, Spain.
F CalabròGU Oncology Unit, San Camillo and Forlanini Hospital, Rome, Italy.
M KramerDepartment of Urology, University Clinic Schleswig-Holstein-Lu¨beck, Lu¨beck, Germany.
G de VelascoMedical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
R ZakopoulouClinical Therapeutics, University of Athens, Athens, Greece.
K TzannisSecond Propaedeutic Department of Internal Medicine, ATTIKON University Hospital, National & Kapodistrian University of Athens, Athens, Greece.
C N SternbergEnglander Institute for Precision Medicine, Department of Medical Oncology, Weill Cornell Medicine, Meyer Cancer Center, New York, USA.
National and Kapodistrian University of Athens · GRHospital Universitario 12 De Octubre · ESUniversity of Lübeck · DECardiff University · GBCarlo Forlanini Hospital · ITHospital Universitario HM Sanchinarro · ESInstitut Gustave Roussy · FRRoyal Marsden Hospital · GBWeill Cornell Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe impact of pretreatment factors on immune checkpoint inhibition in platinum-refractory advanced urothelial cancer (aUC) deserves further evaluation. The aim was to study the association of Bellmunt risk factors, time from last chemotherapy (TFLC), previous therapy and PD-L1 expression with atezolizumab efficacy in platinum-refractory aUC. PATIENTS AND

methodsThis was a post-hoc analysis of patients who had received prior cisplatin or carboplatin in the prospective, single-arm, phase IIIb SAUL study (NCT02928406). Patients were treated with 3-weekly atezolizumab 1200 mg intravenously. The primary outcome was overall survival (OS). Relationships were analysed using Cox regression and long-rank test.

resultsOf 997 patients in SAUL, 969 were eligible for this analysis. The number of Bellmunt risk factors was associated with OS (P < 0.001); median OS (mOS) for 0, 1 and 2-3 risk factors was 17.9, 8.9 and 3.3 months, respectively. Significant associations were also observed between OS and TFLC (P < 0.001), programmed death-ligand 1 (PD-L1) expression (P = 0.002), and prior perioperative chemotherapy (P = 0.013); mOS was 6.97 versus 11.63 months for TFLC ≤6 versus >6 months, 7.75 versus 11.6 months for PD-L1 expression on <1% of tumour-infiltrating immune cells (ICs) (IC0)/expression on 1% to <5% of tumour-infiltrating ICs (IC1) versus expression on ≥5% of tumour-infiltrating ICs (IC2/3) and 10.2 versus 7.8 months for prior versus no prior perioperative chemotherapy, respectively. The type of platinum compound and number of previous treatment lines were not associated with outcomes.

conclusionsPost-platinum atezolizumab is active in aUC, irrespective of previous platinum compound and lines of therapy. Bellmunt risk stratification, PD-L1 expression, TFLC and perioperative chemotherapy were identified as prognostic factors for OS with second-line atezolizumab, indicating the need for novel prognostic signatures for immunotherapy-treated patients with aUC.

Indexed as

Carcinoma, Transitional CellUrinary TractAntibodies, Monoclonal, HumanizedB7-H1 AntigenHumansPlatinumProspective StudiesAntibodies, Monoclonal, HumanizedatezolizumabB7-H1 AntigenPlatinumbladder cancerimmunotherapyPD-L1platinumprognostic factorsurothelial carcinoma

Identifiers

PMID33984672
PMCPMC8134736
OpenAlexW3163490080

What OpenQuestion holds

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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.