Evidence map›Paper›PMID 33231726›Full record

Observational studyCancer immunology, immunotherapy : CII2021

Blood serum amyloid A as potential biomarker of pembrolizumab efficacy for patients affected by advanced non-small cell lung cancer overexpressing PD-L1: results of the exploratory "FoRECATT" study.

Vincenzo Di Noia, Ettore D'Argento, Sara Pilotto, Emanuele Vita, Miriam Grazia Ferrara, Paola Damiano, Marta Ribelli, Antonella Cannella, Antonella Virtuoso, Andrea Fattorossi and 5 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Cancer immunology, immunotherapy : CII, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% 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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 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

15 authors at 4 institutions in 1 country.

Vincenzo Di NoiaMedical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy. vincenzo.dinoia@gavazzeni.it.ORCID http://orcid.org/0000-0003-2009-5791
Ettore D'ArgentoComprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy.
Sara PilottoU.O.C. of Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy.
Emanuele VitaMedical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Miriam Grazia FerraraMedical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Paola DamianoMedical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Marta RibelliMedical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Antonella CannellaMedical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Antonella VirtuosoMedical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Andrea FattorossiDepartment of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Giovanni Luca CeresoliDepartment of Medical Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy.
Michele MilellaU.O.C. of Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy.
Giordano Domenico BerettaDepartment of Medical Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy.
Giampaolo Tortora *Medical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Emilio Bria *Medical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.
Università Cattolica del Sacro Cuore · ITAgostino Gemelli University Polyclinic · ITHumanitas Gavazzeni · ITUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIdentifying the patients who may benefit the most from immune checkpoints inhibitors remains a great challenge for clinicians. Here we investigate on blood serum amyloid A (SAA) as biomarker of response to upfront pembrolizumab in patients with advanced non-small-cell lung cancer (NSCLC).

methodsPatients with PD-L1 ≥ 50% receiving upfront pembrolizumab (P cohort) and with PD-L1 0-49% treated with chemotherapy (CT cohort) were evaluated for blood SAA and radiological response at baseline and every 9 weeks. Endpoints were response rate (RR) according to RECIST1.1, progression-free (PFS) and overall survival (OS). The most accurate SAA cut-off to predict response was established with ROC analysis in the P cohort.

resultsIn the P Cohort (n = 42), the overall RR was 38%. After a median follow-up of 18.5 months (mo), baseline SAA ≤ the ROC-derived cut-off (29.9 mg/L; n = 28/42.67%) was significantly associated with higher RR (53.6 versus 7.1%; OR15, 95% CI 1.72-130.7, p = 0.009), longer PFS (17.4 versus 2.1 mo; p < 0.0001) and OS (not reached versus 7.2mo; p < 0.0001) compared with SAA > 29.9 mg/L. In multivariate analysis, low SAA positively affects PFS (p = 0.001) and OS (p = 0.048) irrespective of ECOG PS, number of metastatic sites and pleural effusion. SAA monitoring (n = 40) was also significantly associated with survival endpoints: median PFS 17.4 versus 2.1 mo and median OS not reached versus 7.2 mo when SAA remained low (n = 14) and high (n = 12), respectively. In the CT Cohort (n = 30), RR was not affected by SAA level (p > 0.05) while low SAA at baseline (n = 17) was associated with better PFS (HR 0.38, 95% CI 0.16-0.90, p = 0.006) and OS (HR 0.25, 95% CI 0.09-0.67, p < 0.001).

conclusionLow SAA predicts good survival outcomes irrespective of treatment for advanced NSCLC patients and higher likelihood of response to upfront pembrolizumab only. The strong prognostic value might be exploited to easily identify patients most likely to benefit from immunotherapy. A further study (FoRECATT-2) is ongoing to confirm results in a larger sample size and to investigate the effect of SAA on immune response in vitro assays.

Indexed as

Adenocarcinoma of LungAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCase-Control StudiesFemaleFollow-Up StudiesHumansLung NeoplasmsMaleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCD274 protein, humanpembrolizumabSAA1 protein, humanSerum Amyloid A ProteinBiomarker of responseNSCLCPembrolizumabPredictive/prognostic factors to immune-checkpoint inhibitorsSerum amyloid A

Identifiers

PMID33231726
PMCPMC8139913
OpenAlexW3108179194

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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.