Evidence map›Paper›PMID 32474768›Full record

ArticleCancer immunology, immunotherapy : CII2020

Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50.

Alessio Cortellini, Marcello Tiseo, Giuseppe L Banna, Federico Cappuzzo, Joachim G J V Aerts, Fausto Barbieri, Raffaele Giusti, Emilio Bria, Diego Cortinovis, Francesco Grossi and 60 more

Open access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 6 pooled it
5.4field-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.

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

70 citing papers in PubMed, 6 syntheses or guidelines pooled it, 88 citations in OpenAlex.

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10 more citing papers are in PubMed but not listed here.

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

70 authors at 20 institutions in 5 countries.

Alessio CortelliniMedical Oncology, St. Salvatore Hospital, L'Aquila, Italy. alessiocortellini@gmail.com.ORCID http://orcid.org/0000-0002-1209-5735
Marcello TiseoMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Giuseppe L BannaOncology Department, United Lincolnshire Hospital NHS Trust, Lincoln, UK.
Federico CappuzzoDepartment of Oncology and Hematology, AUSL Romagna, Ravenna, Italy.
Joachim G J V AertsDepartment of Pulmonary Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.
Fausto BarbieriDepartment of Oncology and Hematology, Modena University Hospital, Modena, Italy.
Raffaele GiustiMedical Oncology Unit, Sant' Andrea Hospital fo Rome, Rome, Italy.
Emilio BriaComprehensive Cancer Center, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
Diego CortinovisMedical Oncology, Ospedale San Gerardo, Monza, Italy.
Francesco GrossiMedical Oncology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Maria R MigliorinoPneumo-Oncology Unit, St. Camillo-Forlanini Hospital, Rome, Italy.
Domenico GalettaThoracic Oncology Unit, Clinical Cancer Center, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Francesco PassigliaDepartment of Oncology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, TO, Italy.
Daniele SantiniMedical Oncology, Campus Bio-Medico University, Rome, Italy.
Rossana BerardiOncology Clinic, Ospedali Riuniti Di Ancona, Università Politecnica Delle Marche, Ancona, Italy.
Alessandro MorabitoThoracic Medical Oncology, Istituto Nazionale Tumori 'Fondazione G Pascale', IRCCS, Naples, Italy.
Carlo GenovaLung Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Francesca MazzoniDepartment of Oncology, Careggi University Hospital, Florence, Italy.
Vincenzo Di NoiaMedical Oncology, University Hospital of Foggia, Foggia, Italy.
Diego SignorelliDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Alessandro TuziMedical Oncology, ASST-Sette Laghi, Varese, Italy.
Alain GelibterMedical Oncology (B), Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Paolo MarchettiMedical Oncology Unit, Sant' Andrea Hospital fo Rome, Rome, Italy.
Marianna MacerelliDepartment of Oncology, University Hospital Santa Maria Della Misericordia, Udine, Italy.
Francesca RastelliMedical Oncology, Fermo Area Vasta 4, Fermo, Italy.
Rita ChiariMedical Oncology, Ospedali Riuniti Padova Sud "Madre Teresa Di Calcutta", Monselice, Italy.
Danilo RoccoPneumo-Oncology Unit, Monaldi Hospital, Naples, Italy.
Stefania GoriOncology Unit, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, VR, Italy.
Michele De TursiDepartment of Medical, Oral and Biotechnological Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.
Giovanni MansuetoMedical Oncology, F. Spaziani Hospital, Frosinone, Italy.
Federica ZorattoMedical Oncology, Santa Maria Goretti Hospital, Latina, Italy.
Matteo SantoniDepartment of Oncology, Macerata Hospital, Macerata, Italy.
Marianna TudiniMedical Oncology, AV2 Fabriano ASUR Marche, Fabriano, Italy.
Erika RijavecMedical Oncology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Marco FilettiMedical Oncology Unit, Sant' Andrea Hospital fo Rome, Rome, Italy.
Annamaria CatinoThoracic Oncology Unit, Clinical Cancer Center, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Pamela PizzutiloThoracic Oncology Unit, Clinical Cancer Center, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Luca SalaMedical Oncology, Ospedale San Gerardo, Monza, Italy.
Fabrizio CitarellaMedical Oncology, Campus Bio-Medico University, Rome, Italy.
Russano MarcoMedical Oncology, Campus Bio-Medico University, Rome, Italy.
Mariangela TorniaiOncology Clinic, Ospedali Riuniti Di Ancona, Università Politecnica Delle Marche, Ancona, Italy.
Luca CantiniDepartment of Pulmonary Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.
Giada TargatoDepartment of Oncology, University Hospital Santa Maria Della Misericordia, Udine, Italy.
Vincenzo SforzaThoracic Medical Oncology, Istituto Nazionale Tumori 'Fondazione G Pascale', IRCCS, Naples, Italy.
Olga NigroMedical Oncology, ASST-Sette Laghi, Varese, Italy.
Miriam G FerraraComprehensive Cancer Center, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
Ettore D'ArgentoComprehensive Cancer Center, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
Sebastiano ButiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Paola BordiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Lorenzo AntonuzzoDepartment of Oncology, Careggi University Hospital, Florence, Italy.
Simona ScodesDepartment of Oncology and Hematology, AUSL Romagna, Ravenna, Italy.
Lorenza LandiDepartment of Oncology and Hematology, AUSL Romagna, Ravenna, Italy.
Giorgia GuaitoliDepartment of Oncology and Hematology, Modena University Hospital, Modena, Italy.
Cinzia BaldessariDepartment of Oncology and Hematology, Modena University Hospital, Modena, Italy.
Luigi Della GravaraPneumo-Oncology Unit, Monaldi Hospital, Naples, Italy.
Maria Giovanna Dal BelloLung Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Robert A BelderbosDepartment of Pulmonary Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.
Paolo BironzoDepartment of Oncology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, TO, Italy.
Simona CarnioDepartment of Oncology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, TO, Italy.
Serena RicciardiPneumo-Oncology Unit, St. Camillo-Forlanini Hospital, Rome, Italy.
Alessio GriecoPneumo-Oncology Unit, St. Camillo-Forlanini Hospital, Rome, Italy.
Alessandro De TomaDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Claudia ProtoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Alex FriedlaenderOncology Department, University Hospital of Geneva, Geneva, Switzerland.
Ornella CantaleOncology Department, United Lincolnshire Hospital NHS Trust, Lincoln, UK.
Biagio RicciutiDana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Alfredo AddeoOncology Department, University Hospital of Geneva, Geneva, Switzerland.
Giulio MetroDepartment of Medical Oncology, Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia, Perugia, Italy.
Corrado FicorellaMedical Oncology, St. Salvatore Hospital, L'Aquila, Italy.
Giampiero PorzioMedical Oncology, St. Salvatore Hospital, L'Aquila, Italy.
Azienda Unità Sanitaria Locale Della Romagna · ITCarlo Forlanini Hospital · ITErasmus MC · NLFondazione IRCCS Istituto Nazionale dei Tumori · ITIstituto Tumori Bari · ITOspedale San Luigi Gonzaga · ITUniversità Campus Bio-Medico · ITUniversity of L'Aquila · ITUniversity of Modena and Reggio Emilia · ITUniversity of Parma · ITAzienda Ospedaliera San Gerardo · ITAzienda Ospedaliero-Universitaria Careggi · ITCTO Andrea Alesini · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITOspedale Monaldi · ITOspedale Policlinico San Martino · ITOspedale Santa Maria della Misericordia di Udine · ITPoliclinico Umberto I · ITUnited Lincolnshire Hospitals NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSingle-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%.

methodsWe conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%.

resultsOne thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2-49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9-9.5; 599 events) and 17.2 months (95% CI 15.3-22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis.

conclusionPembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effectiveness in clinical subgroups, such as patients with poorer PS and with liver/bone metastases, still remain to be addressed. We confirmed that the absence of tobacco exposure, and the presence of bone and liver metastasis are associated with worse clinical outcomes to pembrolizumab. Increasing levels of PD-L1 expression may help identifying a subset of patients who derive a greater benefit from pembrolizumab monotherapy.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedProgression-Free SurvivalRetrospective StudiesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanpembrolizumabBone metastasesLiver metastasesPD-L1Performance statusRadiotherapySmoking status

Identifiers

PMID32474768
PMCPMC11027629
OpenAlexW3029424640

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