Evidence map›Paper›PMID 33676426›Full record

Observational studyBMC cancer2021

Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group.

Mariano Provencio, Josefa Terrasa, Pilar Garrido, Rosario García Campelo, Francisco Aparisi, Pilar Diz, David Aguiar, Carlos García-Giron, Julia Hidalgo, Carlos Aguado and 21 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03790397 (A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT03790397 completednot on this map

A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain

TypeobservationalSponsorFundación GECPRan2019 to 2020Enrolled169ConditionsNon Small Cell Lung CancerArmsOsimertinib
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Real-world clinical experience with osimertinib in advanced EGFR-mutated non-small cell lung cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Observational
  3. Article
  4. Review
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  6. Review
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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

31 authors at 20 institutions in 1 country.

Mariano ProvencioMedical Oncology Department, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain. mprovenciop@gmail.com.ORCID https://orcid.org/0000-0001-9053-9197
Josefa TerrasaMedical Oncology Department, Hospital Universitari Son Espases, Islas Balears, Palma de Mallorca, Spain.
Pilar GarridoMedical Oncology Department, IRYCIS Hospital Universitario Ramón y Cajal, Madrid, Spain.
Rosario García CampeloMedical Oncology Department, Hospital Universitario A Coruña, A Coruña, Spain.
Francisco AparisiMedical Oncology Department Valencia, Hospital General Universitario de Valencia, Madrid, Spain.
Pilar DizMedical Oncology Department León, Complejo Asistencial Universitario de León, Madrid, Spain.
David AguiarMedical Oncology Department, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de GC, Spain.
Carlos García-GironMedical Oncology Department, Hospital Universitario De Burgos, Burgos, Spain.
Julia HidalgoMedical Oncology Department, Hospital Lluís Alcanyis, Xátiva, Valencia, Spain.
Carlos AguadoMedical Oncology Department, Hospital Clínico San Carlos, Madrid, Spain.
Jorge García GonzálezMedical Oncology Department Santiago de Compostela, Hospital Clínico Universitario de Santiago, Madrid, Spain.
Emilio EstebanMedical Oncology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
Lorenzo Gómez-AldavaríMedical Oncology Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
Teresa MoranInstitut Català d'Oncologia Badalona, Medical Oncology Department, Badalona, Barcelona, Spain.
Oscar JuanMedical Oncology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
Luís Enrique CharaMedical Oncology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain.
Juan L MartiMedical Oncology Department, Hospital General Universitario de Alicante, Alicante, Spain.
Rafael López CastroMedical Oncology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
Ana Laura OrtegaMedical Oncology Department, Complejo Hospitalario de Jaen, Jaen, Spain.
Elia Martínez MorenoMedical Oncology Department, Hospital Virgen de la Salud, Toledo, Spain.
Juan CovesMedical Oncology Department, Hospital Son Llàtzer, Palma de Mallorca, Spain.
Ana M Sánchez PeñaMedical Oncology Department, Hospital Universitario de Getafe, Getafe, Madrid, Spain.
Joaquim Bosch-BarreraDepartment of Oncology, Catalan Institute of Oncology. Dr. Josep Trueta University Hospital, Girona, Spain.
Amparo Sánchez GastaldoMedical Oncology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Natalia Fernández NúñezMedical Oncology Department, Hospital Universitario Lucus Augusti, Lugo, Spain.
Edel Del BarcoMedical Oncology Department, Hospital Universitario de Salamanca, Salamanca, Spain.
Manuel CoboHospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Unidad de Gestión Clínica Intercentros de Oncología Médica, Málaga, Spain.
Dolores IslaMedical Oncology Department, Hospital Universitario Lozano Blesa, Zaragoza, Aragón, Spain.
Margarita MajemMedical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Fátima NavarroMedical Oncology Department, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.
Virginia CalvoMedical Oncology Department, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain. vircalvo@hotmail.com.ORCID http://orcid.org/0000-0002-3503-4847
Hospital Universitario Puerta de Hierro Majadahonda · ESComplejo Asistencial Universitario de Palencia · ESComplejo Hospitalario de Jaén · ESComplejo Hospitalario de Salamanca · ESComplejo Hospitalario Universitario de Albacete · ESComplejo Hospitalario Universitario de Santiago · ESComplexo Hospitalario Universitario A Coruña · ESHospital Clínico San Carlos · ESHospital Clínico Universitario de Valladolid · ESHospital Clínico Universitario Lozano Blesa · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital de Sant Pau · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital General Universitario De Valencia · ESHospital Son Llatzer · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario Central de Asturias · ESHospital Universitario de Burgos · ESHospital Universitario de Getafe · ESHospital Universitario de Gran Canaria Doctor Negrín · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain.

methodsPost-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. One hundred-fifty five patients were enrolled (August 2016-December 2018) from 30 sites. PRIMARY

objectiveprogression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.

results70% women, median age 66. 63.9% were non-smokers and 99% had adenocarcinoma. Most patients had received at least one prior treatment (97%), 91.7% had received previous EGFR-tyrosine kinase inhibitors and 2.8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11.8 months. One hundred-fifty five patients were evaluable for response, 1.3% complete response, 40.6% partial response, 31% stable disease and 11.6% disease progression. Objective response rate was 42%. Median progression-free survival was 9.4 months. Of the 155 patients who received treatment, 76 (49%) did not reported any adverse event, 51% presented some adverse event, most of which were grade 1 or 2. The resource cost study indicates early use is warranted.

conclusionThis study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events.

trial registrationClinical trial registration number: NCT03790397 .

Indexed as

AcrylamidesAdultAgedAged, 80 and overAniline CompoundsCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleFollow-Up StudiesHumansIndolesLungLung NeoplasmsMaleMiddle AgedMutationAcrylamidesAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesEGFR-activating mutationsNon-small cell lung cancerOsimertinibReal-world dataSecond lineT790M EGFR mutation

Identifiers

PMID33676426
PMCPMC7937205
OpenAlexW3114095594

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.