<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1699-714X</journal-id>
<journal-title><![CDATA[Revista de la OFIL ]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. OFIL·ILAPHAR]]></abbrev-journal-title>
<issn>1699-714X</issn>
<publisher>
<publisher-name><![CDATA[Organización de Farmacéuticos Ibero-Latinoamericanos]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1699-714X2021000200196</article-id>
<article-id pub-id-type="doi">10.4321/s1699-714x2021000200015</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Uso compasivo de durvalumab en cáncer de pulmón no microcítico: resultados en vida real]]></article-title>
<article-title xml:lang="en"><![CDATA[Compassionate use of durvalumab in non-small cell lung cáncer: real-life results]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gil-Sierra]]></surname>
<given-names><![CDATA[MD]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martín-Rodríguez]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Briceño-Casado]]></surname>
<given-names><![CDATA[MP]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Hospital Doctor José Molina Orosa Servicio de Farmacia ]]></institution>
<addr-line><![CDATA[Arrecife Las Palmas]]></addr-line>
<country>España</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Hospital Universitario de Puerto Real UGC Farmacia ]]></institution>
<addr-line><![CDATA[Puerto Real Cádiz]]></addr-line>
<country>España</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>06</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>06</month>
<year>2021</year>
</pub-date>
<volume>31</volume>
<numero>2</numero>
<fpage>196</fpage>
<lpage>200</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S1699-714X2021000200196&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S1699-714X2021000200196&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S1699-714X2021000200196&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Objetivos:  Durvalumab está financiado en cáncer de pulmón no microcítico (CPNM) localmente avanzado irresecable con expresión PD-L1 &#8805;1%, sin progresión tras quimiorradioterapia basada en platino y duración del tratamiento de 12 meses. Los pacientes deben presentar buen estado general (PS). Hasta ahora, sólo el uso compasivo ha sido autorizado, sin algunos requisitos de financiación exigidos. El objetivo es describir las condiciones del uso compasivo de durvalumab en CPNM, comparándose con las condiciones de financiación, así como proporcionar resultados en vida real de efectividad y seguridad.  Métodos:  Se desarrolló un estudio descriptivo retrospectivo entre 01/12/2017-29/02/2020. La efectividad se evaluó con supervivencia global (SG) y supervivencia libre de progresión (SLP) mediante método Kaplan Meier utilizando SPSS Statistics®. La seguridad se evaluó con reacciones adversas (RAs), grado, interrupciones y suspensiones.  Resultados:  Fueron reclutados 5 pacientes. Se determinó PD-L1 &#8805;1% en uno. El 80% presentaron PS0. La mediana de seguimiento fue 19 (7-25) meses. Uno de los pacientes (20%) cumplió criterios de financiación. No se registraron fallecimientos, no pudiéndose estimar la media de SG. La media de SLP fue 20,8 (13,6-28,1) meses. Se observaron 17 episodios de RAs, siendo las más frecuentes: 4 (23,5%) infecciones respiratorias, 3 (17,6%) tos y 2 (11,7%) lesiones eritematosas. Se notificaron 16 (94,1%) RAs grado 1, y 8 interrupciones de tratamiento, sin suspensiones.  Conclusiones:  Existen importantes discrepancias entre el uso compasivo de durvalumab en CPNM localmente avanzado irresecable y las condiciones de financiación. Durvalumab ha demostrado importante efectividad y tolerancia aceptable, aunque estos resultados deben evaluarse con cautela.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[SUMMARY  Objectives:  Durvalumab is funded in unresectable locally advanced non-small cell lung cancer (NSCLC) with PD-L1 expression &#8805;1%, without progression after platinum-based chemoradiotherapy and treatment duration of 12 months. Patients must present adequate performance status (PS). Until now, only compassionate use has been authorized, without some funding requirements. The aim is to describe conditions of compassionate use of durvalumab in locally advanced and unresectable NSCLC, comparing with the financing conditions, as well as to provide the real-life results of effectiveness and security.  Methods:  A retrospective descriptive study from 01/12/2017 to 29/02/2020 was conducted. The effectiveness was assessed with overall survival (OS) and progression-free survival (PFS) by Kaplan Meier method using SPSS Statistics®. Safety was evaluated through adverse reactions (ARs), grade, interruptions and suspensions.  Results:  There were 5 male patients recruited. PD-L1 was &#8805;1% in one patient. The 80% of patients presented PS0. The median follow-up was 19 (7-25) months. One of the patients (20%) met the funding criteria. There were no deaths, so the mean OS could not be calculated. The mean PFS was 20.8 (13.6-28.1) months. There were 17 RAs episodes. The most frequent RAs were: 4 (23.5%) respiratory infections, 3 (17.6%) cough and 2 (11.7%) erythematous lesions. There were 16 (94.1%) RAs grade 1, and 8 treatment interruptions were recorded, without suspensions.  Conclusions:  There are important discrepancies between the compassionate use of durvalumab in unresectable locally advanced NSCLC and the financing conditions. Durvalumab has showed an important effectiveness and aceptable tolerance, although these results should be evaluated with caution.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Durvalumab]]></kwd>
<kwd lng="es"><![CDATA[cáncer]]></kwd>
<kwd lng="es"><![CDATA[efectividad]]></kwd>
<kwd lng="es"><![CDATA[seguridad]]></kwd>
<kwd lng="en"><![CDATA[Durvalumab]]></kwd>
<kwd lng="en"><![CDATA[cancer]]></kwd>
<kwd lng="en"><![CDATA[effectiveness]]></kwd>
<kwd lng="en"><![CDATA[safety]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Bogos]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Kiss]]></surname>
<given-names><![CDATA[Z]]></given-names>
</name>
<name>
<surname><![CDATA[Gálffy]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Tamási]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Ostoros]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Müller]]></surname>
<given-names><![CDATA[V]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Revising Incidence and Mortality of Lung Cancer in Central Europe: An Epidemiology Review From Hungary]]></article-title>
<source><![CDATA[Frontiers in Oncology]]></source>
<year>2019</year>
<volume>9</volume>
<page-range>1051</page-range></nlm-citation>
</ref>
<ref id="B2">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Rich]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Beckett]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
<name>
<surname><![CDATA[Baldwin]]></surname>
<given-names><![CDATA[David]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Status of Lung Cancer Data Collection in Europe]]></article-title>
<source><![CDATA[JCO Clinical Cancer Informatics]]></source>
<year>2018</year>
<volume>2</volume>
<page-range>1-12</page-range></nlm-citation>
</ref>
<ref id="B3">
<nlm-citation citation-type="">
<collab>Sociedad Española de Oncología Médica</collab>
<source><![CDATA[Las cifras del cáncer en España 2018 SEOM: Sociedad Española de Oncología Médica]]></source>
<year>2019</year>
</nlm-citation>
</ref>
<ref id="B4">
<nlm-citation citation-type="">
<collab>Lungcancer.org</collab>
<source><![CDATA[Types and Staging of Lung Cancer]]></source>
<year>2020</year>
</nlm-citation>
</ref>
<ref id="B5">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Yu]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
<name>
<surname><![CDATA[Boyle]]></surname>
<given-names><![CDATA[TA]]></given-names>
</name>
<name>
<surname><![CDATA[Zhou]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Rimm]]></surname>
<given-names><![CDATA[DL]]></given-names>
</name>
<name>
<surname><![CDATA[Hirsch]]></surname>
<given-names><![CDATA[FR]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[PD-L1 Expression in Lung Cancer]]></article-title>
<source><![CDATA[Journal of Thoracic Oncology]]></source>
<year>2016</year>
<volume>11</volume>
<numero>7</numero>
<issue>7</issue>
<page-range>964-75</page-range></nlm-citation>
</ref>
<ref id="B6">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Vidarsdottir]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
<name>
<surname><![CDATA[Tran]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Nodin]]></surname>
<given-names><![CDATA[B]]></given-names>
</name>
<name>
<surname><![CDATA[Jirström]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Planck]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Mattsson]]></surname>
<given-names><![CDATA[JSM]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Comparison of Three Different TTF-1 Clones in Resected Primary Lung Cancer and Epithelial Pulmonary Metastases]]></article-title>
<source><![CDATA[American Journal of Clinical Pathology]]></source>
<year>2018</year>
<volume>150</volume>
<numero>6</numero>
<issue>6</issue>
<page-range>533-44</page-range></nlm-citation>
</ref>
<ref id="B7">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Rittmeyer]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Barlesi]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Waterkamp]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
<name>
<surname><![CDATA[Park]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Ciardiello]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[von Pawel]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial]]></article-title>
<source><![CDATA[Lancet]]></source>
<year>2017</year>
<volume>389</volume>
<numero>10066</numero>
<issue>10066</issue>
<page-range>255-65</page-range></nlm-citation>
</ref>
<ref id="B8">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Gil-Sierra]]></surname>
<given-names><![CDATA[MD]]></given-names>
</name>
<name>
<surname><![CDATA[Fenix-Caballero]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Alegre-del Rey]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Pembrolizumab plus Chemotherapy in Lung Cancer]]></article-title>
<source><![CDATA[The New England Journal of Medicine]]></source>
<year>2018</year>
<volume>379</volume>
<numero>11</numero>
<issue>11</issue>
</nlm-citation>
</ref>
<ref id="B9">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Horn]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Spigel]]></surname>
<given-names><![CDATA[DR]]></given-names>
</name>
<name>
<surname><![CDATA[Vokes]]></surname>
<given-names><![CDATA[EE]]></given-names>
</name>
<name>
<surname><![CDATA[Holgado]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Ready]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Steins]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057)]]></article-title>
<source><![CDATA[Journal of Clinical Oncology]]></source>
<year>2017</year>
<volume>35</volume>
<numero>35</numero>
<issue>35</issue>
<page-range>3924-33</page-range></nlm-citation>
</ref>
<ref id="B10">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Eberhardt]]></surname>
<given-names><![CDATA[WEE]]></given-names>
</name>
<name>
<surname><![CDATA[De Ruysscher]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
<name>
<surname><![CDATA[Weder]]></surname>
<given-names><![CDATA[W]]></given-names>
</name>
<name>
<surname><![CDATA[Le Péchoux]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[De Leyn]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
<name>
<surname><![CDATA[Hoffmann]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[2nd ESMO Consensus Conference in Lung Cancer: locally advanced stage III non-small-cell lung cancer]]></article-title>
<source><![CDATA[Annals of Oncology]]></source>
<year>2015</year>
<volume>26</volume>
<numero>8</numero>
<issue>8</issue>
<page-range>1573-88</page-range></nlm-citation>
</ref>
<ref id="B11">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Saijo]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Fukuoka]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Thongprasert]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Ichinose]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
<name>
<surname><![CDATA[Mitsudomi]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<name>
<surname><![CDATA[Mok]]></surname>
<given-names><![CDATA[TSK]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Lung cancer working group report]]></article-title>
<source><![CDATA[Japanese Journal of Clinical Oncology]]></source>
<year>2010</year>
<volume>40</volume>
<numero>Suppl 1</numero>
<issue>Suppl 1</issue>
<page-range>i7-i12</page-range></nlm-citation>
</ref>
<ref id="B12">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Postmus]]></surname>
<given-names><![CDATA[PE]]></given-names>
</name>
<name>
<surname><![CDATA[Kerr]]></surname>
<given-names><![CDATA[KM]]></given-names>
</name>
<name>
<surname><![CDATA[Oudkerk]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Senan]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Waller]]></surname>
<given-names><![CDATA[DA]]></given-names>
</name>
<name>
<surname><![CDATA[Vansteenkiste]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up]]></article-title>
<source><![CDATA[Annals of Oncology]]></source>
<year>2017</year>
<volume>28</volume>
<numero>suppl 4</numero>
<issue>suppl 4</issue>
<page-range>iv1-21</page-range></nlm-citation>
</ref>
<ref id="B13">
<nlm-citation citation-type="">
<source><![CDATA[Ficha Tecnica Imfinzi 50 mg/ml concentrado para solución para perfusión]]></source>
<year>2018</year>
</nlm-citation>
</ref>
<ref id="B14">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Antonia]]></surname>
<given-names><![CDATA[SJ]]></given-names>
</name>
<name>
<surname><![CDATA[Villegas]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Daniel]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
<name>
<surname><![CDATA[Vicente]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
<name>
<surname><![CDATA[Murakami]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Hui]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC]]></article-title>
<source><![CDATA[The New England Journal of Medicine]]></source>
<year>2018</year>
<volume>379</volume>
<numero>24</numero>
<issue>24</issue>
<page-range>2342-50</page-range></nlm-citation>
</ref>
<ref id="B15">
<nlm-citation citation-type="">
<collab>Ministerio de Sanidad, Consumo y Bienestar Social</collab>
<source><![CDATA[Profesionales de la Salud. Buscador situación financiación medicamentos]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B16">
<nlm-citation citation-type="">
<collab>Agencia Española de Medicamentos y Productos Sanitarios</collab>
<source><![CDATA[Gestión de Medicamentos en Situaciones Especiales]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B17">
<nlm-citation citation-type="">
<collab>Agencia Española de Medicamentos y Productos Sanitarios</collab>
<source><![CDATA[Informe de Posicionamiento Terapéutico de durvalumab (Imfinzi®) en el tratamiento del cáncer de pulmón no microcítico]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B18">
<nlm-citation citation-type="">
<collab>International Business Machines Corporation (IBM)</collab>
<source><![CDATA[Versiones de prueba de SPSS]]></source>
<year>2019</year>
</nlm-citation>
</ref>
<ref id="B19">
<nlm-citation citation-type="">
<collab>Agencia Española de Medicamentos y Productos Sanitarios</collab>
<source><![CDATA[Información relacionada con el tratamiento con olaratumab (Lartruvo®): resultados del estudio post-autorización requerido por las Autoridades Sanitarias]]></source>
<year>2019</year>
</nlm-citation>
</ref>
<ref id="B20">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Brody]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Zhang]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
<name>
<surname><![CDATA[Ballas]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Siddiqui]]></surname>
<given-names><![CDATA[MK]]></given-names>
</name>
<name>
<surname><![CDATA[Gupta]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
<name>
<surname><![CDATA[Barker]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[PD-L1 expression in advanced NSCLC: Insights into risk stratification and treatment selection from a systematic literature review]]></article-title>
<source><![CDATA[Lung Cancer]]></source>
<year>2017</year>
<volume>112</volume>
<page-range>200-15</page-range></nlm-citation>
</ref>
<ref id="B21">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Yoshimura]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Inoue]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
<name>
<surname><![CDATA[Mori]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Iwashita]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
<name>
<surname><![CDATA[Kahyo]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<name>
<surname><![CDATA[Kawase]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Distinct prognostic roles and heterogeneity of TTF1 copy number and TTF1 protein expression in non-small cell lung cancer]]></article-title>
<source><![CDATA[Genes Chromosomes Cancer]]></source>
<year>2017</year>
<volume>56</volume>
<numero>7</numero>
<issue>7</issue>
<page-range>570-81</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
