BACKGROUND:Sotorasib 960 mg once daily is approved to treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Sotorasib exhibits non-dose proportional pharmacokinetics and clinical responses at lower doses; therefore, we evaluated the efficacy and safety of sotorasib 960 mg and 240 mg. METHODS:In this phase 2, randomized, open-label study, adults with KRAS G12C-mutated advanced NSCLC received sotorasib 960 mg or 240 mg once daily. Primary endpoints were objective response rate (ORR) and safety. Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetics. The study was not powered for formal statistical hypothesis testing. RESULTS:In the 960 mg group (n = 104), ORR was 32.7 % and DCR was 86.5 %. In the 240 mg group (n = 105), ORR was 24.8 % and DCR was 81.9 %. Median PFS was 5.4 months (960 mg) and 5.6 months (240 mg). At a median follow-up of 17.5 months, median OS was 13.0 months (960 mg) and 11.7 months (240 mg). AUC0-24 h and Cmax were 1.3-fold numerically higher with the 960 mg dose. Treatment-emergent adverse events (TEAEs, ≥10 %) for 960 mg and 240 mg doses, respectively, were diarrhea (39.4 %; 31.7 %), nausea (23.1 %; 19.2 %), increased alanine aminotransaminase (14.4 %; 17.3 %), and increased aspartate aminotransferase (13.5 %; 13.5 %). CONCLUSIONS:Patients treated with sotorasib 960 mg once daily had numerically higher ORR and DCR, and longer DOR and OS, than patients treated with 240 mg in this descriptive analysis. TEAEs were manageable with label-directed dose modifications. CLINICAL TRIAL REGISTRATION:NCT03600883.

INTRODUÇÃOO cancro do pulmão (CP) é o cancro que causa mais mortes na Europa e em Portugal. 1,2 Em Portugal, este é o terceiro tipo de cancro com maior incidência, com 5415 portugueses a serem diagnosticados em 2020, tendo-se registado 4797 mortes. 2 Em média, diagnosticamos, todos os dias, 15 portugueses com CP e 13 morrem devido a esta doença.Comparativamente a outras neoplasias, como o cancro da mama e colorretal, o CP apresenta uma taxa de sobrevivência muito baixa, sendo que em Portugal a probabilidade de sobreviver cinco anos após diagnóstico é apenas 15%. 3 Esta taxa está associada ao facto de cerca de 75% dos casos serem diagnosticados em estádios avançados da doença. 4odavia, em estádios precoces, a taxa de sobrevivência cinco anos após diagnóstico, é de 70% -90%. 4 rastreio do CP com tomografia computorizada de baixa dose (TCBD), demonstrou, nomeadamente nos estudos National Lung Screening Trial (NLST) 5 e NELSON, 6 um aumento de diagnósticos em estádios precoces e redução de mortalidade por CP superior a 20%.É de realçar a robustez de ambos os estudos, com o estudo NLST 5 a incluir 53 454 indivíduos com elevada carga tabágica e realização anual de TCBD durante três anos.O estudo NELSON 6 incluiu 15 789 indivíduos com elevada carga tabágica, realização de TCBD no momento da inclusão e após um, três e cinco anos e meio, tendo realizado um seguimento de 10 anos.Ambos demonstraram a segurança e eficácia do rastreio do CP com TCBD, sendo que, no estudo NELSON, o número de TCBD realizadas para prevenir uma morte foi de 130. 7 Adicionalmente, estudos de custo efetividade, nomeadamente o de Gómez-Carballo et al (2022) realizado em Espanha, revelaram que o rastreio do CP é custo efetivo na população de risco.8 Em 2022, a Comissão Europeia (CE) atualizou as suas recomendações de rastreios de base populacional.9 Neste seguimento, a CE recomenda que os países europeus iniciem estudos de viabilidade de rastreio do CP a nível nacional usando TCBD, através da implementação de projetos-piloto, associados a programas de cessação tabágica.9 Em Portugal, é premente iniciar a implementação de um projeto-piloto, seguindo as recomendações da CE, e permitindo a adaptação do plano de rastreio à realidade portuguesa e a preparação gradual do sistema de saúde para a implementação a nível nacional.

Non-small-cell lung cancer (NSCLC) is a major cause of cancer-related death worldwide. In recent years, the discovery of actionable molecular alterations has changed the treatment paradigm of the disease. Tissue biopsies have been the gold standard for the identification of targetable alterations but present several limitations, calling for alternatives to detect driver and acquired resistance alterations. Liquid biopsies reveal great potential in this setting and also in the evaluation and monitoring of treatment response. However, several challenges currently hamper its widespread adoption in clinical practice. This perspective article evaluates the potential and challenges associated with liquid biopsy testing, considering a Portuguese expert panel dedicated to thoracic oncology point of view, and providing practical insights for its implementation based on the experience and applicability in the Portuguese context.

Chemotherapy-induced nausea and vomiting (CINV) negatively impact cancer patients' quality of life and treatment outcomes. This study evaluated the achievement of complete response to CINV prophylaxis during the first five days after chemotherapy in adult outpatient cancer clinics with solid malignant tumours receiving Moderate or Highly Emetogenic Chemotherapy (MEC or HEC) in Portugal. During the study, patients completed three evaluations, and nausea severity and CINV impact on patients' daily life was assessed. A complete response (no emetic episodes, no use of rescue antiemetic medication, and no more than mild nausea) was observed in 72% of the cycles (N = 161) throughout the five days after chemotherapy. Amongst the patient population, 25% classified their CINV episodes as severe. Though more than half of the patients achieved a complete response, suggesting that a therapeutic effort is being made to minimise this side effect, the overall scenario is barely optimistic. Significantly, new CINV-control measures in MEC/HEC patients should be adopted, specifically avoiding the single use of dexamethasone and 5-HT3 and raising awareness of using NK1-RAs. Thus, it is critical to improve CINV prophylactic treatment and implement practical international antiemetic guidelines in Portuguese clinical practice, envisaging the improvement of supportive care for cancer patients.

Doente de 57 anos, professor, ex grande fumador de 40 UMA, adenocarcinoma pulmonar, dezembro de 2018, estadio IIIB (TTF1 +; expressão de PD-L1 negativa; NGS - tissue lung custum - sem qualquer mutação ou translocação ECOG1; terapêutica combinada, de quimioterapia/radioterapia, janeiro/19, progressão para estadio IV, 2 linhas sucessivas de quimioterapia (carboplatinum/pemetrexed) e imunoterapia (atezolizumab) com progressão em fevereiro/20.

Objective: To analyze patient-reported swallowing difficulties, healthcare resource utilization and associated costs during the PROCLAIM study. Methods: Patients with stage III non-squamous non-small cell lung cancer received pemetrexed-cisplatin (PemCis) combined with concurrent thoracic radiotherapy followed by consolidation pemetrexed, or concurrent chemoradiotherapy with etoposide-cisplatin (EtoCis) followed by standard consolidation chemotherapy. Patient - reported swallowing function was measured using diaries. Resource utilization (hospitalizations, transfusions, concomitant medications) was compared between treatment arms using Fisher's exact test and independent t-test. Medical resource use costs were analyzed using nonparametric Wilcoxon rank sum test. Results: Patient-reported difficulty in swallowing function (diary score ≥4) was 33.8% in the PemCis arm and 29% in the EtoCis arm. Overall resource use, including hospitalizations, was similar between treatment arms; however, fewer patients in the PemCis arm received transfusions and selected concomitant medications. Concurrent phase analyses were consistent with the overall study. A significantly lower percentage of patients (31.1% vs. 40.8%) were hospitalized in the PemCis arm. Total costs were significantly higher in the PemCis arm. Other medical costs (excluding study treatment costs) during the concurrent phase were lower for patients in the PemCis arm, due to significantly lower hospitalization costs and lower use of concomitant medications. Subgroup analysis yielded similar results. Conclusions: Patient-reported difficulty in swallowing post-baseline and resource utilization were consistent with previously reported safety outcomes. In the overall study, higher total costs for PemCis were driven by study drug cost. When adjusting for treatment duration, other monthly medical costs were favorable to PemCis. Patients on pemetrexed remained longer on therapy, suggesting better tolerability. ClinicalTrials.gov identifier: NCT00686959.

À luz dos conhecimentos atuais, o tratamento de imunoterapia no cancro do pulmão de não pequenas células doença avançada apresenta os melhores resultados nos doentes com expressão de programmed death ligand 1 (PD-L1) positiva.Apresentamos dois casos clínicos diferentes, ambos de sucesso: o primeiro referente a um doente do sexo masculino, 91 anos, com expressão de PD-L1 de 90% e com elevada taxa de resposta ao tratamento de imunoterapia com pembrolizumab na dose de 200 mg, a cada 3 semanas; no segundo caso trata-se de uma doente do sexo feminino, de 47 anos, com expressão de PD-L1 negativa e em que a imunoterapia foi usada como segunda linha, após se verificar progressão sob tratamento com quimioterapia, tendo-se verificado também neste caso uma resposta completa com o uso de atezolizumab, na dose de 1200 mg, a cada 3 semanas.

O aparecimento de terapêuticas dirigidas, trouxe na última década uma enorme esperança para os doentes com cancro do pulmão. Os inibidores dos recetores do fator de crescimento epidérmico (EGFR), erlotinib e gefitinib (inibidores de tirosina quinase TKI), estiveram na vanguarda das mudanças da prática de tratamento para doença avançada do cancro do pulmão de não pequenas células (CPNPC), nos últimos 10 anos, com a descoberta de mutações EGFR que conferem sensibilidade a inibidores da tirosina quinase no CPNPC. O ano de 2004, marcou o início da era da medicina de precisão para o cancro do pulmão. Os estudos randomizados de fase III investigaram o papel de dois inibidores de EGFR-TKI, gefitinib e erlotinib, como tratamento de primeira linha em comparação com a quimioterapia à base de platina, em doentes com CPNPC doença avançada com mutações de ativação do EGFR. Um TKI de segunda geração (afatinib) encontra-se já aprovado pela EMA com a mesma indicação após resultados dos clínicos do Lux Lung 3 e 6. No entanto, os doentes com mutação EGFR positiva, regra geral, progridem após 10-12 meses de tratamento, necessitando de novas opções terapêuticas. Inibidores de 3ª geração entretanto desenvolvidos (dirigidos à mutação de resistência do T790M, e outras, após rebiópsia), demostraram uma notável eficácia, em doentes já tratados e com um perfil de toxicidade ainda menor que os TKI de 1ª e 2ª geração. Recebido: 30/05/2016 - Aceite: 03/06/2016

Abstract Objectives: To assess the effect of long-term pemetrexed maintenance therapy on patients’ renal function. Methods: In the PARAMOUNT phase III trial (NCT 00789373), pemetrexed was compared with placebo as maintenance treatment in advanced nonsquamous non-small-cell lung cancer patients who completed 4 cycles of pemetrexed plus cisplatin induction therapy. To evaluate changes in renal function during pemetrexed continuation maintenance treatment, we retrospectively analyzed changes in serum creatinine (sCr), treatment-emergent adverse events, dose delays and treatment discontinuations associated with impaired renal function. Results: Creatinine clearance ≥45 mL/min was required before the start of any cycle. Patients on pemetrexed maintenance had a significantly higher percentage maximum increase in sCr over baseline versus placebo for the range of ≥10% to ≥90% increase (p < .05). The risk of experiencing renal events leading to dose delays and discontinuations was higher with higher increases in sCr but reversible in most patients. sCr increases of ≥30% and ≥40% were associated with gender (female), age (<70 years) and longer exposure to pemetrexed compared with placebo. Sixteen (4%) pemetrexed patients and 1 (1%) placebo patient discontinued treatment due to drug-related renal events; 13/16 (81%) of those pemetrexed patients had sCr increases ≥30% and 7/13 (54%) had pre-existing conditions and/or were receiving nephrotoxic drugs. Conclusions: The appearance of renal events leading to dose delays and/or treatment discontinuations was associated with sCr increase of at least 30%. However, it was difficult to identify patients at a higher risk of treatment discontinuation due to a drug-related renal event based only on changes in pre-maintenance laboratory values.

A Unidade de Oncologia Pulmonar do Hospital CUF Porto, iniciou a sua atividade no tratamento de doentes com patologia do foro torácico em janeiro de 2014. Tendo em conta toda a infraestrutura pré-existente no Hospital na área do diagnóstico e estadiamento, deu-se início à consulta Especializada em Oncologia Pulmonar com referenciação de doentes, quer interna, quer externamente, organizando o serviço centrado na doença e no doente.

É com o maior gosto, que participo em mais uma edição da revista científica do Grupo José de Mello Saúde - Gazeta Médica, desta vez fazendo o seu Editorial, na qualidade de Editor Associado da revista. A reedição de uma Revista que teve a sua primeira edição há cerca de 70 anos (1948) e descontinuada 16 anos mais tarde em 1964, tendo emergido com a dinâmica que se reconhece nos seus três primeiros números, pressupõe-lhe uma longa vida e uma enorme vitalidade, pelo seu já reconhecimento e desenvolvimento científico. Os números até agora editados foram pautados pela multidisciplinaridade, rigor científico e inovação adaptada aos nossos dias, fazendo jus ao que de melhor se produz em medicina. O quarto número da revista apresenta-se mais uma vez duma forma multidisciplinar, quer na abordagem das várias áreas das ciências médico/cirúrgicas, quer no tipo de trabalho apresentado. Assim ao abrirmos com chave de ouro, este número da revista com o artigo de perspetiva “Saúde e Educação” da Prof. Maria Amélia Ferreira, Presidente da Faculdade de Medicina da Universidade do Porto, passando por artigos originais e de revisão de grande valor nos vários temas da Medicina atual, aos casos clínicos das várias especialidades, mostrando o trabalho do nosso dia-a-dia e finalizando com um tema histórico, fica-nos a expectativa de no futuro podermos ver incluídos também estudos prospetivos a serem efetuados no âmbito da nossa atividade de investigação clínica. A atividade assistencial aos doentes, pilar de atuação do médico, conduz-nos muitas vezes a falta de tempo para escrever e registar adequadamente o nosso trabalho, atentos às inúmeras solicitações a que todos estamos diariamente sujeitos, mas não podemos abdicar da responsabilidade que cada um de nós tem na área da investigação clínica, fator muito importante no desenvolvimento das melhores terapêuticas e atitudes para os nossos doentes, podendo, por um lado rever a forma como os tratamos e por outro lado, oferecer-lhes o que de melhor se faz no mundo científico. Estou a falar exatamente sobre estudos de investigação clínica da iniciativa do investigador, académicos ou outros, considerando igualmente aqueles que têm a indústria como promotor. Se alguns hospitais do grupo, nomeadamente o Hospital de Braga (com o centro clínico académico), apresentam já um amplo desenvolvimento nesta altura, ainda nos encontramos em período de grande desenvolvimento noutras unidades, não querendo deixar aqui de referir o esforço efetuado durante o ano em curso pela Academia CUF no desenvolvimento desta área de trabalho, inclusive com a implementação a tempo inteiro da figura do study coordinator em várias unidades do grupo, motor importante para um trabalho eficaz, responsável e cientificamente rigoroso. Prevê-se para 2017 uma duplicação dos estudos, a fazer crer pelas várias parcerias e pelos múltiplos feasibilities em curso, esperando que estas e outras iniciativas, possam levar rapidamente à submissão, aceitação e publicação de trabalhos de investigação ou de revisão nas páginas da Gazeta Médica. Contudo, há que louvar o muito que se tem feito (em pouco tempo), inclusivamente a publicação do livro “70 Anos/Excelência Clínica” e a edição para breve, do livro de “Casos Clínicos Multidisciplinares”, que a somar à edição trimestral da Gazeta Médica constituem nesta data, já três importantes focos científicos. Estas iniciativas são a expressão máxima da vontade duma equipa multidisciplinar motivada e coesa, para levar em frente uma obra científica igualmente importante, como tratar os doentes, que todos dias em nós confiem. Contamos com todos para prosseguirmos! Bárbara Parente Editorial Board / Conselho Editorial

8529 Background: Standard of care for inoperable stage III NSCLC is concurrent chemoradiotherapy. Safety and resource utilization are important for treatment decisions. Methods: Resource utilization among patients (pts) in PROCLAIM (NCT00686959) receiving pemetrexed+ cisplatin (PemCis) and concurrent radiotherapy (RT) for 3 cycles, followed by 4 cycles of Pem consolidation (Arm A; N= 283) was compared with pts receiving etoposideCis (EtoCis) and concurrent RT for 2 cycles followed by consolidation platinum-based doublet for up to 2 cycles (Arm B; N= 272). Possible consolidation therapies in Arm B were EtoCis, vinorelbineCis, and paclitaxel+ carboplatin. Overall efficacy and safety results by study phase were previously presented. A pt diary assessed swallowing issues. Results: Table shows resource utilization including hospitalizations, transfusions and selected concomitant medications. Study …

8529 Background: Standard of care for inoperable stage III NSCLC is concurrent chemoradiotherapy. Safety and resource utilization are important for treatment decisions. Methods: Resource utilization among patients (pts) in PROCLAIM (NCT00686959) receiving pemetrexed+cisplatin (PemCis) and concurrent radiotherapy (RT) for 3 cycles, followed by 4 cycles of Pem consolidation (Arm A; N = 283) was compared with pts receiving etoposideCis (EtoCis) and concurrent RT for 2 cycles followed by consolidation platinum-based doublet for up to 2 cycles (Arm B; N = 272). Possible consolidation therapies in Arm B were EtoCis, vinorelbineCis, and paclitaxel+carboplatin. Overall efficacy and safety results by study phase were previously presented. A pt diary assessed swallowing issues. Results: Table shows resource utilization including hospitalizations, transfusions and selected concomitant medications. Study phase analyses are consistent with the overall treatment assessment. 33.8% of pts in Arm A vs 29.0% in Arm B reported swallowing diary score of ≥ 4, indicating an inability to swallow solids or liquids, which is comparable to Gr 2-4 dysphagia during the overall treatment (26.5% vs 23.2%, respectively). Conclusions: While overall resource use, including hospitalizations, was similar between treatment groups, the number of pts receiving transfusions, ESAs and CSFs was lower in Arm A, consistent with the previously reported lower incidence of Gr 3/4 anemia and neutropenia during overall treatment. Clinical trial information: NCT00686959. Arm A N = 283 Arm B N = 272 Pts with ≥ 1 hospitalization, n (%) 82 (29.0) 77 (28.3) Drug-related AEs 64 (22.6) 81 (29.8) Nondrug-related AEs 66 (23.3) 78 (28.7) Pts receiving ≥ 1 transfusion, n (%) 163 151 Total # of transfusions 274 (96.8) 259 (95.2) Pts receiving concomitant medication, n (%) 222 (78.5) 207 (76.1) Antiemetics and antinauseants 215 (76.0) 213 (78.3) Analgesics 192 (67.8) 174 (64.0) Anti-infectives (systemic) 9 (3.2) 21 (7.7) ESAs 23 (8.1) 65 (23.9) G-CSF/GM-CSF Abbreviations: ESAs, erythropoietic agents; G-CSF, granulocyte colony stimulating factor; GM-CSF, granulocyte macrophage colony stimulating factor.

Abstract The identification of mutations in circulating tumor DNA (ctDNA) can serve as a biomarker for non-invasive diagnosis and real time therapeutic monitoring. Although next generation sequencing (NGS) is a promising technology, the intrinsic low abundance of ctDNA in the high background of wild-type cell free DNA (cfDNA) makes the detection and quantification of such mutations in plasma a challenging task. This study aims to measure the performance of NGS analysis when applied to the identification of somatic mutations in plasma samples. Plasma samples from two healthy controls were used to isolate cfDNA. Constitutional genomic DNA from these controls was previously genotyped using the Human OmniExpress BeadChip. A custom multiplex PCR panel was designed to target 420 unique variants. To cover a broad range (0.5%-100%) of minor allele frequencies (MAF), as expected for somatic mutations in the plasma of cancer patients, the cfDNA samples from the two controls were mixed at five different rations (7:25, 1:6, 1:8, 1:20 and 1:100). Because sequence coverage is a key driver of accuracy, 5 different coverage profiles (100x, 500x, 1000x, 2000x and 5000x) were established for each of the cfDNA pools. On total 25 libraries were generated, pooled and sequenced with the Ion PGM system. Ion Reporter software was used for data analysis. The observed MAFs were compared with expected results for all the variants of each cfDNA pool. Median exon sequencing coverage of 133x, 650x, 1312x, 2628x and 5466x was obtained for each of the 5 cfDNA pools, with >99% of the amplicons covered. Overall base substitution and indel detection performance was high (>95% of the variants were detected across the different coverage levels). A direct correlation between expected and observed MAFs for the known variants was observed. For variants present at MAF ≥5%, a sensitivity of 91.4% and 100% was achieved at 100x and ≥500x coverage levels, respectively. For variants with 5% ≤ MAF ≤ 10% at 100x of coverage, the average quality score was Q30. Overall, positive predictive value remained high (>98%), with an average of 5 false-positive calls across the full coverage range. To validate our approach we analyzed 10 pairs of primary tumour/plasma samples. All cases carried known mutations of the EGFR gene detected during routine analysis. We were able to detect the corresponding mutation in the plasma samples in all cases. MAF in plasma samples ranged from 3% to 85%. Here we demonstrate that NGS can be used to detect mutations in cfDNA. Our approach with controlled data sets also enabled us to define allele frequency, allele depth, and allele quality score cutoffs for a reliable detection of low MAF variants in ctDNA. Citation Format: Ana Justino, Gabriela Fernandes, Ana Barroso, Barbara Parente, Venceslau Hespanhol, Jose C. Machado, Jose L. Costa. Next generation sequencing performance for the detection of mutations in plasma cell free DNA. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 4930. doi:10.1158/1538-7445.AM2015-4930

Abstract Tumor-specific (somatic) mutations in plasma can serve as biomarkers for tumor detection, monitor tumor response to specific therapies, detect residual disease after surgery, and long-term follow-up. The intrinsic low abundance of circulating cell-free tumor DNA (cfDNA) makes the detection and quantification of such mutations in plasma a challenging task. This small scale study aims to establish a comprehensive strategy to be used in the detection of clinical relevant somatic alterations in plasma of lung cancer patients. Plasma samples obtained at different stages of disease progression and/or treatment were collected from a group of 11 lung cancer patients and used to isolate cfDNA. Genetic alterations in the EGFR gene (p.E746_A750del and p.L858R) identified at diagnosis in tumor biopsies were used as surrogate markers to optimize and validate the next generation sequencing strategy and data analysis workflow. The Ion AmpliSeq Colon and Lung cancer panel was used to analyze hotspot and targeted regions of 22 genes implicated in colon and lung cancers, including the EGFR gene mutations mentioned. The amplified products were used to prepare libraries and were sequenced using the Ion PGM system. Quantitative real time PCR and digital PCR assays were used to confirm selected results. Tumor derived genetic alterations could be identified in as little as 10ng of cfDNA. EGFR alterations identified in cfDNA mirrored the alterations identified in all tumor biopsies. EGFR alterations with allelic frequencies as low as 3% could be detected in cfDNA. Additionally, in case of samples collected after therapy, a clear decrease in the cfDNA allelic frequency of the EGFR mutation, that made the patient eligible for therapy, was observed. Furthermore, the screening of a larger panel of genes allowed the identification in two cases of additional gene mutations (e.g. MET and KRAS) that may have impact in the clinical management of patients. In this study, we demonstrate the capacity to identify clinically relevant somatic EGFR mutations in plasma. The possibility to assess information from a larger panel of genes makes this strategy attractive for further optimization of treatment options. The strategy is now being extended to a larger cohort of patients to push forward the concept of liquid biopsy in the clinical management of cancer patients. Citation Format: Jose L. Costa, Ana Justino, Ana Barroso, Barbara Parente, Jose C. Machado. Detection of somatic alterations in plasma from lung cancer patients. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 1512. doi:10.1158/1538-7445.AM2014-1512

Undernutrition is associated with worse clinical outcomes and so screening is recommended. Given the paucity of information on nutritional status and on the clinical impact of undernutrition in Pulmonology patients who have been hospitalized, it is of the utmost importance that it is studied.

Introduction: EGFR mutation, has been recognized as a prognostic and predictive factor of response to treatment with tyrosine kinase inhibitors in non-small cells lung carcinoma (NSCLC) at advanced stages, however little is known about their prognostic value in operable disease. Objective: Evaluate if the presence of EGFR mutation influences the progression-free survival (PFS) and overall survival (OS) in patients with NSCLC in surgical stage Methods: Retrospective study conducted by consulting patients clinical files between 01/01/2006 to 31/12/2012, in which the study of EGFR mutation was performed and maintained in follow-up until 31/12/2013. Data analyzed: demographic, smoking history, diagnostic, EGFR, surgery and complications; PFS and OS. Results: 63 patients (70% men), 14.3% EGFR positive. Mean age: 62.06 (+ / - 10.62) years. 27% non-smokers, 35% smokers and 38% former smokers. Histology: adenocarcinoma (81%), squamous (12.7%) and large cell (6.3%). EGFR positive population presented a median PFS of 62.8 months and wild type patients of 44.4 months (p = 0.595). Mean OS in EGFR positive was 77.2 months and in wild type patients was 69.9 months (p = 0.309). EGFR mutation was not associated with increased OS or PFS according to the following OR ((SLP) 1.07 95% CI 0.2 to 5, OR (SG): 8 95% 0, 3 to 24). When we evaluated the PFS according to the pathological stage, we see that the early stages are associated with an increased PFS (p = 0.011). Discussion: In our series, in patients with surgical stage, pathological stage of the disease appears to have a greater prognostic value for relapse than mutational status of EGFR. EGFR mutation was not associated with an increase in PFS or OS in patients with NSCLC in surgical stage.