Browsing by Author "Hespanhol, V"
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- Rastreio do Cancro do Pulmão em Portugal: Um Projeto Piloto da PULMONALEPublication . Estevinho, F; Parente, B; Barata, F; Magalhães, I; França, M; Fidalgo, P; Santos, P; Hespanhol, V; Araújo, A
- Real-world data from the Portuguese Nivolumab Expanded Access Program (EAP) in previously treated Non Small Cell Lung Cancer (NSCLC)Publication . Figueiredo, A; Almeida, M A; Almodovar, M T; Alves, P; Araújo, A; Araújo, D; Barata, F; Barradas, L; Barroso, A; Brito, U; Camacho, E; Canário, D; Cardoso, T; Chaves, A; Costa, L; Cunha, J; Duarte, J; Estevinho, F; Felizardo, M; Fernandes, J P; Ferreira, L; Ferreira, L; Fidalgo, P; Freitas, C; Garrido, P; Gil, N; Hasmucrai, D; Jesus, E; Lopes, J A; de Macedo, J E; Meleiro, A; Neveda, R; Nogueira, F; Pantorotto, M; Parente, B; Pego, A; Rocha, M; Roque, J; Santos, C; Saraiva, J; Silva, E; Silva, S; Simões, S; Soares, M; Teixeira, E; Timóteo, T; Hespanhol, VOBJECTIVE: The main aim of the study was to evaluate the efficacy and safety profile of Nivolumab, an immune-checkpoint-inhibitor antibody, in advanced, previously treated, Non-Small Cell Lung Cancer (NSCLC) patients, in a real world setting. METHODS: We performed a retrospective, multicentre data analysis of patients who were included in the Portuguese Nivolumab Expanded Access Program (EAP). Eligibility criteria included histologically or citologically confirmed NSCLC, stage IIIB and IV, evaluable disease, sufficient organ function and at least one prior line of chemotherapy. The endpoints included Overall Response Rate (ORR), Disease Control Rate (DCR), Progression Free Survival (PFS) and Overall Survival (OS). Safety analysis was performed with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, and immune-related Adverse Events (irAEs) were treated according to protocol treatment guidelines. Tumour response was assessed using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Data was analysed using SPSS, version 21.0 (IBM Statistics). RESULTS: From June 2015 to December 2016, a total of 229 patients with advanced NSCLC were enrolled at 30 Portuguese centres. Clinical data were collected up to the end of July 2018. The baseline median age was 64 years (range 37-83) and the majority of patients were males (70.3%) and former/current smokers (69.4%). Patients with non-squamous histology predominated (88.1%), and 67.6% of the patients had received 2 or more prior lines of chemotherapy. Out of 229 patients, data was available for 219 patients (3 patients did not start treatment, while data was unavailable in 7 patients); of the 219 patients, 15.5% were not evaluated for radiological tumour assessment, 1.4% had complete response (CR), 21% partial response (PR), 31% stable disease (SD) and 31.1% progressive disease (PD). Thus, the ORR was 22.4% and DCR was 53.4% in this population. At the time of survival analysis the median PFS was 4.91 months (95% CI, 3.89-6.11) and median OS was 13.21 months (95% CI, 9.89-16.53). The safety profile was in line with clinical trial data. CONCLUSIONS: Efficacy and safety results observed in this retrospective analysis were consistent with observations reported in clinical trials and from other centres.
- Recommendations for the implementation of a national lung cancer screening program in Portugal—A consensus statementPublication . Fernandes, MG; Dias, M; Santos, R; Ravara, S; Fernandes, P; Firmino-Machado, J; Antunes, JP; Fernandes, O; Madureira, A; Hespanhol, V; Rodrigues, C; Vicente, CA; Alves, S; Mendes, G; Ilgenfritz, R; Pinto, BS; Alves, J; Saraiva, I; Bárbara, C; Cipriano, MA; Figueiredo, A; Uva, MS; Jacinto, N; Curvo-Semedo, L; Morais, ALung cancer (LC) is a leading cause of cancer-related mortality worldwide. Lung Cancer Screening (LCS) programs that use low-dose computed tomography (LDCT) have been shown to reduce LC mortality by up to 25 % and are considered cost-effective. The European Health Union has encouraged its Member States to explore the feasibility of LCS implementation in their respective countries. The task force conducted a comprehensive literature review and engaged in extensive discussions to provide recommendations. These recommendations encompass the essential components required to initiate pilot LCS programs following the guidelines established by the World Health Organization. They were tailored to align with the specific context of the Portuguese healthcare system. The document addresses critical aspects, including the eligible population, methods for issuing invitations, radiological prerequisites, procedures for reporting results, referral processes, diagnostic strategies, program implementation, and ongoing monitoring. Furthermore, the task force emphasized that pairing LCS with evidence-based smoking cessation should be the standard of care for a high-quality screening program. This document also identifies areas for further research. These recommendations aim to guarantee that the implementation of a Portuguese LCS program ensures high-quality standards, consistency, and uniformity across centres.
- Sedation with midazolam in flexible bronchoscopy - a prospective studyPublication . Rolo, R; Mota, PC; Coelho, F; Alves, D; Fernandes, G; Cunha, J; Hespanhol, V; Magalhães, AINTRODUCTION: Sedatives have been increasingly used to improve patient comfort during flexible bronchoscopy (FOB). Due to its rapid-onset, anxiolytic and amnestic properties, midazolam is one of the most commonly used sedatives. OBJECTIVES: To evaluate the effect of sedation with midazolam, including patient tolerance, complications and its potential use on a daily routine basis. MATERIAL AND METHODS: A multi-centre, prospective, randomized, placebo-controlled study was made on 100 patients submitted to FOB in two Pulmonology Departments. Midazolam (0.05mg/kg) was administered to patients in Group 1 and saline solution (0,9% NaCl) to patients in Group 2, five minutes before the procedure. The Hospital Anxiety and Depression Scale (HADS-A) was used to determine patient anxiety level. Subjective questionnaires concerning main fears and complaints were answered before and after FOB. RESULTS: Mean age was 56.0 ± 14.1 years; 66% male. Most (65%) patients had low score (<7) in HADS-A scale with no difference between groups. No significant differences were seen between groups concerning FOB duration, procedures, lidocaine dosage and complications. Systolic blood pressure during and after FOB was significantly higher (p<0.003) in Group 2. Patients in Group 1 experienced less cough (32% vs 56%; p=0.03) and dyspnea (2% vs 34%; p<0.001) than in Group 2, while nausea (6% vs 18%; p>0.05) and pain (4% vs 12%; p>0.05) were not statistically different. Willingness to repeat the exam was reported in all patients in Group 1 and in 82% in Group 2 (p=0.003). CONCLUSION: Sedation with midazolam in FOB improved patient's comfort and decreased complaints, without significant haemodynamic changes. It should be offered to the patient on a routine basis.
- T790M-EGFR mutation frequency in advanced NSCLC patients on progression from a previous TKI therapy: results from a Portuguese studyPublication . Teixeira, E; Araújo, A; Hespanhol, V; Parente, B; Barata, F
- The Impact of Polymorphic Variations in the 5p15, 6p12, 6p21 and 15q25 Loci on the Risk and Prognosis of Portuguese Patients with Non-Small Cell Lung CancerPublication . de Mello, RA; Ferreira, M; Soares-Pires, F; Costa, S; Cunha, J; Oliveira, P; Hespanhol, V; Reis, RMINTRODUCTION: Polymorphic variants in the 5p15, 6p12, 6p21, and 15q25 loci were demonstrated to potentially contribute to lung cancer carcinogenesis. Therefore, this study was performed to assess the role of those variants in non-small cell lung cancer (NSCLC) risk and prognosis in a Portuguese population. MATERIALS AND METHODS: Blood from patients with NSCLC was prospectively collected. To perform an association study, DNA from these patients and healthy controls were genotyped for a panel of 19 SNPs using a Sequenom® MassARRAY platform. Kaplan-Meier curves were used to assess the overall survival (OS) and progression-free survival (PFS). RESULTS: One hundred and forty-four patients with NSCLC were successfully consecutively genotyped for the 19 SNPs. One SNP was associated with NSCLC risk: rs9295740 G/A. Two SNPs were associated with non-squamous histology: rs3024994 (VEGF intron 2) T/C and rs401681 C/T. Three SNPs were associated with response rate: rs3025035 (VEGF intron 7) C/T, rs833061 (VEGF -460) C/T and rs9295740 G/A. One SNP demonstrated an influence on PFS: rs401681 C/T at 5p15, p = 0.021. Four SNPs demonstrated an influence on OS: rs2010963 (VEGF +405 G/C), p = 0.042; rs3025010 (VEGF intron 5 C/T), p = 0.047; rs401681 C/T at 5p15, p = 0.046; and rs31489 C/A at 5p15, p = 0.029. CONCLUSIONS: Our study suggests that SNPs in the 6p12, 6p21, and 5p15 loci may serve as risk, predictive and prognostic NSCLC biomarkers. In the future, SNPs identified in the genomes of patients may improve NSCLC screening strategies and therapeutic management as well.