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1.
Curr Oncol ; 31(6): 3350-3360, 2024 Jun 16.
Artículo en Inglés | MEDLINE | ID: mdl-38920738

RESUMEN

Background and Objectives: Death is an unavoidable experience in any person's life and affects not only the dying person but also their caregivers. The dying process has been displaced from homes to health care facilities in the majority of cases. Facing death and dying has become an everyday life of health care professionals (HCP), especially in palliative care (PC) settings. This study aimed to investigate the death attitudes among HCPs in Serbia. Materials and Methods: The Serbian version of the Death Attitude Profile-Revised (DAP-RSp) was used as a measurement instrument. Results: The average age of the 180 included participants was 42.2 ± 9.9 years; the majority were females (70.0%), with more than 10 years of working experience (73.0%), physicians (70.0%) and those working in a non-oncological (non-ONC) field (57.78%). The mean total score of DAP-RSp was 124.80 ± 22.44. The highest mean score was observed in the neutral acceptance dimension (NA) (5.82 ± 0.90) and lowest in the Escape acceptance (EA) (2.57 ± 1.21). Higher negative death attitudes were reported among nurses compared to physicians (p = 0.002). Statistically significant differences were observed in the fear of death (FD) and death avoidance (DA) domains, favoring PC specialists and oncologists (p = 0.004; p = 0.015). Physicians working in Oncology (ONC) showed lower FD values (p = 0.001) compared to non-ONC departments. Conclusions: Attitudes toward death among HCPs are of great importance for the well-being of both HCPs and patients. Negative attitudes can lead to deficient care. The fear of death is highly represented among Serbian HCPs working in non-ONC fields, including both nurses and physicians. This study emphasizes the need for further research to comprehensively explore and understand HCPs' attitudes toward death. This research highlights the need for the development of an educational curriculum across all levels of medical education, aimed at overcoming the fear of death and enhancing coping strategies, which will improve the care for patients diagnosed with terminal illnesses.


Asunto(s)
Actitud del Personal de Salud , Actitud Frente a la Muerte , Personal de Salud , Humanos , Femenino , Masculino , Adulto , Personal de Salud/psicología , Persona de Mediana Edad , Serbia , Peninsula Balcánica , Encuestas y Cuestionarios
2.
J Clin Oncol ; 41(26): 4208-4217, 2023 09 10.
Artículo en Inglés | MEDLINE | ID: mdl-37379502

RESUMEN

PURPOSE: Lazertinib is a potent, CNS-penetrant, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This global, phase III study (LASER301) compared lazertinib versus gefitinib in treatment-naïve patients with EGFR-mutated (exon 19 deletion [ex19del]/L858R) locally advanced or metastatic non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were 18 years and older with no previous systemic anticancer therapy. Neurologically stable patients with CNS metastases were allowed. Patients were randomly assigned 1:1 to lazertinib 240 mg once daily orally or gefitinib 250 mg once daily orally, stratified by mutation status and race. The primary end point was investigator-assessed progression-free survival (PFS) by RECIST v1.1. RESULTS: Overall, 393 patients received double-blind study treatment across 96 sites in 13 countries. Median PFS was significantly longer with lazertinib than with gefitinib (20.6 v 9.7 months; hazard ratio [HR], 0.45; 95% CI, 0.34 to 0.58; P < .001). The PFS benefit of lazertinib over gefitinib was consistent across all predefined subgroups. The objective response rate was 76% in both groups (odds ratio, 0.99; 95% CI, 0.62 to 1.59). Median duration of response was 19.4 months (95% CI, 16.6 to 24.9) with lazertinib versus 8.3 months (95% CI, 6.9 to 10.9) with gefitinib. Overall survival data were immature at the interim analysis (29% maturity). The 18-month survival rate was 80% with lazertinib and 72% with gefitinib (HR, 0.74; 95% CI, 0.51 to 1.08; P = .116). Observed safety of both treatments was consistent with their previously reported safety profiles. CONCLUSION: Lazertinib demonstrated significant efficacy improvement compared with gefitinib in the first-line treatment of EGFR-mutated advanced NSCLC, with a manageable safety profile.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Humanos , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/genética , Carcinoma de Pulmón de Células no Pequeñas/patología , Gefitinib/uso terapéutico , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología , Inhibidores de Proteínas Quinasas/efectos adversos , Receptores ErbB/genética , Mutación
3.
J Clin Med ; 12(3)2023 Feb 02.
Artículo en Inglés | MEDLINE | ID: mdl-36769843

RESUMEN

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a global pandemic and one group of patients has developed a severe form of COVID-19 pneumonia with an urgent need for hospitalization and intensive care unit (ICU) admission. The aim of our study was to evaluate the prognostic role of MDW, CRP, procalcitonin (PCT), and lactate in critically ill COVID-19 patients. The primary outcome of interest is the 28 day mortality of ICU patients with confirmed SARS-CoV-2 infection and sepsis (according to Sepsis 3 criteria with acute change in SOFA score ≥ 2 points). Patients were divided into two groups according to survival on the 28th day after admission to the ICU. Every group was divided into two subgroups (women and men). Nonparametric tests (Mann-Whitney) for variables age, PCT, lactate, and MDW were lower than alpha p < 0.05, so there was a significant difference between survived and deceased patients. The Chi-square test confirmed statistically significant higher values of MDW and lactate in the non-survivor group. We found a significant association between MDW, lactate, procalcitonin, and fatal outcome, higher values were reported in the deceased group.

4.
J Cancer ; 13(10): 3084-3090, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36046658

RESUMEN

Introduction: We have been using cryo-biopsy for endobronchial lesions for lung cancer diagnosis and debulking. Cryo-biopsy is also known to be an excellent tool for diagnosis of lung interstitial disease. Recently cryo-biopsy with the 1.1mm probe was used for lymphnode biopsy. Patients and Methods: 311 patients participated with lymphadenopathy and at least one lung lesion. The following tools were used for diagnosis; 22G Mediglobe Sonotip, 22G Medigolbe, 21G Olympus, 19G Olympus and 1.1mm cryo probe ERBE CRYO 2 system (3 seconds froze). A PENTAX Convex-probe EBUS was used for biopsy guidance. Results: Cell-blocks slices had a higher number in the 19G needle group (19G> Cryo Probe>22G Mediglobe Sonotip >21G Olympus >22G Mediglobe). Conclusion: Cryo biopsy of the lymphnodes is safe with the 1.1mm cryo probe. Further studies are needed in order to evaluate new probes and the technique specifications.

5.
J Cancer ; 13(10): 2982-2987, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36046659

RESUMEN

Background: There are still diagnostic issues with lung cancer and mediastinum lymphadenopathy. Endobronchial ultrasound (EBUS) is a state of the art equipment for the diagnosis of lymphadenopathy and central lesions. Objective: To investigate the sample size with one pass. Patients and Methods: 248 Stage IV patients were included in our study. All patients had a CT of the thorax with either lymphadenopathy or lyphadenopathy plus pulmonary lesions. Patients had a biopsy with endobronchial ultrasound with 22G Mediglope, 22G Mediglope Sonotip, 21G Olympus and 19G Olympus needle. We collected information regarding the cancer type, cell block, tissue, age, sex, lesion size and needle type. Results: The cancer type diagnosis was associated with the needle diameter. The number of cell-blocks were associated with the lesion size and needle diameter. Slices from the tissue and cell-blocks were again associated with the lesion size and needle diameter. Conclusion: One pass is enough for cancer diagnosis, however; careful selection has to be made among patients regarding the needle diameter. In the case of lymphoma suspicion we should use 19G needle.

6.
Dose Response ; 20(2): 15593258221111666, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35783235

RESUMEN

Background: This study aimed to evaluate for the first time whether certain genetic and clinical factors could serve as minimally invasive predictors of survival and toxicity to platinum-based chemotherapy in advanced lung adenocarcinoma. Methods: The study included 121 advanced lung adenocarcinoma patients treated with platinum-based dublets until progression or unacceptable toxicity. Response was evaluated using standard radiological methods and toxicity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Genotyping was performed using PCR-RFLP. Statistical significance was set at P < .05. Results: No significant influence of the examined polymorphisms on the occurrence of high-grade toxicity was detected. However, TP53 72Pro allele carriers were more prone to nausea (P = .037) and thrombocytopenia (P = .051). Anemia and neuropathy occurred more frequently in XRCC1 399Arg allele carriers (Pearson χ2 test, P = .025 and P = .004 respectively). RAD51 135CC carriers were significantly more prone to neutropenia (P = .027). Conclusions: A set of easily determined genetic and clinical predictors of survival and specific toxicity profiles of platinum-based chemotherapy in advanced lung adenocarcinoma were determined in this study, which might be useful for the construction of population-specific, time- and cost-efficient prognostic and predictive algorithms.

7.
JMIR Med Inform ; 10(6): e35307, 2022 Jun 02.
Artículo en Inglés | MEDLINE | ID: mdl-35653170

RESUMEN

BACKGROUND: Owing to the nature of health data, their sharing and reuse for research are limited by legal, technical, and ethical implications. In this sense, to address that challenge and facilitate and promote the discovery of scientific knowledge, the Findable, Accessible, Interoperable, and Reusable (FAIR) principles help organizations to share research data in a secure, appropriate, and useful way for other researchers. OBJECTIVE: The objective of this study was the FAIRification of existing health research data sets and applying a federated machine learning architecture on top of the FAIRified data sets of different health research performing organizations. The entire FAIR4Health solution was validated through the assessment of a federated model for real-time prediction of 30-day readmission risk in patients with chronic obstructive pulmonary disease (COPD). METHODS: The application of the FAIR principles on health research data sets in 3 different health care settings enabled a retrospective multicenter study for the development of specific federated machine learning models for the early prediction of 30-day readmission risk in patients with COPD. This predictive model was generated upon the FAIR4Health platform. Finally, an observational prospective study with 30 days follow-up was conducted in 2 health care centers from different countries. The same inclusion and exclusion criteria were used in both retrospective and prospective studies. RESULTS: Clinical validation was demonstrated through the implementation of federated machine learning models on top of the FAIRified data sets from different health research performing organizations. The federated model for predicting the 30-day hospital readmission risk was trained using retrospective data from 4.944 patients with COPD. The assessment of the predictive model was performed using the data of 100 recruited (22 from Spain and 78 from Serbia) out of 2070 observed (records viewed) patients during the observational prospective study, which was executed from April 2021 to September 2021. Significant accuracy (0.98) and precision (0.25) of the predictive model generated upon the FAIR4Health platform were observed. Therefore, the generated prediction of 30-day readmission risk was confirmed in 87% (87/100) of cases. CONCLUSIONS: Implementing a FAIR data policy in health research performing organizations to facilitate data sharing and reuse is relevant and needed, following the discovery, access, integration, and analysis of health research data. The FAIR4Health project proposes a technological solution in the health domain to facilitate alignment with the FAIR principles.

9.
Open Res Eur ; 2: 34, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-37645268

RESUMEN

Due to the nature of health data, its sharing and reuse for research are limited by ethical, legal and technical barriers. The FAIR4Health project facilitated and promoted the application of FAIR principles in health research data, derived from the publicly funded health research initiatives to make them Findable, Accessible, Interoperable, and Reusable (FAIR). To confirm the feasibility of the FAIR4Health solution, we performed two pathfinder case studies to carry out federated machine learning algorithms on FAIRified datasets from five health research organizations. The case studies demonstrated the potential impact of the developed FAIR4Health solution on health outcomes and social care research. Finally, we promoted the FAIRified data to share and reuse in the European Union Health Research community, defining an effective EU-wide strategy for the use of FAIR principles in health research and preparing the ground for a roadmap for health research institutions. This scientific report presents a general overview of the FAIR4Health solution: from the FAIRification workflow design to translate raw data/metadata to FAIR data/metadata in the health research domain to the FAIR4Health demonstrators' performance.

10.
Expert Rev Respir Med ; 15(11): 1483-1491, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34591723

RESUMEN

INTRODUCTION: Lung cancer is diagnosed at a late stage due to lack of early disease symptoms. Therefore an efficient treatment is necessary for prolonged disease free survival. PATIENTS AND METHODS: In our study we recruited 124 patients NSCLC patients with adenocarcinoma and squamus cell carcinoma. All recuited patients had Programmed death-ligand 1 expression ≥50 (PD-L1)with DAKO technique. Immunotherapy was administered with as first line treatment. Re-biopsies were performed in the main lung lesion every 4 months with the restaging of the patient and also in the metastastic sites in other organs that occurred during treatment. PD-L1 expressed was evaluated in the biopsies of the metastatic sites. RESULTS: It appears thereafter that the PD-L1 expression could easily be claimed as a promising bio-index with a cutoff value 65, below which a negative prognosis of the disease progress will be evident and above that value a positive continuation of the disease will be prominent. CONCLUSION: The findings of this study suggest that the PD-L1-65 index works adequately either concerning the neo-metastatic sites or the patient disease responses. Re-biopsies in new metastastic sites are necessary since we probably have a new cancer and chemotherapy should be added. More studies should confirm are results and change the NSCLC treatment approach of these patients.


Asunto(s)
Antígeno B7-H1 , Carcinoma de Pulmón de Células no Pequeñas , Inhibidores de Puntos de Control Inmunológico , Neoplasias Pulmonares , Biopsia , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Proyectos Piloto
11.
Lung Cancer Manag ; 10(3): LMT49, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34408790

RESUMEN

Endobronchial ultrasound (EBUS) is a very useful tool for the diagnosis of lymphadenopathy of the mediastinum. Nowadays, EBUS can substitute video-assisted thoracic surgery when a 19G needle is used. Several studies have provided data for efficient diagnosis not only for lung cancer, but for also sarcoidosis, tuberculosis and lymphoma. We present five cases of EBUS-transbronchial needle biopsy 19G needle used for the diagnosis of mediastinum lymphadenopathy. We present not only the pathological diagnosis, but also the steps for the differential clinical and pathological differential diagnosis for sarcoidosis, tuberculosis, cancer metastasis, respiratory infection and lymphoma.

12.
Expert Rev Respir Med ; 15(11): 1437-1445, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34403620

RESUMEN

INTRODUCTION: Lung cancer still remains undiagnosed for most patients until the disease is inoperable. AREAS COVERED: We performed search on PubMed with the keywords: EBUS, radial-EBUS, bronchoscopy, lung cancer, electromagnetic navigation, ct-biopsy, transthoracic biopsy. We present diagnostic equipment and imaging techniques such as positron emission tomography, endoscopical navigation systems, endobronchial ultrasound, radial-endobronchial ultrasound, transthoracic ultrasound biopsy, and computed tomography guided biopsies. EXPERT OPINION: However, lack of early disease symptoms remains the most important issue and therefore we should direct our efforts to screening and early disease diagnosis. An algorithm is proposed for biopsy upon initial disease diagnosis.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Algoritmos , Carcinoma de Pulmón de Células no Pequeñas/diagnóstico por imagen , Carcinoma de Pulmón de Células no Pequeñas/patología , Detección Precoz del Cáncer , Humanos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/patología , Estadificación de Neoplasias
13.
Cancer Chemother Pharmacol ; 88(3): 485-497, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34097100

RESUMEN

PURPOSE: Trifluridine/tipiracil (FTD/TPI) is approved for advanced colorectal and gastric/gastroesophageal cancer; however, data in patients with renal impairment (RI) are limited. This phase I study evaluated FTD/TPI in patients with advanced solid tumors and varying degrees of RI to develop dosing guidance. METHODS: Patients were enrolled into normal renal function (CrCl ≥ 90 mL/min), mild RI (CrCl 60-89 mL/min), or moderate RI (CrCl 30-59 mL/min) cohorts and administered the recommended FTD/TPI dose (35 mg/m2 twice daily, days 1-5 and 8-12; 28-day cycle). Based on interim pharmacokinetics/safety data, patients with severe RI (CrCl 15-29 mL/min) were enrolled and received FTD/TPI 20 mg/m2 twice daily. RESULTS: Forty-three patients (normal renal function [n = 12]; mild RI [n = 12]; moderate RI [n = 11]; severe RI [n = 8]) were enrolled and treated. At steady state, compared to values in patients with normal renal function, FTD area under the curve (AUC) was not significantly different in patients with RI, but TPI AUC was significantly higher and increased with RI severity. FTD/TPI safety profile was consistent with prior experience, but grade ≥ 3 adverse events (AEs) were more frequent in the RI cohorts (83.3% [mild], 90.9% [moderate], 75.0% [severe], and normal [50.0%]). Hematologic AEs (anemia and neutropenia) were more frequent with RI. Overall, seven patients discontinued because of unrelated, nonhematologic AEs. CONCLUSION: FTD/TPI is safe and tolerable at the recommended 35 mg/m2 dose in patients with mild/moderate RI and at the reduced 20 mg/m2 dose in patients with severe RI. TRIAL REGISTRATION: NCT02301117, registration date: November 21, 2014.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Enfermedades Renales/fisiopatología , Neoplasias/tratamiento farmacológico , Pirrolidinas/administración & dosificación , Timina/administración & dosificación , Trifluridina/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Anemia/inducido químicamente , Anemia/epidemiología , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/farmacocinética , Área Bajo la Curva , Estudios de Cohortes , Combinación de Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neutropenia/inducido químicamente , Neutropenia/epidemiología , Pirrolidinas/efectos adversos , Pirrolidinas/farmacocinética , Índice de Severidad de la Enfermedad , Timina/efectos adversos , Timina/farmacocinética , Trifluridina/efectos adversos , Trifluridina/farmacocinética
14.
Case Rep Oncol ; 14(2): 716-724, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34177521

RESUMEN

Traditionally, tissue availability from rebiopsy is a prerequisite for adequate sequencing of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in therapy for advanced-stage lung cancer. Tissue biopsy truly is the gold standard for genetic analyses, but in some cases, such as with inadequate localization of the lesion or a patient's inadequate performance status, comorbidities, or unwillingness to undergo an invasive procedure, liquid biopsy-based ctDNA analysis can be a noninvasive alternative approach. However, in some cases the gold standard might not shine that much. It is known that tumor heterogeneity or an inadequate amount of tissue might significantly interfere with the results of testing. In this paper, we present cases of patients with a negative tissue biopsy but a positive liquid biopsy which identified coexisting T790M mutation. These results enabled adequate sequencing and treatment with third-line EGFR-TKIs. Such possibilities stress the need to individualize testing for driver mutations in cases where it is clinically highly indicated.

15.
J Cancer ; 12(9): 2560-2569, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33854617

RESUMEN

Introduction: Immunotherapy is being used for the past five years either as first line or second line treatment with great results. Chemotherapy and radiotherapy have been also used as combination to immunotherapy to further enhance this type of treatment. Intratumoral treatment has been previously proposed as a treatment option for certain non-small cell lung cancer patients. Patients and Methods: We recruited in total seventy four patients with non-small cell lung cancer in their second line treatment who received only chemotherapy in their first line treatment with programmed death-ligand-1 ≤ 50. Only adenocarcinoma or squamous cell carcinoma, and all negative for epidermal growth factor receptor, anaplastic lymphoma kinase, proto-oncogene tyrosine-protein kinase-1 and proto-oncogene B-Raf. Data were first examined with descriptive statistics choosing frequencies for categorical variables and histograms for the continuous ones. Twenty five received only intravenous immunotherapy and forty-nine intravenous cisplatin with immunotherapy. Data were first examined with descriptive statistics choosing frequencies for categorical variables and histograms for the continuous ones. Results: The relationships between changes of performance status and disease progression were examined via a single correspondence analysis. The two-dimensional scores (coordinates) derived from the correspondence analysis were then regressed against the predictors to form distinct splits and nodes obtaining quantitative results. The best fit is usually achieved by lowering exhaustively the AICc criterion and looking in parallel the change of R2 expecting improvements more than 5%. both types of therapy are capable of producing best ameliorative effects, when either the programmed death-ligand-1 expression or parenchymal site in joint with low pack years are present in the sampling data. Conclusions: Intratumoral treatment combination with cisplatin plus immunotherapy indifferent of nivolumab or pembrolizumab combination is an effective choice. In specific for those with endobronchial lesions. Moreover; patients with programmed death-ligand-1 ≥ 50 had their performance status and disease progression improved over the eight month observation.

16.
Respir Med Case Rep ; 32: 101328, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33457198

RESUMEN

Bronchogenic cysts are rare congenital malformations which derive from primitive ventral foregut. They are usually observed in intrathoracically. A fifty year old male was admitted for the investigation of a three month chest pain. Computed tomography scan of the thorax revealed a lesion around the esophagus and left stem bronchus. Endobronchial ultrasound with convex probe and a 19G needle biopsy revealed a bronchogenic cystic which was removed with video assisted thoracic surgery. Initial radiologic assessment although was thought to be lung cancer because of the smoking habit it turned out to be benignancy. EBUS-TBNAB with 10G needle is safe and absolutely necessary for these lesions, as they take large samples.

17.
Expert Rev Med Devices ; 18(2): 197-201, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33482695

RESUMEN

INTRODUCTION: Thyroid cancer is usually diagnosed both with imaging techniques and transdermal biopsy. Laboratory tests are also included in the initial work-up. PATIENTS AND METHODS: One hundred and thirty patients were included in our study with pathological imaging findings in the thyroid region. Biopsies were performed with 22 G with transdermal convex probe, EBUS 22 G Mediglobe® needle and 19 G Olympus® needle. We investigated the efficiency and safety of both techniques and identified the best candidates for each method. DISCUSSION: 19 G needle identified cancer types such as; Lymphoma, Medullary thyroid cancer, and Hurthle cell cancer, which we know from previous pathology studies that a larger sample is necessary for diagnosis. No safety issues were observed for both techniques and the EBUS technique produced more cell block material when 22 G needle was compared to transdermal biopsy in peritracheal lesions. CONCLUSION: The method of biopsy should be made based on the size and accessibility of the lesion.


Asunto(s)
Biopsia por Aspiración con Aguja Fina Guiada por Ultrasonido Endoscópico , Neoplasias de la Tiroides/diagnóstico , Neoplasias de la Tiroides/patología , Análisis de Varianza , Biopsia por Aspiración con Aguja Fina Guiada por Ultrasonido Endoscópico/métodos , Humanos , Máscaras Laríngeas , Agujas , Estudios Retrospectivos
18.
Adv Ther ; 38(1): 350-365, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33123968

RESUMEN

INTRODUCTION: Multilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation). METHODS: In this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m2 or placebo before topotecan 1.5 mg/m2 on days 1-5 of each 21-day cycle. Primary endpoints were duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN). Additional endpoints were prespecified to further assess the effect of trilaciclib on myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy. RESULTS: Thirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P < 0.0001) and occurrence of SN (40.6% versus 75.9%; adjusted one-sided P = 0.016), with numerical improvements in additional neutrophil, red blood cell, and platelet measures. Patients receiving trilaciclib had fewer grade ≥ 3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%). Myelopreservation benefits extended to improvements in PROs, specifically in those related to fatigue. Antitumor efficacy was comparable between treatment arms. CONCLUSIONS: Compared with placebo, the addition of trilaciclib prior to topotecan for the treatment of patients with previously treated ES-SCLC improves the patient experience of receiving chemotherapy, as demonstrated by a reduction in chemotherapy-induced myelosuppression, improved safety profile, improved quality of life and no detrimental effects on antitumor efficacy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02514447.


Asunto(s)
Neoplasias Pulmonares , Carcinoma Pulmonar de Células Pequeñas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Método Doble Ciego , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Pirimidinas , Pirroles , Calidad de Vida , Topotecan/uso terapéutico
19.
Curr Health Sci J ; 47(4): 507-515, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-35444815

RESUMEN

BACKGROUND: The first wave of the COVID-19 pandemic initiated officially in October 2020. Since then several observations have been made regarding the disease and its symptoms. PATIENTS AND METHODS: We included eighty seven in our observational study. Our main aim was to investigate their long term respiratory follow-up in correlation with their initial radiological and laboratory findings and values. The nose swab PCR test for COVID-19 was used for diagnosis. Patients were monitored at 3 and 6 months after their hospital reception whereas basic parameters of health condition (smoking, PO2, SPO2, WBC, CXR, CRP, intercurrent findings, days of nursing, colchicine administration) in joint with gender and age were recorded. RESULTS: Males seem more susceptible to the viral disease than females in a ratio 1,8:1. The parameters FEV1 and FVC (as % relative changes) were not affected, apart from the DLCO to which CRP (in loge+1 transformation) and SPO2 showed a statistically significant effect. CONCLUSION: None of these patients were intubated, or admitted to the intensive care unit. The respiratory function is affected by the virus and the effect is reversed within the first three months. Males are more affected and the radiological and laboratory findings are associated with the respiratory functions.

20.
Expert Rev Respir Med ; 15(5): 675-679, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33275458

RESUMEN

Objectives: Lung cancer is still diagnosed at advanced stage and early treatment initiation is needed. Therefore, we need biomarkers or clusters of information that can provide early treatment prognosis.Methods: Biopsies were acquired from 471 patients-lung masses with CT-guided biopsy, convex probe transthorasic biopsy, and EBUS-TBNA convex probe with 18 G needles and 19 G needles.Results: Standardized uptake value (SUV) measurement is associated with female, smoking status, hepatic metastasis, adenocarcinoma and programmed death-ligand 1 (PD-L1). In specific we expect that SUV ≥ 7 is associated with PD-L1 ≥ 50.Conclusions: Lung masses indifferent of size that have SUV ≥ 7 will also have PD-L1 expression ≥ 50. Also, it is likely that these patients will be female with intense smoking habit and hepar or multiple metastasis.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Antígeno B7-H1 , Carcinoma de Pulmón de Células no Pequeñas/diagnóstico por imagen , Biopsia por Aspiración con Aguja Fina Guiada por Ultrasonido Endoscópico , Femenino , Humanos , Neoplasias Pulmonares/diagnóstico por imagen , Pronóstico
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