Elena Brozos-Vázquez

Complexo Hospitalario Universitario A Coruña

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Rafael López‐López

Instituto de Investigación Sanitaria de Santiago

Yolanda Vidal-Ínsua

Complejo Hospitalario Universitario de Santiago

Ignacio Escobar

Bellvitge University Hospital

Sonia Candamio-Folgar

Universidade de Santiago de Compostela

Francisca Vázquez-Rivera

Complejo Hospitalario Universitario de Santiago

Laura Muinelo‐Romay

Instituto de Investigación Sanitaria de Santiago

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Ángel Díaz‐Lagares

Servicio Gallego de Salud

Nicolás Costa‐Fraga

Universidade de Santiago de Compostela

Enrique Aranda

Centro de Investigación Biomédica en Red de Cáncer

Andrés J. Muñoz Martín

Hospital General Universitario Gregorio Marañón

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Servicio Gallego de Salud

Complexo Hospitalario Universitario A Coruña

Universidade de Santiago de Compostela

Complejo Hospitalario Universitario de Santiago

Instituto de Investigación Sanitaria de Santiago

Universidade da Coruña

Centro de Investigación Biomédica en Red de Cáncer

Instituto de Salud Carlos III

Instituto de Investigación Biomédica de A Coruña

University Hospital Complex Of Vigo

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SEOM clinical guidelines on venous thromboembolism (VTE) and cancer (2023)

Clinical & Translational Oncology (2024)

Laura Ortega Francisco José Pelegrín Mateo Rut Porta Balanyà Jacobo Rogado Silverio Ros

Abstract The Spanish Society of Medical Oncology (SEOM) last published clinical guidelines on venous thromboembolism (VTE) and cancer in 2019, with a partial update in 2020. In this new update to the guidelines, SEOM seeks to incorporate recent evidence, based on a critical review of the literature, to provide practical current recommendations for the prophylactic and therapeutic management of VTE in patients with cancer. Special clinical situations whose management and/or choice of currently recommended therapeutic options (low-molecular-weight heparins [LMWHs] or direct-acting oral anticoagulants [DOACs]) is controversial are included.

10.1007/s12094-024-03605-2

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Direct oral anticoagulants for the treatment and prevention of venous thromboembolism in patients with cancer: current evidence

Clinical & Translational Oncology (2020)

Ignacio Escobar Elena Brozos-Vázquez David Gutiérrez Abad Virginia Martínez-Marín Vanessa Pachón

Abstract Venous thromboembolic disease (VTED) is a common and clinically important complication in patients with cancer, contributing to its mortality and morbidity. Direct oral anticoagulant agents (DOACs), including direct thrombin inhibitors and direct factor Xa inhibitors, are as effective as vitamin K antagonists for the treatment of VTED and are associated with less frequent and severe bleeding. They have advantages over low-molecular-weight heparin, but comparative long-term efficacy and safety data are lacking for these compounds. Recent randomized clinical trials suggest a role for DOACs in the treatment of VTED in patients with cancer. This review will discuss the existing evidence and future perspectives on the role of DOACs in the treatment of VTE based on the current evidence about their overall efficacy and safety and the limited information in patients with cancer; in addition, we will briefly review their pharmacokinetic properties with special reference to potential interactions.

Venous thromboembolic disease

10.1007/s12094-020-02506-4

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Effectiveness and safety of encorafenib-cetuximab in BRAF^V600E metastatic colorectal cancer: Confidence study.

Journal of Clinical Oncology (2023)

Ana Fernández Montés Javier Ros Begoña Graña Pilar García‐Alfonso Elena Brozos-Vázquez

126 Background: BRAF V600E mutant metastatic colorectal cancer (mCRC) has a poor prognosis. The BEACON trial demonstrated an improvement in tumor response, overall survival (OS), and progression-free survival (PFS) when administering encorafenib-cetuximab (EC) to patients (pts) who progressed after 1 or 2 therapy lines. This study provides a retrospective analysis of the effectiveness and safety of EC in the real-world setting in Spain. Methods: This retrospective analysis included BRAF V600E mCRC pts treated with EC in 2 nd line treatment, recruited from March to July 2022. The Co-primary study endpoints included effectiveness based on PFS and OS. Secondary endpoints included sociodemographic and clinical characteristics of patients before EC initiation, overall response rate (ORR), and safety. Results: From March to July 2022, 81 evaluable pts were included. Sociodemographic and clinical characteristics are displayed.A median (interquartile range [IQR]) of 6.0 (4.0-13.0) cycles of encorafenib and 6.0 (4.0-14.5) cycles of cetuximab were administered. Median treatment duration was 4.4 (2.6-7.8) months (m) and 4.4 m (2.8-7.6) respectively. The ORR and disease control rate was 33.8 % (CI 95% 23.4-45.5) and 68.8 (CI 95% 57.3 – 78.9) respectively. One (1.2%) pt achieved complete response At data cut-offwith a 9.7 median follow-up, 50 (61.7%) pts had died, all of them due to disease progression. Median (95% Confidence Interval, CI) OS was 12.6 m (8.0-17.3) and median PFS was 5.0 m (3.8-6.2). The 12-m OS and 12-m PFS rates were 54.6% (95% CI, 43.3-65.9) and 19.9% (10.5-29.3) respectively. Pts with neutrophils/lymphocyte ratio (NLR) ≥3 had worse OS (HR, 1.8 95% CI 1.0-3.2; p < 0.049) and worse PFS (HR, 2.3, 1.4-3.8; p < 0.002). Disease progression (86.7%) was the most frequent cause of treatment discontinuation, followed by unacceptable AEs (3.7%). Eleven pts (13.5%) experienced treatment-related graded 3 or 4 AEs, mainly acne (3.7%). Treatment-related deaths were not reported. Conclusions: This study provides real-world data of BRAF V600E mCRC pts treated with EC combination in routine clinical practice in Spain. EC effectiveness and safety were consistent with the results obtained in clinical trials. [Table: see text]

Interquartile range

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Progression-free survival

10.1200/jco.2023.41.4_suppl.126

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Clinical significance of baseline Pan-Immune-Inflammation Value and its dynamics in metastatic colorectal cancer patients under first-line chemotherapy

Scientific Reports (2022)

Martín Pérez-Martelo Alejandro González-García Yolanda Vidal-Ínsua Cristina Blanco-Freire Elena Brozos-Vázquez

Abstract Pan-Immune-Inflammation Value (PIV) has been recently proposed as a new blood-based prognostic biomarker in metastatic colorectal cancer (mCRC). Herein we aimed to validate its prognostic significance and to evaluate its utility for disease monitoring in patients with mCRC receiving first-line chemotherapy. We conducted a single-centre retrospective study involving 130 previously untreated mCRC patients under first-line standard chemotherapy in a real-world scenario. PIV was calculated as (neutrophil count × platelet count × monocyte count)/lymphocyte count at three different time-points: baseline, week 4 after therapy initiation, and at disease progression. We analyzed the influence of baseline PIV on overall survival (OS), progression-free survival (PFS), disease control rate (DCR), and overall response rate (ORR). We also explored the utility of PIV dynamics for disease monitoring. Baseline PIV high was significantly associated with worse OS in univariate [hazard ratio (HR) = 2.10, 95% CI, 1.41–3.15; p = 0.000299] and multivariate (HR = 1.82, 95% CI, 1.15–2.90; p = 0.011) analyses. Baseline PIV was also associated with worse PFS in univariate (HR = 2.04, 95% CI, 1.40–2.97; p = 0.000187) and multivariate (HR = 1.56, 95% CI, 1.05–2.31; p = 0.026) analyses. Baseline PIV was not correlated either with DCR or ORR. Regarding PIV dynamics, there was a statistically significant increase from week 4 to disease progression ( p = 0.0003), which was at the expense of cases with disease control as best response ( p < 0.0001). In conclusion, this study validates the prognostic significance of baseline PIV in patients with mCRC receiving first-line standard chemotherapy in a real-world scenario. Moreover, it suggests the potential utility of PIV monitoring to anticipate the disease progression among those patients who achieve initial disease control.

Univariate analysis

10.1038/s41598-022-10884-8

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Citations (14)

Contributors

Elsevier eBooks (2021)

José Francisco Noguera Aguilar Mohammed Alhayek-Aí Pedro A. Alonso Aguirre Paula Álvarez-Chaver Sara Alvarez-Gonzalez

10.1016/b978-0-323-90055-3.09988-9

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Safety and efficacy of encorafenib–cetuximab combination in BRAF-mutated metastatic colorectal cancer: real-world evidence from the CONFIDENCE Spanish multicenter study

ESMO Real World Data and Digital Oncology (2024)

Ana Fernández Montés Javier Ros Pilar García‐Alfonso Ana Fernández Montés Elena Brozos-Vázquez

•RW effectiveness and safety of EC align with data from clinical trials.•Better survival outcomes may be potentially derived from early EC administration.•Factors of poor prognosis need to be further investigated to reach consensus. BackgroundDual blockade therapy encorafenib–cetuximab (EC) was recently established as the standard of care for second- or third-line treatment for BRAFV600E-mutated metastatic colorectal cancer (mCRC) patients based on BEACON phase III study results. The CONFIDENCE study aims to provide insight about the real-world (RW) safety and effectiveness of EC in a Spanish cohort.Materials and methodsThis retrospective study included BRAFV600E-mutated mCRC patients treated in second line with EC in the RW setting. The primary endpoint (EC effectiveness) was measured by progression-free survival (PFS) and overall survival (OS). Key secondary endpoints were overall response rate (ORR), disease control rate (DCR), duration of response (DoR), potential factors affecting PFS and OS and safety.ResultsEighty-one patients were included after at least 5 months of follow-up before study onset, 50.6% female with a median age of 66.1 years. Overall, 65% of patients debuted with synchronous metastatic disease. Patients received a median of six EC cycles. The median OS and PFS after 9.7 months of follow-up were 12.6 and 5.0 months, respectively. The median DoR was 5.8 months. ORR was 33.8% and DCR was 68.8%. Alkaline phosphatase, neutrophil/lymphocyte ratio and three or more metastatic lesions were accurate prognostic factors for OS. Additionally, the presence of liver metastases has prognostic value for PFS. The most reported adverse events (AEs) were skin-related toxicities (43.2%). Grade ≥3 AEs occurred in 13.5% of patients.ConclusionsOur results align with the BEACON trial results, confirming the safety and efficacy of EC in the RW setting and additionally provide insight about survival prognostic factors. Dual blockade therapy encorafenib–cetuximab (EC) was recently established as the standard of care for second- or third-line treatment for BRAFV600E-mutated metastatic colorectal cancer (mCRC) patients based on BEACON phase III study results. The CONFIDENCE study aims to provide insight about the real-world (RW) safety and effectiveness of EC in a Spanish cohort. This retrospective study included BRAFV600E-mutated mCRC patients treated in second line with EC in the RW setting. The primary endpoint (EC effectiveness) was measured by progression-free survival (PFS) and overall survival (OS). Key secondary endpoints were overall response rate (ORR), disease control rate (DCR), duration of response (DoR), potential factors affecting PFS and OS and safety. Eighty-one patients were included after at least 5 months of follow-up before study onset, 50.6% female with a median age of 66.1 years. Overall, 65% of patients debuted with synchronous metastatic disease. Patients received a median of six EC cycles. The median OS and PFS after 9.7 months of follow-up were 12.6 and 5.0 months, respectively. The median DoR was 5.8 months. ORR was 33.8% and DCR was 68.8%. Alkaline phosphatase, neutrophil/lymphocyte ratio and three or more metastatic lesions were accurate prognostic factors for OS. Additionally, the presence of liver metastases has prognostic value for PFS. The most reported adverse events (AEs) were skin-related toxicities (43.2%). Grade ≥3 AEs occurred in 13.5% of patients. Our results align with the BEACON trial results, confirming the safety and efficacy of EC in the RW setting and additionally provide insight about survival prognostic factors.

10.1016/j.esmorw.2024.100055

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Characterization of thrombosis risk in ambulatory patients with cancer: results of the observational, prospective, multicenter CARTAGO study

The Oncologist (2024)

Javier Trujillo‐Santos Ignacio Escobar Mercedes Salgado Fernández António Araújo Eva Martínez de Castro

Abstract Background Venous thromboembolism (VTE) is one of the leading causes of death in patients with cancer. Currently, there is a need to develop an easily applicable risk model that can identify patients who will benefit from receiving primary thromboprophylaxis to reduce the incidence of VTE. Patients and methods This was a non-interventional, multicenter, observational, prospective study carried out in 62 Oncology and Hematology services in Spain and Portugal between January 2018 and December 2019. The main objective of the CARTAGO study was to develop a predictive model within a competitive risk framework to assess the risk of VTE in patients with cancer undergoing chemotherapy, biological, or hormonal treatment. Results A total of 1596 patients were analyzed. VTE events occurred in 124 (8%) during the 6-month follow-up period (42% of deep vein thrombosis [DVT], 48% of pulmonary embolism [PE], and 10% of both DVT and PE). Four variables were selected for the multivariate predictive model to determine the risk of VTE (tumor type, D-dimer, compression of a vessel by the tumor, and leukocyte count). The 4 variables were associated with an increased risk of VTE (C-statistic, 0.646 [95%CI, 0.620-0.673]). The most significant variables in the internal validation with bootstrapping were the “very high risk” tumors (hazard ratio [HR] 2.032; 95%CI, 1.287-3.211). Conclusion The CARTAGO model predicts the VTE risk in patients with cancer receiving anticancer therapy in an outpatient setting. This model can easily aid in identifying ambulatory patients who would probably benefit from primary thromboprophylaxis.

10.1093/oncolo/oyae334

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Effective Optimisation of the Patient Circuits of an Oncology Day Hospital: Mathematical Programming Models and Case Study

Mathematics (2021)

Adrián González‐Maestro Elena Brozos-Vázquez Balbina Casas‐Méndez Rafael López‐López Rosa López-Rodríguez

In this paper, we first use the information we have on the patients of an oncology day hospital to distribute the treatment schedules they have in each of the visits to this centre. To do this, we propose a deterministic mathematical programming model in such a way that we minimise the duration of the waiting room stays of the total set of patients and taking into account the restrictions of the circuit. Secondly, we will look for a solution to the same problem under a stochastic approach. This model will explicitly consider the existing uncertainty in terms of the different times involved in the circuit, and this model also allows the reorganisation of the schedules of medical appointments with oncologists. The models are complemented by a tool that solves the problem of assigning nurses to patients. The work is motivated by the particular characteristics of a real hospital and the models are used and compared with data from this case.

10.3390/math10010062

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Citations (2)

437P Designing clinical profiles that influence the discordance of RAS mutations in blood and tissue: Sidedness and anatomical metastasis as factors of disagreement

Annals of Oncology (2020)

Elena Brozos-Vázquez Ramón Manuel Lago‐Lestón M. Covela-Rúa J. De la Cámara-Gómez Ana Fernández Montés

Concordance

Liquid biopsy

Primary tumor

10.1016/j.annonc.2020.08.548

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Improvement of thrombosis management in patients with cancer: a practical consensus document of recommendations for cancer-associated thrombosis patients’ healthcare in Spain

Clinical & Translational Oncology (2024)

Andrés J. Muñoz Martín Antonio Javier Trujillo-Santos Edelmira Martí Luis Jara‐Palomares Raquel Macías Montero

Abstract Cancer patients are at risk of venous thromboembolism (VTE), its recurrence, but also at risk of bleeding while anticoagulated. In addition, cancer therapies have been associated to increased VTE risk. Guidelines for VTE treatment in cancer patients recommend low molecular weight heparins (LMWH) or direct oral anticoagulants (DOAC) for the initial treatment, DOAC for VTE short-term treatment, and LMWH or DOAC for VTE long-term treatment. This consensus article arises from a collaboration between different Spanish experts on cancer-associated thrombosis. It aims to reach an agreement on a practical document of recommendations for action allowing the healthcare homogenization of cancer-associated thrombosis (CAT) patients in Spain considering not only what is known about VTE management in cancer patients but also what is done in Spanish hospitals in the clinical practice. The text summarizes the current knowledge and available evidence on the subject in Spain and provides a series of practical recommendations for CAT management and treatment algorithms to help clinicians to manage CAT over time.

Clinical Practice

10.1007/s12094-023-03379-z

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