Validation of the CoVID-TE model as a tool to predict thrombosis, bleeding, and mortality in the oncology patient with Sars-Cov-2 infection: a study by the SEOM cancer and thrombosis group

Purpose The CoVID-TE model was developed with the aim of predicting venous thrombotic events (VTE) in cancer patients with Sars-Cov-2 infection. Moreover, it was capable of predicting hemorrhage and mortality 30 days following infection diagnosis. The model is pending validation. Methods/patients Multicenter retrospective study (10 centers). Adult patients with active oncologic disease/ antineoplastic therapy with Sars-Cov-2 infection hospitalized between March 1, 2020 and March 1. 2022 were recruited. The primary endpoint was to study the association between the risk categories of the CoVID-TE model and the occurrence of thrombosis using the Chi-Square test. Secondary endpoints were to demonstrate the association between these categories and the occurrence of post-diagnostic Sars-Cov-2 bleeding/ death events. The Kaplan–Meier method was also used to compare mortality by stratification. Results 263 patients were enrolled. 59.3% were men with a median age of 67 years. 73.8% had stage IV disease and lung cancer was the most prevalent tumor (24%). A total of 86.7% had an ECOG 0–2 and 77.9% were receiving active antineoplastic therapy. After a median follow-up of 6.83 months, the incidence of VTE, bleeding, and death 90 days after Sars-Cov-2 diagnosis in the low-risk group was 3.9% (95% CI 1.9–7.9), 4.5% (95% CI 2.3–8.6), and 52.5% (95% CI 45.2–59.7), respectively. For the high-risk group it was 6% (95% CI 2.6–13.2), 9.6% (95% CI 5.0–17.9), and 58.0% (95% CI 45.3–66.1). The Chi-square test for trends detected no statistically significant association between these variables (p > 0.05). Median survival in the low-risk group was 10.15 months (95% CI 3.84–16.46), while in the high-risk group it was 3.68 months (95% CI 0.0–7.79). The differences detected were not statistically significant (p = 0.375) (AU)

Validation of the CoVID-TE model as a tool to predict thrombosis, bleeding, and mortality in the oncology patient with Sars-Cov-2 infection: a study by the SEOM cancer and thrombosis group.

PURPOSE: The CoVID-TE model was developed with the aim of predicting venous thrombotic events (VTE) in cancer patients with Sars-Cov-2 infection. Moreover, it was capable of predicting hemorrhage and mortality 30 days following infection diagnosis. The model is pending validation. METHODS/PATIENTS: Multicenter retrospective study (10 centers). Adult patients with active oncologic disease/ antineoplastic therapy with Sars-Cov-2 infection hospitalized between March 1, 2020 and March 1. 2022 were recruited. The primary endpoint was to study the association between the risk categories of the CoVID-TE model and the occurrence of thrombosis using the Chi-Square test. Secondary endpoints were to demonstrate the association between these categories and the occurrence of post-diagnostic Sars-Cov-2 bleeding/ death events. The Kaplan-Meier method was also used to compare mortality by stratification. RESULTS: 263 patients were enrolled. 59.3% were men with a median age of 67 years. 73.8% had stage IV disease and lung cancer was the most prevalent tumor (24%). A total of 86.7% had an ECOG 0-2 and 77.9% were receiving active antineoplastic therapy. After a median follow-up of 6.83 months, the incidence of VTE, bleeding, and death 90 days after Sars-Cov-2 diagnosis in the low-risk group was 3.9% (95% CI 1.9-7.9), 4.5% (95% CI 2.3-8.6), and 52.5% (95% CI 45.2-59.7), respectively. For the high-risk group it was 6% (95% CI 2.6-13.2), 9.6% (95% CI 5.0-17.9), and 58.0% (95% CI 45.3-66.1). The Chi-square test for trends detected no statistically significant association between these variables (p > 0.05). Median survival in the low-risk group was 10.15 months (95% CI 3.84-16.46), while in the high-risk group it was 3.68 months (95% CI 0.0-7.79). The differences detected were not statistically significant (p = 0.375). CONCLUSIONS: The data from our series does not validate of the CoVID-TE as a model to predict thrombosis, hemorrhage, or mortality in cancer patients with Sars-Cov-2 infection.

Immune checkpoint inhibitor-associated thrombosis in patients with bladder and kidney cancer: a study of the Spanish Society of Medical Oncology (SEOM) thrombosis and cancer group.

PURPOSE: Both venous and arterial thrombotic events (VTE/AT) can be associated with immune checkpoint inhibitors (ICI). However, there is a paucity of information apropos patients in routine clinical practice. METHODS/PATIENTS: Retrospective, multicenter study promoted by the Thrombosis and Cancer Section of the Spanish Society of Medical Oncology (SEOM). Individuals with kidney or bladder cancer who initiated ICI between 01/01/2015 and 12/31/2020 were recruited. Minimum follow-up was 6 months (except in cases of demise). The primary objective was to calculate the incidence of ICI-associated VTE/AT and secondary objectives included to analyze their impact on survival and identify variables predictive of VTE/AT. RESULTS: 210 patients with kidney cancer were enrolled. The incidence of VTE/AT during follow-up (median 13 months) was 5.7%. Median overall survival (OS) was relatively lower among subjects with VTE/AT (16 months, 95% CI 0.01-34.2 vs. 27 months, 95% CI 22.6-31.4; p = 0.43). Multivariate analysis failed to reveal predictive variables for developing VTE/ AT. 197 patients with bladder were enrolled. There was a 9.1% incidence rate of VTE/AT during follow-up (median 8 months). Median OS was somewhat higher in patients with VTE/AT (28 months, 95% CI 18.4-37.6 vs 25 months, 95% CI 20.7-29.3; p = 0.821). Serum albumin levels < 3.5 g/dl were predictive of VTE/ AT (p < 0.05). CONCLUSIONS: There appears to be no association between developing VTE/AT and ICI use in patients with renal or bladder cancer. Serum albumin levels are a predictive factor in individuals with bladder cancer.

Incidence, risk factors, and evolution of venous thromboembolic events in patients diagnosed with pancreatic carcinoma and treated with chemotherapy on an outpatient basis.

BACKGROUND: Pancreatic carcinoma is one of the tumors associated with a higher risk for thromboembolic events, with incidence rates ranging from 5% to 41% in previous retrospective series. PATIENTS AND METHODS: We conducted a retrospective study in eleven Spanish hospitals that included 666 patients diagnosed with pancreatic carcinoma (any stage) between 2008 and 2011 and treated with chemotherapy. The main objective was to evaluate the incidence of venous thromboembolic events (VTE) in this population, as well as potential risk factors for thrombosis. The impact of VTE on mortality was also assessed. RESULTS: With a median follow-up of 9.3 months, the incidence of VTE was 22.1%; 52% were diagnosed incidentally. Our study was unable to confirm the ability of the Khorana score to discriminate between patients in the intermediate or high risk category for thrombosis. The presence of VTE proved to be an independent prognostic factor associated with increased risk of death (HR 2.39, 95% CI 1.96-2.92). Symptomatic events correlated with higher mortality than asymptomatic events (HR 1.72; 95% CI, 1.21-2.45; p = 0.002), but incidental VTE, including visceral vein thrombosis (VVT), negatively affected survival compared to patients without VTE. Subjects who developed VTE within the first 3 months of diagnosis of pancreatic carcinoma had lower survival rates than those with VTE after 3 months (HR 1.92, 95% CI 1.30-2.84; p<0.001). CONCLUSIONS: Pancreatic carcinoma is associated with a high incidence of VTE, which, when present, correlates with worse survival, even when thrombosis is incidental. Early onset VTE has a particularly negative impact.

Molecular characterization of triple negative breast cancer formaldehyde-fixed paraffin-embedded samples by data-independent acquisition proteomics.

Triple negative breast cancer accounts for 15%-20% of all breast carcinomas and is clinically characterized by an aggressive phenotype and poor prognosis. Triple negative tumors do not benefit from targeted therapies, so further characterization is needed to define subgroups with potential therapeutic value. In this work, the proteomes of 125 formalin-fixed paraffin-embedded samples from patients diagnosed with non-metastatic triple negative breast cancer were analyzed using data-independent acquisition + in a LTQ-Orbitrap Fusion Lumos mass spectrometer coupled to an EASY-nLC 1000. 1206 proteins were identified in at least 66% of the samples. Hierarchical clustering, probabilistic graphical models and Significance Analysis of Microarrays were combined to characterize proteomics-based molecular groups. Two molecular groups were defined with differences in biological processes such as glycolysis, translation and immune response. These two molecular groups showed also several differentially expressed proteins. This clinically homogenous dataset may serve to design new therapeutic strategies in the future.

Diagnóstico: pautas diagnósticas y la adecuada gestión del dolor basal y del dolor irruptivo / Diagnosis: diagnostic criteria and adequate management of background and breakthrough pain

Hasta hace unos años, el dolor oncológico se consideraba una condición clínica única, pero estudios recientes nos han permitido diferenciar entre dolor basal y dolor irruptivo. Estos tipos de dolor difieren claramente en su forma de inicio, intensidad y duración, lo que condiciona un manejo específico para cada uno de ellos. Una correcta evaluación de las características del dolor, así como de sus causas, nos permitirá un adecuado diagnóstico y un óptimo tratamiento. La ausencia de consenso unánime respecto a la definición de dolor irruptivo ha llevado a dificultades a la hora de estimar su prevalencia real. Se ha descrito en el 33-95% de los pacientes con dolor crónico oncológico. El dolor irruptivo tiene un impacto negativo en la calidad de vida de los pacientes, por lo que es imprescindible que los profesionales sanitarios sepan identificarlo y tratarlo adecuadamente

Until a few years ago, cancer pain was considered a unique clinical entity. However, recent studies have allowed a distinction to be made between background and breakthrough pain. These types of pain clearly differ in their form of onset, intensity and duration, leading to specific management for each. Adequate assessment of the characteristics of the pain and its causes allows correct diagnosis and optimal treatment. Because of the lack of consensus on the definition of breakthrough pain, it is difficult to estimate its true prevalence. Breakthrough pain has been described in 33%-95% of patients with chronic cancer pain. This type of pain impairs quality of life and it is therefore essential that health professionals are well versed in its correct identification and treatment

Tratamiento del dolor irruptivo / Treatment of breakthrough pain

El dolor irruptivo oncológico es un dolor transitorio, de corta duración (generalmente menos de 60 min), que alcanza su máxima intensidad en 15 min y aparece a pesar de un adecuado tratamiento del dolor basal con analgesia pautada a horas fijas. Estos episodios de dolor irruptivo oncológico se tratan con medicación “de rescate”. Debido a sus características clínicas y a la intensidad de los episodios, el fármaco ideal para su tratamiento sería un opioide de inicio rápido, corta duración del efecto y pocos efectos secundarios. Tradicionalmente, en esta situación se han utilizado los opioides de liberación rápida administrados por vía oral. Sin embargo, las nuevas formulaciones de fentanilo, que se absorben de forma rápida a través de las mucosas (oral e intranasal) parecen adaptarse mejor al patrón temporal de los episodios de dolor irruptivo oncológico. El éxito en el manejo de los episodios de dolor irruptivo dependerá de unas adecuadas identificación y evaluación

Breakthrough cancer pain is a transient, short-lasting (usually less than 60 minutes) exacerbation of pain that reaches maximum intensity within 15 minutes and occurs despite adequate treatment of background pain with around-the-clock analgesia. These episodes of breakthrough pain are treated with “rescue” analgesia. Due to the clinical characteristics and intensity of these exacerbations, the ideal drug for the treatment of breakthrough pain would be a rapid-onset, short-acting opioid with few secondary effects. Traditionally, oral rapid-release opioids have been used in this situation. However, the new fentanyl formulations, which are rapidly absorbed through the mucous membranes (oral, intranasal), seem to be better adapted to the temporal pattern of episodes of breakthrough pain. The success of the management of these episodes depends on adequate identification and evaluation

Tratamiento paliativo del cáncer colorrectal / Palliative treatment of colorectal cancer

El tratamiento de los pacientes con cáncer colorrectal (CCR) metastásico ha cambiado drásticamente en los últimos años. Hasta la década de los noventa la única opción terapéutica era el 5-FU en sus diferentes esquemas de administración, como son la modulación con leucovorín o la infusión continua. Los nuevos fármacos como el CPT-11, oxaliplatino, raltitrexed y fluoropirimidinas orales poseen una marcada actividad y han permitido mejorar los resultados del CCR. Las combinaciones de 5-FU/leucovorín con irinotecán o con oxaliplatino en primera línea han incrementado la supervivencia y la tasa de respuestas, lo que ha permitido el desarrollo de la neoadyuvancia en pacientes con metástasis hepáticas y contribuido a aumentar la tasa de resecciones curativas. Las fluoropirimidinas orales (UFT y capecitabina) poseen una actividad comparable al 5-FU en bolo en primera línea y puede que lleguen a sustituirlo en las combinaciones aportando menor toxicidad y la comodidad de la vía oral. Los nuevos agentes que actúan sobre dianas moleculares muestran una actividad prometedora y llegarán a formar parte de los esquemas terapéuticos futuros del CCR metastásico. (AU)