[Nutritional assessment and intervention in hospitalized cancer patients at risk of or with malnutrition: evaluation of the effect on anthropometric and body composition parameters]. / Valoración e intervención nutricional en pacientes oncológicos hospitalizados en riesgo de desnutrición o con desnutrición: evaluación del efecto sobre parámetros antropométricos y de composición corporal.

Introduction: Introduction: malnutrition is a common problem in cancer patients that worsens during hospitalization and is associated with increased morbidity and mortality, and impaired quality of life. Objectives: to describe the effect of implementing a nutritional assessment and support protocol on the nutritional status of hospitalized cancer patients. Methods: a prospective, cross-sectional, non-controlled, quasi-experimental study in cancer patients admitted to an oncology service consecutively regardless of their nutritional status between September 2019 and March 2020. Anthropometric parameters, body composition, and hand grip strength were measured at admission and discharge. The percentage of patients with malnutrition, dynapenia, and sarcopenia at admission and discharge was calculated. Results: a total of 90 cancer patients participated in this study (mean age: 66 years, 67.8 % men); 33.2 % of the patients had a tumor in the gastrointestinal tract and 73.3 % of the patients were in stage IV; 95 % required nutritional support (nutritional supplementation, enteral nutrition or parenteral nutrition). After the nutritional intervention, no differences were found in the anthropometric parameters with a mean weight loss of 0.1, although improvements in body composition were observed. The percentage of malnourished patients remained stable on admission and discharge regardless of the criteria used. Conclusions: the implementation of a protocol for assessment and nutritional support at admission in cancer patients may help prevent or delay the worsening of their nutritional status during hospital stay.

Introducción: Introducción: la desnutrición es un problema frecuente en los pacientes oncológicos que empeora durante la hospitalización y se asocia con mayor morbimortalidad y deterioro de la calidad de vida. Objetivos: describir el efecto de la implantación de un protocolo de valoración y soporte nutricional sobre el estado nutricional de pacientes oncológicos hospitalizados. Métodos: estudio prospectivo, no controlado y cuasiexperimental en pacientes oncológicos ingresados en un servicio de oncología de forma consecutiva, independientemente de su estado nutricional, entre septiembre de 2019 y marzo de 2020. Se determinaron los parámetros antropométricos, la composición corporal y la fuerza prensora de la mano al ingreso y al alta. Se calculó el porcentaje de pacientes con desnutrición, dinapenia y sarcopenia al ingreso y al alta. Resultados: un total de 90 pacientes oncológicos participaron en este estudio (edad media: 66 años, 67,8 % hombres). El 33,2 % de los pacientes presentaban un tumor en el tracto gastrointestinal y el 73,3 % de los pacientes se encontraban en estadio IV. El 95 % necesitaron soporte nutricional (suplementación nutricional, nutrición enteral o nutrición parenteral). Tras la intervención nutricional no se encontraron diferencias en los parámetros antropométricos, con una pérdida de peso media de 0,1, aunque se observaron mejorías en la composición corporal. El porcentaje de pacientes desnutridos se mantuvo estable al ingreso y al alta independientemente del criterio empleado Conclusiones: la implementación de un protocolo de valoración y soporte nutricional al ingreso en pacientes oncológicos puede ayudar a evitar o retrasar el empeoramiento de su estado nutricional durante la hospitalización.

Relation of Malnutrition and Nosocomical Infections in Cancer Patients in Hospital: An Observational Study.

Aim: To investigate the relation between malnutrition and nosocomial infections (NI) in hospitalized cancer patients. Methods: This observational, cross-sectional, noninterventional, descriptive study was conducted in a 500-bed university hospital in Valencia (Spain). Adult cancer patients admitted to the oncology ward were consecutively enrolled regardless of their nutritional status between November 2019 and March 2020. Patients were nutritionally assessed 24 to 48 hours after admission. Body weight, height and BMI, body composition through measurement of bioelectrical impedance analysis (BIA), and muscle strength and functionality using hand grip strength (HGS) were prospectively collected. The diagnosis of malnutrition and sarcopenia was assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria and the European Working Group on Sarcopenia in Older People (EWGSOP) criteria, respectively. Patients were followed up during their hospital stay or outpatient oncology visits to identify possible NI. Results: A total of 107 patients were included in this study (mean age 66 years; 66.4% were men). The most frequent reason for admission was cancer treatment (19.6%), followed by infections (18.7%) and digestive tract symptoms (18.7%). Overall, 77.5% (83/107) of the patients were malnourished at admission according to the GLIM criteria, while 52.3% (56/107) were sarcopenic. Nosocomial infections (NI) were significantly more frequent in malnourished (52.1%; 25/48) and severely malnourished (42.1%; 8/19) patients, compared with well-nourished patients without malnutrition (25%; 10/40; p=0.035). The mean length of hospital stay was 13.9 days, significantly longer in patients with an NI compared to those without infections (18.6 vs. 10.8 days, p < 0.024). Conclusion: This study evidenced the need to implement a routine protocol for the nutritional assessment and support of cancer patients at risk of malnutrition and sarcopenia to reduce the risk of NI during their hospital stay.

Programmed Death-Ligand 1 (PD-L1) as Immunotherapy Biomarker in Breast Cancer.

Breast cancer constitutes the most common malignant neoplasm in women around the world. Approximately 12% of patients are diagnosed with metastatic stage, and between 5 and 30% of early or locally advanced BC patients will relapse, making it an incurable disease. PD-L1 ligation is an immune inhibitory molecule of the activation of T cells, playing a relevant role in numerous types of malignant tumors, including BC. The objective of the present review is to analyze the role of PD-L1 as a biomarker in the different BC subtypes, adding clinical trials with immune checkpoint inhibitors and their applicable results. Diverse trials using immunotherapy with anti-PD-1/PD-L1 in BC, as well as prospective or retrospective cohort studies about PD-L1 in BC, were included. Despite divergent results in the reviewed studies, PD-L1 seems to be correlated with worse prognosis in the hormone receptor positive subtype. Immune checkpoints inhibitors targeting the PD-1/PD-L1 axis have achieved great response rates in TNBC patients, especially in combination with chemotherapy, making immunotherapy a new treatment option in this scenario. However, the utility of PD-L1 as a predictive biomarker in the rest of BC subtypes remains unclear. In addition, predictive differences have been found in response to immunotherapy depending on the stage of the tumor disease. Therefore, a better understanding of tumor microenvironment, as well as identifying new potential biomarkers or combined index scores, is necessary in order to make a better selection of the subgroups of BC patients who will derive benefit from immune checkpoint inhibitors.

Update on systemic treatment in early triple negative breast cancer.

Triple negative breast cancer (TNBC) is a heterogeneous disease representing about 15% of all breast cancers. TNBC are usually high-grade histological tumors, and are generally more aggressive and difficult to treat due to the lack of targeted therapies available, and chemotherapy remains the standard treatment. There is a close relationship between pathological complete response after chemotherapy treatment and higher rates of disease-free survival and overall survival. In this review of systemic treatment in early triple negative breast cancer, our purpose is to analyze and compare different therapies, as well as to highlight the novelties of treatment in this breast cancer subtype.

Long term control stereotactic body radiotherapy (SBRT) for oligometastatic colorectal cancer: a single center study.

BACKGROUND: To evaluate survival after stereotactic body radiotherapy (SBRT) as radical treatment for metastases of colorectal cancer (CRC) and to identify prognostic factors after treatment. METHODS: Patients with metastatic CRC treated with SBRT on metastatic lesions were retrospectively analyzed between February 2012 and August 2016 at the General University Hospital of Valencia. The follow-up was carried out until July 15, 2018. The data have been collected in a database. Patients may have received prior systemic therapy and/or resection of metastatic disease. Endpoints were timed from end of SBRT and included overall survival (OS) and progression-free survival (PFS). Univariate and multivariate analysis using Cox proportional hazard modeling was used to identify prognostic factors. RESULTS: A total of 49 patients were identified. Before SBRT, 77.5% of the patients have received systemic therapy and 65.2% surgery for metastatic disease. Of metastatic lesions treated with SBRT 53.1% were located in the lung, 30.6% in the liver and 16.3% in other locations. Median survival were: PFS after treatment with SBRT was 9.9 months (95% CI: 4.64-15.1) and the median OS was 28.9 months (95% CI: 19.0-38.7). No relapses were observed in 20% of the patients after SBRT. The treatment was well tolerated and no patient had grade 3 or 4 adverse effects. Right colon [HR 16.53 (95% CI: 3.11-87.87), P value 0.001] and higher tumor stage (III-IV) [HR 12.30 (95% CI: 2.10-71.92), P value 0.005] showed a lower OS in a multivariate analysis. CONCLUSIONS: SBRT for oligometastatic disease is an effective option for patients with advanced CRC, with encorauging survival outcomes. However, a definitive validation in large randomized studies is required.

Working towards a consensus on the oncological approach of breakthrough pain: a Delphi survey of Spanish experts.

PURPOSE: There is a lack of standards for the diagnosis, assessment and management of breakthrough cancer pain (BTcP). La Fundación ECO (the Foundation for Excellence and Quality in Oncology) commissioned a study to establish a consensus and lay the foundations for the appropriate management of BTcP in oncology patients. PATIENTS AND METHODS: A modified Delphi survey comprising two rounds was used to gather and analyze data, which was conducted over the Internet. Each statement that reached a consensus with the respondents was defined as a median consensus score (MED) of ≥7, and agreement among panelists as an interquartile range (IQR) of ≤3. RESULTS: In total, 69 medical oncologists responded, with a broad consensus that BTcP implied exacerbations of high-intensity pain, as opposed to moderate pain. Furthermore, they concurred that appropriate diagnostic equipment is needed, and that rapid-onset fentanyl formulations should be the preferred treatment for BTcP management. The panelists agreed that a lack of appropriate information and training to attend to patients, as well as limited patient visitation rights, were barriers to effective BTcP management. Regarding gaps in detected knowledge, the panelists were unsure of the measures necessary to assess the burden of the disease on the patient's quality of life and associated medication costs. Alongside this, there was a lack of awareness of the technical specifics of the different formulations of rapid-onset fentanyl. CONCLUSION: These results represent the current status of BTcP management. They may inform recommendations and provide a framework for future research.

Role of RAS mutation status as a prognostic factor for patients with advanced colorectal cancer treated with first-line chemotherapy based on fluoropyrimidines and oxaliplatin, with or without bevavizumab: A retrospective analysis.

The role of Kirsten rat sarcoma viral oncogene homolog (KRAS) and neuroblastoma RAS viral oncogene homolog (NRAS) mutations as negative predictors for anti-epidermal growth factor receptor (EGFR) therapies in metastatic colorectal cancer (CRC) has been firmly established. However, whether the RAS mutation status plays a role as a biomarker for anti-vascular endothelial growth factor (VEGF) treatment remains controversial. Data from 93 CRC patients who received first-line cytotoxic chemotherapy with fluoropyrimidines and oxaliplatin, with or without bevacizumab, were analyzed. We investigated the association between the RAS mutation status and clinical outcomes in terms of response rate, progression-free survival (PFS) and overall survival (OS). Mutations in RAS genes were observed in 47 (52.6%) patients (45 KRAS and 2 NRAS mutations). Patients with tumours harbouring RAS mutations were less suitable for primary tumour resection, were more likely to develop lung metastases, and received bevacizumab treatment for a shorter time period compared with those with wild-type tumours. The response rate to chemotherapy did not differ according to the RAS mutation status, and there were no significant differences in PFS [RAS mutation: 12 months, 95% confidence interval (CI): 8.7-15.2 vs. RAS wild-type: 12 months, 95% CI: 9.67-14.32; P=0.857] or OS (RAS mutation: 20 months, 95% CI: 14.3-25.6 vs. RAS wild-type: 24 months, 95% CI: 18.7-29.2; P=0.631). Patients with RAS mutation vs. those with RAS wild-type exhibited a favourable trend in PFS when treated with bevacizumab (13 months, 95% CI: 6.5-19.4 vs. 10 months, 95% CI: 4.2-15.7, respectively; P=0.07) and OS (27 months, 95% CI: 18.5-35.4 vs. 15 months, 95% CI: 12.4-17.5, respectively; P=0.22). In conclusion, RAS mutations are not a prognostic marker for PFS and OS in CRC patients receiving fluoropyrimidine-oxaliplatine treatment, with or without bevacizumab. RAS mutations are not predictive of the lack of efficacy of bevacizumab, and these patients appear to benefit from anti-angiogenic treatment.

SIADH-related hyponatremia in hospital day care units: clinical experience and management with tolvaptan.

Hyponatremia (Na ˂ 135 mmol/l) is the most frequent electrolyte disorder in clinical practice, and the syndrome of inappropriate antidiuretic hormone secretion (SIADH) is the commonest cause of hyponatremia in cancer patients. Correcting hyponatremia in these patients can reduce morbidity and mortality, increase the response to anti-cancer agents, and help reduce hospital length of stay and costs. Tolvaptan is an oral medication used to treat SIADH-related hyponatremia patients that needs to be initiated at hospital so patients can have their serum sodium monitored. If tolvaptan could be initiated in hospital day care units (DCUs), performing the same tests, hospitalization could be avoided, quality of life improved, and costs reduced. This is the first publication where a panel of oncologists are sharing their experience and making some recommendations with the use of tolvaptan to treat SIADH-related hyponatremia in DCU after collecting and examining 35 clinical cases with these type of patients. The conclusion from this retrospective observational analysis is that the use of tolvaptan in DCU is safe and effective in the therapeutic management of SIADH-related hyponatremia.

Epidemiology and characteristics of febrile neutropenia in oncology patients from Spanish tertiary care hospitals: PINNACLE study.

Febrile neutropenia (FN) is one of the most common adverse events associated with myelosuppressive chemotherapy for cancer treatment. The objective of this study was to describe the incidence of hospitalization due to FN in Spanish tertiary care hospitals (PINNACLE study). This epidemiological, retrospective, multicenter, nationwide study involved 119 patients from oncology units of 10 Spanish tertiary care hospitals who were admitted for FN. The primary endpoint was to assess the epidemiology and characteristics of FN. The incidence of admissions due to FN in oncology patients was 2.0% (interquartile range [IQR], 1.6-3.0). In terms of fever and absolute neutrophil count (ANC), 37.0% of the patients had a temperature of ≥38.2°C and an ANC of ≤500/m3. The number of patients who received prophylactic treatment with granulocyte colony-stimulating factor (G-CSF) was significantly higher in the palliative group (32.6%) compared with that in the non-palliative group (13.5%). The hospital length of stay was significantly shorter in patients who received prophylactic G-CSF compared with those who did not (5.0 days; IQR, 4.0-9.0 vs. 7.0 days; IQR, 5.0-11.0, respectively). The hospital length of stay was also significantly shorter in patients receiving palliative treatment (5.0 days; IQR, 3.0-7.0) compared with those receiving non-palliative therapy (7.0 days; IQR, 5.0-12.0). In conclusion, the incidence of admissions due to FN in oncology patients was 2.0% and the duration of hospital stay was 7.0 days. Prophylactic G-CSF treatment was found to be associated with better outcomes and shorter hospital stays. Therefore, the use of this treatment becomes relevant for achieving better clinical outcomes and reducing hospitalization cost in the management of FN.

Professional survey on knowledge and clinical patterns of pain management in Spanish medical oncology.

Cancer pain is still not treated adequately. The barriers impeding its appropriate treatment include lack of knowledge, erroneous beliefs and inappropriate attitudes with regard to pain, which are sustained by some or all of those involved in the problem. The present study shows the results of an exploratory survey using a large sample of specialists in clinical oncology. Its main objective is to evaluate daily analgesic practices and compliance with clinical guidelines in order to identify areas that should be improved in this particular therapeutic field. Information collection from the responders was in the form of a self-administered written questionnaire, structured in three thematic areas: clinical patterns and resources used in pain treatment in clinical practice, pain and pain-relief therapy, and theoretical knowledge and decision-making in clinical practice. The study identified those skills that most need improvement in the treatment of pain (scientific and technical knowledge and clinical decision-making capacity of professionals) in order to reduce the unjustified variability in current clinical practice.

Spanish Society of Medical Oncology consensus on the use of erythropoietic stimulating agents in anaemic cancer patients.

Treatment of anaemia is a very important aspect in the management of cancer patients. In order to carry out a consensus process about the use of erythropoietic stimulating agents (ESAs) in cancer patients, the Spanish Society of Medical Oncology (SEOM) elaborated a working group which coordinated a panel of medical oncology specialists. This working group has reviewed the main issues about the use of ESAs. In addition a consensus meeting was held in Madrid on 25 April 2007. The following conclusions were made: Since ESA treatment increases the haemoglobin (Hb) level and decreases the red blood cell (RBC) transfusion requirements, ESAs should be used within the approved indications in patients undergoing chemotherapy treatment, beginning at a Hb level below 11 g/dl and maintaining it around 12 g/dl, with iron supplements if necessary. Neither increasing the ESA dose in nonresponders nor the use of ESAs in the treatment of chronic cancer-related anaemia is recommended.

Oncologists' perceptions of cancer pain management in Spain: the real and the ideal.

AIM: Studies in some countries suggest that cancer pain is often not adequately controlled, but little is known about the situation in Spain. The objective of this study was to identify medical oncologists' perceptions about pain management in their patients. METHODS: Two-round Delphi survey of 24 medical oncologists from 22 large, geographically diverse hospitals in Spain. Physicians rated each of 150 statements on a Likert scale (1=strongly disagree; 5=strongly agree). The mean, standard deviation and frequency of replies in three agreement categories were calculated for each item. Statements allowing comparison of oncologists' perceptions of how pain is managed in routine clinical practice with how it should be managed were grouped together and analyzed. RESULTS: The most notable discrepancies between the real and the ideal occurred in the failure to provide written information or to confirm that patients understand what they are told, the lack of comprehensive and systematic evaluation of pain, and the lack of use of non-pharmacological treatments (NPTs) for cancer pain. CONCLUSIONS: Medical oncologists need to improve their communication skills, providing patients with both written and verbal information about their disease and the plan for pain management. Pain should be evaluated at each patient visit using validated scales, and greater attention should be paid to the possible use of NPTs.

[Euthanasia in patients with cancer and the continuous-care providers]. / La eutanasia en el paciente con cáncer y los cuidados continuos.

During the clinical evolution of patients with cancer there are many occasions, or phases of the disease, when there are no specific treatments and, as such, we need to provide maximum comfort following appropriate symptom control; in this stage it is fundamental to respect personal autonomy together with the option to reject futile treatment. With appropriate control of symptoms it is possible to reach the stage where the majority of the patients do not continue to suffer. Continuous-care providers for cancer patients are those who are responsible for providing help to resolve these situations. In palliative medicine there are highly-efficacious procedures to the help in these last hours. Sedation is applied when it is impossible to control symptoms by other means. With appropriate Carer cover, it is not necessary to introduce laws on assisted suicide and/or active voluntary euthanasia, neither because of the magnitude of demand, nor because of the difficulties in achieving appropriate control of symptoms.

[Safety and efficacy of oral trans-mucosal fentanyl citrate in the long-term treatment of breakthrough pain in oncology patients: the ECODIR study]. / Tolerabilidad y efectividad del citrato de fentanilo oral transmucosa en el tratamiento a largo plazo del dolor irruptivo en pacientes oncológicos: estudio ECODIR.

INTRODUCTION: Oral trans-mucosal fentanyl citrate (OTFC) is the one drug specifically developed for the management of breakthrough pain. This study assesses the long-term safety and efficacy of OTFC standard clinical conditions. Patients and methods. Six-month observational study performed on cancer patients with episodes of breakthrough pain. Safety was assessed by recording the advent of adverse events and efficacy by the evaluating the intensity of breakthrough pain. RESULTS: 174 cancer patients were recruited into the study. All adverse reactions reported were mild or moderate. OTFC was significantly faster (time to the commencement of pain relief: 12.7 +/- 11.4 vs 32.7 +/- 18.4 minutes; p < 0.001) and potent (post-treatment pain intensity: 3.4 +/- 1.5 vs 4.3 +/- 1.5; p < 0.001) than the previously-used drugs. CONCLUSIONS: This observational study confirms the good safety profile of OTFC as well as its effectiveness over long-term period treatment of breakthrough pain.

[Analysis of tumour-derived DNA in serum in advanced non-microcytic lung cancer: might it be a prognostic factor?]. / Análisis de la concentración sérica del ADN tumoral en el cáncer de pulmón no microcítico y avanzado: 'es útil como factor pronóstico?

INTRODUCTION: Presence of circulating DNA in the serum of patients with cancer makes detection of tumour-specific genetic alterations feasible. OBJECTIVE: To study serum DNA concentration in patients diagnosed as having advanced Non-Small Cell Lung Cancer (NSCLC) and to evaluate its relationship with age, histology, stage, response, time-to-progression (TTP), and survival. METHODS: Serum DNA from 78 patients was purified and spectrophotometrically quantified. RESULTS: No significant correlations were found between serum DNA concentration and age, histology, response and survival. There was a significant correlation with respect to stage (IIIB = 408.75 ng/ml; IV = 478.74 ng/ml; p = 0.02). When patients were grouped according to DNA concentration, significant correlation with TTP was found; establishing a cut-off point at 500 ng/ml ([DNA] < 500 ng/ml TTP = 7.25 months, 95%CI: 3.5-5.25; [DNA ] > or = 500 ng/ml TTP = 4.25 months, 95%CI: 2-6.5; p = 0.05). CONCLUSIONS: Using the present method, DNA concentration quantification appears to be simple, but with certain deficiencies due to inter-sample variability and low specificity. This is because total DNA concentration is measured without distinguishing as to whether it is tumour-related. We suggest that there is a correlation between DNA concentration and prognosis which enables an analysis of the natural history of the disease.