Search

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

Financial difficulties experienced by cancer patients negatively impact the mental health of the patients. The objective of this study was to examine the mediating role of financial difficulties between physical symptoms and depression in patients with advanced cancer. A prospective, cross-sectional design was adopted in the study. The data were collected from 861 participants with advanced cancer in 15 different tertiary hospitals in Spain. The participants’ socio-demographic characteristics were collected using a standardized self-report form. Hierarchical linear regression models were used to explore the mediating role of financial difficulties. In the results, 24% of patients reported a high level of financial difficulties. Physical symptoms were positively associated with financial difficulties and depression (β = 0.46 and β = 0.43, respectively), and financial difficulties was positively associated with depression (β = 0.26). Additionally, financial difficulties played a role in explaining the relationship between physical symptoms and depression, showing a standardized regression coefficient of 0.43 which decreased to 0.39 after the financial difficulties were controlled. Healthcare professionals should consider the importance of providing financial resources and emotional support to help patients and their families cope with the financial burden associated with cancer treatment and its symptoms.

Neuroendocrine neoplasms (NENs) are a heterogeneous family of tumors of challenging diagnosis and clinical management. Their incidence and prevalence continue to rise mainly due to an improvement on diagnostic techniques and awareness. Earlier detection, along with steadfast improvements in therapy, has led to better prognosis over time for advanced gastrointestinal and pancreatic neuroendocrine tumors. The aim of this guideline is to update evidence-based recommendations for the diagnosis and treatment of gastroenteropancreatic and lung NENs. Diagnostic procedures, histological classification, and therapeutic options, including surgery, liver-directed therapy, peptide receptor radionuclide therapy, and systemic hormonal, cytotoxic or targeted therapy, are reviewed and discussed, and treatment algorithms to guide therapeutic decisions are provided.

Introducción: El examen de acceso a la especialización médica en España, conocido como prueba MIR, se convoca anualmente desde 1978 y se realiza simultáneamente en diversas sedes distribuidas por toda España. El acceso a las distintas especialidades médicas está condicionado por el baremo académico o puntaje conseguido en el grado de Medicina, entendiendo como tal el promedio de las calificaciones obtenidas durante la carrera en medicina, así como por el resultado de dicha prueba. Objetivo: El objetivo del presente trabajo fue el análisis los resultados de los médicos presentados a las pruebas MIR de 2019 y 2020, en función de su puntaje. Método: Para este estudio se hizo uso de la información publicada por el Ministerio de Sanidad relativa a los resultados definitivos de las convocatorias de la prueba MIR de 2019 y 2020. Dicha información incluye la nota media del baremo académico o puntaje de todos los médicos que realizaron el examen, así como el número de orden obtenido en la prueba. Resultados: Aunque la nota media del expediente de los opositores tiene un peso únicamente del 10% sobre la puntuación que da lugar a su ordenación en la prueba MIR, existe una correlación importante entre el puntaje y el número de orden obtenido que permite escoger entre las diferentes plazas de formación sanitaria especializada ofertadas en la convocatoria. Conclusiones: En la mayor parte de los casos, los individuos que obtuvieron una mejor nota media en el grado de Medicina son los que obtienen los mejores resultados en la prueba MIR. Esto se debe a un mayor nivel de conocimientos de partida al inicio de la preparación de la prueba, junto con un mejor aprovechamiento de dicho tiempo de preparación, ligado a su capacidad y hábito de trabajo, entrenados previamente a lo largo de los seis cursos del grado. post-print 561 KB

Purpose: Uncertainty surrounding entails significant psychological distress.The aims were to evaluate the incidence of psychological distress at diagnosis of advanced cancer and to analyze whether the relationship between illness uncertainty and psychological distress can be mediated by coping strategies. Methods: A multicenter, prospective,cross-sectional study was conducted in 15 medical oncology departments in Spain. Individuals with unresectable advanced cancer completed questionnaires on uncertainty (Michel Uncertainty of Illness Scale, MUIS), coping strategies (Mental Adjustment to Cancer, M-MAC), and psychological distress (Brief Symptom Inventory, BSI) after the diagnostic and treatment appointment and before beginning systemic cancer treatment. Results:841 patients eligible for systemic treatment with palliative intent were included between February 2020 and April 2022. A total of 71.7% had clinically significant levels of psychological distress. Univariate analyses identified that the groups with less psychological distress were male(ηp2=0.016), married (ηp2=0.006), and had better performance status (ηp2=0.007). The most widely used coping strategies were positive attitude and cognitive avoidance. A positive relationship was found between uncertainty, coping strategies,and psychological distress (pConclusion: Most people with unresectable advanced cancer experience psychological distress in the face of uncertainty. This psychological distress can be mitigated through coping strategies such as cognitive avoidance.

Crossover can bias clinical outcomes of randomized clinical trials by increasing the risk of both type I (false positive) and type II (false negative) errors. To show how crossover can increase type I error, we provide computer simulation and review herein illustrative examples (iniparib, olaratumab) of recently reported RCTs that demonstrated false-positive treatment efficacy signals due to crossover. The ethical issues associated with crossover are also discussed.

An exploratory analysis of registry data from 2437 patients with advanced gastric cancer revealed a surprising association between astrological birth signs and overall survival (OS) with p = 0.01. After dichotomizing or changing the reference sign, p-values

To summarize the current literature on the psychological impact of COVID-19 on patients with cancer, both in terms of the impact of the virus itself and of changes in the healthcare system; and to describe current recommendations for supporting patients with cancer during the pandemic.Multiple studies have shown that patients with cancer experience high levels of psychological distress during COVID-19. Factors of greater vulnerability have been described as: being young, being female, low socioeconomic status, lower educational level, having low levels of hope or optimism, lower social support, and having cancer with curative intent. The severe acute respiratory syndrome-coronavirus-2pandemic has accelerated the healthcare digitization process. All departments involved in the diagnosis and treatment of cancer have made contingency plans to minimize the impact on patients.Psychological distress is one of the most frequently occurring symptoms in patients with cancer during the pandemic. The COVID-19 pandemic has led to a restructuring of the healthcare system. The paradigm shift may pose a challenge for both healthcare professionals and patients.

The aim of this study was to compare physicians' and patients' estimates of risk of relapse and toxicity. A prospective, cross-sectional, multicenter study including 735 patients with cancer and 29 oncologists. Physicians' appraisals of risk of relapse with and without chemotherapy (27.5% and 43.1%) and risk of severe toxicity (12.2%) were more realistic than those of patients (34.6%, 78.5%, and 57.4%, respectively). The greater the risk of recurrence and risk of toxicity estimated, the less physicians expressed satisfaction with SDM. Estimations of risk of relapse and toxicity are important in diagnostic and therapeutic decision-making and can help patients face their situation.

Trifluridine/tipiracil increases overall survival (OS) in patients with refractory, metastatic colorectal cancer (mCRC). A post hoc exploratory analysis of the RECOURSE randomized clinical trial (RCT) established two categories, a good prognosis corresponding to subjects having a low tumor burden and indolent disease. Other models in refractory mCRC are the FAS-CORRECT and Colon Life nomogram. The main objective was to externally validate the prognostic factors of the RECOURSE and FAS-CORRECT trials, and the Colon Life nomogram in a multicenter, real-world series of mCRC treated in 3rd and successive lines with trifluridine/tipiracil. The secondary aim was to develop an OS predictive model, TAS-RECOSMO. Between 2016 and 2019, 244 patients were recruited. Median OS was 8.15 vs 8.12 months for the poor (85% of the subjects) and good (15%) prognosis groups from the RESOURCE trial, respectively, log-rank p = 0.9. The most common grade 3–4 toxicities were neutropenia (17%), asthenia (6%), and anemia (5%). The AFT lognormal model TAS-RECOSMO included six variables: ECOG-PS, KRAS/NRAS/BRAF mutation status, time between diagnosis of metastasis and beginning of trifluridine/tipiracil, NLR, CEA, and alkaline phosphatase. The model’s bootstrapped bias-corrected c-index was 0.682 (95% CI, 0.636–0.722). The factors from the Colon Life model, FAS-CORRECT, and RECOURSE displayed a c-index of 0.690, 0.630, and 0.507, respectively. TAS-RECOSMO, FAS-CORRECT, and the Colon Life nomogram appear to predict OS in patients with refractory mCCR who begin trifluridine/tipiracil treatment in the real world. The prognostic groups of the RECOURCE RCT were unable to capture the situation of real-world subjects treated with trifluridine/tipiracil in this series.

Purpose To report healthcare resource use and associated costs in controlled versus uncontrolled carcinoid syndrome (CS) in patients with neuroendocrine tumours. Methods A cross-sectional, non-interventional multicentre study was conducted with retrospective data analysis. Resource use was compared between two patient groups: those with controlled CS (> 12 months with no uncontrolled CS episodes) and uncontrolled CS ( Results Twenty-six university hospitals in Spain participated, between July 2017 and April 2018. 137 patients were enrolled; 104 were analysed (2 groups of 52). Patients with uncontrolled CS had 10 times more emergency department (ED) visits (mean 1.0 vs 0.10 visits; P = 0.0167), were more likely to have a hospital admission (40.4% vs 19.2%; P = 0.0116) and had longer hospital stays (mean 7.87 vs 2.10 days; P = 0.0178) than those with controlled CS. This corresponded to higher annual hospitalisation costs (mean €5511.59 vs €1457.22; P = 0.028) and ED costs (€161.25 vs €14.85; P = 0.0236). The mean annual total healthcare costs were 60.0% higher in patients with uncontrolled than controlled CS (P = NS). Conclusion This study quantifies higher health resource use, and higher hospitalisation and ED costs in patients with uncontrolled CS. Better control of CS may result 3in lower medical costs.

ObjectivesIntolerance of uncertainty (IU) has been linked to greater psychological distress, whereas hope appears to act as a protective factor against in patients with cancer. The aim of this study is to analyse the modifying effect of uncertainty in the presence of anxiety and depression in patients with advanced lung cancer.MethodsMulticentre, prospective, observational, cross-sectional study of 145 individuals with advanced lung cancer. Participants completed the following questionnaires: IU Scale, Hert Hope Index, Brief Symptom Inventory.ResultsAmong patients with advanced lung cancer, anxiety and depression were prevalent, 30% and 35%, respectively. Uncertainty and hope with respect to their illness negatively affected their psychological distress. Hope and uncertainty accounted for 22% of the variance in anxiety and 34% of depressive symptoms. The hypothesised modifying effects (uncertainty×hope) was not supported in the depressive and anxious symptom models.ConclusionsOur findings indicate that hope and uncertainty are important considerations in understanding mental health in people diagnosed with advanced lung cancer. Identifying patients who lack the resources needed to manage uncertainty and hope in relation to their disease could inform psychosocial intervention provision to improve quality of life.

BackgroundCancer negatively affects patients’ physical and mental health. This work sought to analyze the sociodemographic and clinical variables that modulate psychological distress in individuals with resected vs unresectable cancer before and after receiving systemic antineoplastic treatment, and to evaluate how different coping strategies and spiritual well-being influence psychological distress in these subjects.MethodsObservational, prospective, consecutive study performed in 15 hospitals in Spain. The study consists of two cohorts: patients with resected locally and locally advanced cancer receiving adjuvant chemotherapy (NEOcoping study, 2016 and 2018) and those with unresectable locally advanced and advanced cancer, eligible for systemic treatment (NEOetic study, 2020 and 2021). Participants completed the following scales: BSI-18 (psychological distress) at baseline and after antineoplastic treatment; MINI-MAC (coping), and FACIT-sp (spirituality), before initiating systemic treatment.ResultsFourteen hundred and fifty patients were recruited; 941 had resected cancer and 509 had advanced cancer. The advanced cancer sample included more males, older, less educated, and more unemployed individuals. Before starting systemic treatment, the advanced, unresectable disease group suffered more psychological distress than those with resected cancer (66.9 vs. 63.7, p=0.001) and used more coping strategies, especially positive attitude (79.1 vs. 75.6, p=0.001) and cognitive avoidance (64.3 vs. 53.6, p=0.001). Participants with resected cancer displayed greater spiritual well-being (36.5 vs 33.2, p=0.001). After receiving systemic treatment, psychological distress decreased in cases of advanced cancer and increased in resected cancer, albeit still higher in subjects with advanced cancer, particularly anxiety (61.4 vs 60.9) and depression (61.0 vs 60.6), (p=0.001 in both cases).ConclusionPatients with advanced cancer exhibit greater psychological distress, use more coping strategies, and have less spiritual well-being, but their psychological distress improves with antineoplastic treatment.

The aim of this study was to analyze the associations between perceived social support and sociodemographic variables on coping strategies. A prospective, cross-sectional, multicenter study was conducted in 404 women with resected, non-metastatic breast cancer. Participants completed questionnaires: perceived social support (MSPSS), coping strategies (Mini-MAC), and psychological distress (BSI-18). Sociodemographic factors as age, education, and partnership status were associated with coping strategies. As for maladaptive strategies, hopelessness was more frequent in older people and lower educational level; fatalism in older and single people, and cognitive avoidance was associated with lower educational level. Suppor t from family, friends, and partners was associated with a greater fighting spirit. In contrast, high psychological distress (anxiety and depression) was associated with greater use of maladaptive strategies. Young people, a high level of education, having a partner, low psychological distress, and seeking social support were associated with the use of adaptive cancer coping strategies.

Depressive symptoms are common in individuals with advanced cancer. Objectives. This study sought to analyze the relationship between physical and functional status and depressive symptoms, and to assess the role of mental adjustment across these variables in people with advanced cancer. Methods. A prospective, cross-sectional design was adopted. Data were collected from 748 participants with advanced cancer at 15 tertiary hospitals in Spain. Participants completed self-report measures: Brief Symptom Inventory (BSI), Mini-Mental Adjustment to Cancer (Mini-MAC) scale, and the European Organization for Research and Treatment of Cancer (EORTC) questionnaire. Results. Depression was present in 44.3% of the participants and was more common among women, patients

Background Pancreatic neuroendocrine tumors are rare neoplasms for which few predictive and/or prognostic biomarkers have been validated. Our previous work suggested the potential of the combined expression of N-myc downstream-regulated gen-1 (NDRG-1), O6-methylguanine DNA methyltransferase (MGMT) and Pleckstrin homology-like domain family A member 3 (PHLDA-3) as prognostic factors for relapse and survival. Methods In this new multicenter study we evaluated immunohistochemistry expression in 76 patients with advanced PanNET who were treated with capecitabine-temozolomide or everolimus. Based on the immunohistochemistry panel, an immunohistochemistry prognostic score (IPS) was developed. Results In patients treated with capecitabine and temozolomide, low IPS was an independent prognostic factor for progression-free-survival and overall-survival. Similar findings were observed with highest IPS for overall-survival in patients treated with everolimus. Conclusion From our knowledge, it is the first time that a simple IPS could be useful to predict outcome for patients with metastatic pancreatic neuroendocrine tumors treated with everolimus or capecitabine and temozolomide.

Background/Objective: Resilience is the capacity to adaptively confront stress. The aim of this study was to evaluate the psychometric properties, convergent validity, and factorial invariance of the Spanish version of the Brief Resilient Coping Scale (BRCS). Method: Exploratory and confirmatory factor analyses based on a cross validation were conducted to explore the scale's dimensionality and test for strong (scalar) measurement invariance across gender, age, tumor site, and survival, by fitting multiple-group confirmatory solutions. An extended structural equation model was used to assess external validity. Prospective, multicenter cohort study of 636 patients who completed the BRCS, Satisfaction with Life Scale (SWLS), and Spiritual well-being (FACIT-sp) scales. Results: The data supported a unidimensional structure. The BRCS is a very short, narrow bandwidth measure, with items demonstrating high discriminating power. A strong invariance solution demonstrated excellent fit across gender, age, tumor site, and survival. Scores derived from the unidimensional structure exhibited satisfactory degrees of reliability (v = .86) and determinacy (FDI = .94). BRCS revealed substantial associations with satisfaction with life and spirituality well-being (all p < .001), factors widely related to resilience, particularly in cancer patients. Conclusions: The Spanish version of the BRCS is a reliable, valid resilience measure in advanced cancer.

To identify distinct trajectories of toxicity in colorectal cancer (CRC) patients after adjuvant chemotherapy and its impact on quality of life (QoL) and psychological symptoms. A prospective, multicenter study was conducted in 157 patients. A latent class analysis defined the unobserved latent constructs that can be predicted as symptom clusters, considering the intensity of four types of adverse events (AEs). Patients completed EORTC-QLQ-C30, BSI-18, PDRQ-9, and DRS scales. Ninety-six percent had some degree of toxicity, with grades 3–4 being the most common: neurotoxicity (7.2%), hematological (13.1%), digestive (5.2%), and skin toxicity (1.4%). Three distinct latent classes were identified (high [72.5%], mild [16.9%], and low [10.6%] toxicity). Patients with high toxicity had the worst QoL scores and moderately high somatization and psychological distress scores. Adjuvant chemotherapy for CRC was associated with frequent toxicity that negatively impacted QoL and psychological wellbeing.

Purpose: The limited knowledge of the molecular alterations that characterize poorly differentiated neuroendocrine carcinomas has limited the clinical development of targeted agents directed to driver mutations. Here we aim to identify new molecular targets in colon neuroendocrine carcinomas (co-NEC) and proof the efficacy of matching drugs. Experimental Design: We performed a multi-omic analysis of co-NEC to identify genetic or epigenetic alterations that could be exploited as effective drug targets. We compared co-NEC samples with colorectal carcinomas (CRC) to identify neuroendocrine-specific traits. Patients with co-NEC and patient-derived xenografts were treated with a BRAFV600E-blocking drug to demonstrate sensitivity. Results: co-NEC and CRC are similar in their mutational repertoire, although co-NECs are particularly enriched in BRAFV600E mutations. We report for the first time that V600EBRAF-mutant co-NECs may benefit from BRAF inhibition in monotherapy and how EGFR status is essential to predict innate sensitivity and acquired resistance by a differential methylation of its gene regulatory regions. Conclusions: The identification of V600E BRAF mutations in high-grade co-NECs has allowed the description of radiological responses to combination therapy of BRAF and MEK inhibitors in basket clinical trials. However, the molecular rationale for this treatment combination was based on the presence of the BRAF mutation and the efficacy observed in other cancer types such as melanoma. Future drug development in this setting should test BRAF inhibitors upfront and the addition of anti-EGFR antibodies instead of MEK inhibitors for an efficient blockade of acquired resistance.

This research explores the results that an examinee would obtain if taking a multiple-choice questions test in which they have doubts as to what the true answer is among different options. This problem is analyzed by making use of combinatorics and analytical and sampling methodologies. The Spanish exam through which doctors become medical specialists has been employed as an example. Although it is difficult to imagine that there are candidates who respond randomly to all the questions of such an exam, it is common that they may doubt over what the correct answer is in some questions. The exam consists of a total of 210 multiple-choice questions with 4 answer options. The cut-off mark is calculated as one-third of the average of the 10 best marks in the exam. According to the results obtained, it is possible to affirm that in the case of doubting over two or three of the four possible answers in certain group questions, answering all of them will in most cases lead to obtaining a positive result. Moreover, in the case of doubting between two answer options in all the questions of the MIR test, it would be possible to exceed the cut-off mark.

[Introduction] Somatostatin analogs (SSA) prolong progression-free survival (PFS) in patients with well-differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs). However, the eligibility criteria in randomized clinical trials (RCTs) have been restricted, which contrasts with the vast heterogeneity found in NENs., [Methods] We identified patients with well-differentiated (Ki-67% ≤20%), metastatic GEP-NENs treated in first line with SSA monotherapy from the Spanish R-GETNE registry. The therapeutic effect was evaluated using a Bayesian Cox model. The objective was to compare survival-based outcomes from real-world clinical practice versus RCTs., [Results] The dataset contained 535 patients with a median age of 62 years (range: 26–89). The median Ki-67% was 4 (range: 0–20). The most common primary tumor sites were as follows: midgut, 46%; pancreas, 34%; unknown primary, 10%; and colorectal, 10%. Half of the patients received octreotide LAR (n = 266) and half, lanreotide autogel (n = 269). The median PFS was 28.0 months (95% CI: 22.1–32.0) for octreotide versus 30.1 months (95% CI: 23.1–38.0) for lanreotide. The overall hazard ratio for lanreotide versus octreotide was 0.90 (95% credible interval: 0.71–1.12). The probability of effect sizes >30% with lanreotide versus octreotide was 2 and 6% for midgut and foregut NENs, respectively., [Conclusion] Our study evaluated the external validity of RCTs examining SSAs in the real world, as well as the main effect-modifying factors (progression status, symptoms, tumor site, specific metastases, and analytical data). Our results indicate that both octreotide LAR and lanreotide autogel had a similar effect on PFS. Consequently, both represent valid alternatives in patients with well-differentiated, metastatic GEP-NENs., The study has been funded by a restricted grant from Novartis Farmacéutica, S.A. RGETNE and the GETNE group is partially funded by Ipsen, Novartis, Pfizer and AAA. Dr Angela Lamarca received funding from ASCO Conquer Cancer Foundation Young Investigator Award and The Christie Charity. Dr Jorge Barriuso received funding from the received funding from the ENETS Centre of Excellence Fellowship Grant Award.

Purpose The aim of this study was to analyze the internal structure of the EORTC QLQ-C30, to examine the validity and normative data for cancer patients. Method Exploratory and Confirmatory factor analyses were conducted to explore the scale’s dimensionality and test for strong measurement invariance across sex and tumor site. All the analyses were based on a multicenter cohort of 931 patients who completed the Brief Symptom Inventory (BSI-18) and the EORTC QLQ-C30. Results Our findings indicate that the EORTC QLQ-C30 has acceptable psychometric properties and an internal structure that is well accounted for a bifactor model: a general factor that evaluates quality of life and a group factor that would analyze physical health that would be defined by physical function, role function, and fatigue. The result of the multi-group CFA revealed a strong invariance according to sex, tumor, and over time. Reliability of the EORTC exceeding 0.86 and the simple sum of the items of the scale was a good indicator of oncology patients’ quality of life. Both factors correlate closely with depression, anxiety, and psychological distress and are sensitive to change, especially the quality of life, with a significant decrease in the post-test. Conclusion The Spanish version of the EORTC QLQ-C30 proved to be a valid, reliable instrument to appraise quality of life in cancer patients. The normative data collected from this study may be useful for the early detection of initial symptoms of deterioration of quality of life in oncology patients.

Systems tend toward inertia until an external pressure pushes them toward change; thus, a situation of crisis such as the COVID-19 pandemic represents an opportunity for technological innovation. The prevailing need for treatments and vaccines has impelled innovation in the world of randomized clinical trials (RCT), resorting to ideas that had been floating around for a while. Is this merely a circumstantial phenomenon or are new methods here to stay?

Quality of life (QoL) is a complex, ordinal endpoint with multiple conditioning factors. A predictive model of QoL after adjuvant chemotherapy can support decision making or the communication of information about the range of treatment options available. Patients with localized breast cancer (n = 219) were prospectively recruited at 17 centers. Participants completed the EORTC QLQ-C30 questionnaire. The primary aim was to predict health status upon completion of adjuvant chemotherapy adjusted for multiple covariates. We developed a Bayesian model with six covariates (chemotherapy regimen, TNM stage, axillary lymph node dissection, perceived risk of recurrence, age, type of surgery, and baseline EORTC scores). This model allows both prediction and causal inference. The patients with mastectomy reported a discrete decline on all QoL scores. The effect of surgery depended on the interaction with age. Women with ages on either end of the range displayed worse scores, especially with mastectomy. The perceived risk of recurrence had a striking effect on health status. In conclusion, we have developed a predictive model of health status in patients with early breast cancer based on the individual’s profile.

PURPOSEApproved systemic therapies for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) have shown limited capacity to reduce tumor burden and no antitumor activity after progression to targeted agents (TAs). We investigated the efficacy and safety of lenvatinib in patients with previously treated advanced GEP-NETs.PATIENTS AND METHODSThis was a multicenter, single-arm, open-label, phase II trial with two parallel cohorts (ClinicalTrials.gov identifier: NCT02678780 ) involving 21 institutions in 4 European countries. Eligible patients had histologically confirmed advanced grade 1-2 pancreatic (panNET) or GI (GI-NET) NETs with documented tumor progression after treatment with a TA (panNET) or somatostatin analogs (GI-NET). Patients were treated with lenvatinib 24 mg once daily until disease progression or treatment intolerance. The primary end point was overall response rate by central radiology review. Secondary end points included progression-free survival, overall survival, duration of response, and safety.RESULTSBetween September 2015 and March 2017, a total of 111 patients were enrolled, with 55 (panNET) and 56 (GI-NET) patients in each cohort. The median follow-up was 23 months. The overall response rate was 29.9% (95% CI, 21.6 to 39.6): 44.2% (panNET) and 16.4% (GI-NET). The median (range) duration of response was 19.9 (8.4-30.8) and 33.9 (10.6-38.3) months in the panNET and GI-NET groups, respectively. The median progression-free survival was 15.7 months (95% CI, 14.1 to 19.5). The most common adverse events were fatigue, hypertension, and diarrhea; 93.7% of patients required dose reductions or interruptions.CONCLUSIONWe report the highest centrally confirmed response reported to date with a multikinase inhibitor in advanced GEP-NETs, with a particularly strong response in the panNET cohort. This study provides novel evidence for the efficacy of lenvatinib in patients with disease progression following treatment with other TAs, suggesting the potential value of lenvatinib in the treatment of advanced GEP-NETs.

Introduction The VELOUR study evaluated the efficacy and safety of adding aflibercept to FOLFIRI (fluorouracil, leucovorin, irinotecan) in second-line therapy for metastatic colorectal cancer (mCRC). However, a nomogram that can stratify patients according to prognosis is unavailable, and the frequency and effect of the pragmatic use of modified schedules in actual practice remains unknown. Method The sample consists of 250 patients with mCRC treated with aflibercept and irinotecan-based chemotherapy at nine Spanish academic centers between January 2013 and September 2015. The result of a Cox proportional hazards model regression for overall survival (OS), adjusted for covariates available in daily practice, was represented as a nomogram and web-based calculator. Harrell's c-index was used to assess discrimination. Results The prognostic nomogram for OS includes six variables: Eastern Cooperative Oncology Group performance status, tumor location, number of metastatic sites, mutational status, better response to previous treatment(s), and carcinoembryonic antigen. The model is well calibrated and has acceptable discriminatory capacity (optimism-corrected c-index, 0.723; 95% confidence interval [CI], 0.666-0.778). Median OS was 6.1 months (95% CI, 5.1-8.8), 12.4 months (95% CI, 9.36-14.8), and 22.9 months (95% CI, 16.6-not reached) for high-, intermediate-, and low-risk groups, respectively. Age, comorbidity, or use of modified FOLFIRI regimens did not affect prognosis in this series. Grade 3-4 adverse events were less common following modified schedules. The admission rate because of toxicity was higher in ≥65 years (9.7% vs. 19.6%; odds ratio, 2.26; p = .029). Conclusion We have developed and internally validated a prognostic model for use in individuals with colorectal cancer initiating therapy with FOLFIRI-aflibercept to predict both OS and the effect of pragmatic modifications of the classic regime on efficacy and safety. This can aid in decision making and in designing future trials. Implications for practice In this study, the authors developed and conducted the internal validation of a prognostic nomogram that makes it possible to stratify patients who are eligible for second-line FOLFIRI-aflibercept based on their probability of survival. This model was developed in a multicenter sample from nine Spanish hospitals. Furthermore, to increase the study's validity, the practical use of aflibercept in this setting was investigated, including doses or pragmatic modifications. The results suggest that the modified schedules often used in this daily clinical practice-based patient population are associated with less severe toxicity without apparent detriment to survival endpoints. It is believed that these data complement the information provided by the VELOUR trial and are relevant for the oncologist in treating colon cancer in the second-line setting.

Depression in cancer patients is prevalent and negatively impacts their quality of life. Likewise, it correlates with lower overall survival. The aim of this work is to analyze whether different coping strategies, as well as sociodemographic and clinical factors are associated with the presence of depressive symptoms in individuals with a resected, non-metastatic neoplasm about to initiate adjuvant chemotherapy.NEOcoping is a cross-sectional, prospective, observational, multicenter study. Clinical (tumor site and stage, time to diagnosis, risk of recurrence, and type of adjuvant treatment) and sociodemographic characteristics (age, gender, marital status, educational level, occupational sector, and employment status), coping strategies (Mini-MAC scale), and depressive symptoms (BSI scale) were collected. A two-block linear regression model was performed to determine the predictive variables of depressive symptoms.524 adults with resected, non-metastatic cancer were recruited. Twenty-six percent of patients have clinically significant depressive symptoms. Being female, 40 years of age, having breast and stomach cancer, and 50% chance of recurrence were associated with increased risk of depression. Likewise, depression was associated with greater helplessness and anxious preoccupation, and less fighting spirit. Age, gender, and risk of recurrence accounted for only 7% of the variance in depressive symptoms. Including coping strategies in the regression analysis significantly increased the variance explained (48.5%).Early psychological intervention in patients with maladaptive coping strategies may modulate the onset of depressive symptoms, especially in those at higher risk for depression.

Introduction The aim was to analyze the effects of pessimism, depression, fatigue, and pain on functional health-related quality of life (HRQoL) in patients with resected, non-advanced breast cancer. Methods A prospective, multicenter study was conducted in 440 breast cancer patients. They completed the Brief Symptom Inventory (BSI), the European Organization for Research and Treatment of Cancer QoL-Questionnaire-Core-30 (EORTC-QLQ-C30), and the Revised Life Orientation Test (LOT-R). Results Prevalence rates of pessimism and depression were 23.3% and 40.0%, respectively. Fatigue and pain were the most common symptoms, 8.8% and 4.2%, respectively. Patients without a partner were more pessimistic that partnered ones; those with a lower level of education and subjects without a partner exhibited more depression. Depression was a major factor that proved to have the greatest explanatory power for HRQoL (physical, role, emotional, cognitive, and social functioning) and global health status (R2 range: 0.13 to 0.39). Of the five domains, fatigue had a significant effect on four and pain, on two. Conclusion This study reveals the impact of depression and pessimism on physical, psychological, social, and quality-of-life aspects and the importance of evaluating them in patients who are going to initiate adjuvant chemotherapy for breast cancer.