Psychological factors and prognostic communication preferences in advanced cancer: multicentre study.

OBJECTIVES: Communication regarding prognosis to patients with advanced cancer is fundamental for informed medical decision making. Our objective was to analyse (1) the proportion of subjects with advanced cancer who prefer to know their prognosis, (2) the characteristics associated with patients' preference for prognostic information, (3) the psychological factors that impact the preference to know prognosis and 4) the concordance between preference for prognostic information perceived among physicians and patients. 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 the following questionnaires: Mental Adjustment to Cancer; Trust in the Physician; Uncertainty in Illness Scale Patient's Prognostic Preferences. RESULTS: Fifty-two per cent of advanced cancer sufferers preferred to know the prognosis of their disease. Compared with participants who preferred not to know, those who did reported more uncertainty, greater satisfaction with their physician and higher scores on positive attitude (all p=0.001). Thirty-seven per cent of the physicians believed that patients want to know their prognosis, indicating that they underestimate the number of such patients. No significant differences were found regarding preference to know prognosis as a function of sociodemographic and clinical variables. CONCLUSIONS: A substantial proportion of individuals with advanced cancer prefer to know the prognosis of their disease. It appears that knowing their prognosis was mainly motivated by a need to maintain a positive attitude, lessen uncertainty and by satisfaction with the physician. It is important to explore patients' preferences for information to offer more personalised communication.

What do patients and oncologists think about the evaluation and management of cancer-related anorexia-cachexia? The Quasar_SEOM study

Introduction Cancer patients often suffer from malnutrition and early detection and raising awareness of nutritional issues is crucial in this population. Methods The Spanish Oncology Society (SEOM) conducted the Quasar_SEOM study to investigate the current impact of the Anorexia–Cachexia Syndrome (ACS). The study employed questionnaires and the Delphi method to gather input from both cancer patients and oncologists on key issues related to early detection and treatment of ACS. A total of 134 patients and 34 medical oncologists were surveyed about their experiences with ACS. The Delphi methodology was used to evaluate oncologists' perspectives of ACS management, ultimately leading to a consensus on the most critical issues. Results Despite widespread acknowledgement of malnutrition in cancer as a significant issue by 94% of oncologists, the study revealed deficiencies in knowledge and protocol implementation. A mere 65% of physicians reported being trained to identify and treat these patients, with 53% failing to address ACS in a timely manner, 30% not monitoring weight, and 59% not adhering to any clinical guidelines. The lack of experience was identified as the primary hindrance to the use of orexigens in 18% of cases. Furthermore, patients reported concerns and a perception of inadequate attention to malnutrition-related issues from their physicians. Conclusion The results of this study point to a gap in the care of this syndrome and a need to improve education and follow-up of cancer patients with anorexia-cachexia (AU)

What do patients and oncologists think about the evaluation and management of cancer-related anorexia-cachexia? The Quasar_SEOM study.

INTRODUCTION: Cancer patients often suffer from malnutrition and early detection and raising awareness of nutritional issues is crucial in this population. METHODS: The Spanish Oncology Society (SEOM) conducted the Quasar_SEOM study to investigate the current impact of the Anorexia-Cachexia Syndrome (ACS). The study employed questionnaires and the Delphi method to gather input from both cancer patients and oncologists on key issues related to early detection and treatment of ACS. A total of 134 patients and 34 medical oncologists were surveyed about their experiences with ACS. The Delphi methodology was used to evaluate oncologists' perspectives of ACS management, ultimately leading to a consensus on the most critical issues. RESULTS: Despite widespread acknowledgement of malnutrition in cancer as a significant issue by 94% of oncologists, the study revealed deficiencies in knowledge and protocol implementation. A mere 65% of physicians reported being trained to identify and treat these patients, with 53% failing to address ACS in a timely manner, 30% not monitoring weight, and 59% not adhering to any clinical guidelines. The lack of experience was identified as the primary hindrance to the use of orexigens in 18% of cases. Furthermore, patients reported concerns and a perception of inadequate attention to malnutrition-related issues from their physicians. CONCLUSION: The results of this study point to a gap in the care of this syndrome and a need to improve education and follow-up of cancer patients with anorexia-cachexia.

External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry.

BACKGROUND: Trastuzumab combined with cisplatin and fluoropyrimidines, either capecitabine or 5-fluorouracile (XP/FP), is the standard first-line treatment for advanced, HER2-positive, gastric cancer patients based on the ToGA trial. Despite the lack of phase III trials, many clinicians administer trastuzumab with alternative regimens. One meta-analysis suggests that substituting cisplatin for oxaliplatin might lead to greater efficacy and less toxicity. METHODS: 594 patients with HER2-positive gastroesophageal adenocarcinoma were recruited from the AGAMENON-SEOM registry. The objective was to evaluate the external validity of clinical trials with chemotherapy and trastuzumab. RESULTS: The regimens used in at least 5% of the patients were XP (27%), oxaliplatin and capecitabine (CAPOX) (26%), oxaliplatin and 5-fluorouracil (FOLFOX) (14%), FP (14%), triplet with anthracycline/docetaxel (7%), and carboplatin-FU (5%). Median exposure to trastuzumab was longer with FOLFOX (11.4 months, 95% CI, 9.1-21.0) versus ToGA regimens (7.5, 6.4-8.5), p < 0.001. Patients with HER2-IHC 3+ cancers had higher response rates than those with IHC 2+/FISH+, odds-ratio 1.97 (95% CI, 1.25-3.09). The results achieved with CAPOX-trastuzumab were comparable to those attained with ToGA regimens. FOLFOX-trastuzumab was superior to ToGA schemes in terms of overall survival (OS), with a greater magnitude of effect in IHC 2+/FISH+ tumors (HR 0.47, 0.24-0.92) compared with IHC 3+ (HR 0.69, 0.49-0.96), and in diffuse (HR 0.37, 0.20-0.69) versus intestinal-type tumors (HR 0.76, 0.54-1.06). CONCLUSION: We have updated the external validity of clinical trials with trastuzumab in first-line treatment of gastric cancer. Our data confirm the comparable outcomes of ToGA regimens and CAPOX-trastuzumab in clinical practice and point toward a possible benefit of FOLFOX-trastuzumab, contingent on the subtypes typically less sensitive to trastuzumab, to be confirmed in clinical trials.

Is advanced esophageal adenocarcinoma a distinct entity from intestinal subtype gastric cancer? Data from the AGAMENON-SEOM Registry.

BACKGROUND: Advanced esophageal adenocarcinoma (EAC) is generally treated similarly to advanced gastroesophageal junction (GEJ-AC) and gastric (GAC) adenocarcinomas, although GAC clinical trials rarely include EAC. This work sought to compare clinical characteristics and treatment outcomes of advanced EAC with those of GEJ-AC and GAC and examine prognostic factors. PATIENTS AND METHODS: Participants comprised patients with advanced EAC, intestinal GEJ-AC, and GAC treated with platin and fluoropyrimidine (plus trastuzumab when HER2 status was positive). Overall and progression-free survival were estimated using the Kaplan-Meier method. Cox proportional hazards regression gauged the prognostic value of the AGAMENON model. RESULTS: Between 2008 and 2019, 971 participants from the AGAMENON-SEOM registry were recruited at 35 centers. The sample included 67.3% GAC, 13.3% GEJ-AC, and 19.4% EAC. Pulmonary metastases were most common in EAC and peritoneal metastases in GAC. Median PFS and OS were 7.7 (95% CI 7.3-8.0) and 13.9 months (12.9-14.7). There was no difference in PFS or OS between HER2- and HER2+ tumors from the three locations (p > 0.05). Five covariates were found to be prognostic for the entire sample: ECOG-PS, histological grade, number of metastatic sites, NLR, and HER2+ tumors treated with trastuzumab. In EAC, the same variables were prognostic except for grade. The favorable prognosis for HER2+ cancers treated with trastuzumab was homogenous for all three subgroups (p = 0.351) and, after adjusting for the remaining covariates, no evidence supported primary tumor localization as a prognostic factor (p = 0.331). CONCLUSION: Our study supports the hypothesis that EAC exhibits clinicopathological characteristics, prognostic factors, and treatment outcomes comparable to intestinal GEJ-AC and GAC.

External validity of docetaxel triplet trials in advanced gastric cancer: are there patients who still benefit?

BACKGROUND: The purpose of our study was to develop an online calculator to estimate the effect of docetaxel triplets (DPF) in first line of advanced gastric cancer (AGC), and to assess the external validity of docetaxel trials in individual patients. METHODS: The study includes patients with HER2(-) AGC treated with platin and fluoropyrimidine (PF) or with DPF in first line. Treatment effect and interactions were assessed using Bayesian accelerated failure time models. RESULT: The series comprises 1376 patients; 238 treated with DPF and 1138 with PF between 2008 and 2019. DPF was associated with increased progression-free survival (PFS) and overall survival (OS) with time ratio (TR) 1.27 (95% credible interval [CrI], 1.15-1.40), and TR 1.19 (95% CrI, 1.09-1.27), respectively. Serious adverse events were more common with DPF, particularly hematological effects (32% vs 22%). Younger participants received greater DPF dose density without achieving greater disease control, while severe toxicity was likewise higher. DPF yielded superior OS in Lauren intestinal (TR 1.27, 95% CrI, 1.08-1.11) vs diffuse subtype (TR 1.17, 95% CrI, 1.09-1.24) and the probability of increasing OS > 15% was 90% vs 67% in each subtype, respectively. The effect dwindles over time, which can be attributed to pathological changes and clinical practice changes. CONCLUSION: Our study confirms the effect of DPF is highly dependent on several clinical-pathological variables, with discreet and gradually declining benefit over platinum doublets in later years, at the expense of increased toxicity. These results may help to underpin the idea that external validity of AGC trials should be revised regularly.

Second-line treatment in advanced gastric cancer: Data from the Spanish AGAMENON registry.

BACKGROUND: Second-line treatments boost overall survival in advanced gastric cancer (AGC). However, there is a paucity of information as to patterns of use and the results achieved in actual clinical practice. MATERIALS AND METHODS: The study population comprised patients with AGC in the AGAMENON registry who had received second-line. The objective was to describe the pattern of second-line therapies administered, progression-free survival following second-line (PFS-2), and post-progression survival since first-line (PPS). RESULTS: 2311 cases with 2066 progression events since first-line (89.3%) were recorded; 245 (10.6%) patients died during first-line treatment and 1326/2066 (64.1%) received a second-line. Median PFS-2 and PPS were 3.1 (95% CI, 2.9-3.3) and 5.8 months (5.5-6.3), respectively. The most widely used strategies were monoCT (56.9%), polyCT (15.0%), ramucirumab+CT (12.6%), platinum-reintroduction (8.3%), trastuzumab+CT (6.1%), and ramucirumab (1.1%). PFS-2/PPS medians gradually increased in monoCT, 2.6/5.1 months; polyCT 3.4/6.3 months; ramucirumab+CT, 4.1/6.5 months; platinum-reintroduction, 4.2/6.7 months, and for the HER2+ subgroup in particular, trastuzumab+CT, 5.2/11.7 months. Correlation between PFS since first-line and OS was moderate in the series as a whole (Kendall's τ = 0.613), lower in those subjects who received second-line (Kendall's τ = 0.539), especially with ramucirumab+CT (Kendall's τ = 0.413). CONCLUSION: This analysis reveals the diversity in second-line treatment for AGC, highlighting the effectiveness of paclitaxel-ramucirumab and, for a selected subgroup of patients, platinum reintroduction; both strategies endorsed by recent clinical guidelines.

Biopsychosocial and clinical characteristics in patients with resected breast and colon cancer at the beginning and end of adjuvant treatment.

BACKGROUND: The aim of this study was to analyze biopsychosocial factors affecting how patients cope with cancer and adjuvant treatment and to appraise psychological distress, coping, perceived social support, quality of life and SDM before and after adjuvant treatment in breast cancer patients compared to colon cancer patients. METHODS: NEOcoping is a national, multicenter, cross-sectional, prospective study. The sample comprised 266 patients with colon cancer and 231 with breast cancer. The instruments used were the Brief Symptom Inventory (BSI), Mini-Mental Adjustment to Cancer (Mini-MAC), Multidimensional Scale of Perceived Social Support (MSPSS), Shared Decision-Making Questionnaire-Patient (SDM-Q-9) and Physician's (SDM-Q-Doc), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). RESULTS: Breast cancer patients reacted worse to the diagnosis of cancer with more symptoms of anxiety, depression, and somatization, and were less satisfied with their involvement than those with colon cancer (p = 0.003). Participants with colon cancer were older and had more physical symptoms and functional limitations at the beginning of adjuvant treatment, while there were scarcely any differences between the two groups at the end of adjuvancy, at which time both groups suffered greater psychological and physical effects and scored lower on coping strategies, except for anxious preoccupation. CONCLUSIONS: Breast cancer patients need more information and involvement of the oncologist in shared decision-making, as well as and more medical and psychological support when beginning adjuvant treatment. Both breast and colon cancer patients may require additional psychological care at the end of adjuvancy.

Quality of life, coping, and psychological and physical symptoms after surgery for non-metastatic digestive tract cancer.

OBJECTIVE: The aim of this study was to investigate the impact of curative surgery for non-metastatic digestive tract cancers on quality of life (QoL), psychological status, and coping strategies. METHODS: A prospective, transversal, multicenter study was conducted in 404 patients: 361 with colorectal, 44 with gastroesophageal, and 35 with pancreaticobiliary cancer six months after surgery. Participants completed questionnaires evaluating QoL, including functioning (EORTC-QLC-C30), coping strategies (Mini-MAC), and psychological distress (BSI-18). RESULTS: The effects of surgery had a strong impact on functional domains, global QoL, and symptoms, especially in pancreaticobiliary and gastroesophageal cancer. Patients with pancreaticobiliary and gastroesophageal cancer had lower functional scale scores than those with colorectal cancer. Fatigue, appetite loss, diarrhea, depression, and psychological distress were the most common symptoms after surgery. Subjects with pancreaticobiliary cancer reported more fatigue, pain, insomnia, depression, somatization and psychological distress, whereas individuals with gastroesophageal cancer exhibited more fatigue, nausea/vomiting, diarrhea, depression, psychological distress, and helplessness than those with colorectal cancer. Only participants with colorectal cancer displayed improved QoL six months post-surgery, albeit their psychological state had worsened. CONCLUSION: Surgeons should discuss expectations regarding symptoms and QoL with patients prior to surgery to minimize physical and psychological impact.

Multistate Models: Accurate and Dynamic Methods to Improve Predictions of Thrombotic Risk in Patients with Cancer.

Research into cancer-associated thrombosis (CAT) entails managing dynamic data that pose an analytical challenge. Thus, methods that assume proportional hazards to investigate prognosis entail a risk of misinterpreting or overlooking key traits or time-varying effects. We examined the AGAMENON registry, which collects data from 2,129 patients with advanced gastric cancer. An accelerated failure time (AFT) multistate model and flexible competing risks regression were used to scrutinize the time-varying effect of CAT, as well as to estimate how covariates dynamically predict cumulative incidence. The AFT model revealed that thrombosis shortened progression-free survival and overall survival with adjusted time ratios of 0.72 and 0.56, respectively. Nevertheless, its prognostic effect was nonproportional and disappeared over time if the subject managed to survive long enough. CAT that occurred later had a more pronounced prognostic effect. In the flexible competing risks model, multiple covariates were seen to have significant time-varying effects on the cumulative incidence of CAT (Khorana score, secondary thromboprophylaxis, high tumor burden, and cisplatin-containing regimen), whereas other predictors exerted a constant effect (signet ring cells and primary thromboprophylaxis). The model that assumes proportional hazards was incapable of capturing the effect of these covariates and predicted the cumulative incidence in a biased way. This study evinces that flexible and multistate models are a useful and innovative method to describe the dynamic effect of variables associated with CAT and should be more widely used.

Psychometric properties of the Shared Decision-Making Questionnaire (SDM-Q-9) in oncology practice.

Background/Objective: This study sought to assess the psychometric properties of the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) in patients with resected, non-metastatic cancer and eligible for adjuvant chemotherapy. Method: A total of 568 patients were recruited from a multi-institutional, prospective, transversal study. Patients answered the SDM-Q-9 after visiting their medical oncologist who, in turn, completed the SDM-Q-Physician version. Reliability, factorial structures [exploratory factor analysis (EFA), confirmatory factor analysis (CFA)], and convergent validity of the SDM-Q-9 scores were explored. Results: SDM-Q-9 showed a clear factorial structure, compatible with a strong and replicable general factor and a secondary group factor, in patients with resected, non-metastatic cancer. Total sum scores derived from the general factor showed good reliability in terms of omega coefficient: .90. The association between patient and physician perception of SDM was weak and failed to reach statistical significance. Males and patients over 60 years of age displayed the greatest satisfaction with SDM. Conclusions: SDM-Q-9 can aid in evaluating SDM from the cancer patients' perspective. SDM-Q-9 is helpful in studies examining patient perspectives of SDM and as an indicator of the degree of quality and satisfaction with health care and patient-physician relationship.

Antecedentes/Objetivo: Este estudio analiza las propiedades psicométricas del Questionnaire Shared Decision-Making (SDM-Q-9) en pacientes con cáncer resecado, no metastásico y elegible para quimioterapia adyuvante. Métodos: Un total de 568 pacientes fueron reclutados en un estudio multi-institucional, prospectivo, transversal. Los pacientes respondieron al SDM-Q-9 después de visitar a su oncólogo que, a su vez, completó el SDM-Q-versión médico. Se estudiaron la fiabilidad, la estructura factorial (análisis factorial exploratorio y análisis factorial confirmatorio) y la validez convergente de las puntuaciones del SDM-Q-9. Resultados: La escala SDM-Q-9 mostró una estructura factorial clara, compatible con un factor general fuerte y replicable y un factor de grupo secundario, en pacientes con cáncer resecado y no metastásico. La puntuación del factor general mostró una buena fiabilidad en términos de coeficiente omega: 0,90. La asociación entre la percepción del médico y del paciente en la SDM fue débil y no logró alcanzar significación estadística. Los hombres y los pacientes mayores de 60 años mostraron mayor satisfacción con la toma de decisión compartida. Conclusiones: SDM-Q-9 puede ayudar en la evaluación de la toma de decisión compartida desde la perspectiva de los pacientes de cáncer y como indicador del grado de calidad y satisfacción en el cuidado de la salud en la relación médico-paciente.

Psychometric properties of the Shared Decision-Making Questionnaire (SDM-Q-9) in oncology practice / Propiedades psicométricas del Questionnaire Shared Decision-Making (SDM-Q-9) en oncología

Background/Objective: This study sought to assess the psychometric properties of the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) in patients with resected, non-metastatic cancer and eligible for adjuvant chemotherapy. Method: A total of 568 patients were recruited from a multi-institutional, prospective, transversal study. Patients answered the SDM-Q-9 after visiting their medical oncologist who, in turn, completed the SDM-Q-Physician version. Reliability, factorial structures [exploratory factor analysis (EFA), confirmatory factor analysis (CFA)], and convergent validity of the SDM-Q-9 scores were explored. Results: SDM-Q-9 showed a clear factorial structure, compatible with a strong and replicable general factor and a secondary group factor, in patients with resected, non-metastatic cancer. Total sum scores derived from the general factor showed good reliability in terms of omega coefficient: .90. The association between patient and physician perception of SDM was weak and failed to reach statistical significance. Males and patients over 60 years of age displayed the greatest satisfaction with SDM. Conclusions: SDM-Q-9 can aid in evaluating SDM from the cancer patients' perspective. SDM-Q-9 is helpful in studies examining patient perspectives of SDM and as an indicator of the degree of quality and satisfaction with health care and patient-physician relationship

Antecedentes/Objetivo: Este estudio analiza las propiedades psicométricas del Questionnaire Shared Decision-Making (SDM-Q-9) en pacientes con cáncer resecado, no metastásico y elegible para quimioterapia adyuvante. Métodos: Un total de 568 pacientes fueron reclutados en un estudio multi-institucional, prospectivo, transversal. Los pacientes respondieron al SDM-Q-9 después de visitar a su oncólogo que, a su vez, completó el SDM-Q-versión médico. Se estudiaron la fiabilidad, la estructura factorial (análisis factorial exploratorio y análisis factorial confirmatorio) y la validez convergente de las puntuaciones del SDM-Q-9. Resultados: La escala SDM-Q-9 mostró una estructura factorial clara, compatible con un factor general fuerte y replicable y un factor de grupo secundario, en pacientes con cáncer resecado y no metastásico. La puntuación del factor general mostró una buena fiabilidad en términos de coeficiente omega: 0,90. La asociación entre la percepción del médico y del paciente en la SDM fue débil y no logró alcanzar significación estadística. Los hombres y los pacientes mayores de 60 años mostraron mayor satisfacción con la toma de decisión compartida. Conclusiones: SDM-Q-9 puede ayudar en la evaluación de la toma de decisión compartida desde la perspectiva de los pacientes de cáncer y como indicador del grado de calidad y satisfacción en el cuidado de la salud en la relación médico-paciente

Surgery for metastases for esophageal-gastric cancer in the real world: Data from the AGAMENON national registry.

INTRODUCTION: The effect of surgery for metastases in patients with esophagogastric cancer is unknown, given the lack of randomized clinical trials; likewise, the criteria for selecting eligible patients remain to be determined. METHODS: This registry evaluates the results of patients with advanced adenocarcinoma of the stomach, distal esophagus, or gastro-esophageal junction from 32 centers. To assess selection criteria and prognostic factors, a state arrival extended Markov proportional hazards (PH) model was used. RESULTS: 1792 subjects were analyzed, 5% of whom (n = 92) underwent surgery for metastasis. The most common surgeries were peritoneal (29%), hepatic (24%), and distant lymph nodes (11%). Subjects chosen for metastasectomy had higher survival rates, HR 0.34 (95% CI, 0.06-0.80, p = 0.021). Patients who underwent surgery had a mOS since metastasectomy of 16.7 months (95% CI, 12.5-22.4). The 1- and 3-year relapse rates following R0 resection were 58% and 65%, respectively. Median time since R0 metastasectomy until relapse was 8.4 months (95% CI, 7.6-23.7). The 3-year OS after surgery was 30.6% (95% CI, 19.3-40.4). Duration of chemotherapy prior to surgery (months) increased mortality (HR 1.04 [95% CI, 1.01-1.07]), p = 0.009. The only significant interaction involved the use of anti-HER2 therapy. CONCLUSION: The AGAMENON registry suggests that subjects with limited metastatic disease, selected on a clinical basis, can benefit from early surgeries. Prospective trials are needed to confirm these data.

Efficacy and safety of chemotherapy in older versus non-older patients with advanced gastric cancer: A real-world data, non-inferiority analysis.

OBJECTIVE: Advanced gastric cancer (AGC) is a common neoplasm in older adults. Nevertheless, there are few specific management data in the literature. The aim of this study was to assess non-inferiority of survival and efficacy-related outcomes of chemotherapy used in older vs non-older patients with AGC. MATERIALS AND METHODS: We recruited 1485 patients from the AGAMENON registry of AGC treated with polychemotherapy between 2008-2017. A statistical analysis was conducted to prove non-inferiority for overall survival (OS) associated with the use of chemotherapy schedules in individuals ≥70 vs.<70years. The fixed-margin method was used (hazard ratio [HR]<1.176) that corresponds to conserving at least 85% efficacy. RESULTS: 33% (n=489) of the cases analyzed were ≥70 years. Two-agent chemotherapies and combinations with oxaliplatin (48% vs. 29%) were used more often in the older patients, as were modified schedules and/or lower doses. Toxicity grade 3-4 was comparable in both groups, although when looking at any grade, there were more episodes of enteritis, renal toxicity, and fatigue in older patients. In addition, toxicity was a frequent cause for discontinuing treatment in older patients. The response rate was similar in both groups. After adjusting for confounding factors, the non-inferiority of OS associated with schedules administered to the older vs. younger subjects was confirmed: HR 1.02 (90% CI, 0.91-1.14), P (non inferiority)=0.018, as well as progression-free survival: HR 0.97 (90% CI, 0.87-1.08), P(non-inferiority)=0.001. CONCLUSION: In this AGC registry, the use of chemotherapy with schedules adapted to patients ≥70 years provided efficacy that was not inferior to that seen in younger cases, with comparable adverse effects.

The mediating role of spirituality (meaning, peace, faith) between psychological distress and mental adjustment in cancer patients.

OBJECTIVE: The objectives of this study were (a) to determine the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) scale and (b) to provide that FACIT scores behave one-dimensional to establish the mediating role of spiritual well-being in psychological distress and mental adjustment in a sample of patients with non-metastatic, resected cancer. METHOD: A total of 504 consecutive patients completed the FACIT-Sp, Brief Symptom Inventory, and Mini-Mental Adjustment to Cancer scales. The dimensionality and structure of the scale were assessed by semi-confirmatory factor analysis; the reliability of the derived scale scores was evaluated using the omega coefficient, and regression analysis appraised the FACIT-Sp's mediating role between psychological distress and mental adjustment. RESULTS: A clear and theoretically interpretable solution in two factors that agreed generally with solutions reported in other languages was obtained for the FACIT item scores and omega reliabilities of the derived Meaning/Peace (0.85) and Faith (0.86) scales were acceptable. The oblique solution in two factors was compatible with an essentially unidimensional solution of general well-being and associated strongly with psychological distress and mental adjustment. Spiritual well-being acted as a partial mediator between psychological distress and mental adjustment strategies, such as fighting spirit, hope, and cognitive avoidance. CONCLUSIONS: The Spanish version of the FACIT-Sp scale is a reliable and valid clinical evaluation tool, and further highlights the potential clinical implications of spirituality for improving quality of life and adjustment to cancer.

Psychometric properties of Liverpool Stoicism Scale (LSS) in a cohort of patients with resected cancer in adjuvant treatment / Propiedades psicométricas de la Liverpool Stoicism Scale (LSS) en una cohorte de pacientes con cáncer resecado en tratamiento adyuvante

Stoicism has been used to describe a wide range of behaviors in the face of disease that go from silence, resistance to the adversity, or ‘to make the best of a bad disease’. This study pursued two objectives: 1) analyze the psychometric properties of the Spanish version of the LSS; 2) assess the relation between stoicism and gender, age, and the five-factor personality model. NEOcoping is a prospective, multicenter, observational, non-interventionist study. Patients were recruited consecutively at thirteen Spanish teaching hospitals. The following scales were administered: Liverpool Stoicism Scale (LSS) and Big Five Inventory (BFI-10). A total of 443 patients (250 females) with a mean age of 59.8 years (SD =12.3) were enrolled. Colon cancer was the most common, followed by breast cancer. At the total-scale level, mean LSS was lower than the originally reported British sample. The four-factor structure fitted the data well, had a clear interpretation, and the derived scales showed acceptable reliabilities. The personality trait of introversion predicted 4.1% of the variance of stoicism (p<001). Even though it needs to be improved, the LSS scale demonstrates acceptable psychometric properties to appraise stoicism in the Spanish population with resected cancer (AU)

El estoicismo se ha utilizado para describir una amplia gama de comportamientos frente a la enfermedad que van desde el silencio a la resistencia a la adversidad. Este estudio tiene dos objetivos: 1) analizar las propiedades psicométricas de la versión española del LSS; 2) evaluar la relación entre estoicismo, género, edad y el modelo de los cinco grandes factores de personalidad. NEOcoping es un estudio prospectivo, multicéntrico, observacional, no-intervencionista. Los pacientes fueron reclutados consecutivamente en 13 hospitales universitarios de España. Se aplicó la Liverpool Stoicism Scale (LSS) y el Big Five Inventory (BFI-10). Participaron 443 pacientes (250 mujeres) con una edad media de 59,8 años (SD =12,3). El cáncer de colon y mama fueron los más frecuentes. A nivel de escala total, la puntuación media de la LSS fue inferior a la muestra Británica. La estructura propuesta en cuatro factores proporciona un buen ajuste a los datos, y las puntuaciones en las escalas derivadas presentan fiabilidades aceptables. El rasgo de personalidad de introversión fue capaz de predecir el 4,1% de la variancia de estoicismo (p<001). Aunque debe ser mejorada, la LSS presenta globalmente unas propiedades psicométricas aceptables para evaluar el estoicismo en pacientes españoles con cáncer resecado (AU)

Lauren subtypes of advanced gastric cancer influence survival and response to chemotherapy: real-world data from the AGAMENON National Cancer Registry.

BACKGROUND: The choice of chemotherapy in HER2-negative gastric cancer is based on centre's preferences and adverse effects profile. No schedule is currently accepted as standard, nor are there any factors to predict response, other than HER2 status. We seek to evaluate whether Lauren type influences the efficacy of various chemotherapies and on patient overall survival (OS). METHODS: We have conducted a multicenter study in 31 hospitals. The eligibility criteria include diagnosis of stomach or gastroesophageal junction adenocarcinoma, HER2 negativity, and chemotherapy containing 2-3 drugs. Cox proportional hazards regression adjusted for confounding factors, with tests of 'treatment-by-histology' interaction, was used to estimate treatment effect. RESULTS: Our registry contains 1303 tumours analysable for OS end points and 730 evaluable for overall response rate (ORR). A decrease in ORR was detected in the presence of a diffuse component: odds ratio 0.719 (95% confidence interval (CI), 0.525-0.987), P=0.039. Anthracycline- or docetaxel-containing schedules increased ORR only in the intestinal type. The diffuse type displayed increased mortality with hazard ratio (HR) of 1.201 (95% CI, 1.054-1.368), P=0.0056. Patients receiving chemotherapy with docetaxel exhibited increased OS limited to the intestinal type: HR 0.65 (95% CI, 0.49-0.87), P=0.024, with no increment in OS for the subset having a diffuse component. With respect to progression-free survival (PFS), a significant interaction was seen in the effect of docetaxel-containing schedules, with better PFS limited to the intestinal type subgroup, in the comparison against any other schedule: HR 0.65 (95% CI, 0.50-0.85), P=0.015, and against anthracycline-based regimens: HR 0.64 (95% CI, 0.46-0.88), P=0.046. CONCLUSIONS: As a conclusion, in this registry, Lauren classification tumour subtypes predicted survival and responded differently to chemotherapy. Future clinical trials should stratify effect estimations based on histology.

Clinical features and short-term outcomes of cancer patients with suspected and unsuspected pulmonary embolism: the EPIPHANY study.

The study aimed to identify predictors of overall 30-day mortality in cancer patients with pulmonary embolism including suspected pulmonary embolism (SPE) and unsuspected pulmonary embolism (UPE) events. Secondary outcomes included 30- and 90-day major bleeding and venous thromboembolism (VTE) recurrence.The study cohort included 1033 consecutive patients with pulmonary embolism from the multicentre observational ambispective EPIPHANY study (March 2006-October 2014). A subgroup of 497 patients prospectively assessed for the study were subclassified into three work-up scenarios (SPE, truly asymptomatic UPE and UPE with symptoms) to assess outcomes.The overall 30-day mortality rate was 14%. The following variables were associated with the overall 30-day mortality on multivariate analysis: VTE history, upper gastrointestinal cancers, metastatic disease, cancer progression, performance status, arterial hypotension <100 mmHg, heart rate >110 beats·min-1, basal oxygen saturation <90% and SPE (versus overall UPE).The overall 30-day mortality was significantly lower in patients with truly asymptomatic UPE events (3%) compared with those with UPE-S (20%) and SPE (21%) (p<0.0001). Thirty- and 90-day VTE recurrence and major bleeding rates were similar in all the groups.In conclusion, variables associated with the severity of cancer and pulmonary embolism were associated with short-term mortality. Our findings may help to develop pulmonary embolism risk-assessment models in this setting.

Prognostic value of computed tomography pulmonary angiography indices in patients with cancer-related pulmonary embolism: Data from a multicenter cohort study.

OBJECTIVE: To analyze the prognostic value of pulmonary artery obstruction versus right-ventricle (RV) dysfunction radiologic indices in cancer-related pulmonary embolism (PE). METHODS: We enrolled 303 consecutive patients with paraneoplastic PE, evaluated by computed tomography pulmonary angiography (CTPA) between 2013 and 2014. The primary outcome measure was serious complications at 15days. Multivariate analyses were conducted by using binary logistic and robust regressions. Radiological features such as the Qanadli index (QI) and RV dysfunction signs were analyzed with Spearman's partial rank correlations. RESULTS: RV diameter was the only radiological variable associated with an adverse outcome. Subjects with enlarged RV (diameter>45mm) had more 15-day complications (58% versus 40%, p=0.001). The QI correlated with the RV diameter (r=0.28, p<0.001), left ventricle diameter (r=-0.19, p<0.001), right ventricular-to-left ventricular diameter ratio (r=0.39, p<0.001), pulmonary artery diameter (r=0.22, p<0.001), and pulmonary artery/ascending aorta ratio (r=0.27, p<0.001). A QI≥50% was only associated with 15-day complications in subjects with enlarged RV, inverted intraventricular septum, or chronic cardiopulmonary diseases. The central or peripheral PE location did not affect the correlations among radiological variables and was not associated with clinical outcomes. CONCLUSIONS: Right ventricular dysfunction signs in CTPA are more useful than QI in predicting cancer-related PE outcome.

Prognostic significance of performing universal HER2 testing in cases of advanced gastric cancer.

BACKGROUND: Trastuzumab significantly improves overall survival (OS) when added to cisplatin and fluoropyrimidine as a treatment for HER2-positive advanced gastric cancers (AGC). The aim of this study was to evaluate the impact of the gradual implementation of HER2 testing on patient prognosis in a national registry of AGC. METHODS: This Spanish National Cancer Registry includes cases who were consecutively recruited at 28 centers from January 2008 to January 2016. The effect of missing HER2 status was assessed using stratified Cox proportional hazards (PH) regression. RESULTS: The rate of HER2 testing increased steadily over time, from 58.3 % in 2008 to 92.9 % in 2016. HER2 was positive in 194 tumors (21.3 %). In the stratified Cox PH regression, each 1 % increase in patients who were not tested for HER2 at the institutions was associated with an approximately 0.3 % increase in the risk of death: hazard ratio, 1.0035 (CI 95 %, 1.001-1.005), P = 0.0019. Median OS was significantly lower at institutions with the highest proportions of patients who were not tested for HER2. CONCLUSION: Patients treated at centers that took longer to implement HER2 testing exhibited worse clinical outcomes. The speed of implementation behaves as a quality-of-care indicator. Reviewed guidelines on HER2 testing should be used to achieve this goal in a timely manner.