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Resumen Introducción: La medición de la calidad de vida (CV) en el paciente oncológico permite establecer una percepción del individuo sobre su estado de salud-enfermedad y el tratamiento instaurado. El objetivo del presente estudio es analizar la influencia de la situación nutricional en la CV de los pacientes. Material y Métodos: Se llevó a cabo un estudio transversal en el Hospital Ramón y Cajal en 53 pacientes oncológicos durante un periodo de 6 meses. A estos pacientes se les realizó la valoración global subjetiva (VGS), un recuerdo 24h de la ingesta del día anterior y se les administró el cuestionario European Organisation for Research and Treatment of Cancer quality of Life Questionnaire Core 30 (EORTC QLQ-C30). De estos 53 pacientes, 9 fueron excluidos debido a una incompleta cumplimentación del cuestionario EORTC QLQ C-30. De los 44 pacientes restantes, el 52,3% pertenecía al grupo de normonutridos sin riesgo (VGS A); el 27,3 % al grupo de pacientes en riesgo de desnutrición o desnutrición moderada (VGS B) y el 20,5% restantes al grupo de pacientes con grave desnutrición (VGS C). Resultados: Las escalas funcionales (funcionamiento físico, social, emocional y cognitivo) fueron las menos afectadas por la situación nutricional de los pacientes, con valor de p>0,05, mientras que la escala funcional o de rol (p=0,002), junto con la escala global de salud (p=0,049), así como los síntomas de fatiga (p=0,011), náuseas y vómitos (p=0,004) y el ítem simple de pérdida de apetito (p=0,001) son las que mostraron una asociación estadísticamente significativa con la situación nutricional. Conclusiones: La desnutrición afecta negativamente a la CV de los pacientes oncológicos especialmente en las escalas de funcional, escala global de salud y de síntomas. Son necesarios más estudios para evaluar si la intervención nutricional precoz puede revertir esta influencia negativa de la desnutrición.

Background: Despite a number of treatment options, patients with diffuse large B-cell lymphoma (DLBCL) whose disease has become refractory to treatment have a poor prognosis. Selinexor is a novel, oral drug that is approved to treat patients with relapsed/refractory DLBCL. In this post hoc analysis of the SADAL study, a multinational, open-label study, we evaluated subpopulations to determine if response to single agent selinexor is impacted by number of lines of prior treatment, autologous stem cell transplant (ASCT), response to first and most recent therapies, and time to progressive disease. Patients: Patients (n = 134) with DLBCL after 2-5 prior therapies were enrolled in SADAL and received 60mg selinexor twice weekly. Results: The median overall survival was 9.0 months and median progression free survival was 2.6 months. Patients who had the best overall response rate (ORR) and disease control rate were those who had prior ASCT (42.5% and 50.0%) or responded to last line of therapy (35.9% and 43.5%). Patients with primary refractory DLBCL also showed responses (ORR 21.8%). Adverse events between subgroups were similar to the overall study population, the most common being thrombocytopenia (29.1%), fatigue (7.5%), and nausea (6.0%). Conclusion: Regardless of prior therapy and disease refractory status, selinexor treatment demonstrated results consistent with its novel mechanism of action and lack of cross-resistance. Thus, single agent oral selinexor can induce deep, durable, and tolerable responses in patients with DLBCL who have recurrent disease after several chemoimmunotherapy combination regimens. © 2021

BACKGROUND:Circulatory shock is a life-threatening disorder that is associated with high mortality, with a state of systemic and tissue hypoperfusion that can lead to organ failure, including the brain, where altered mental state is often observed. We hypothesized that cerebral autoregulation (CA) is impaired in patients with circulatory shock. METHODS:Adult patients with circulatory shock and healthy controls were included. Cerebral blood flow velocity (CBFV, transcranial Doppler ultrasound) and arterial blood pressure (BP, Finometer or intra-arterial line) were continuously recorded during 5-minutes in both groups. Autoregulation Index (ARI) was estimated from the CBFV response to a step change in BP, derived by transfer function analysis; ARI ≤ 4 was considered as impaired CA. The relationship between organ dysfunction, assessed with the Sequential Organ Failure Assessment (SOFA) score and the ARI was assessed with linear regression. RESULTS:Twenty-five shock patients and 28 age-matched healthy volunteers were studied. The mean ± SD SOFA score was 10.8 ± 4.3. Shock patients compared to control subjects had lower ARI values (4.0 ± 2.1 vs. 5.9 ± 1.5, p = 0.001). Impaired CA was more common in shock patients (44.4% vs. 7.1%, p = 0.003). There was a significant inverse relationship between the ARI and the SOFA score (R = -0.63, p = 0.0008). CONCLUSIONS:These results suggest that circulatory shock is often associated with impaired CA and that the severity of CA alterations are correlated with the degree of multiple organ failure, reinforcing the need to monitor cerebral hemodynamics in patients with circulatory shock.

Aim: This study was designed to evaluate the role of magnetic resonance imaging (MRI) on preoperative restaging of locally advanced rectal cancer after neoadjuvant chemoradiotherapy (CRT), in order to facilitate individualization of surgical management. Method: We analyzed 117 patients who had received neoadjuvant CRT, underwent a MRI before and after CRT. All patients underwent restaging MRI followed by surgery after the end of CRT. The primary end point of this study was to estimate the accuracy of post-CRT MRI as compared with pathologic staging. Results: Pathologic T classification matched the post-CRT MRI findings in 44 (37.6%) of 117 patients. Sensitivity in T0, T1, T2, T3 and T4 was 23.8%, 16.7%, 25.6%, 48.9% and 83.3% respectively. Specificity in T0, T1, T2, T3 and T4 were 87.5%, 93.7%, 79.5%, and 64% and 88.3% respectively. Sensitivity in N0 and N1 were 82% and 20% respectively. Specificity was 88% in N0 and 87% in N1. Fifty two (44.4%) of 117 patients were downstaged in T classification. Pathologic N classification matched the post-CRI MRI findings in 73 (62.4%) of 117 patients. Twenty one (17.9%) were overstaged in N classification. Twenty seven (23%) of 117 patients who had been down staged on MRI after CRT were confirmed on the pathological staging with same stage (T and N). 17p with ypT0 were correlated with MRI after CRT in 5 patients (4.3%). Conclusion: MRI has low accuracy for restaging locally advanced rectal cancer after preoperative CRT so it is currently not consistent enough for clinical application.

Aim: Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Patients & methods: Functional Assessment of Cancer Therapy (FACT)-Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase IIb trial SADAL (NCT02227251) were analyzed with mixed-effects models. Results: Treatment responders maintained higher FACT-Lymphoma (p ≤ 0.05), FACT-General (p < 0.05) and EuroQoL five-dimensions five-levels index scores (p < 0.001) beginning in cycle 3. The estimated difference in health state utilities for treatment response and progressive disease was both statistically significant and clinically meaningful (mean difference: 0.07; p = 0.001). Conclusion: In patients with relapsed/refractory diffuse large B-cell lymphoma, objective response to selinexor was associated with HRQoL maintenance, reduction in disease-related HRQoL decrements and higher health utilities. © 2021 Patrick Daniele.

Purpose Standard of care for locally advanced rectal cancer is neoadjuvant chemoradiotherapy followed by surgery. This study identified predictive factors for tumour response in our series. Patients and methods Between January 2005 and December 2018, 292 patients with locally advanced rectal cancer treated by preoperative chemo-radiation before surgery were retrospectively analyzed. The radiation dose was 50.4 Gy with fluoropyrimidine-based chemotherapy regimens. Patients-tumour and treatment-factors were tested for influence on tumour down staging and regression grade using Mandard scoring system on surgical specimens (TRG). Results Median age was 69 years (range 39-87); 33.9% of patients was Stage II and 54.5% Stage IIIB. Tumour down staging occurred in 211 patients (73%), including 63 patients (21.6%) with ypT0 (documented T0 at surgery) and 148 patients (50.7%) with a satisfactory tumour regression grade defined as TRG2‒3. Upper rectal tumours were identified to predictive factors for pathologic complete response by univariate analysis (p = 0.002). TRG1‒3 was associated with intervals from chemo-radiation to surgery (p = 0.004); TRG1‒3 rates were higher with longer intervals: 1.71% in ≤ 5 weeks, 23.63% in 6-8 weeks and 46.9% in ≥ 9 weeks; and PTV 50.4 ≥ 800cc (p = 0.06); 3 and 5 years survivals were 85% and 90% for the group as a whole. Among ypT0 cases, the overall survival was 91.1% without significantly different (p = 0.25) compared with the remaining group, 87.2%. Among ypT0 cases, the relapse-free survival was 94.5%, with significantly different (p = 0.03) compared with the remaining group 78.2%. There were no treatment-associated fatalities. Thirty-two patients (10.96%) experienced Grade III/IV toxicities (proctitis, ephitelitis and neutropenia). Conclusions Tumour localization was identified as predictive factors of pathologic complete response for locally advanced rectal cancer treated with preoperative chemo-radiation. Upper rectal tumours are more likely to develop complete responses. Delay in surgery was identified as a favorable predictive factor for TRG1‒3. The relapse-free survival in pathologic complete response group was higher compared with non-pathologic complete response. RESUMO Objetivo O tratamento padrão para o câncer retal localmente avançado é a quimiorradioterapia neoadjuvante, seguida de cirurgia. Este estudo identificou fatores preditivos de resposta tumoral em nossa série. Pacientes e métodos Entre janeiro de 2005 e dezembro de 2018, 292 pacientes com câncer retal localmente avançado, tratados com quimiorradiação pré-operatória, foram retrospectivamente analisados. O tratamento quimioterápico foi à base de fluoropirimidina e a dose de radiação foi de 50,4 Gy. Os tumores dos pacientes e os fatores do tratamento foram testados quanto à influência no estadiamento do tumor e no grau de regressão usando o sistema de classificação de Mandard em espécimes cirúrgicos (TRG). Resultados A mediana das idades foi 69 anos (variação de 39 a 87); 33,9% dos pacientes estavam no estágio II e 54,5% no estágio IIIB. O estadiamento do tumor ocorreu em 211 pacientes (73%), incluindo 63 pacientes (21,6%) com ypT0 (T0 documentado na cirurgia) e 148 pacientes (50,7%) com grau satisfatório de regressão do tumor, definido como TRG2‒3. Os tumores retais superiores foram identificados como fatores preditivos de resposta patológica completa por análise univariada p = 0,002. TRG1‒3 foi associado aos intervalos entre a quimioterapia e a cirurgia p = 0,004; As taxas de TRG1‒3 foram maiores com intervalos mais longos: 1,71% em ≤ 5 semanas, 23,63% em 6-8 semanas e 46,9% em ≥ 9 semanas; e PTV 50,4 ≥ 800cc (p = 0,06); as sobrevidas de 3 e 5 anos foram de 85% e 90% para o grupo em geral. Entre os casos de ypT0, a sobrevida global foi de 91,1%, sem diferença significativa (p = 0,25) na comparação com o grupo restante (87,2%). Entre os casos de ypT0, a sobrevida livre de recidiva foi de 94,5%, com diferença significativa (p = 0,03) na comparação com o grupo restante (78,2%). Não houve fatalidades associadas ao tratamento. Trinta e dois pacientes (10,96%) apresentaram toxicidade de grau III/IV (proctite, efitelite e neutropenia). Conclusões A localização do tumor foi identificada como fator preditivo de resposta patológica completa para o câncer retal localmente avançado tratado com quimiorradiação pré-operatória. Os tumores retais superiores têm mais probabilidade de desenvolver respostas completas. O atraso da cirurgia foi identificado como um fator preditivo favorável para o TRG1‒3. A sobrevida livre de recidiva no grupo com resposta patológica completa à quimiorradioterapia pré-operatória foi maior comparado ao grupo com resposta patológica incompleta.

Introduction/Background Our purpose is to evaluate the influence of surgical management and the prognostic factors for Disease-Free Survival (DFS) and Overall Survival (OS) in endometrial cancer (EC). Methodology Retrospective review of 180 patients underwent standard surgical staging with pelvic and para-aortic lymphadenectomy in 130 cases. Mean age was 63 years (27–94). Mean BMI 30 kg/m2 (15–51). Mean Ca 1.25 prior to surgery was 61 U/dL (2–4,228). Mean removed nodes was 21 pelvic nodes (9–56, involved nodes 12.3%) and 19 para-aortic nodes (7–51, involved nodes 14.8%). A laparoscopic approach was performed in 65% patients. Mean follow-up was 46 months. The factors that impact on survival were compared using univariate and multivariate analysis. Results The estimated 5-year DFS and OS comparated rates were respectively, according to FIGO local stages (I) 93.9 and 90.2%, vs advanced stages (II–IV) 0 and 53.7% (p=0.00 Hazard ratio 5.58 (CI 95%, 2.74–11.35) and p=0.00 Hazard ratio 4.19 (CI 95%, 2.11–8.34); obesity BMI 30 82.7 and 80.8 (p=0.61 and p=0.38); preoperative Ca125 levels Conclusion DFS and OS increased in case of complete debulking, low Ca12.5 leves prior to surgery, the abscence of lymph involvement and patients who underwent lymphadenectomy. Disclosure Nothing to disclose.

Introduction/Background To evaluate the influence of surgical strategy on survival for patients with stage III or IV epithelial ovarian cancer (EOC). Methodology Retrospective data collection in a single and reference cancer center. Currently the strategies in advanced ovarian cancer are changing. Our purpose was to analyse the Overall Survival (OS) and Disease Free Survival (DFS) comparing the ‘state of the art’ procedures, Primary Debulking Surgery (PDS) and interval surgery after 3–6 cycles of Neoadjuvant Chemotherapy (NAC). Incidentally, we tested the risk factors for recurrence. Results Median age was 59 years (40–80). Exploratory laparoscopy was performed in 52 patients, 28 underwent PDS and 24 NAC. Median Laparoscopic Predictive Score (Fagotti) was 2.2 (0–6) and 5.8 (2–10) (p=0.00), median Peritoneal Carcinomatosis Index was 12.5 (2–18) y 18.3 (10–24) (p=0.00) and mean of Ca125 prior to surgery was 489 y 949 U/dL (p=0.00) respectively. Pelvic and para-aortic lymphadenectomy was performed in 20 patients during PDS (14 cases with involved nodes, 48%) and 19 patients during interval surgery NAC (in 6 cases with involved nodes, 25%) (p=0.11). The median Surgical Complexity Score (Aletti) was 5 and 6.5 (p=0.21), with 80 and 24 points in the Comprehensive Compilation Index (modified from Clavien-Dindo Classification) for complications respectively (p=0.13). There were not significant differences in the complete resection rate (61 vs 63%, p=0.99), DFS (12 vs 15 months, p=0.80), and 5-years OS (59 vs 25%, p=0.32). Complete surgery were significantly associated with a better OS in univariate analysis (Hazard ratio 3.34 (95% CI, 1.19–9.40, p=0.015). Conclusion A significative improvement of OS has been observed in relation with complete tumour resection (microscopial residual tumor). In this study, NAC is non-inferior to PDS and is an acceptable standard of treatment of advanced and bulky EOC. Disclosure Nothing to disclose.

PURPOSE To propose adaptive setup protocols using Bayesian statistics that facilitate, based on a prediction of coverage probability, making a decision on which patients should follow daily imaging prior to treatment delivery. MATERIALS AND METHODS The suitability of the treatment margins was assessed combining interfraction variability measurements of the first days of treatment with previous data gathered from our patient population. From this information, we decided if a patient needs an online imaging protocol to perform daily isocenter correction before each treatment fraction. We applied our method to five different datasets. Protocol parameters were selected from each dataset based on coverage probability, the expected imaging workload of the treatment unit, and the accuracy of patient classification. Time trends were assessed and included in the proposed protocols. To validate the accuracy of the protocols, they were applied to a validation dataset of prostate cancer patients. RESULTS Adaptive setup protocols lead expected population coverage >97% in all datasets analyzed when time trends were considered. The reduction in imaging workload ranged from 40% in lung treatments to 28.5% in prostate treatments. Results of the protocol on the validation dataset were very similar to those previously predicted. CONCLUSIONS The adaptive setup protocols based on Bayesian statistics presented in this study enable the optimization of imaging workload in the treatment unit ensuring that appropriate dose coverage remains unchanged.