Subgroup Of Low-risk Patients Research Articles

Early Surveillance Endoscopy Should Be Performed Selectively After Transanal Endoscopic Microsurgery for Rectal Lesions.

Introduction Local recurrence (LR) rates after transanal endoscopic microsurgery (TEM) are unclear, and the utility of early postoperative surveillance for low-risk lesions is unknown. This study aimed to define LR after TEM for benign polyps and invasive adenocarcinoma, describe risk factors for LR, and evaluate the utility of early surveillance endoscopy. Methods This retrospective cohort study was conducted at two hospitals in Winnipeg, Manitoba, Canada. Adult patients who underwent TEM between 2009 and 2020 were evaluated for inclusion. The primary outcome was the rate of LR on surveillance endoscopy. Other outcomes included risk factors for LR and diagnostic yield of surveillance endoscopy. Results Among 357 patients who underwent TEM for benign polyps, LR was 10.5% (95% confidence interval (CI) 5.8-15.2) at three years. Positive margin was correlated with LR on multivariate analysis (hazard ratio (HR) 8.01, 95% CI 2.78-23.08). TEM defect closure was associated with lower LR on multivariate analysis (HR 0.19, 95% CI 0.06-0.59). Among 124 patients who underwent TEM for rectal adenocarcinoma, LR was 15.0% (95% CI 6.0-24.0) at three years. The first surveillance endoscopy had a 1.4% yield for low-risk patients (benign lesion, negative margins, and closed TEM defect) and 6.9% for all others. Conclusions LR at three years after TEM was 10.5% for benign polyps and 15.0% for adenocarcinomas. Early surveillance endoscopy can be considered low yield in some patients after TEM, which can be informative for shared decision-making regarding whether to proceed with early endoscopy in a low-risk subgroup of patients.

The Impact of Intrauterine Manipulators on Outcome and Recurrence Patterns of Endometrial Cancer Patients Undergoing Minimally Invasive Surgery.

Objective: To evaluate the use of manipulators on the outcome of women who had minimally invasive surgery for endometrial cancer. Methods: Retrospective analysis of patients operated with or without an intrauterine manipulator. Results: Six hundred ninety-nine patients were included. The median follow-up was 44 months (range, 29-67). Nineteen (8.8%) patients had positive cytology in the manipulator group versus 21 (4.4%) in the comparison group (p = 0.02). Total recurrence rate was similar between the groups (12.3% vs. 11.9%; p = 0.8). Vaginal vault recurrence was the most common site of recurrence with higher incidence in the manipulator group (4.5% vs. 1.3%; p = 0.007). Subgroup analysis of low-risk patients who did not receive adjuvant treatment showed higher recurrence rate (8.3% vs. 3%; p = 0.023) and worse disease-free survival (p = 0.01) for the manipulator group. After controlling for other variables, the use of a manipulator did not affect the risk of recurrence for the whole cohort (hazard ratio [HR], 1.28; confidence interval [95% CI], 0.7-2.1, p = 0.3) and for the low-risk subgroup of patients who did not receive adjuvant treatment (HR, 2.47; 95% CI, 0.8-7, p = 0.08). Conclusion: The use of a manipulator increases the risk of positive cytology as well as vaginal vault recurrences, but it does not reduce the overall survival of patients.

Development and validation of the OSASH score to predict overall survival of hepatocellular carcinoma after surgical resection: a dual-institutional study

ObjectiveTo develop and validate a risk score based on preoperative clinical-radiological parameters for predicting overall survival (OS) in patients undergoing surgical resection for hepatocellular carcinoma (HCC).MethodsFrom July 2010 to December 2021, consecutive patients with surgically-proven HCC who underwent preoperative contrast-enhanced MRI were retrospectively enrolled. A preoperative OS risk score was constructed in the training cohort using a Cox regression model and validated in a propensity score-matched internal validation cohort and an external validation cohort.ResultsA total of 520 patients were enrolled, among whom 210, 210, and 100 patients were from the training, internal validation, and external validation cohorts, respectively. Independent predictors for OS included incomplete tumor “capsule,” mosaic architecture, tumor multiplicity, and serum alpha-fetoprotein, which were incorporated into the “OSASH score.” The C-index the OSASH score was 0.85, 0.81, and 0.62 in the training, internal, and external validation cohorts, respectively. Using 32 as the cutoff point, the OSASH score stratified patients into prognostically distinct low- and high-risk groups among all study cohorts and six subgroups (all p < 0.05). Furthermore, patients with BCLC stage B-C HCC and OSASH-low risk achieved comparable OS to that of patients with BCLC stage 0-A HCC and OSASH-high risk in the internal validation cohort (5-year OS rates, 74.7 vs. 77.8%; p = 0.964).ConclusionThe OSASH score may help predict OS in HCC patients undergoing hepatectomy and identify potential surgical candidates among those with BCLC stage B-C HCC.Clinical relevance statementBy incorporating three preoperative MRI features and serum AFP, the OSASH score may help predict postsurgical overall survival in patients with hepatocellular carcinoma and identify potential surgical candidates among those with BCLC stage B and C HCC.Key Points• The OSASH score incorporating three MRI features and serum AFP can be used to predict OS in HCC patients who received curative-intent hepatectomy.• The score stratified patients into prognostically distinct low- and high-risk strata in all study cohorts and six subgroups.• Among patients with BCLC stage B and C HCC, the score identified a subgroup of low-risk patients who achieved favorable outcomes after surgery.

Risk factors for lymph node metastasis in patients with pT2 colon cancer in Denmark from 2016 to 2019-A nationwide cohort study.

The majority of patients with pT2 colon cancer have no lymph node metastasis (LNM). Knowledge of risk factors for LNM in pT2 colon cancer could identify patients at low risk and thereby potential candidates for local tumour excision. The aim of this work was to identify risk factors for LNM in pT2 colon cancer and describe a subgroup of low-risk patients. This is a retrospective cohort study of patients with pT2 colon cancer from a nationwide Danish colorectal cancer database. Age, tumour size, location, histological type, mismatch repair protein status and venous, lymphatic and perineural invasion were included as potential risk factors in multivariate analysis. The primary outcome was LNM. We identified 1306 patients with pT2 colon cancer. LNM was present in 244 (19%). Demographic data were comparable in patients with and without LNM, and 864 patients who had complete histological data were included for multivariate analysis. Lymphatic (OR=3.60, 95% CI 2.14-5.9), venous (OR=1.70, 95% CI 1.03-2.74) and perineural (OR=4.61, 95% CI 1.60-13.5) invasion were independent risk factors for LNM. Patients with deficient mismatch repair protein tumours had a decreased risk of LNM (OR=0.55, 95% CI 0.31-0.95). Patients with clinical Stage I colon cancer and without risk factors had a 10.5% (47/443) risk of LNM. For patients with tumours with deficient mismatch repair protein status and no risk factors, the risk was 7.9%. Lymphatic, venous and perineural invasion are significant risk factors for LNM, and we identified a subgroup of patients with a low risk of LNM.

Postoperative Chemoradiotherapy versus Radiotherapy Alone in Major Salivary Gland Cancers: A Stratified Study Based on the External Validation of the Distant Metastasis Risk Score Model.

The role of additional chemoradiotherapy (CRT) for distant metastasis (DM) on the resected malignancy of the major salivary gland (SGM) remained unknown. We conducted this study to externally validate a recently reported DM risk score model and compare the survival outcome between adjuvant CRT and RT alone. We retrospectively reviewed the patients with SGM following postoperative radiotherapy (PORT). The cumulative incidence of DM was assessed using a competing risk method. Multivariate analysis was performed with Cox proportional-hazards regression to identify significant predictors for DM. Patients were classified as high- and low-risk subgroups with the cutoff value of the DM risk score model. The inverse probability of treatment weighting (IPTW) was conducted to minimize the bias of the groups. A total of 586 eligible patients were analyzed and 67 cases underwent adjuvant CRT. The 5-year incidence of DM was 19.5% (95% CI 16.0-23.0%). The model reasonably discriminated the DM risk between the high- and low-risk subgroup in our cohort, and the c-index was 0.75. No survival benefit was observed for the CRT group compared with RT alone in the entire cohort after IPTW (p = 0.095). After subgroup analysis, increased mortality was identified with the administration of CRT in the low-risk subset (p = 0.002) while no significant difference in OS was illustrated in the high-risk subgroup (p = 0.98). This external validation provides further exploration of the DM risk score model in major SGM. Our results demonstrated no support for the utility of additional chemotherapy to PORT in the major SGM, especially in the low-risk subgroup of patients with DM.

From the Editor’s Desk...

From the Editor’s Desk...

Outcomes Following Acute Pulmonary Embolism in an Irish Population of over 1 Million Individuals: Opportunities for Quality Improvement and More Effective Resource Utilisation

IntroductionPulmonary embolism (PE) is a leading cause of cardiovascular morbidity worldwide. The risk of early death in the setting of untreated PE may be as high as 30%. However, diagnostic and therapeutic advances in recent years have led to a progressive decline in global PE-related mortality and recent data describing rates of in-hospital death following PE suggest a mortality rate of approximately 5-15%. Moreover, strategies directed at stratification of PE severity have been shown to safely identify a sub-group of low-risk patients (up to 30-50% of all patients) for whom outpatient management is feasible without the need for hospital admission. Avoiding hospitalisation for low-risk PE patients is associated with improved patient satisfaction and avoids exposing patients to the risks associated with hospital admission. Ambulatory PE management would also be predicted to lead to significant healthcare cost-savings. However ambulatory care models for low-risk PE appear to be under-utilised despite these potential benefits. Barriers to implementation include access to outpatient follow-up services and the perceived risks associated with this model of care.The Ireland East Hospital Group (IEHG) is the largest hospital network in the Republic of Ireland, consisting of 11 hospitals (including large academic centres, community general hospitals and the national maternity hospital). The IEHG serves a population of over 1.1 million individuals. We sought to determine the frequency of admissions to hospital with PE and to assess key outcomes, including length-of-stay (LOS) and in-hospital mortality within this population.MethodsData pertaining to PE diagnosis from January 2018 to December 2020 were obtained from NQAIS Clinical (National Quality Assessment and Improvement System; an electronic reporting tool which is populated with anonymised data extracted from the hospital in-patient enquiry system). This system compiles diagnostic data on all patients by ICD-10 code at the time of discharge. For the purposes of this analysis the ICD-10 codes I26.0 and I26.9 were used to identify patients with PE and only admission episodes where PE was the primary diagnosis were included; cases of ‘secondary PE’ (historical PE or hospital-acquired) were excluded. Projected population figures, extrapolated from Census 2016 data, were obtained from Health Atlas Ireland (an open-source application providing access to datasets developed by the Health Intelligence Unit of the Health Service Executive of Ireland).ResultsDuring the 3-year study period, 958 in-patient episodes occurred where PE was recorded as the primary diagnosis, corresponding to an incidence of 0.37 per 1000 adults per annum (95% CI 0.35 to 0.40). The incidence was highest in the over 85 years age-group (1.07 per 1000 per annum; 95% CI 0.80 to 1.33). PE was more common in women in all age-groups apart from the 46-65 years age group [males: 0.51 (95% CI 0.44-0.51) vs females: 0.36 (95% CI 0.3-0.42) per 1000].In 82.7% of episodes, the ultimate discharge destination was to home. In 5.3% the discharge destination was a nursing home and 4.6% were transferred to another hospital. The all-cause in-hospital mortality rate was 3.1% (30 fatalities; 18 females, 12 males). Most deaths occurred in the 66-85 years age-group (n=14), with 9 fatalities in the age >85 years group and 7 fatal PE events in the 46-65 years age-group.Average hospital LOS was 7.8 days. 8.9% of inpatient episodes resulted in same-day discharge. In 55.9% of episodes, discharge occurred after day 4. Those discharged to home had an average length of stay of 6.31 days, while patients awaiting nursing home facilities averaged 26.5 days.ConclusionThe incidence of acute presentation with PE within this population is consistent with international reports. The rate of in-hospital mortality compares favourably with these international standards. The mortality rate may reflect improvements in PE care but may also reflect the inclusion of a significant number of ‘low-risk’ individuals in the analysis (many of whom may have been suitable for outpatient management). The mortality rate might also reflect increased detection of small, low-risk distal PE (as a result of advances in diagnostics). In any event, these data suggest that more widespread implementation of outpatient PE management is likely to be feasible and would represent an opportunity for improved resource utilisation. DisclosuresNi Ainle: Leo Pharma: Research Funding; Actelion: Research Funding; Daiichi-Sankyo: Research Funding; Bayer Pharma: Research Funding. Kevane: Leo Pharma: Research Funding.

Abstract 654: Discovery and validation of a gene expression signature for recurrence prediction in high-risk diffuse-type gastric cancer

Abstract Background: Diffuse type gastric cancer (DGC), represented by low sensitivity to 5-fluorouracil based chemotherapy and poor prognosis, is a heterogenous malignancy in which patient subsets exhibit diverse oncological risk-profiles. The current risk stratification criteria based on the TNM staging system are inadequate in predicting the prognosis and in guiding optimal treatment in patients with DGC. Our study aimed to develop molecular biomarkers for prognostic risk-stratification in patients with DGC. Methods: We undertook a systematic and comprehensive discovery and validation effort to identify recurrence prediction biomarkers by analyzing genome-wide transcriptomic expression profiling data from 157 patients with DGC (GSE62254, GSE13861, and TCGA-STAD). Rigorous bioinformatic approaches were used to identify biomarker panels, followed by evaluation of their performance in two independent clinical cohorts (a training cohort, n=180; a validation cohort, n=74) using qRT-PCR assays. Furthermore, using Cox proportional hazard and Kaplan-Meier analyses, the clinical significance of the biomarkers was evaluated for their ability to predict recurrence individually, and when analyzed in combination with key prognostic factors. Results: Genome-wide transcriptomic profiling identified a 7-gene panel for robust prediction of recurrence in DGC patients (AUC=0.91; 95% CI: 0.83-0.96), which was successfully validated in an independent dataset (AUC=0.86; 95% CI: 0.66-0.96). Examination of 180 tissue specimens from a training cohort allowed us to establish a risk prediction model (AUC=0.78; 95% CI: 0.71-0.84), which was subsequently validated in an independent cohort of 74 GC patients (AUC=0.83; 95% CI: 0.72-0.90). The Kaplan-Meier analyses exhibited a consistently superior performance of our 7-gene risk-prediction model in the identification of high and low-risk patient subgroups. Interestingly, the performance of our gene panel to predict recurrence was significantly improved when combined with the tumor stage, in both clinical cohorts (AUC=0.83; 95% CI: 0.76-0.88 - training cohort; AUC=0.89; 95% CI: 0.80-0.95 - validation cohort). Finally, for an easier clinical translation, we established a nomogram that comprised of the 7-gene panel and the tumor stage, which robustly predicted prognosis in patients with DGC. Conclusions: We developed a novel gene expression-based risk-stratification model for predicting recurrence and the identification of high-risk patients, which could facilitate individualized treatments and improving the survival outcomes in patients suffering from DGC. Citation Format: Inseob Lee, Divya Sahu, Hoon Hur, Jeong-Hwan Yook, Byung-Sik Kim, Ajay Goel. Discovery and validation of a gene expression signature for recurrence prediction in high-risk diffuse-type gastric cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 654.

Identification of Very Low-Risk Subgroups of Patients with Primary Mediastinal Large B-Cell Lymphoma Treated with R-CHOP.

R-CHOP can cure approximately 75% of patients with primary mediastinal large B-cell lymphoma (PMLBCL), but prognostic factors have not been sufficiently evaluated yet. R-da- EPOCH is potentially more effective but also more toxic than R-CHOP. Reliable prognostic classification is needed to guide treatment decisions. We analyzed the impact of clinical prognostic factors on the outcome of 332 PMLBCL patients ≤65 years treated with R-CHOP ± radiotherapy in a multicenter setting in Greece and Cyprus. With a median follow-up of 69 months, 5-year freedom from progression (FFP) was 78% and 5-year lymphoma specific survival (LSS) was 89%. On multivariate analysis, extranodal involvement (E/IV) and lactate dehydrogenase (LDH) ≥2 times upper limit of normal (model A) were significantly associated with FFP; E/IV and bulky disease (model B) were associated with LSS. Both models performed better than the International Prognostic Index (IPI) and the age-adjusted IPI by Harrel's C rank parameter and Akaike information criterion. Both models A and B defined high-risk subgroups (13%-27% of patients [pts]) with approximately 19%-23% lymphoma-related mortality. They also defined subgroups composing approximately one-fourth or one-half of the patients, with 11% risk of failure and only 1% or 4% 5-year lymphoma-related mortality. The combination of E/IV with either bulky disease or LDH ≥2 times upper limit of normal defined high-risk but not very-high-risk subgroups. More importantly, their absence defined subgroups comprising approximately one-fourth or one-half of the pts, with 11% risk of failure and minimal lymphoma-related mortality, who may not need more intensive treatment such as R-da-EPOCH. By analyzing the impact of baseline clinical characteristics on outcomes of a large cohort of patients with primary mediastinal large B-cell lymphoma homogeneously treated with R-CHOP with or without radiotherapy, we developed novel prognostic indices which can aid in deciding which patients can be adequately treated with R-CHOP and do not need more intensive regimens such as R-da-EPOCH. The new indices consist of objectively determined characteristics (extranodal disease or stage IV, bulky disease, and markedly elevated serum lactate dehydrogenase), which are readily available from standard initial staging procedures and offer better discrimination compared with established risk scores (International Prognostic Index [IPI] and age-adjusted IPI).

Discovery and validation of an expression signature for recurrence prediction in high-risk diffuse-type gastric cancer.

Diffuse type gastric cancer (DGC), represented by low sensitivity to chemotherapy and poor prognosis, is a heterogenous malignancy in which patient subsets exhibit diverse oncological risk-profiles. This study aimed to develop molecular biomarkers for robust prognostic risk-stratification and improve survival outcomes in patients with diffuse type gastric cancer (DGC). We undertook a systematic and comprehensive discovery and validation effort to identify recurrence prediction biomarkers by analyzing genome-wide transcriptomic profiling data from 157 patients with DGC, followed by their validation in 254 patients from 2 clinical cohorts. Genome-wide transcriptomic profiling identified a 7-gene panel for robust prediction of recurrence in DGC patients (AUC = 0.91), which was successfully validated in an independent dataset (AUC = 0.86). Examination of 180 specimens from a training cohort allowed us to establish a gene-based risk prediction model (AUC = 0.78; 95% CI 0.71-0.84), which was subsequently validated in an independent cohort of 74 GC patients (AUC = 0.83; 95% CI 0.72-0.90). The Kaplan-Meier analyses exhibited a consistently superior performance of our risk-prediction model in the identification of high- and low-risk patient subgroups, which was significantly improved when we combined our gene signature with the tumor stage in both clinical cohorts (AUC of 0.83 in the training cohort and 0.89 in the validation cohort). Finally, for an easier clinical translation, we established a nomogram that robustly predicted prognosis in patients with DGC. Our novel transcriptomic signature for risk-stratification and identification of high-risk patients with recurrence could serve as an important clinical decision-making tool in patients with DGC.

Ten-year incidence and assessment of safe screening intervals for diabetic retinopathy: the OPHDIAT study

BackgroundTo estimate the 10-year incidence of referable diabetic retinopathy (DR) in a French population with type 1 and 2 diabetes mellitus (DM). A secondary objective was the assessment of safe...

Characteristics and risk factors of recurrence in clinical stage I non-small cell lung cancer patients undergoing anatomic segmentectomy.

Although lobectomy is the standard surgical procedure for small-sized non-small cell lung cancer (NSCLC), segmentectomy has been performed for various reasons. The aim of this study was to investigate the characteristics of and risk factors for recurrence in early-stage NSCLC patients undergoing segmentectomy. We retrospectively reviewed 179 patients with clinical stage I NSCLC who underwent segmentectomy. Preoperative factors were analyzed using the log-rank test for univariate analyses. Multivariate analyses were performed using a Cox proportional hazards regression model to identify independent risk factors for recurrence. For the significant factors, optimal cutoff points were determined by receiver operating characteristic (ROC) analysis. During the follow-up period of 51months, 18 patients developed recurrence; 5 had locoregional (including 2 with margin recurrences only), 9 had distant, and 4 had both locoregional and distant recurrence. Multivariate and ROC analysis identified radiologic solid tumor size with a cutoff point of 1.5cm as an independent risk factor for recurrence. Three patients in the solid size < 1.5cm group (n = 119) developed recurrence, 2 of whom had surgical margin recurrence, compared to 15 patients in the solid size ≥ 1.5cm group (n = 60). The indication for segmentectomy should be decided upon with caution, and the segments to be resected should be carefully considered to secure an appropriate surgical margin in this low-risk subgroup of patients because they may have a relatively higher risk of surgical margin recurrence, despite being at decreased risk.

Development and validation of a nomogram to predict the overall survival of patients with neuroblastoma.

Neuroblastoma is the most prevalent malignancy in infants characterized by heterogeneous prognosis. It is critical to stratify the risks for patients with neuroblastoma. To stratify the risks for neuroblastoma, clinical characteristics of neuroblastoma patients were retrieved from the Therapeutically Applicable Research to Generate Effective Treatment program. All patients were randomly sampled into the development and validation sets. Cox regression was used to construct a prediction nomogram. The discrimination and calibration capacity of the nomogram was assessed. Prognostic index (PI) was calculated and tested to evaluate the performance of the nomogram. This nomogram demonstrated reasonable discrimination and calibration capacity. The nomogram derived PI exhibited acceptable accuracy in predicting the prognosis for neuroblastoma patients. The overall survival rate was significantly different between the PI discriminated high and low-risk patient subgroups. In conclusion, besides traditional staging systems, some newly defined risk factors could be involved in risk stratification for patients with neuroblastoma. Our nomogram may aid the risk stratification for neuroblastoma patients.

Identification and targeting of CD22ΔE12 as a molecular RNAi target to overcome drug resistance in high-risk B-lineage leukemias and lymphomas.

AimCD22ΔE12 as an oncogenic driver lesion in aggressive and drug-resistant B-precursor acute lymphoblastic leukemia (BPL) cells. The purpose of the present study was to identify the CD22ΔE12-specific signature transcriptome in human BPL cells and evaluate the clinical potential of a nanoscale formulation of CD22ΔE12-siRNA as an RNAi therapeutic against drug-resistant BPL. CD22ΔE12-siRNA nanoparticles significantly improved the event-free survival (EFS) outcome of NOD/SCID (NS) mice challenged with human BPL xenograft cells.MethodsGene expression and translational bioinformatics methods were applied to examine the expression of the CD22ΔE12-specific signature transcriptome in human BPL cells in subsets of BPL patients. Survival analysis for mice challenged with BPL cells and treated with CD22ΔE12 siRNA was performed using standard methods.ResultsLeukemia cells from CD22ΔE12-Tg mice exhibit gene and protein expression profiles consistent with constitutive activation of multiple signaling networks, mimicking the profiles of relapsed BPL patients as well as newly diagnosed high-risk patients with BCR-ABL+/Philadelphia chromosome (Ph)+ BPL as well as Ph-like BPL. A nanoscale formulation of CD22ΔE12-siRNA abrogated the in vivo clonogenicity of the leukemia-initiating leukemic cell fraction in xenograft specimens derived from patients with relapsed BPL and significantly improved the EFS outcome of NS mice challenged with drug-resistant human BPL xenograft cells.ConclusionThe CD22-RNAi technology is applicable to all BPL patients both high risk and standard risk. That is because CD22ΔE12 is a characteristic feature of drug-resistant leukemic clones that escape chemotherapy and cause relapse in both high risk and low risk subgroups of patients. The technology therefore has the potential (1) for prevention of relapses by selectively killing the clones that are most likely to escape chemotherapy and cause relapse as well (2) for treatment of relapses in BPL. This research project may also lead to innovative salvage regimens against other forms of CD22ΔE12-positive relapsed B-lineage leukemias and lymphomas.

Prognostic significance of NCCN-International Prognostic Index (NCCN-IPI) for patients with peripheral T-cell lymphoma treated with CHOP-based chemotherapy

目的明确美国国家综合癌症网络国际预后指数（NCCN-IPI）对外周T细胞淋巴瘤（PTCL）患者化疗后的预后评估价值。方法回顾性分析2003年1月至2013年5月接受CHOP或CHOP样方案化疗的162例初治PTCL患者的临床资料，采用国际预后指数（IPI）和NCCN-IPI进行危险分层和预后评估。结果①162例患者预期5年总生存（OS）和无进展生存（PFS）率分别为33%和20%，中位OS和PFS时间分别为17.0和9.2个月。②多因素分析提示美国东部肿瘤协作组体能状态评分（ECOG评分）≥2分（PFS：HR＝2.418，95%CI 1.535～3.809，P<0.001；OS：HR＝2.347，95%CI 1.435～3.839，P＝0.001）和存在特定的结外病变部位（PFS：HR＝1.800，95%CI 1.216～2.665，P＝0.003；OS：HR＝1.608，95%CI 1.054～2.454，P＝0.027）是影响患者PFS和OS的独立危险因素；ALK+是影响间变性大细胞淋巴瘤患者PFS（HR＝0.424，95%CI 0.184～0.975，P＝0.043）及OS（HR＝0.276，95%CI 0.087～0.877，P＝0.029）的独立预后良好因素。③NCCN-IPI低危组患者的生存率显著高于IPI低危组患者（5年OS率74%对54%，χ2＝5.041，P＝0.025；5年PFS率50%对38%，χ2＝5.295，P＝0.021），差异均有统计学意义。结论NCCN-IPI较IPI对低危PTCL患者具有更好的预后判断意义，可作为PTCL患者有效的预后分层工具。

Outcomes of ventricular tachycardia ablation in patients with structural heart disease: The impact of electrical storm.

AimsTo investigate predictors of long-term outcomes after catheter ablation (CA) for ventricular tachycardia (VT) and the impact of electrical storm (ES) prior to index ablation procedures.MethodsWe studied consecutive patients with structural heart disease and VT (n = 328; age: 63±12 years; 88% males; 72% ischaemic cardiomyopathy; LVEF: 32±12%) who had undergone CA. According to presenting arrhythmia at baseline, they were divided into ES (n = 93, 28%) and non-ES groups. Clinical predictors of all-cause mortality were investigated and a clinically useful risk score (SCORE) was constructed.ResultsDuring a median follow-up of 927 days (IQR: 564–1626), 67% vs. 60% of patients (p = 0.05) experienced VT recurrence in the ES vs. the non-ES group, respectively; and 41% vs. 32% patients died (p = 0.02), respectively. Five factors were independently associated with mortality: age >70 years (hazard ratio (HR): 1.6, 95% confidence interval (CI): 1.1–2.4, p = 0.01), NYHA class ≥3 (HR: 1.9, 95% CI: 1.2–2.9, p = 0.005), a serum creatinine level >1.3 mg/dL (HR: 1.6, 95% CI: 1.1–2.3, p = 0.02), LVEF ≤25% (HR: 2.4, 95% CI: 1.6–3.5, p = 0.00004), and amiodarone therapy (HR: 1.5, 95% CI: 1.0–2.2, p = 0.03). A risk SCORE ranging from 0–4 (1 point for either high-risk age, NYHA, creatinine, or LVEF) correlated with mortality. ES during index ablation independently predicted mortality only in patients with a SCORE ≤1.ConclusionsAdvanced LV dysfunction, older age, higher NYHA class, renal dysfunction, and amiodarone therapy, but not ES, were predictors of poor outcomes after CA for VT in the total population. However, ES did predict mortality in a low-risk sub-group of patients.

Emergency Room Risk Stratification of Patients with Chest Pain without ST Segment Elevation

Background: Emergency room triage of patients with chest pain is an ongoing challenge.Over the years a number of modalities have been evolved for rapid diagnosis and better risk stratification of patients. Aim: to investigate the prognostic factors in patients who came to the Emergency Department with chest pain suspected of acute coronary syndrome without ST segment elevation. Patients and Methods: one-hundred and three consecutive patients (from Suez Canal university Hospital and Al Monira General Hospital) were evaluated by recording clinical history, electrocardiogram and troponin determination. Early (< 24 h) exercise testing was done for the low-risk subgroup of patients (n= 28). All patients were followed up for 3 months for major events (acute myocardial infarction or death). Results: Major events occurred in 14 patients (9.6%). Multivariate analysis identified the following predictors: age ≥65 years (OR = 1.7; p = 0.05), diabetes mellitus (OR = 2.9; p = 0.001), previous ischemic heart disease (OR = 2.5; p = 0.004), ST depression (OR = 2.1; p = 0.048) and troponin elevation (OR = 2.6; p = 0.003). These five predictors were used to construct a risk score based on their odds ratios, which allowed event risk stratification 0-3 points low risk 48% of the studied patients, 4-7 points intermediate risk 31% of the studied patients, 8 points or more high risk 21%of studied patients. Conclusions: In patients with chest pain, the combination of clinical, electrocardiographic and biochemical data available on admission to the emergency service allows rapid prognostic stratification. Early exercise testing is advisable for the final stratification of low risk patients.

A Predictive Model for Parametrial Invasion in Patients With FIGO Stage IB Cervical Cancer: Individualized Approach for Primary Treatment.

The aim of this study was to preoperatively identify high- and low-risk subgroups of patients with parametrial involvement in those with FIGO (International Federation of Gynecology and Obstetrics) stage IB cervical cancer treated with radical hysterectomy according to menopause. We retrospectively reviewed data of 197 patients with FIGO stage IB cervical cancer. None of the patients had definite evidence of parametrial invasion in a preoperative examination and underwent type III radical hysterectomy between February 2006 and March 2015. Preoperative risk criteria predicting parametrial involvement were identified in premenopausal and postmenopausal women, respectively. Tumor size on magnetic resonance imaging (MRI) more than 4 cm (odds ratio [OR], 10.029; 95% confidence interval [95% CI], 2.300-43.741; P = 0.002) and serum squamous cell carcinoma-antigen level of 3.60 ng/mL or more (OR, 4.132; 95% CI, 1.086-5.723; P = 0.037) were independent factors for parametrial invasion in premenopausal women. Significant factors associated with parametrial involvement in postmenopausal women were tumor size on MRI more than 3 cm (OR, 11.353; 95% CI, 2.614-49.306; P = 0.001) and Cyfra 21-1 level of 2.40 ng/mL or more (OR, 8.048; 95% CI, 1.240-52.221; P = 0.029). Patients were categorized into low- and high-risk groups according to risk criteria. Significant differences in the rates of parametrial invasion were observed between the groups (2.3% vs 38.6% in the premenopausal group, P < 0.001; 11.1% vs 77.3% in the postmenopausal group, P < 0.001). A model using preoperative tumor size on MRI, serum squamous cell carcinoma-antigen, and Cyfra 21-1 level was highly predictive of parametrial invasion in patients with FIGO stage IB cervical cancer. In particular, postmenopausal women were likely to have microscopic parametrial invasion, even among tumors 3 cm or less. Therefore, individualized approaches considering several preoperative factors are needed.

Prospective multicenter validation of the Glasgow Blatchford bleeding score in the management of patients with upper gastrointestinal hemorrhage presenting at an emergency department

The Glasgow Blatchford Bleeding Score (GBS) has been developed to assess the need for treatment in patients with acute upper gastrointestinal hemorrhage (UGIH) presenting at emergency departments (EDs). We aimed (a) to determine the validity of the GBS and Rockall scoring systems for prediction of need for treatment and (b) to identify the optimal cut-off value of the GBS. We carried out a population-based, prospective multicenter study of 520 consecutive patients presenting with acute UGIH at EDs of three hospitals. The accuracy of GBS and Rockall scores in predicting the need for treatment (i.e. endoscopic, surgical, or radiological intervention and blood transfusion) was analyzed using receiver operating characteristic curves. Receiver operating characteristic curve analysis showed that the GBS had a good discriminative ability to determine the need for treatment in patients with acute UGIH (area under the curve: 0.88; 95% confidence interval: 0.85-0.91). The GBS was superior to both the clinical Rockall and the full Rockall score in predicting the need for treatment (area under the curve: 0.86 vs. 0.70 vs. 0.77). At a cut-off value of up to 2, the GBS had the optimal combination of sensitivity (99.4%) and specificity (42.4%). The GBS is superior compared with both Rockall scores in predicting the need for treatment in patients with suspected acute UGIH presenting at EDs in the Netherlands. Patients with a GBS of 2 or less form a subgroup of low-risk patients. These low-risk patients are eligible for outpatient management, which might reduce hospital admissions and healthcare costs.

The price of a QALY—cost-effectiveness of statins in CKD

A new study suggests that low-cost generic statins are cost-effective for primary prevention of cardiovascular disease in high-risk but not in low-risk subgroups of patients with mild-to-moderate chronic kidney disease (CKD). The cost-effectiveness of statins is markedly reduced in patients with progressive CKD and in those at high-risk of drug-related adverse events.