Cumulative 5-year Research Articles

Treatment strategies for patients over 80 years of age with oral squamous cell carcinoma

ObjectiveTo analyze the clinical characteristics of patients with oral squamous cell carcinoma aged ≥80 years, focusing on surgical treatments. Study DesignWe reviewed patients with oral squamous cell carcinoma aged ≥80 years who underwent surgery between 2005 and 2018. Basic information, comorbidities, multiple primary cancers, initial treatment, complications, and outcomes were evaluated. ResultsOf 197 patients aged ≥80 years, 119 patients underwent surgery (50 males, 69 females; mean age: 83.5 years). The gingiva was the most common primary tumor site (63 patients, 52.9%). The stage classification was stage I in 35 patients (29.4%), stage II in 44 (37%), stage III in 16 (13.4%), stage IVA in 22 (18.5%), and stage IVB in 2 (1.7%). Comorbidities were identified in 112 patients (94.1%). Surgery was the initial treatment in 111 patients (93.3%). Eight (6.7%) patients received postoperative adjuvant chemotherapy/radiotherapy; 20 patients (16.8%) underwent free tissue transplantation. Perioperative complications were observed in 36 patients (30.3%). The cumulative 5-year and 10-year overall survival rates were 82% and 68.3%, respectively; the disease-specific survival rates were 90%. ConclusionGood treatment outcomes were obtained with radical surgery. Surgery should be the first choice if quality of life is assured and there are no issues with surgical tolerance, regardless of age.

Cumulative seizure occurrence and the predictors of seizure in low- and high-grade gliomas

Objective: We aimed to determine the cumulative seizure occurrence, 1-year, and 5-years of preoperative seizures in gliomas, and an update on the predictors. Methods: This was a retrospective analysis of 239 patients with histopathologically confirmed gliomas in University Malaya Medical Centre, Malaysia, between 2008-2020. Kaplan-Meier curves were used to determine the cumulative incidence of seizures. Logistic regression was performed to determine the predictors of preoperative seizures. Results: A total of 80/239 patients (33.5%) had preoperative seizures. They were more commonly seen in those with younger age of presentation (40.0% in those <40 years old vs. 26.9% in ≥40 years old, p<0.05) and low-grade tumors (42.2% vs. 28.8% in high-grade tumors). Those with cortical involvement, especially the frontal lobe, or without focal deficit, headache, nausea, or vomiting were more likely to have seizures preoperatively. Logistic regression identified three significant predictors for preoperative seizure: absence of focal deficits at presentation (OR 6.090, 95% CI 3.110-11.925, p<0.001), cortical location (OR 3.834, 95% CI 1.363-10.786, p<0.05) and absence of headache at presentation (OR 2.487, 95% CI 1.139-5.431, p<0.05). The cumulative incidence of seizure was 29% at one year and 32% at 5-year for gliomas. Specifically, the seizure incidence was higher in low-grade gliomas (39% at 1-year) and certain tumor types such as ganglioglioma (50%), oligodendroglioma (48%), and astrocytoma (45%). Conclusion: The cumulative incidence of preoperative seizures in low-grade gliomas and certain tumor types is high. The predictors included cortical involvement and absence of focal neurological deficit or headache at presentation.

Healthcare costs and resource utilization associated with renal cell carcinoma among older Americans: A longitudinal case-control study using the SEER-Medicare data.

To determine 1-year and 5-year total healthcare costs and healthcare resource (HRU) associated with renal cell carcinoma (RCC) in older Americans, from a healthcare sector perspective. This was a longitudinal, retrospective cohort study using the Surveillance, Epidemiology and End Results-Medicare linked data (2006-2014), which included older (≥66 years) patients with primary RCC and 1:5 matched noncancer controls. Patients/controls were followed from diagnosis (pseudo-diagnosis for controls) until death or up to loss-to-follow-up (censored). Per-patient average 1-year and 5-year cumulative total and incremental total healthcare costs and HRU were reported. A total of 11,228 RCC patients were matched to 56,140 controls. Per-patient cumulative average 1-year (incremental = $38,291 [$36,417-$40,165]; $57,588 vs. $19,297) and 5-year (incremental = $68,004 [$55,123-$80,885]; $183,550 vs. $115,547) total costs (excluding prescription drug costs) were 3 and 1.6 times higher for RCC vs. controls. These estimates were 3.6 and 1.7 times higher for RCC vs. controls when prescription costs were included in total costs. Prescription drug costs accounted for 8.4% (incremental = $3,715) and 18.1% (incremental = $15,375) of the 1-year and 5-year incremental total costs, respectively. RCC patients had greater cumulative number of hospitalizations, emergency department visits and prescriptions in 1- and 5-years, compared to controls. Average first year total cost for a patient with incident diagnosis of RCC is substantially higher than that for controls and it varies depending on the stage at diagnosis. Study findings could help in planning future resource allocation and in determining research and unmet needs in this patient population.

Short versus Standard Length Implants with Sinus Floor Elevation for the Atrophic Posterior Maxilla.

Objectivesthe aim of this clinical study was to compare clinical and radiological outcomes of short dental implants inserted in pristine bone to standard length implants inserted in combination with sinus floor elevation.Materials and methodsFor this clinical study, the clinical and radiological outcome of 126 short dental implants (84 patients), inserted in pristine bone were compared with 312 standard length implants (156 patients), placed in combination with maxillary sinus floor elevation procedures.ResultsThe short implant group (test group [TG]; mean follow-up (± standard deviation (SD) 56.6 ± 42.9 months) and the augmented group (control group [CG]; mean follow-up 41.6 ± 37.6 months) showed cumulative survival rates of 91.8% and 92.4%. Cumulative 5-year implant survival rates were 91.8% for the TG and 90.7% for the CG (p=0.421). Mean marginal bone loss was significantly higher in the CG than in the TG, with a mean MBL of 0.70 ± 0.72 mm in the TG and 0.96 ± 0.91 mm in the CG (p<0.001). A comparable and promising oral health-related quality of life (OHRQoL) was observed in the control and test groups.ConclusionsAfter over 3 years, short implants placed in the resorbed posterior maxilla obtained similar results to standard implants combined with maxillary sinus floor augmentation procedures.

Improving the Prediction of Relapse After Nucleos(t)ide Analogue Discontinuation in Patients With Chronic Hepatitis B.

Current guidelines recommend rules for stopping nucleos(t)ide analogues (NAs) in patients with chronic hepatitis B (CHB), but off-therapy relapse is still high. This study aimed to identify predictors of off-therapy relapse and improve existing stopping rules. This retrospective study included 488 patients with CHB (262 hepatitis B e antigen [HBeAg]-positive and 226 HBeAg-negative) who discontinued NAs. Posttreatment relapse was investigated. During the median follow-up period of 73.3 months, the cumulative 5-year and 10-year virologic relapse (VR) rates were 73.5% and 76.1%, respectively. In HBeAg-positive patients, end-of-therapy hepatitis B surface antigen (HBsAg) levels (hazard ratio [HR], 1.93 [95% confidence interval {CI}, 1.42-2.61]) and consolidation duration ≥2 years (HR, 0.31 [95% CI: .17-.58]) were independent predictors of VR. Consolidation ≥2 years and low HBsAg levels (≤560 IU/mL) significantly lowered VR rates. In HBeAg-negative patients, only the HBsAg level (HR, 1.61 [95% CI: 1.24-2.11]) was independently predictive of VR. Cirrhosis was significantly associated with higher VR rates in HBeAg-negative patients with low HBsAg levels (≤800 IU/mL). Combining end-of-therapy HBsAg levels with current stopping rules or consolidation duration further reduced off-therapy relapse, with 2-year VR rates of approximately 15%-25% in HBeAg-positive patients and 35% in HBeAg-negative patients. End-of-therapy HBsAg levels, consolidation duration, and cirrhosis are key determinants of off-therapy relapse. Together with low HBsAg levels, extended consolidation therapy for ≥2 years should be ensured, and cirrhotic patients should continue NAs even if low HBsAg levels are achieved. A combination of these parameters will help identify individuals at low risk of relapse and significantly improve the predictive ability of the existing stopping rules.

Impact of sex on management and survival in aortic stenosis

Increasing attention has been paid to sex differences in recent studies, but only a few have focused on such differences in aortic stenosis (AS). We sought to evaluate the differences between genders in AS outcomes and management. We included 2429 patients(51.5% men; 49.5% women) with severe AS. Women were olde r( P < 0.001), more often symptomatic( P = 0.007), and presented with smaller aortic valve area( P < 0.001), and greater ejection fraction( P < 0.001) than men. Despite that women have a longer life expectancy than men in the general population, estimated five-year survival of patients with severe AS was lower for women compared to men(62 ± 2% versus 69 ± 1% respectively, P < 0.001). The 5-year survival was lower compared to expected survival, especially for women (62 ± 2% vs. 71% for women and 69 ± 1% vs. 71% for men). The cumulative 5-years incidence of aortic valve replacement (AVR) was 79 ± 2% for men, and only 70 ± 2% for women ( P < 0.001) and, being male was independently predictive of AVR (OR:1.49 [1.18–1.97]; P = 0.011). After age-matching, women still presented with more symptoms ( P = 0.004), lower AVR rates (64.4% versus 69.1%, P = 0.018) and lower 5-year survival than men (66 ± 2%[expected:75%] versus 68 ± 2% [expected 70%], P < 0.001) ( Fig. 1 ). Women with severe AS present at a more advance stage of the disease, at older ages with more symptoms, and incur higher mortality than men. This excess mortality is related to a combination of late diagnosis and a less frequent and later referral for AVR than in men. This justifies appropriate measures to improve the situation and to ensure that both sexes receive equivalent care.

Impact of sex on management and survival in aortic stenosis

Abstract Background Increasing attention has been paid to differences between the sexes in recent studies, but only a few have focused on such differences in aortic stenosis (AS). Purpose We sought to evaluate the differences between genders in AS outcomes and management. Methods We included 2429 patients (51.5% men; 49.5% women) with severe AS. Median follow-up was 42.0 (21–78) months. Results Women were older (p&amp;lt;0.001), more often symptomatic (p=0.007), and presented with smaller aortic valve area (p&amp;lt;0.001), and greater ejection fraction (p&amp;lt;0.001) than men. Despite that women have a longer life expectancy than men in the general population, estimated five-year survival of patients with severe AS was lower for women compared to men (62±2% versus 69±1% respectively, p&amp;lt;0.001). The 5-year survival was lower compared to expected survival, especially for women (62±2% vs. 71% for women and 69±1% vs. 71% for men). The cumulative 5-years incidence of AVR was 79±2% for men, and only 70±2% for women (p&amp;lt;0.001) and, being male was independently predictive of AVR (OR: 1.49 [1.18–1.97]; p=0.011). After propensity matching, when both genders were comparable in terms of characteristics and management (AVR), women, as expected due to their higher life expectancy than men, had better 5-year survival than men (69±2% vs. 62±2%; p=0.023). Conclusion Women with severe AS present at a more advance stage of the disease, at older ages with more symptoms, and incur higher mortality than men. This excess mortality is related to a combination of late diagnosis and a less frequent and later referral for AVR than in men. This justifies appropriate measures to improve the situation and to ensure that both sexes receive equivalent care. Figure 1. (A) Survival curves. (B) Surgery incidence. Funding Acknowledgement Type of funding source: None

Switching to Single-use Flexible Ureteroscopes for Stones Management: Financial Impact and Solutions to Reduce the Cost Over a 5-Year Period

ObjectivesTo assess the financial impact of switching to single-use ureteroscopes (sURS) in urolithiasis management for a hospital, over a 5-year period, and to identify possible solutions to contain or reduce it. MethodsA Budget Impact (BI) model was designed for a public hospital performing around 200 ureteroscopies or extracorporeal shockwave lithotripsies per year. The BI was estimated as the difference between financial balances (between costs and revenues) of 2 environments (with and without sURS). The population was defined as adults treated for urolithiasis. The BI model was based on assumptions about the expected progression in the incidence of urolithiasis, and the expected change in clinical practices due to the availability of sURS. We considered the costs and revenues of hospital stays, the purchase price of sURS and the costs of digital or fiberoptic reusable ureteroscopes (rURS). Univariate and multivariate sensitivity analyses were performed. ResultsThe cumulative 5-year financial impact of switching completely to sURS was €807,824 and €649,677 in comparison with fiberoptic and digital rURS respectively. This impact could be reduced by half or more if the health-care facility were to adopt different solutions, including negotiating the purchase price of sURS, developing outpatient activity and reducing production costs for ureteroscopy procedures. ConclusionThe BI model gives decision-makers a more accurate picture of the financial impact of switching to sURS and highlights ways to reduce the expected additional cost.

P0345THE EFFICACY OF THE CORTICOSTEROIDS COMBINED ORAL CYCLOPHOSPHAMIDE FOR IGA NEPHROPATHY WITH REAL INSUFFICIENCY

Abstract Background and Aims IgA nephropathy (IgAN) is the most type of primary glomerulonephritis and one of the major causes of end-stage renal disease (ESRD). The KDIGO clinical practice guidelines for glomerulonephritis suggest not the use of immunosuppressive drugs in IgAN patients with estimated glomerular filtration rate (eGFR) ≤50 mL/min/1.73m2. However, VALIGA study showed that immunosuppressive drugs were more frequently used in IgAN patients with eGFR &amp;lt; 30 mL/min/1.73m2 than in those with eGFR ≥ 30 ml/ min/1.73m2 (60% vs. 44 %; p = 0.004). The immunosuppressive drugs could be effective for IgAN with renal insufficiency in few studies, such as corticosteroids combined oral cyclophosphamide (CS + oral CTX). Therefore, in our present study, we evaluated the efficacy and treatment-related complications of the patients with eGFR from 15 ml/min/1.73m2 to 59 ml/min/1.73m2 who receive supportive care, or CS, or CS + oral CTX. Method 1602 renal biopsy–proven patients were reviewed between January 2008 and December 2016 in the Xijing Hospital. Patients were excluded from the study if they had secondary IgAN. The inclusion criteria were the primary IgAN with eGFR from 15 ml/min/1.73m2 to 59 ml/min/1.73m2 (n = 389). We extracted the patients with receive supportive care, or corticosteroids, or corticosteroids combined oral cyclophosphamide (n = 212). We further excluded patients: &amp;lt; 8 glomeruli (n = 10), diabetes mellitus (n = 4), a follow-up less than 6 months (n = 22), and incomplete data (n = 7). The remaining 169 patients were included in the study (Figure 1). The data included baseline demographic at renal biopsy, renal biopsy, treatment, follow-up parameters and outcomes. The primary endpoint was the combined event of a ≥ 50% reduction in eGFR and/or ESRD. Univariate and multivariate Cox regression analyses were conducted to determine which variables were associated with renal survival. Variables were entered into a multivariate Cox regression model using an Enter method, which were derived from adjusted models: model 1 was adjusted for age, sex, MAP, proteinuria, and eGFR; model 2 was adjusted for the variables in model 1 plus RAS; model 3 was adjusted for the variables in model 1 plus M1, E1, S1, T1-2, and C1-2; model 4 was adjusted for the variables in model 3 plus RAS. Results In all patients, the mean age was 36.0 years, the median proteinuria at the time of the biopsy was 1.6 g/day, the mean MAP was 108.7 mmHg, and eGFR was 40.4 ml/min/per 1.73 m2, the mean follow-up period was 43.3 months, 75 (44.9%) patients had reached combined event. The cumulative 5-year and 10-year renal survival rate were 39.3% and 9.3%, respectively, in the no-IS group ; 56.5% and 25.1%, respectively, in the CS group and 63.4% and 27.1%, respectively, in the CS + CTX group (Figure 2). Both univariate and multivariate Cox analyses shown that CS did not reduce the risk of combined event, whereas CS + CTX significantly reduced the risk of combined event. CS + CTX (HR = 0.367, 95%CI 0.198-0.682, P = 0.002) was notably associated with the risk of combined event after adjusted for age, sex, MAP, proteinuria, eGFR, M1, E1, S1, T1-2, C1-2, and ARB. The two groups did not differ significantly in treatment-related complications. Conclusion CS + oral CTX is possibly more effective than supportive care, or CS for IgAN patients with eGFR from 15 ml/min/1.73m2 to 59 ml/min/1.73m2. Furthermore, randomized controlled trials further verified the findings of the present study.

Incidence of Multiple Metachronous Gastric Cancers After Pyloric-Preserving Gastrectomy.

Pylorus-preserving gastrectomy (PPG) is widely used for early gastric cancer located in the middle third of the stomach. The minimization of the extent of gastrectomy may increase the risk of metachronous multiple gastric cancer (MGC). We report the findings of a study that was conducted to evaluate the prevalence of MGC after PPG. The clinical data of 533 patients who underwent PPG for gastric cancer between 1993 and 2018 were reviewed. The clinicopathological characteristics at the time of the primary treatment that were predictive of the development of MGC were explored. The median (range) observation period was 112.4 (8.1-290.7) months. Metachronous MGC was diagnosed in 33 of the 533 patients. The cumulative 5-year and 10-year event rates were 3.3% and 6.2%, respectively. The patient gender, presence/absence of synchronous MGC and the macroscopic type of the primary gastric cancer were significantly associated with the risk of development of metachronous MGC. Multivariate analysis identified the presence of synchronous MGC (hazard ratio [HR]: 4.828, 95% confidence interval [CI]; 1.611-12.30, p = 0.004) and Type 0-IIa primary gastric cancer (HR 2.810, 95% CI; 1.113-7.090, p = 0.029) as independent factors associated with the risk of development of MGC. All the patients could be treated by surgical or endoscopic resection for the metachronous MGC. Recurrence was observed in one patient. There was quite a few incidence of development of metachronous MGC after PPG. Nevertheless, PPG remains reasonable treatment option, if adequate postoperative surveillance can be ensured.

ANCA-associated vasculitis with dominant renal involvement: clinical and morphological presentation and outcomes

THE AIM: The analysis of clinical and morphological presentations and outcomes of primary systemic vasculitis associated with anti-neutrophil cytoplasmic antibodies (ANCA-V) with dominant kidney involvement; the determination of clinical and morphological parameters associated with prognosis.PATIENTS AND METHODS. Eighty nine patients with morphologically confirmed ANCA-associated kidney vasculitis on standard immunosuppressive therapy (IST) were included in this retrospective study. Clinical, immunological, and histological indices were analyzed at the time of the kidney biopsy, and early in the short-term (3-6 months) and in the long-term follow-up. The following outcomes were evaluated: the achievement of clinical and immunological remission of the disease; eGFR at the end of follow-up, the progression of renal disease (by the composite point: initiation of renal replacement therapy (RRT) or the estimated glomerular filtration rate (eGFR) &lt;15 ml/min/1.73m2 or decrease in eGFR &gt;50 %); all-cause mortality. The prognostic significance of clinical and morphological parameters was evaluated in multivariable regression models.RESULTS. Most of cases (78 %) were represented by rapidly progressive or acute nephritic syndrome. Mean eGFR was 23 ml/min/1.73 m2. Fifteen percent of patients required acute dialysis. Dominant morphological phenotypes of glomerular lesions were sclerotic (34 %) and mixed (36 %) according to the International Pathology Classification (IPC). Median follow-up was 24 (8; 55) months. Cumulative 5-year and 10-year patient’s survivals and were 92 % and 86 %, respectively. Cumulative 5-year and 10-year renal survivals were 86 % and 68 %, respectively. The cumulative 5-year and 10-year proportions of cases without progression of kidney disease were 80 % and 55 %, respectively. Within 3-6 months of the induction IST 81 % of patients achieved clinical remission (complete (59 %) or partial (22 %)) (CR3-6), while 84 % of patients had immunological remission. Serum creatinine (Pcr) at the time of kidney biopsy was only the factor associated with the risk of renal progression (Expβ=1.73 (95 %CI 1.40-2.14) per 0.1 mmol/l increase). IPC classes and ANCA Renal Risk Score (ARRS) groups as well as other morphological indices of kidney injury had no independent associations with the renal outcomes in Cox models adjusted for Pcr. The independent factors associated with eGFR at the end of follow-up were: CR3-6 (β=0.36±0.08, p&lt;0.001); age (β=-0.34±0.09, p&lt;0.001), Pcr (β=-0.35±0.09, p&lt;0.001) and the global glomerulosclerosis (β=0.28±0.08, p&lt;0.001). CR3-6 (β=0.57±0.10, p&lt;0.001), and the proportion of cellular crescents (β=0.26±0.12, p=0.023) and interstitial inflammation (β=0.27±0.11, p=0.026) were also independently associated with the change of eGFR by the end of follow-up.CONCLUSION. An unfavorable renal prognosis for ANCA-V determined by severe renal dysfunction due to inflammatory and fibrotic alterations of the organ can be significantly improved by adequate therapy with the achievement of higher patient’s and kidney’s survival. The baseline serum creatinine is only the factor associated with the long-term risks of dialysis and kidney disease progression. In addition to baseline serum creatinine and the development of early clinical remission, the separate assessment of global glomerular sclerosis, cellular crescents, and interstitial inflammation may be more useful for the individual prediction of long-term eGFR changes than IPC classes or ARRS.

Clinical characteristics and survival of 413 patients with systemic lupus erythematosus in southeastern areas of South Korea: A multicenter retrospective cohort study.

To investigate demographic, clinical, laboratory, and immunological characteristics of patients with systemic lupus erythematosus (SLE) in southeastern areas of South Korea, and to perform survival analysis. We retrospectively evaluated 413 patients with SLE diagnosed in 3 tertiary rheumatology centers in South Korea from 1992 to 2016 by reviewing their medical charts. All patients fulfilled the 1997 revised American College of Rheumatology classification criteria for SLE. Most patients were women (92%), and the mean (±standard deviation) age at diagnosis was 30.9 (±12.9) years. The most common clinical manifestation was leukopenia (74.3%), followed by lymphopenia (73.6%), arthritis (59.1%), malar rash (48.4%), thrombocytopenia (46.5%), oral ulcer (35.1%), and biopsy-proven lupus nephritis (31.2%). Anti-nuclear, anti-double-stranded DNA, anti-Smith, and anti-Ro antibodies were positive in 97.8%, 70.1%, 38.4%, and 63% of patients, respectively. Twenty (4.8%) patients died during a median follow-up of 83months, and the cumulative 5-year and 10-year survival rates were 96.9% and 95.5%, respectively. The major causes of death were infection (50%) and lupus flare-up (50%). Male (hazards ratio [HR]=7.19, P=.001), pleuritis and/or pericarditis (HR=3.28, P=.012), childhood-onset (HR=3.57, P=.012), and late-onset (HR=4.65, P=.011) were independent risk factors for death. Compared with SLE cohorts in other ethnicities or countries, our patients tended to have a higher frequency of anti-Ro antibodies and hematologic disorders. This study describes clinical features of SLE in South Korea and suggests a remarkable phenotypic heterogeneity of SLE.

Cholangiocarcinoma in Patients with Primary Sclerosing Cholangitis (PSC): a Comprehensive Review.

Cholangiocarcinoma (CCA) is the most common malignancy in patients with primary sclerosing cholangitis (PSC) and carries a high rate of mortality. Although the pathogenesis of CCA in PSC is largely unknown, inflammation-driven carcinogenesis concomitant with various genetic and epigenetic abnormalities are underlying factors. The majority of CCA cases develop from a dominant stricture (DS), which is defined as a stricture with a diameter < 1.5mm in the common bile duct or < 1.0mm in the hepatic duct. In PSC patients presenting with an abrupt aggravation of jaundice, pain, fatigue, pruritus, weight loss, or worsening liver biochemistries, CCA should be suspected and evaluated utilizing a variety of diagnostic modalities. However, early recognition of CCA in PSC remains a major challenge. Importantly, 30-50% of CCA in PSC patients are observed within the first year following the diagnosis of PSC followed by an annual incidence ranging from 0.5 to 1.5 per 100 persons, which is nearly 10 to 1000 times higher than that in the general population. Cumulative 5-year, 10-year, and lifetime incidences are 7%, 8-11%, and 9-20%, respectively. When PSC-associated CCA is diagnosed, most tumors are unresectable, and no effective medications are available. Given the poor therapeutic outcome, the surveillance and management of PSC patients who are at an increased risk of developing CCA are of importance. Such patients include older males with large-duct PSC and possibly concurrent ulcerative colitis. Thus, more attention should be paid to patients with these clinical features, in particular within the first year after PSC diagnosis. In contrast, CCA is less frequently observed in pediatric or female PSC patients or in those with small-duct PSC or concurrent Crohn's disease. Recently, new biomarkers such as antibodies to glycoprotein 2 have been found to be associated with an increased risk of developing CCA in PSC. Herein, we review the literature on the pathogenesis, incidence, clinical features, and risk factors, with a focus on various diagnostic modalities of PSC-associated CCA.

Increased serological, cancer-associated protein biomarker levels at diagnosis of large bowel adenoma: Risk of subsequent primary malignancy?

Background: Blood-based, cancer-associated biomarkers may detect subjects at risk of having neoplastic diseases. The aim of the present study was to evaluate whether elevated serological protein biomarker levels may identify adenoma patients, who are at increased risk of being diagnosed with subsequent primary malignancy.Methods: Levels of CEA, CA19-9, TIMP-1 and YKL-40 were determined in blood samples collected prior to diagnostic bowel endoscopy due to symptoms of colorectal neoplasia. Follow-up time was ten years, and identified adenoma patients, who were diagnosed with subsequent primary intra- or extra-colonic malignant diseases. The biomarker levels were also determined in 400 subjects, who underwent diagnostic colonoscopy, had clean colorectum and were without apparent co-morbidity; these levels were used as reference levels. In the present study, biomarkers were interpreted as elevated when levels were above the reference intervals adjusting for age and gender. The 1-year and 5-years cumulative incidences were calculated.Results: Primary malignancies were identified in 175 (19%) of the 923 subjects diagnosed with adenomas at the primary bowel endoscopy. In detail, 20 of the 175 subjects were diagnosed with colorectal cancer (CRC) and 155 subjects with extra-colonic cancers. Thirty patients were diagnosed with malignancy within the first year. Three groups were established: 0: no elevated biomarkers; 1: 1 of the 4 biomarkers elevated; and 2: ≥2 biomarkers elevated. The cumulative 5-years incidence of malignancy was: 0: 6.9%; 1: 11.8%; and 2: 17.5% (p = .0009).Conclusion: Elevated blood-based, cancer-associated protein biomarker levels in subjects diagnosed with adenomas at large bowel endoscopy identifies subjects at increased risk of being diagnosed with subsequent primary malignancy.

Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States commercial payer population: potential economic implications of a new minimally invasive technology

IntroductionLow back pain is common and treatment costly with substantial lost productivity and lost wages in the working-age population. Chronic low back pain originating in the sacroiliac (SI) joint (15%–30% of cases) is commonly treated with nonoperative care, but new minimally invasive surgery (MIS) options are also effective in treating SI joint disruption. We assessed whether the higher initial MIS SI joint fusion procedure costs were offset by decreased nonoperative care costs from a US commercial payer perspective.MethodsAn economic model compared the costs of treating SI joint disruption with either MIS SI joint fusion or continued nonoperative care. Nonoperative care costs (diagnostic testing, treatment, follow-up, and retail pharmacy pain medication) were from a retrospective study of Truven Health MarketScan® data. MIS fusion costs were based on the Premier’s Perspective™ Comparative Database and professional fees on 2012 Medicare payment for Current Procedural Terminology code 27280.ResultsThe cumulative 3-year (base-case analysis) and 5-year (sensitivity analysis) differentials in commercial insurance payments (cost of nonoperative care minus cost of MIS) were $14,545 and $6,137 per patient, respectively (2012 US dollars). Cost neutrality was achieved at 6 years; MIS costs accrued largely in year 1 whereas nonoperative care costs accrued over time with 92% of up front MIS procedure costs offset by year 5. For patients with lumbar spinal fusion, cost neutrality was achieved in year 1.ConclusionCost offsets from new interventions for chronic conditions such as MIS SI joint fusion accrue over time. Higher initial procedure costs for MIS were largely offset by decreased nonoperative care costs over a 5-year time horizon. Optimizing effective resource use in both nonoperative and operative patients will facilitate cost-effective health care delivery. The impact of SI joint disruption on direct and indirect costs to commercial insurers, health plan beneficiaries, and employers warrants further consideration.

O-0014 - Intraoperative Radiotherapy Reduces Local Recurrence Rates in Patients with Locally Advanced Rectal Cancer with Microscopically Involved Circumferential Resection Margins

Background: Local control is one of the main goals of the surgical treatment of rectal cancer. The most important predictive factor for local control is the circumferential resection margin (CRM). Unfortunately, CRM involvement still occur in 19-24% of the patients with locally advanced rectal cancer (LARC), despite using (chemo-) radiotherapy and total mesorectal excision (TME). In these patients, local recurrence rates may be reduced by administering intra-operative radiotherapy (IORT). One single dose of IORT is considered the biological equivalent of two to three times the dose given by conventional fractionation and this dose preceded by an external radiation dose should be sufficient to eradicate microscopic remnant. Furthermore, IORT may also be beneficial in patients with radical resections with a clear but narrow CRM (<2mm), because these patients also have a higher risk of local recurrences. This study evaluated the effect of IORT in patients with LARC after TME with a microscopic involved CRM or a clear but narrow CRM. Methods: Between 1996 and 2012, all surgically treated patients with LARC and a CRM less than 2 mm after (chemo-)radiotherapy followed by TME were analyzed. These patients were divided into a group with radical resections with a clear but narrow CRM (<2mm) and a group with a microscopic involved CRM. In these groups, the outcome of the patients who were treated with IORT was compared with the outcome of patients who were treated without IORT. Results: Ninety-five of the 409 surgically treated patients with LARC had a CRM less than 2mm after neoadjuvant (chemo-)radiotherapy based on final pathology report. Forty-three patients had a radical resection with a clear but narrow CRM and 48 patients had a microscopic involved CRM. Four patients were excluded from further analysis due to a macroscopic non radical resection. Of the patients with radical resections with a clear but narrow CRM, 21 patients were treated with IORT and 22 patients were treated without IORT. The baseline characteristics of the patients treated with and without IORT were similar. There was no difference in the cumulative 5-years local recurrence-free survival (70 vs. 79%, p = 0.63). Of the patients with a microscopic involved CRM, 31 patients were treated with IORT and 17 patients were treated without IORT. Baseline characteristic of the patients treated with and without IORT were similar, except that patients treated without IORT had more stage IV disease (52 vs. 13%, p = 0.01). In this group, there was a significant difference in the cumulative 5-years local recurrence-free survival in favor of the 31 patients treated with IORT compared with the 17 patients who were not treated with IORT (84 vs. 41% p = 0.01). Multivariable analysis confirmed that IORT was independently associated with a decreased local recurrence rate in these patients. Conclusion: IORT reduces local recurrence rates in patients with LARC with a microscopic involved CRM.

027 Le mélanome conjonctival : un cancer de l’œil de plus en plus fréquent

To summarize a Finnish population-based study on conjunctival melanoma to better understand its behavior and to improve treatment. Data from 85 patients diagnosed from 1967 to 2000 were ascertained from cancer registry and patient charts. Data were analyzed using advanced survival statistics. The age-adjusted incidence of conjunctival melanomas doubled from 0.4 to 0.8 per million during the study period. The cumulative 5-year and 10-year probabilities of survival were 83% (95% CI, 72–89) and 67% (95% CI, 54–77), respectively, considering melanoma deaths. Non-limbal location of the primary tumour (hazard ratio, 4.6, P < 0.001), thickness (HR 1.3 for each 1 mm increase, P = 0.007) and local recurrence (HR 1.8 for each recurrence, P < 0.001) were associated with decreased survival. No histopathologic factor significantly contributed to estimating survival after considering tumor location and size. In 9 (45%) of 20 patients with an established metastatic pattern the initial metastasis was regional lymphatic. The 10-year cumulative incidences of regional and systemic metastases were 11% and 18%. Regional metastasis was more frequent if the primary was >2 mm thick and if the tumor was non-limbal. Median survival after initial regional and systemic metastasis was 30 and 8 months ( P = 0.012). The incidence of conjunctival melanoma is increasing analogous to cutaneous melanoma. Every attempt should be made to prevent local recurrence. Patients with high risk characteristics for regional lymphatic metastasis might benefit from sentinel lymph node biopsy.

Clinicopathologic Features of Ampullary Carcinoma Without Jaundice

To evaluate clinicopathological features of ampullary carcinoma without jaundice. : Obstructive jaundice is the most common symptom of patients with ampullary carcinoma. However, some patients with ampullary carcinoma do not have jaundice at the time of diagnosis. Clinicopathologic findings of 23 patients with ampullary carcinoma showing no visible jaundice (serum total bilirubin <3.0 mg/dL) and 38 patients with ampullary carcinoma showing jaundice at the time of diagnosis were retrospectively compared. Fifteen of 23 patients with nonjaundiced ampullary carcinoma complained of fever and/or abdominal pain. Five asymptomatic patients were found to have a dilated bile duct on screening ultrasound or to have a tumor-like swelling of the papilla of Vater during routine upper gastrointestinal endoscopy. There was no significant difference in age, sex, size, macroscopic type, histologic type, rates of duodenal invasion, pancreatic invasion, and lymph node metastasis, and prognosis between the two groups. The cumulative 5-year and 10-year survival rates of nonjaundiced patients were 70.2% and 49.0%, compared with 33.6% and 29.4% of jaundiced patients. Ten of the 23 nonjaundiced ampullary carcinomas (43%) were in Stage I, whereas 4 of the 38 jaundiced ampullary carcinomas (11%) were in Stage I (P < 0.01). Mechanisms of nonjaundice in ampullary carcinoma were suspected to be determinant by the infiltrating pattern of the carcinoma to the lower portion of the bile duct. Mechanisms of nonjaundice in ampullary carcinoma might be determined by the infiltrating pattern of the carcinoma to the lower portion of the bile. As a greater number of nonjaundiced ampullary carcinomas were in an early stage, detection of them may provide an improved clinical outcome.

Implant-Borne Prosthetic Rehabilitation of Bone-Grafted Cleft Versus Traumatic Anterior Maxillary Defects

This study hypothesizes comparable implant success in bone-grafted cleft-alveolus versus traumatic anterior maxillary defects. Though of different pathogenesis, both defects comprise bone deficit, scarred periosteum, and soft tissues. Additional complicating factors are isolated. Twenty cleft and 20 traumatic defect cases were followed-up 48 months in average. After 9 secondary and 11 tertiary cleft-osteoplasties, 25 implants were inserted; in traumatic defects following 8 two-stage and 12 one-stage osteoplasties, 37 incisor or canine implants were inserted. After secondary and tertiary cleft-osteoplasties, 57 and 13 months elapsed until implantation, 4 months in the two-stage posttraumatic osteoplasties. Implants were loaded at 6 months by single crowns. Four (20%) cleft patients faced 2 failures and 2 first-year losses; 2 (10%) trauma cases faced 2 failures and 2 first-year losses; and cumulative 5-year implant success was 80% and 88%, respectively. Other parameters' 12-month results were: values for mean cleft, trauma patients (+/- standard deviation), significance of comparison in t testing at a cut-off level of alpha = 0.05; bone loss 0.3+/-0.5 mm, 0.5+/-0.7 mm, P < .2; Periotest score 1.1+/-3.1, 1.2+/-2.5, P < .7; gingival recession 2.1+/-0.3 mm, 2.2+/-0.5 mm, P < .6; periimplant probing depth 2.5+/-0.5 mm, 2.8+/-2.6 mm, P < .3. Similar success rates without statistically significant differences were found; a multiple factor analysis discerned as positive predictive factors the following; generous transplant volume, 3 to 6 months latency, sufficient implant dimension, early adulthood. Early loading cannot be encouraged from the success rates. Negative predictive factors were spongiosa or milled-bone transplants, dehiscence, smoking, and anorexia. Intraorally harvested membranous bone transplants may prospectively amend secondary osteoplasty-associated bone resorption. Donor site morbidity, local growth, and tooth breakthrough require additional observation in a prospective study when implant insertion should directly follow the growth spurt.

4723 Long-term outcome of endoscopic mucosal resection for early gastric cancer.

BACKGROUND: Endoscopic mucosal resection (EMR) for intramucosal early gastric cancer (EGC) has become popular in Japan. However, its longterm results have not been clearly reported. AIM, PATIENTS AND METHODS: To elucidate the effectiveness of EMR for EGC, we studied the prognosis of 288 EGC patients who were treated by EMR with submucosal saline injection technique and compared with that of non-concurrent 46 EGC patients who took no treatment at all (NTx group). Endoscopy was repeated 1, 3, 6, 12 months or more after endoscopic resection. RESULTS: We resected 320 EGCs in 288 patients between `90 and `97. Of those who treated by EMR, 253 patients had intramucosal differentiated EGC without ulcerative change that absolutely indicates EMR (IND group) and 35 patients had submucosal, undifferentiated or ulcerative EGC (CIND group). In IND group, 143 patients failed to achieve complete resection and residual cancers were revealed in 40 patients. Endoscopic re-treatment was performed in 32 patients and operations in eight patients. In CIND group, additional operations were undergone in 16 patients and were not in 19 patients who were not candidates for surgical resection. There was no procedure-related mortality. 25 patients died of causes other than gastric cancer in IND group, whereas 7 patients died of gastric cancer and 7 died of other causes in CIND group during the mean periods of 43 months. The cumulative 5-years' survival rate was significantly higher in IND group than that of in CIND group and NTx group, (85%, 55% and 53%, respectively). CONCLUSION: EMR is effective treatment for intramucosal differentiated EGC without ulcerative change but not for submucosal, undifferentiated or ulcerative EGC.