444 Background: Differentiating between patients with small renal tumors not selected for treatment from those who choose elective active surveillance (AS) using administrative data is a significant challenge. Using active treatment as a benchmark, our objective was to compare survival outcomes between all patients with localized kidney cancer who received non-surgical management (NSM) with those meeting more stringent NSM criteria who are more likely to clinically resemble AS. Methods: Using linked SEER-Medicare data, we identified all patients ≥66 years old with localized T1 (<7cm) Renal Cell Carcinoma from 1995-2009. Treatment groups were defined as active treatment (partial or radical nephrectomy), all NSM (no treatment within 6 months of diagnosis), and stringent NSM (further exclusion of patients with lack of imaging or presence of hospice claims). Patients undergoing ablative treatment were excluded from analyses. Overall and cancer specific mortality were assessed using Cox and Fine and Gray proportional hazard models with propensity score based weighting. Results: Of 15,450 identified patients, 2,089 (13.5%) underwent NSM. Of these, 1,182 (56.6% of NSM, 7.7% of overall sample) met stringent NSM criteria. Following adjustment, the all NSM group demonstrated significant increases in cancer specific (sHR 1.91 [CI 1.26-2.88]) and overall (HR 1.49 [CI 1.16-1.92]) mortality compared to patients undergoing active treatment. In contrast, for patients meeting stringent NSM criteria, these differences in cancer specific (sHR 1.48 [CI 0.82-2.68]) and overall (HR 1.33 [CI 0.998-1.77]) mortality were attenuated and no longer met statistical significance. Conclusions: Compared to active treatment, patients meeting stringent NSM criteria demonstrated improved survival outcomes when compared to all-comers with localized kidney cancer who were managed non-surgically. Our findings support that a validated, claims-based algorithm that more accurately identifies patients undergoing elective AS is needed to objectively assess the safety and effectiveness of this clinical strategy.
To determine whether increasing biologically effective dose (BED) with stereotactic body radiation therapy (SBRT) is associated with improved local control (LC) or toxicities in patients with locally advanced pancreatic cancer.A PICOS/PRISMA/MOOSE selection protocol was used to identify 15 studies across 12 institutions in 5 countries where patients received definitive SBRT for nonmetastatic disease. Biologically equivalent doses were calculated with an α/β of 10 (ie, BED10) for LC and acute toxicity and 3 (ie, BED3) for late toxicity. Fixed and random effects models were used to characterize LC and grade 3/4 toxicities by BED.There were 508 patients included with a median follow-up time of 9.1 months. The median dose was 30 Gy, and the most common regimen was 30 Gy/5 fractions. There was no significant difference in LC rates at 1 year between the BED10<70 Gy versus ≥70 Gy groups, with an estimate of 0.60 (95% confidence interval [CI], 0.36-0.81) versus 0.83 (95% CI, 0.63-0.97), respectively. There was no significant difference in acute toxicity rates between the BED10<70 Gy versus ≥70 Gy groups, with an estimate of 0.02 (95% CI, 0.00-0.08) versus 0.05 (95% CI, 0.00-0.22), respectively. Given the dose distribution across studies, 3 intervals were used to characterize BED3. There were no significant differences in late toxicity among those receiving BED3<100, 100 to 200, or >200 Gy.SBRT for pancreatic cancer results in LC rates of 60% to 83% and clinically significant toxicity of <7%. Increasing BED10 beyond 70 Gy was not associated with increased rates of 1-year LC or acute toxicity. Increasing BED3 beyond 100 Gy was not associated with increased rates of late toxicity.
Background/Statement of Purpose Syndrome of Undifferentiated Recurrent Fevers (SURF) is characterized by recurrent fevers and autoinflammation without a confirmed molecular diagnosis of a Hereditary Recurrent Fever syndrome (HRF), and not fulfilling criteria for Periodic Fever, Adenitis, Pharyngitis, Aphthous stomatitis syndrome (PFAPA). The goal of this study was to characterize clinical features of SURF patients compared to PFAPA, and to analyze their cytokine signature, genetic variations, and responses to treatment. Methods We enrolled 46 patients followed at Cincinnati Children's Hospital Medical Center. Baseline data and inflammatory cytokines were collected at enrollment, and their clinical course was followed. Cytokine analysis was performed using a cytokine multiplex assay. Many patients had specific or whole exome genetic testing. Results The prevalence of rash and arthralgias were higher in SURF compared to PFAPA. Pharyngitis and adenopathy were less frequent. A subset of SURF patients clustered together with elevated pro‐inflammatory cytokines and more frequently required biologic therapy. Focused analysis of WES data revealed that variants of unknown clinical significance (VUCS) were frequently identified in genes implicated in B cell development, immunodeficiencies, and inflammatory bowel disease risk. Treatments for SURF patients commonly included on‐demand steroids, colchicine, and anti‐IL1 therapy. Conclusion Our findings suggest SURF is a heterogeneous group but has distinct clinical and immunologic features from disorders like PFAPA. Patients have frequent VUCS, which may have relevance to disease pathogenesis. A subset of patients showed more inflammation and increased need for biologic use. Further research is necessary to define whether there exist distinct SURF endotypes and to better predict treatment outcomes.
641 Background: Weighing operative, oncologic and comorbid risks guide treatment recommendations for localized kidney cancers. We hypothesize that individualized surgical decision making may also be influenced by surgical center and volume. Methods: The National Cancer Database (NCDB) was queried for patients 18-80 years old with pT1a-T2bN0M0 RCC, treated by partial (PN) or radical nephrectomy (RN), or ablation (ABL) from 2004-2014. After adjusting for clinicopathologic characteristics, we evaluated the association of hospital volume (vol) and center classification with receipt of PN. High vol was defined as the top 10% in treatment volume. Results: 142,090 patients met inclusion criteria, where 58% (n = 82,498) and 41% (n = 58,873) were treated by RN and PN, respectively, and 1% (n = 719) by ABL. The utilization of PN increased over time (2004: 24% vs 2014: 53%; p < 0.001). Stratified by tumor stage, 60% (n = 47,484) of pT1a and 24% (n = 9,906) of pT1b tumors were treated by PN. On multivariate analysis, patients treated at a high-vol center (OR 1.89, 95% CI 1.57-2.28) had a greater likelihood of receiving a PN when compared to treatment elsewhere. Additionally, compared to a community cancer program, treatment at a comprehensive community cancer center (OR 1.39, 95%CI 1.23-1.57), academic/research (OR 1.67, 95%CI 1.47-1.90), or integrated network cancer program (OR 1.48, 95%CI 1.24-1.77) had a higher likelihood of receiving a PN. The median distance travelled was 9.8 and 18.1 miles, for treatment at non high vol and high vol centers, respectively. An inverse correlation was noted between increasing tumor stage and receipt of PN, compared to pT1a tumors (pT1b [OR 0.22, 95%CI 0.20-0.23], pT2a [OR 0.06, 95%CI 0.05-0.06], pT2b [OR 0.03, 95%CI 0.02-0.03]). Conclusions: In the NCDB, despite increased utilization of PN at higher vol centers, the majority of localized renal tumors are still treated with RN. Smaller tumor size, treatment at a higher vol centers, comprehensive community cancer centers, academic/research programs, or integrated network cancer programs increase the likelihood of receipt of PN. Evaluation of population based trends aid in understanding localized RCC surgical management and may help quality improvement efforts.
221 Background: Sp, or severe muscle wasting, has been implicated as an important prognostic factor in cancer pts. We assessed the association between body composition changes and outcomes in pts with esophageal cancer undergoing tri-modality therapy. Methods: Following IRB approval, we reviewed all pts who underwent chemoradiation followed by esophagectomy at an NCI-designated cancer center from 2000-2013. Pts who underwent CT assessment pre- and post-neoadjuvant chemoradiation were included in the analysis. Sp was defined as a lumbar skeletal muscle area/height of 55.4 cm 2 /m 2 for males and 38.9 cm 2 /m 2 for females. Fat mass (FM), fat-free mass (FFM), subcutaneous fat to muscle ratio (SFMR), and visceral to subcutaneous adipose tissue ratio (VSATR) were also derived using CT-based measures. Changes in the above parameters and Sp were correlated to post-operative (post-op) complications (cx), treatment (tx) response, disease free survival (DFS), and overall survival (OS). Analysis was performed using non-parametric Wilcoxon and Kruskal-Wallis tests, and Kaplan-Meier curves with log-rank tests. Results: A total of 48 pts met the inclusion criteria; the median age was 62 (range 42-80) with a median follow up of 28 months (range 4-103). Most pts had T3 (85%), N1 (70%), or M0/M1a disease (92%). Ten pts (21%) had Sp at the initiation of tx, with 9 of these remaining Sp post-tx, and 1 patient developing Sp. Post-tx Sp was associated with an increased rate of post-op mortality (p=0.03). Three of the 10 patients with Sp died post-op versus 1/36 in the non-Sp group. Post-tx Sp was associated with a decreased rate of post-op strictures (p = 0.04). Thirteen of the 36 pts in the non-Sp group developed strictures versus none in the Sp group. There was a significant change in all other measures pre vs. post-tx; FM (-4.3 kg/m 2 , p<0.01), FFM (-5.0 kg/m 2 , p<0.01), SFMR (-0.1, p=0.04), and VSATR (-0.02, p<0.01). None of these were correlated with post-op cx, tx response, DFS, or OS. Conclusions: Post-tx Sp was associated with an increased incidence of post-op mortality but a lower rate of strictures. Our study was limited by sample size, and further studies should examine the relationship between Sp and peri-operative outcomes.
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