Background Neoadjuvant therapy is an emerging paradigm in pancreatic cancer care; however, its role for resectable disease remains controversial in the absence of conclusive randomized controlled ...trials. The purpose of the present study is to assess the impact of neoadjuvant therapy on survival in resected pancreatic cancer patients by clinical stage. Methods A retrospective cohort study using the National Cancer Data Base from 2004 to 2012 including nonmetastatic pancreatic adenocarcinoma patients who underwent pancreatectomy and initiated chemotherapy. Propensity score matching within each stage was used to account for potential selection bias between patients undergoing neoadjuvant therapy and upfront surgery. Overall survival was compared by the Kaplan-Meier method. Results In the study, 1,541 and 7,159 patients received neoadjuvant therapy followed by surgery and upfront surgery succeeded by adjuvant therapy, respectively. In clinical stage III pancreatic cancer ( n = 486), neoadjuvant therapy was associated with significant survival benefit after matching (median survival 22.9 vs 17.3 months; log-rank P < .0001) compared with conventional upfront surgery followed by adjuvant therapy; however, no survival difference was found between the 2 treatment sequences in patients with clinical stage I ( n = 3,149; median survival, 26.2 vs 25.7 months; P = .4418) and II ( n = 5,065; median survival, 23.5 vs 23.0 months; P = .7751) disease after matching. Conclusion The survival impact of neoadjuvant therapy is stage-dependent. Neoadjuvant therapy does not disadvantage survival compared with conventional upfront surgery followed by adjuvant therapy in any stage, and is associated with a significant survival advantage in stage III pancreatic cancer.
Background
Enrollment criteria are routinely utilized in patient selection in SEER‐Medicare but little is known about how this may be impacting research outcomes. This study evaluated demographics ...and survival among pancreatic cancer patients who are included and excluded from SEER‐Medicare analyses.
Methods
Patients ≥66 years old with pancreatic cancer were identified (SEER‐Medicare, 2008–2015). Two patient cohorts were compared: included (continuous enrollment in Medicare Parts A and B and no enrollment in Medicare Advantage), and excluded. Mortality was assessed using a Standardized Mortality Ratio.
Results
Among 49,017 patients with pancreatic cancer, 59.5% were in the included cohort. The excluded cohort was younger (median age 74 vs. 77) with more male (49.9% vs. 47.8%), non‐white (33.0% vs. 21.3%) and urban‐dwelling patients (91.0% vs. 85.0%). Those excluded had a higher mortality risk (SMR 1.06, 95%CI 1.04–1.07).
Conclusions
There are significant differences in patient demographics and mortality among those who are and are not routinely included in SEER‐Medicare analyses and our study provides a critical opportunity to quantify this potential bias.
Blacks are affected disproportionately by pancreatic adenocarcinoma and have been linked with poor survival. Surgical resection remains the only potential curative option. If surgical disparities ...exist, then they may provide insight into outcome discrepancies.
Patients with pancreatic adenocarcinoma were identified using the National Cancer Institute's Surveillance, Epidemiology, and End Results data from 1992 to 2002. Univariate analyses were used to compare demographics, tumor characteristics, and surgical data; and logistic regression was used to determine independent predictors for recommendation/performance of surgery. Kaplan-Meier survival was assessed, and a Cox proportional hazards model was used to examine adjusted predictors of survival.
In total, 27,828 patients were identified; 81.4% were white, 11.5% were black, 7.2% were of other race. White patients and black patients presented with similar stage and had surgery recommended at similar rates (34.5% vs 34%, respectively; P = .57). Black patients underwent fewer resections (10.6% vs 12.7%; P < .001). Multivariate analysis confirmed that black patients were less likely to undergo resection (adjusted odds ratio, 0.69; 95% confidence interval 95% CI, 0.57-0.84). Overall, black patients had worse univariate survival. The survival among black patients who underwent resection did not differ statistically from the survival of similar white patients, although the median survival trended lower (11 months vs 13 months; P = .13). In a multivariate Cox model, black race predicted worse survival (hazards ratio, 1.11; 95% CI, 1.07-1.16), and pancreatic resection was protective (hazards ratio, 0.56; 95% CI, 0.53-0.59).
Black and white patients with pancreatic adenocarcinoma presented with similar stages and were recommended for pancreatectomy at similar rates, yet black patients underwent fewer resections. After resection, crude survival did not differ significantly between white and black patients, although multivariate analysis demonstrated a survival disadvantage for blacks despite adjusting for resection. The current results suggested that pancreatectomy may be underused for blacks. Maximizing resection rates for appropriate patients may be an important component in reducing outcome disparities for pancreatic adenocarcinoma.
Background Necrotizing soft-tissue infections (NSTI) are rare, potentially fatal, operative emergencies. We studied a national cohort of patients to determine recent trends in incidence, treatment, ...and outcomes for NSTI. Methods We queried the Nationwide Inpatient Sample (1998–2010) for patients with a primary diagnosis of NSTI. Temporal trends in patient characteristics, treatment (debridement, amputation, hyperbaric oxygen therapy HBOT), and outcomes were determined with Cochran-Armitage trend tests and linear regression. To account for trends in case mix (age, sex, race, insurance, Elixhauser index) or receipt of HBOT on outcomes, multivariable analyses were conducted to determine the independent effect of year of treatment on mortality, any major complication, and hospital length of stay (LOS) for NSTI. Results We identified 56,527 weighted NSTI admissions, with an incidence ranging from approximately 3,800–5,800 cases annually. The number of cases peaked in 2004 and then decreased between 1998 and 2010 ( P < .0001). The percentage of female patients decreased slightly over time (38.6–34.1%, P < .0001). Patients were increasingly in the 18- to 34–year-old (8.8–14.6%, P < .0001) and 50- to 64-year-old age groups (33.2–43.5, P < .0001), Hispanic (6.8–10.5%, P < .0001), obese (8.9–24.6%, P < .0001), and admitted with >3 comorbidities (14.5–39.7%, P < .0001). The percentage of patients requiring only one operative debridement increased somewhat (43.2–46.2%, P < .0001), whereas the use of HBOT was rare and decreasing (1.6–0.8%, P < .0001). The percentage of patients requiring operative wound closure decreased somewhat (23.5–20.8%, P < .0001). Although major complication rates increased (30.9–48.2%, P < .0001), hospital LOS remained stable (18–19 days) and mortality decreased (9.0–4.9%, P < .0001) on univariate analyses. On multivariable analyses each 1-year incremental increase in year was associated with a 5% increased odds of complication (odds ratio 1.05), 0.4 times decrease in hospital LOS (coefficient −0.41), and 11% decreased odds of mortality (odds ratio 0.89). Conclusion There were potentially important national trends in patient characteristics and treatment patterns for NSTI between 1998 and 2010. Importantly, though patient acuity worsened and complication rates increased, but LOS remained relatively stable and mortality decreased. Improvements in early diagnosis, wound care, and critical care delivery may be the cause.
Background Regionalization of care has been proposed for complex operations based on hospital/surgeon volume–mortality relationships. Controversy exists about whether more common procedures should be ...performed at high-volume centers. Using mortality alone to assess routine operations is hampered by relatively low perioperative mortality. We used a large national database to analyze the risk of major in-hospital complications after laparoscopic cholecystectomy (LC). Study Design Patients undergoing LC were identified in the Nationwide Inpatient Sample 1998–2006 from states with surgeon/hospital identifiers. Previously validated major complications including acute myocardial infarction, pulmonary compromise, postoperative infection, deep vein thrombosis, pulmonary embolism, hemorrhage, and reoperation were assessed. Univariate and multivariable analyses were performed and independent risk factors of complications were identified. Results A total of 1,102,071 weighted patient discharges were identified, with a complication rate of 6.8%. Univariate analyses showed that advanced age, male gender, and higher Charlson Comorbidity Score were associated with higher complication rates (p < 0.0001). Higher surgeon volume (≥36/year versus <12/year) and higher hospital volume (≥225/year versus ≤120/year) were associated with fewer complications (6.7% versus 7.0%, 6.4% versus 7.0%, respectively; p < 0.0001). Multivariable analysis showed that advanced age (65 years or older versus younger than 65 years; adjusted odds ratio AOR = 2.16; 95% CI, 2.01–2.32), male gender (AOR = 1.14; 95% CI, 1.10–1.19), and comorbidities (Charlson Comorbidity Score 2 versus 0; AOR = 2.49; 95% CI, 2.34–2.65) were associated with complications. Neither surgeon nor hospital volume was independently associated with increased risk of complications. Conclusions Major in-hospital complications after LC are associated with individual patient characteristics rather than surgeon or hospital operative volumes. These results suggest regionalization of general surgical procedures might be unnecessary. Rather, careful patient selection and preoperative preparation can diminish overall complication rates.
Background
The volume-outcome relationship has been well-established for pancreaticoduodenectomy (PD). It remains unclear if this is primarily driven by hospital volume or individual surgeon ...experience.
Objective
This study aimed to determine the relationship of hospital and surgeon volume on short-term outcomes of patients with pancreatic adenocarcinoma undergoing PD.
Methods
Patients >65 years of age who underwent PD for pancreatic adenocarcinoma were identified from the Surveillance, Epidemiology, and End Results (SEER)–Medicare database (2008–2015). Analyses were stratified by hospital volume and then surgeon volume, creating four volume cohorts: low-low (low hospital, low surgeon), low-high (low hospital, high surgeon), high-low (high hospital, low surgeon), high-high (high hospital, high surgeon). Propensity scores were created for the odds of undergoing surgery with high-volume surgeons. Following matching, multivariable analysis was used to assess the impact of surgeon volume on outcomes within each hospital volume cohort.
Results
In total, 2450 patients were identified: 54.3% were treated at high-volume hospitals (27.0% low-volume surgeons, 73.0% high-volume surgeons) and 45.7% were treated at low-volume hospitals (76.9% low-volume surgeons, 23.1% high-volume surgeons). On matched multivariable analysis, there were no significant differences in the risk of major complications, 90-day mortality, and 30-day readmission based on surgeon volume within the low and high hospital volume cohorts.
Conclusion
Compared with surgeon volume, hospital volume is a more significant factor in predicting short-term outcomes after PD. This suggests that a focus on resources and care pathways, in combination with volume metrics, is more likely to achieve high-quality care for patients undergoing PD across all hospitals.
Background Insufficient examination of lymph nodes after pancreaticoduodenectomy can lead some pancreatic cancer patients with N1 disease to be misclassified as N0. We examined trends in lymph node ...dissection throughout time and investigated how these changes affect lymph node status and its prognostic value. Methods The National Cancer Data Base was queried for patients with nonmetastatic pancreatic adenocarcinoma (2004–2013) who underwent classic pancreaticoduodenectomy with antrectomy. Logistic regression was performed for odds of node positivity. Kaplan-Meier curves and Cox proportional hazards models were used to assess the impact of lymph node status on overall survival for patients diagnosed during 2-year intervals from 2004–2012. Results Median number of examined lymph nodes was 10 (interquartile range 6–15) in 2004 vs 17 (interquartile range 12–24) in 2013. Number of lymph nodes examined was a significant predictor of N1 disease ( P < .0001), with a plateau at 30 nodes. N1 disease increased from 64.4% to 68.0% ( P < .0001). Survival for both N1 and N0 subgroups improved. In successive multivariate models, N0 versus N1 status was consistently protective for overall survival ( P < .0001), but there was no change in the magnitude of its hazard ratio over time (overall hazard ratio 0.691; 95% confidence interval 0.660–0.723). Conclusion Contemporary patients have an adequate number of nodes examined during standard pancreaticoduodenectomy. This, along with rising rates of N1 cancer detection and improved survival for both node-positive and node-negative patients, suggest more accurate classification of lymph node status. However, no increased benefit is achieved beyond 30 nodes. Overall, lymph node status remains a strong prognosticator for overall survival.
Background
Gallbladder cancer has a high mortality rate and an increasing incidence. The current National Comprehensive Cancer Network (NCCN) guidelines recommend resection for all T1b and ...higher-stage cancers. This study aimed to evaluate re-resection rates and the associated survival impact for patients with gallbladder cancer.
Methods
Patients with gallbladder adenocarcinoma who underwent resection were identified from the National Cancer Database (2004–2015). Re-resection was defined as definitive surgery within 180 days after the first operation. Propensity scores were created for the odds of a patient having a re-resection. Patients were matched 1:2. Survival analyses were performed using the Kaplan–Meier and Cox proportional hazard methods.
Results
The study identified 6175 patients, and 466 of these patients (7.6%) underwent re-resection. Re-resection was associated with younger median age (65 vs 72 years;
p
< 0.0001), private insurance (41.6% vs 27.1%;
p
< 0.0001), academic centers (50.4% vs 29.7%;
p
< 0.0001), and treatment location in the Northeast (22.8% vs 20.4%;
p
= 0.0011). Compared with no re-resection, re-resection was associated with pT stage (pT2: 47.6% vs 42.8%;
p
= 0.0139) and pN stage (pN1-2: 28.1% vs 20.7%;
p
< 0.0001), negative margins on final pathology (90.1% vs 72.6%;
p
< 0.0001), and receipt of chemotherapy (53.7% vs 35.8%;
p
< 0.0001). The patients who underwent re-resection demonstrated significantly longer overall survival (OS) than the patients who did not undergo re-resection (median OS, 44.0 vs 23.0 months;
p
< 0.0001). After propensity score-matching, re-resection remained associated with superior survival (median OS, 44.0 vs 31.0 months;
p
= 0.0004).
Conclusions
Re-resection for gallbladder cancer is associated with improved survival but remains underused, particularly for early-stage disease.
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