Patient and Caregiver Considerations and Priorities When Selecting Hospitals for Complex Cancer Care.

BACKGROUND: Healthcare policies have focused on centralizing care to high-volume centers in an effort to optimize patient outcomes; however, little is known about patients' and caregivers' considerations and selection process when selecting hospitals for care. We aim to explore how patients and caregivers select hospitals for complex cancer care and to develop a taxonomy for their selection considerations. METHODS: This was a qualitative study in which data were gathered from in-depth interviews conducted from March to November 2019 among patients with hepatopancreatobiliary cancers who were scheduled to undergo a pancreatectomy (n = 20) at a metropolitan, urban regional, or suburban medical center and their caregivers (n = 10). RESULTS: The interviews revealed six broad domains that characterized hospital selection considerations: hospital factors, team characteristics, travel distance to hospital, referral or recommendation, continuity of care, and insurance considerations. The identified domains were similar between participants seen at the metropolitan center and urban/suburban medical centers, with the following exceptions: participants receiving care specifically at the metropolitan center noted operative volume and access to specific services such as clinical trials in their hospital selection; participants receiving care at urban/suburban centers noted health insurance considerations and having access to existing medical records in their hospital selection. CONCLUSIONS: This study delineates the many considerations of patients and caregivers when selecting hospitals for complex cancer care. These identified domains should be incorporated into the development and implementation of centralization policies to help increase patient access to high-quality cancer care that is consistent with their priorities and needs.

Paraconduit Hiatal Hernia Following Esophagectomy: Incidence, Risk Factors, Outcomes and Repair.

BACKGROUND: Paraconduit hiatal hernia (PCHH) is a known complication of esophagectomy with significant morbidity. PCHH may be more common with the transition to a minimally invasive approach and improved survival. We studied the PCHH occurrence following minimally invasive esophagectomy to determine the incidence, treatment, and associated risk factors. METHODS: We retrospectively reviewed records of patients who underwent esophagectomy at an academic tertiary care center between 2013-2020. We divided the cohort into those who did and did not develop PCHH, identifying differences in demographics, perioperative characteristics and outcomes. We present video of our laparoscopic repair with mesh. RESULTS: Of 49 patients who underwent esophagectomy, seven (14%) developed PCHH at a median of 186 d (60-350 d) postoperatively. They were younger (57 versus 64 y, P< 0.01), and in cases of resection for cancer, more likely to develop tumor recurrence (71% versus 23%, P= 0.02). There was a significant difference in 2-y cancer free survival of patients with a PCHH (PCHH 19% versus no hernia 73%, P< 0.01), but no significant difference in 5-y overall survival (PCHH 36% versus no hernia 68%, P= 0.18). Five of seven PCHH were symptomatic and addressed surgically. Four PCHH repairs recurred at a median of 409 d. CONCLUSIONS: PCHH is associated with younger age and tumor recurrence, but not mortality. Safe repair of PCHH can be performed laparoscopically with or without mesh. Further studies, including systematic video review, are needed to address modifiable risk factors and identify optimal techniques for durable repair of post-esophagectomy PCHH.

Short-term Preoperative Diet Decreases Bleeding After Partial Hepatectomy: Results From a Multi-institutional Randomized Controlled Trial.

BACKGROUND: Our previous case series suggested that a 1-week, low-calorie and low-fat diet was associated with decreased intraoperative blood loss in patients undergoing liver surgery. OBJECTIVE: The current study evaluates the effect of this diet in a randomized controlled trial. METHODS: We randomly assigned 60 patients with a body mass index ≥25 kg/m(2) to no special diet or an 800-kcal, 20 g fat, and 70 g protein diet for 1 week before liver resection. Surgeons were blinded to diet assignment. Hepatic glycogen stores were evaluated using periodic acid Schiff (PAS) stains. RESULTS: Ninety four percent of the patients complied with the diet. The diet group consumed fewer daily total calories (807 vs 1968 kcal, P < 0.001) and fat (21 vs 86 g, P < 0.001) than the no diet group. Intraoperative blood loss was less in the diet group: mean blood loss 452 vs 863 mL (P = 0.021). There was a trend towards decreased transfusion in the diet group (138 vs 322 mL, P = 0.06). The surgeon judged the liver to be easier to manipulate in the diet group: 1.86 versus 2.90, P = 0.004. Complication rate (20% vs 17%), length of stay (median 5 vs 4 days) and mortality did not differ between groups. There was no difference in hepatic steatosis between groups. There was less glycogen in hepatocytes in the diet group (PAS stain score 1.61 vs 2.46, P < 0.0001). CONCLUSIONS: A short-course, low-fat, and low-calorie diet significantly decreases bleeding and makes the liver easier to manipulate in hepatic surgery.

AGI-134: a fully synthetic α-Gal glycolipid that converts tumors into in situ autologous vaccines, induces anti-tumor immunity and is synergistic with an anti-PD-1 antibody in mouse melanoma models.

BACKGROUND: Treatments that generate T cell-mediated immunity to a patient's unique neoantigens are the current holy grail of cancer immunotherapy. In particular, treatments that do not require cumbersome and individualized ex vivo processing or manufacturing processes are especially sought after. Here we report that AGI-134, a glycolipid-like small molecule, can be used for coating tumor cells with the xenoantigen Galα1-3Galß1-4GlcNAc (α-Gal) in situ leading to opsonization with pre-existing natural anti-α-Gal antibodies (in short anti-Gal), which triggers immune cascades resulting in T cell mediated anti-tumor immunity. METHODS: Various immunological effects of coating tumor cells with α-Gal via AGI-134 in vitro were measured by flow cytometry: (1) opsonization with anti-Gal and complement, (2) antibody-dependent cell-mediated cytotoxicity (ADCC) by NK cells, and (3) phagocytosis and antigen cross-presentation by antigen presenting cells (APCs). A viability kit was used to test AGI-134 mediated complement dependent cytotoxicity (CDC) in cancer cells. The anti-tumoral activity of AGI-134 alone or in combination with an anti-programmed death-1 (anti-PD-1) antibody was tested in melanoma models in anti-Gal expressing galactosyltransferase knockout (α1,3GT-/-) mice. CDC and phagocytosis data were analyzed by one-way ANOVA, ADCC results by paired t-test, distal tumor growth by Mantel-Cox test, C5a data by Mann-Whitney test, and single tumor regression by repeated measures analysis. RESULTS: In vitro, α-Gal labelling of tumor cells via AGI-134 incorporation into the cell membrane leads to anti-Gal binding and complement activation. Through the effects of complement and ADCC, tumor cells are lysed and tumor antigen uptake by APCs increased. Antigen associated with lysed cells is cross-presented by CD8α+ dendritic cells leading to activation of antigen-specific CD8+ T cells. In B16-F10 or JB/RH melanoma models in α1,3GT-/- mice, intratumoral AGI-134 administration leads to primary tumor regression and has a robust abscopal effect, i.e., it protects from the development of distal, uninjected lesions. Combinations of AGI-134 and anti-PD-1 antibody shows a synergistic benefit in protection from secondary tumor growth. CONCLUSIONS: We have identified AGI-134 as an immunotherapeutic drug candidate, which could be an excellent combination partner for anti-PD-1 therapy, by facilitating tumor antigen processing and increasing the repertoire of tumor-specific T cells prior to anti-PD-1 treatment.

Phase I study to evaluate toxicity and feasibility of intratumoral injection of α-gal glycolipids in patients with advanced melanoma.

Effective uptake of tumor cell-derived antigens by antigen-presenting cells is achieved pre-clinically by in situ labeling of tumor with α-gal glycolipids that bind the naturally occurring anti-Gal antibody. We evaluated toxicity and feasibility of intratumoral injections of α-gal glycolipids as an autologous tumor antigen-targeted immunotherapy in melanoma patients (pts). Pts with unresectable metastatic melanoma, at least one cutaneous, subcutaneous, or palpable lymph node metastasis, and serum anti-Gal titer ≥1:50 were eligible for two intratumoral α-gal glycolipid injections given 4 weeks apart (cohort I: 0.1 mg/injection; cohort II: 1.0 mg/injection; cohort III: 10 mg/injection). Monitoring included blood for clinical, autoimmune, and immunological analyses and core tumor biopsies. Treatment outcome was determined 8 weeks after the first α-gal glycolipid injection. Nine pts received two intratumoral injections of α-gal glycolipids (3 pts/cohort). Injection-site toxicity was mild, and no systemic toxicity or autoimmunity could be attributed to the therapy. Two pts had stable disease by RECIST lasting 8 and 7 months. Tumor nodule biopsies revealed minimal to no change in inflammatory infiltrate between pre- and post-treatment biopsies except for 1 pt (cohort III) with a post-treatment inflammatory infiltrate. Two and four weeks post-injection, treated nodules in 5 of 9 pts exhibited tumor cell necrosis without neutrophilic or lymphocytic inflammatory response. Non-treated tumor nodules in 2 of 4 evaluable pts also showed necrosis. Repeated intratumoral injections of α-gal glycolipids are well tolerated, and tumor necrosis was seen in some tumor nodule biopsies after tumor injection with α-gal glycolipids.

Advantages of day-before lymphoscintigraphy and undiluted methylene blue dye injections for sentinel lymph node biopsies for melanoma.

BACKGROUND AND OBJECTIVES: Lymphatic mapping (LM) and blue dye injections are essential to identification of sentinel lymph nodes (SLN) for melanoma. LM is performed the day before (DB) or the same day (SD) of surgery, but the optimal timing is unknown. Similarly, methylene blue (MB), used during SLN biopsy (SLNB), is administered diluted (dMB) or undiluted (uMB), but the relative efficacies are unknown. METHODS: Patients who underwent SLNB for melanoma from 2009 to 2013 at our institution were evaluated. Outcomes included operative correlation with LM, SLN identification, and postoperative complications. RESULTS: One hundred seventy-one patients underwent SLNB. Sixty-seven (39%) had DB LM. Sixty-seven (39%) received uMB. Operative findings correlated with both LM groups, though the DB patients had lower background count (P = 0.018) and lower highest SLN radioactive signal count (P = 0.046). More uMB patients had blue SLNs (90% vs. 68%, P = 0.001). There was no difference in the total number of SLNs or complication rates in the LM and MB groups. CONCLUSIONS: This is the first study to compare the use of DB LM with SD LM and the efficacy of uMB versus dMB. DB LM and uMB offer advantageous alternatives for patients and their surgeons without loss of accuracy or increased morbidity. J. Surg. Oncol. 2016;114:947-950. © 2016 Wiley Periodicals, Inc.

Thirty-day outcomes underestimate endocrine and exocrine insufficiency after pancreatic resection.

BACKGROUND: Long-term incidence of endocrine and exocrine insufficiency after pancreatectomy is poorly described. We analyze the long-term risks of pancreatic insufficiency after pancreatectomy. METHODS: Subjects who underwent pancreatectomy from 2002 to 2012 were identified from a prospective database (n = 227). Subjects who underwent total pancreatectomy or pancreatitis surgery were excluded. New post-operative endocrine and exocrine insufficiency was defined as the need for new pharmacologic intervention within 1000 days from resection. RESULTS: 28 (16%) of 178 subjects without pre-existing endocrine insufficiency developed post-operative endocrine insufficiency: 7 (25%) did so within 30 days, 8 (29%) between 30 and 90 days, and 13 (46%) after 90 days. 94 (43%) of 214 subjects without pre-operative exocrine insufficiency developed exocrine insufficiency: 20 (21%) did so within 30 days, 29 (31%) between 30 and 90 days, and 45 (48%) after 90 days. Adjuvant radiation was associated with new endocrine insufficiency. On multivariate regression, pancreaticoduodenectomy and chemotherapy were associated with a greater risk of exocrine insufficiency. CONCLUSION: Reporting 30-day functional outcomes for pancreatic resection is insufficient, as nearly 45% of subjects who develop disease do so after 90 days. Reporting of at least 90-day outcomes may more reliably assess risk for post-operative endocrine and exocrine insufficiency.

Treatment of peritoneal carcinomatosis with intraperitoneal administration of Ad-hARF.

BACKGROUND: Peritoneal dissemination of cancer is a terminal condition with limited therapeutic options. Because the peritoneal cavity is a single enclosed space, regional treatment approaches for isolated peritoneal cancrinomatosis are appealing. There is a potential role for gene therapy in the management of peritoneal cancrinomatosis. MATERIALS AND METHODS: An adenoviral construct of the human p14ARF gene (a tumor suppressor) and a 22 amino acid sequence of the ARF gene product, which has cell membrane penetrating properties, were assayed for proapoptotic properties in a human colorectal cancer cell line (Clone A) cells in vitro. Peritoneal carcinomatosis derived from Clone A cells was also established in nude mice and then treated with intraperitoneal administration of an adenoviral construct of the human p14ARF gene. RESULTS: Treatment of ARF-negative Clone A cells with Ad-hARF in vitro reestablished ARF function. However, the cell penetrating ARF-related peptide did not restore ARF function in Clone A cells. Treatment of Clone A peritoneal xenografts with a single intraperitoneal dose of Ad-hARF (9 × 10(6) viral particles) suppressed the progression of peritoneal disease. Weekly (six times) administration of the Ad-hARF at a lower dose (3 × 10(6) viral particles) also suppressed tumor progression. CONCLUSIONS: Treatment of peritoneal carcinomatosis by intraperitoneal administration of adenoviral constructs of inactivated tumor suppressor genes may be a feasible clinical approach, and ARF may represent a suitable molecular target for tumors where the ARF gene is inactivated.

Electronic medical record: research tool for pancreatic cancer?

BACKGROUND: A novel data warehouse based on automated retrieval from an institutional health care information system (HIS) was made available to be compared with a traditional prospectively maintained surgical database. METHODS: A newly established institutional data warehouse at a single-institution academic medical center autopopulated by HIS was queried for International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis codes for pancreatic neoplasm. Patients with ICD-9-CM diagnosis codes for pancreatic neoplasm were captured. A parallel query was performed using a prospective database populated by manual entry. Duplicated patients and those unique to either data set were identified. All patients were manually reviewed to determine the accuracy of diagnosis. RESULTS: A total of 1107 patients were identified from the HIS-linked data set with pancreatic neoplasm from 1999-2009. Of these, 254 (22.9%) patients were also captured by the surgical database, whereas 853 (77.1%) patients were only in the HIS-linked data set. Manual review of the HIS-only group demonstrated that 45.0% of patients were without identifiable pancreatic pathology, suggesting erroneous capture, whereas 36.3% of patients were consistent with pancreatic neoplasm and 18.7% with other pancreatic pathology. Of the 394 patients identified by the surgical database, 254 (64.5%) patients were captured by HIS, whereas 140 (35.5%) patients were not. Manual review of patients only captured by the surgical database demonstrated 85.9% with pancreatic neoplasm and 14.1% with other pancreatic pathology. Finally, review of the 254 patient overlap demonstrated that 80.3% of patients had pancreatic neoplasm and 19.7% had other pancreatic pathology. CONCLUSIONS: These results suggest that cautious interpretation of administrative data rely only on ICD-9-CM diagnosis codes and clinical correlation through previously validated mechanisms.

Higher flow rates improve heating during hyperthermic intraperitoneal chemoperfusion.

BACKGROUND/OBJECTIVES: Heated intraperitoneal chemotherapy (HIPEC) kills cancer cells via thermal injury and improved chemotherapeutic cytotoxicity. We hypothesize that higher HIPEC flow rates improve peritoneal heating and HIPEC efficacy. METHODS: (1) A HIPEC-model (30.8 L cooler with attached extracorporeal pump) was filled with 37°C water containing a suspended 1 L saline bag (SB) wrapped in a cooling sleeve, creating a constant heat sink. (2) HIPECs were performed in a swine model. Inflow, outflow, and peritoneal temperatures were monitored as flow rates varied. (3) Flow rates and temperatures during 20 HIPECs were reviewed. RESULTS: Higher flow rates decreased time required to increase water bath (WB) and SB temperature to 43°C. With a constant heat sink, the minimum flow rate required to reach 43°C in the WB was 1.75 L/min. Higher flow rates lead to greater temperature gradients between the WB and SB. In the swine model, the minimum flow rate required to reach 43°C outflow was 2.5-3.0 L/min. Higher flows led to more rapid heating of the peritoneum and greater peritoneal/outflow temperature gradients. Increased flow during clinical HIPEC suggested improved peritoneal heating with lower average visceral temperatures. CONCLUSIONS: There is a minimum flow rate required to reach goal temperature during HIPEC. Flow rate is an important variable in achieving and maintaining goal temperatures during HIPEC.

Changes in Stage at Presentation among Lung and Breast Cancer Patients During the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic altered access to healthcare by decreasing the number of patients able to receive preventative care and cancer screening. We hypothesized that, given these changes in access to care, radiologic screening for breast and lung cancer would be decreased, and patients with these cancers would consequently present at later stages of their disease. STUDY DESIGN: This is a retrospective cross-sectional study of 2017 to September 2021 UMass Memorial Tumor Registry data for adult breast and lung cancer patients. Changes in stage at presentation of breast and lung cancer during the COVID-19 pandemic were measured, defined as before and during COVID-19. RESULTS: There were no statistically significant changes in the overall stage of presentation before or during the COVID-19 pandemic for either breast or lung cancer patients. Analysis of case presentation and stage during periods of COVID-19 surges that occurred during the time of this study compared with prepandemic data demonstrated a statistically significant decrease in overall presentation of breast cancer patients in the first surge, with no other statistically significant changes in breast cancer presentation. A nonstatistically significant decrease in lung cancer presentation was seen during the initial surge of COVID-19. There was also a statistically significant increase in early-stage presentation of lung cancer during the second and third COVID-19 surges. CONCLUSIONS: In the 2 years after the COVID-19 pandemic, we were not able to demonstrate stage migration at presentation of breast and lung cancer patients to later stages despite decreases in overall presentation during the initial 2 years of the COVID pandemic. An increase in early-stage lung cancer during the second and third surges is interesting and could be related to increased chest imaging for COVID pneumonia.

Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Malignant intraductal papillary mucinous neoplasm: are we doing the right thing?

BACKGROUND: Because of the malignant potential, resection has been recommended for some intraductal papillary mucinous neoplasms (IPMN). We hypothesize that a large cancer database could be used to evaluate national resection rates and survival for malignant IPMN. MATERIALS AND METHODS: Using the Surveillance Epidemiology and End Results (SEER) database, 1988-2003, cases of malignant IPMN were identified using histology codes. Age-adjusted incidence rates were calculated; Cochran-Armitage tests evaluated trends over time. Predictors of resection were evaluated using χ(2) and logistic regression. Kaplan-Meier curves and Cox models were constructed to evaluate survival. RESULTS: Of 1834 patients, 209 (11.4%) underwent resection. Annual age-adjusted incidence decreased over the study time-course (P<0.05), while annual proportion of patients presenting with localized lesions and the proportion being resected increased (P<0.05). Predictors of resection on multivariate analysis included localized stage [versus distant, adjusted odds ratio (OR) 31; 95% confidence interval (CI) 17-56], and more recent diagnosis [referent 1988-1991; 2000-2003, OR 3.0 (95%CI 1.7-5.3)]. Median survival for resected patients was 16 mo versus 3 mo without resection (P<0.0001). After adjusting for age, gender, stage, year, and tumor location, surgical resection remained a significant predictor of survival [hazard ratio 0.44 (95% CI 0.36-0.54), P<0.0001]. CONCLUSIONS: In this population-based cohort, detection of malignant IPMNs is decreasing, with an increasing proportion of patients diagnosed at local stages and undergoing resection. Increased awareness of IPMN may be contributing to earlier detection, which might include benign/premalignant lesions, and greater utilization of resection for appropriate candidates; thus, we may be improving survival for this most treatable form of pancreatic cancer.

Utility of HNF-1B and a panel of lineage-specific biomarkers to optimize the diagnosis of pancreatic ductal adenocarcinoma.

Pancreatic ductal adenocarcinoma (PDAC) represents one of the most common cancers with dismal prognosis. Definitive diagnosis of PDAC remains challenging due to the lack of specific biomarkers. A transcription factor essential for pancreatic development named HNF-1B can be a potential biomarker for PDAC. However, HNF-1B was not entirely specific for PDAC and can be expressed in cancers of Müllerian tract, kidney, lung, bladder and prostate. To solve this issue, we investigated the expression of a panel of well-established lineage-specific biomarkers for non-pancreatic origins, including TTF1 and Napsin A for lung, RCC for kidney, ER and PR for breast, NKX3.1 for prostate, PAX8 for Müllerian tract, GATA3 for breast and bladder, and keratin CK7 and CK20 in 149 PDACs, using immunohistochemistry and tissue microarray. A two-tier scoring system for HNF-1B expression in tumor cells was used. Chi-square and Fisher's exact tests were performed using SAS software version 9.4 to test the association between HNF-1B expression and tumor morphology and differentiation. The results showed that PAX8 was focally positive in 6 cases (4.0%). GATA3 was focally positive in 5 cases (3.4%). Napsin A was all negative except for 1 case with focal weak staining. All other lineage-specific markers such as TTF1, RCC, ER, PR and NKX3.1 were completely negative in all PDACs. Consistent with our previous result, the majority of PDACs (88.6%) was positive for HNF-1B, including 78 cases (59.1%) with "strong" and 54 cases (40.9%) with "weak" staining pattern. There was no significant association between HNF-1B expression and cytoplasmic clearing morphology. Addition of keratins may further aid the diagnosis of PDAC since the majority of PDACs (84.6%) was CK7+/CK20-, only a minority of PDACs (11.4%) was CK7+/CK20+, 2.7% were CK-/CK20-, and 1.3% were CK7-/CK20+. In conclusion, HNF-1B can serve as a useful biomarker to aid the diagnosis of PDAC when combined with other lineage-specific biomarkers to exclude the other origins.

Does the ACS NSQIP Surgical Risk Calculator Accurately Predict Complications Rates After Anterior Lumbar Interbody Fusion Procedures?

STUDY DESIGN: Clinical case series. OBJECTIVE: The aim of this study was to determine the effectiveness of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator in the prediction of complications after anterior lumbar interbody fusion (ALIF). SUMMARY OF BACKGROUND DATA: Identifying at-risk patients may aid in the prevention of complications after spine procedures. The ACS NSQIP surgical risk calculator was developed to predict 30-day postoperative complications for a variety of operative procedures. METHODS: Medical records of patients undergoing ALIF at our institution from 2009 to 2019 were retrospectively reviewed. Demographic and comorbidity variables were entered into the ACS NSQIP surgical risk calculator to generate percentage predictions for complication incidence within 30 days postoperatively. The observed incidences of these complications were also abstracted from the medical record. The predictive ability of the ACS NSQIP surgical risk calculator was assessed in comparison to the observed incidence of complications using area under the curve (AUC) analyses. RESULTS: Two hundred fifty-three (253) patients were analyzed. The ACS NSQIP surgical risk calculator was a fair predictor of discharge to non-home facility (AUC 0.71) and surgical site infection (AUC 0.70). The ACS NSQIP surgical risk calculator was a good predictor of acute kidney injury/progressive renal insufficiency (AUC 0.81). The ACS NSQIP surgical risk calculator was not an adequate predictive tool for any other category, including: pneumonia, urinary tract infections, venous thromboembolism, readmission, reoperations, and aggregate complications (AUC < 0.70). CONCLUSION: The ACS NSQIP surgical risk calculator is an adequate predictive tool for a subset of complications after ALIF including acute kidney injury/progressive renal insufficiency, surgical site infections, and discharge to non-home facilities. However, it is a poor predictor for all other complication groups. The reliability of the ACS NSQIP surgical risk calculator is limited, and further identification of models for risk stratification is necessary for patients undergoing ALIF.Level of Evidence: 3.

Coordination and optimization of FDG PET/CT and COVID-19 vaccination; Lessons learned in the early stages of mass vaccination.

As the world embarks on mass vaccination for COVID-19, we are beginning to encounter unintended dilemmas in imaging oncology patients; particularly with regards to FDG PET/CT. In some cases, vaccine-related lymphadenopathy and FDG uptake on PET/CT can mimic cancer and lead to confounding imaging results. These cases where findings overlap with cancer pose a significant dilemma for diagnostic purposes, follow-up, and management leading to possible treatment delays, unnecessary repeat imaging and sampling, and patient anxiety. These cases can largely be avoided by optimal coordination between vaccination and planned imaging as well as preemptive selection of vaccine administration site. This coordination hinges on patient, oncologist, and radiologists' awareness of this issue and collaboration. Through close communication and patient education, we believe this will eliminate significant challenges for our oncology patients as we strive to end this pandemic.

A simple risk score to predict in-hospital mortality after pancreatic resection for cancer.

BACKGROUND: Pancreatectomy for cancer continues to have substantial perioperative risk, and the factors affecting mortality are ill defined. An integer-based risk score based on national data might help clarify the risk of in-hospital mortality in patients undergoing pancreatic resection. METHODS: Records with the diagnosis of pancreatic cancer were queried from the Nationwide Inpatient Sample for 1998-2006. Procedures were categorized as proximal, distal, or nonspecified pancreatectomies on the basis of ICD-9 codes. Logistic regression and bootstrap methods were used to create an integer risk score for estimating the risk of in-hospital mortality using patient demographics, comorbidities (Charlson comorbidity score), procedure, and hospital type. A random sample of 80% of the cohort was used to create the risk score with a 20% internal validation set. RESULTS: A total of 5715 patient discharges were identified. Composite in-hospital mortality was 5.8%. Predictors used for the final model were age group, Charlson score, sex, type of pancreatectomy, and hospital volume status (low-, medium-, or high-volume center). Integer values were assigned to these characteristics and then used for calculating an additive score. Three clinically useful score groups were defined to stratify the risk of in-hospital mortality (mortality was 2.0, 6.2, and 13.9%, respectively; P < 0.0001), with a 6.95-fold difference between the low- and high-risk groups. There was sufficient discrimination of both the derivation set and the validation set, with c statistics of 0.71 and 0.72, respectively. CONCLUSIONS: An integer-based risk score can be used to accurately predict in-hospital mortality after pancreatectomy and may be useful for preoperative risk stratification and patient counseling.

Trends in adrenalectomy: a recent national review.

BACKGROUND: Adrenalectomy remains the definitive therapy for most adrenal neoplasms. Introduced in the 1990s, laparoscopic adrenalectomy is reported to have lower associated morbidity and mortality. This study aimed to evaluate national adrenalectomy trends, including major postoperative complications and perioperative mortality. METHODS: The Nationwide Inpatient Sample was queried to identify all adrenalectomies performed during 1998-2006. Univariate and multivariate logistic regression were performed, with adjustments for patient age, sex, comorbidities, indication, year of surgery, laparoscopy, hospital teaching status, and hospital volume. Annual incidence, major in-hospital postoperative complications, and in-hospital mortality were evaluated. RESULTS: Using weighted national estimate, 40,363 patients with a mean age of 54 years were identified. Men made up 40% of these patients, and 77% of the patients were white. The majority of adrenalectomies (83%) were performed for benign disease. The annual volume of adrenalectomies increased from 3,241 in 1998 to 5,323 in 2006 (p < 0.0001, trend analysis). The overall in-hospital mortality was 1.1%, with no significant change. Advanced age (< 45 years as the referent; ≥ 65 years: adjusted odds ratio [AOR], 4.10; 95%; confidence Interval [CI], 1.66-10.10) and patient comorbidities (Charlson score 0 as the referent; Charlson score ≥ 2: AOR, 4.33; 96% CI, 2.34-8.02) were independent predictors of in-hospital mortality. Indication, year, hospital teaching status, and hospital volume did not independently affect perioperative mortality. Major postoperative in-hospital complications occurred in 7.2% of the cohort, with a significant increasing trend (1998-2000 [5.9%] vs 2004-2006 [8.1%]; p < 0.0001, trend analysis). Patient comorbidities (Charlson score 0 as the referent; Charlson score ≥ 2: AOR, 4.77; 95% CI, 3.71-6.14), recent year of surgery (1998-2000 as the referent; 2004-2006: AOR, 1.40; 95% CI, 1.09-1.78), and benign disease (malignant disease as the referent; benign disease: AOR, 1.98; 95% CI, 1.55-2.53) were predictive of major postoperative complications at multivariable analyses, whereas laparoscopy was protective (no laparoscopy as the referent; laparoscopy: AOR, 0.62; 95% CI, 0.47-0.82). CONCLUSION: Adrenalectomy is increasingly performed nationwide for both benign and malignant indications. In this study, whereas perioperative mortality remained low, major postoperative complications increased significantly.

A neoadjuvant strategy for pancreatic adenocarcinoma increases the likelihood of receiving all components of care: lessons from a single-institution database.

BACKGROUND: Recent studies have shown adjuvant therapy improves outcomes from pancreatic cancer (PC). This study investigates receipt and timing of PC treatments, and association with outcomes. METHODS: The analysis cohort consisted of patients with newly-diagnosed PC at a single institution over 5 years. Primary Endpoints were (i) receipt of recommended therapy, and (ii) overall survival (OS). RESULTS: Among 102 patients, 52 underwent resection. Out of 36 localized resected and 16 locally advanced resected (LAR) patients, 26 and 13, respectively, received adjuvant therapy. Six of the latter group received neoadjuvant therapy. Median OS for resected patients was 15.7 months (range 0.6-51.4), compared with 7.7 for unresected patients (range 0.4-32.0) (P < 0.001), and 14.0 months for patients with resection alone (range 0.6-24.4) vs. 16.1 for patients who also received adjuvant therapy (range 3.2-51.4) (P= 0.027). Out of 46 patients undergoing up-front resection, 33 had R0 surgical margins. For the six LAR patients undergoing neoadjuvant therapy, all margins were R0. CONCLUSION: After resection, a substantial proportion of patients do not receive adjuvant therapy, and have worse survival. In this study, neoadjuvant treatment increased both the proportion of patients receiving all components of recommended therapy and the R0 resection rate.

Perioperative mortality for management of hepatic neoplasm: a simple risk score.

OBJECTIVES: To develop a population-based risk score for stratifying patients by risk of in-hospital mortality following procedural intervention for hepatic neoplasm. BACKGROUND: There has been growing support for the value of surgical management of hepatic neoplastic disease, both primary and metastatic. Advances in surgical and ablative technologies have contributed to a decrease in the mortality associated with these procedures. However, multiple patient-, disease- and treatment-related factors can contribute to perioperative morbidity and mortality. METHODS: Using the Nationwide Inpatient Sample from 1998 to 2005, a retrospective cohort of patient-discharges for hepatic procedures with a concurrent diagnosis of hepatic primary or metastatic neoplasm to the liver was assembled. Procedures were categorized as lobectomy, wedge resection, or enucleation/ablation. Logistic regression and bootstrap methods were used to create an integer score for estimating the risk of in-hospital mortality using patient demographics, comorbidities, procedure type, tumor type, and hospital characteristics. A randomly selected sample of 80% of the cohort was used to create the risk score. Testing was conducted in the remaining 20% validation-set. RESULTS: In total, 12,969 patient-discharges were identified. Overall in-hospital mortality was 3.45%. Predictive characteristics incorporated into the model included: age, sex, Charlson comorbidity score, procedure type, hospital type, and type of neoplasm. Integer values were assigned to these, and used to calculate an additive score. Five clinically relevant groups were assembled to stratify risk, with a 36-fold gradient in mortality. Rates in the groups were as follows: 0.9%, 2.5%, 6.8%, 17.6%, and 35.9%. In the derivation set, as well as in the validation set, the simple score discriminated well, with c-statistics of 0.76 and 0.70, respectively. CONCLUSIONS: An integer-based risk score can be used to predict in-hospital mortality after hepatic procedure for neoplasm, and may be useful for preoperative risk stratification and patient counseling.