Effects of ketorolac on complications and postoperative pancreatic fistula in patients undergoing pancreatectomy.

BACKGROUND: There are conflicting data on the risk of postoperative pancreatic fistula (POPF) associated with postoperative NSAID use. The primary objective of this multi-center retrospective study was to assess the relationship between ketorolac use and POPF. The secondary objective was to assess for effect of ketorolac use on overall complication rate. METHODS: Retrospective chart review of patients undergoing pancreatectomy from January 1, 2005-January 1, 2016 was performed. Data on patient factors (age, sex, comorbidities, previous surgical history etc.), operative factors (surgical procedure, estimated blood loss, pathology etc.), and outcomes (morbidities, mortality, readmission, POPF) were collected. The cohort was compared based on ketorolac use. RESULTS: The study included 464 patients. Ninety-eight (21%) patients received ketorolac during the study period. Ninety-six (21%) patients were diagnosed with POPF within 30 days. There was a significant association between ketorolac use and clinically relevant POPF (21.4 vs. 12.7%) (p = 0.04, 95% CI [1.76, 1.04-2.97]). There was no significant difference in overall morbidity or mortality between the groups. DISCUSSION: Though there was no overall increase in morbidity, there was a significant association between POPF and ketorolac use. The use of ketorolac after pancreatectomy should be judicious.

Inaccurate pretreatment staging can impact survival in early stage esophageal adenocarcinoma.

BACKGROUND: Given the survival advantage of neoadjuvant treatment for locally advanced esophageal cancer, accurate clinical staging is necessary. The aim of this study was to assess the clinical (c) and pathologic (p) staging concordance rates for presumably early stage esophageal adenocarcinoma patients that had upfront esophagectomy (UFE) and evaluate if survival (OS) was negatively affected by inaccurate preoperative staging and subsequent treatment selection. METHODS: An NCDB retrospective review of nonmetastatic esophageal adenocarcinoma patients that had UFE. The rates of concordance between c and p staging system and OS were calculated. RESULTS: Of 2775 patients, most patients presented with cN0 (82.8%) and cT1 tumors (53.6%). The overall concordance between c and p staging was 78.8% for T-classification (moderate agreement; weighted κ = 0.729; P < .001) and 78.8% for N-classification (weak agreement; weighted κ = 0.448; P < .001). Patients that were upstaged due to a lack of concordance between T-classification had decreased 5- and 10-year OS (30% and 16%, P < .001) and those upstaged due to discordant N-classification had decreased 5- and 10-year OS (28% and 23%, P < .001)." CONCLUSIONS: Preoperative staging of esophageal adenocarcinoma has moderate reliability and accuracy for predicting pT and pN classification. Up to 25% of patients have discordant clinical and pathological staging, which impacts OS.

Colon cancer as a subsequent malignant neoplasm in young adults.

BACKGROUND: The incidence of colon cancer (CC) is rising in younger adults and can occur de novo or in patients previously treated for another cancer. To the authors' knowledge, the impact on survival of CC occurring as a subsequent malignant neoplasm (SMN) has not been described for younger patients, which the authors anticipate to be lower with SMNs than that of primary CC. METHODS: Patients aged <50 years with CC in the 2004 through 2014 National Cancer Data Base were identified. Patients were stratified by primary or subsequent occurrence. The impact of SMN status on overall survival (OS) was evaluated. RESULTS: Of 41,915 patients, 2852 (6.8%) had colon SMNs. More patients with colon SMNs were aged 40 to 49 years compared with patients with primary CC (83% vs 77%; P < .001). Patients with colon SMNs presented with earlier clinical and pathological T, N, and M classifications (all P < .001). Colon SMNs more commonly occurred in the right colon, whereas primary CC was found to have a higher prevalence in the sigmoid colon (P < .001). Patients with colon SMNs more frequently underwent total colectomy (17% vs 5%; P < .001), but received less chemotherapy (53% vs 65%; P < .001). When adjusted for demographic, tumor, and treatment characteristics, SMN status was associated with a 23% decreased OS compared with primary CC (95% CI, 1.14-1.31; P < .001). Chemotherapy offered a 33% improvement in OS (95% CI, 0.56-0.8; P < .001). CONCLUSIONS: Colon SMNs in younger patients present at an earlier stage and are treated more aggressively surgically compared with primary CCs. Patients with SMNs of the colon have decreased survival, although chemotherapy offers a survival advantage. Further investigation is warranted to determine whether these disparities are due to the effects of cancer treatment or differences in tumor biology.

Impact of Effective Systemic Therapy on Metastasectomy in Stage IV Melanoma: A Matched-Pair Analysis.

BACKGROUND: Although resection historically played a prominent role in the treatment of metastatic melanoma, recent advances have altered the therapeutic landscape, and potentially the role of surgery. We examined surgical selection and metastasectomy outcomes before and after the onset of the effective drug therapy era. METHODS: Patients with stage IV melanoma were identified and characterized by treatment era (either 1965-2007 or 2008-2015) and by systemic therapy agents. BRAF and/or MEK inhibitors, as well as checkpoint inhibitors, were included as modern agents. Selection factors for metastasectomy were examined by era. A matched-pair analysis of outcomes of surgical and non-surgical patients receiving modern systemic agents was performed. RESULTS: Among 2353 eligible patients, 1065 (45.2%) underwent surgical treatment. Factors associated with selection for metastasectomy in the early era included female sex, no prior stage III disease, single-organ involvement, and M1a (vs. M1c) disease (all p < 0.007). In the current era, the proportion of surgically treated patients increased modestly (54.5% vs. 44.7%, p = 0.02) and age was the only independent selection factor (p < 0.01). Surgery followed by modern therapy in 47 matched pairs was associated with higher 5-year melanoma-specific survival (MSS) versus modern therapy alone (58.8% vs. 38.9%, p = 0.049). Multivariable regression showed single-organ involvement (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.21-0.90, p = 0.02) and first-line surgery (HR 0.47, 95% CI 0.23-0.98, p = 0.04), as well as use of modern agents (HR 0.29, 95% CI 0.21-0.40, p < 0.001), were independently associated with improved MSS. CONCLUSIONS AND RELEVANCE: While modern systemic agents have improved outcomes in stage IV melanoma, metastasectomy remains associated with favorable survival. Resection remains a viable therapeutic approach, possibly worthy of prospective evaluation.

Can high-volume teams of anesthesiologists and surgeons decrease perioperative costs for pancreatic surgery?

BACKGROUND: Pancreatic surgery outcomes are associated with surgeon and center experience. Anesthesiologists as potential value drivers for pancreatic surgery have not been explored. We sought to evaluate whether anesthesiologists impact perioperative costs for pancreatic surgery. METHODS: Within an integrated health care system, 796 pancreatic surgeries (526 PDs and 270 DPs) were performed from January 2014 to June 2017. Mean direct operative and anesthesia costs driven by anesthesiologists (operating room (OR) time, anesthesia billing and anesthesia procedures) were determined for each case. The volumes of pancreatic cases per anesthesiologist were calculated, and those above the 75th percentile for volume (4 cases) were considered high-volume. A multivariable analysis of OR/anesthesia costs was performed. RESULTS: Mean OR and anesthesia costs for PD were $7064 for low-volume anesthesiologists (LVA), higher than $5968 for high-volume anesthesiologists (HVA) (p < 0.001). By multivariable analysis, HVA were associated with decreased costs of $2278 (p < 0.001). Teams of HVA and high-volume surgeons (HVS) were also associated with decreased mean costs of $1790 (p = 0.04). CONCLUSION: These data suggest that anesthesiologists experienced in the management of complex pancreatic operations such as PDs may contribute to improved efficiencies in care by reducing perioperative costs.

Resectable Distal Pancreas Cancer: Time to Reconsider the Role of Upfront Surgery.

BACKGROUND: Neoadjuvant chemotherapy (NAC) is increasingly utilized to optimize survival in proximal pancreatic adenocarcinoma. However, few studies have explored the impact of NAC in distal pancreas cancer. METHODS: Patients with resectable pancreatic adenocarcinoma of the body or tail treated with either upfront pancreatectomy or NAC followed by surgery were identified in the 2006-2014 National Cancer Database. Trends in utilization, predictors of use, and impact of NAC on overall survival were determined. RESULTS: Of 1485 patients, 176 (11.9%) received NAC. Use of NAC increased from 9.3% in 2006 to 16.9% in 2013 [odds ratio 1.14; 95% confidence interval (CI) 1.05-1.24; p = 0.001]. NAC patients were younger, had higher clinical stage, and preoperative CA 19-9 levels (all p < 0.05). After adjustment for patient-, tumor-, and treatment-related factors, increased clinical stage was the greatest independent predictor of neoadjuvant approach (p < 0.001). On multivariable analysis, survival benefit from NAC did not reach threshold of significance (95% CI 0.66-1.04; p = 0.10) for the entire cohort. However, NAC was associated with a significant survival advantage in clinical stage III with a 51% decreased yearly risk of death (adjusted hazard ratio 0.49; 95% CI 0.25-0.98; p = 0.04). A trend towards improved survival with NAC was observed among stage IIA (p = 0.09) and IIB (p = 0.07) patients. CONCLUSIONS: Neoadjuvant chemotherapy is associated with improved overall survival in Stage III distal pancreatic adenocarcinoma and shows promise in earlier stage disease. However, only a small percentage of patients receive NAC. Prospective evaluation of NAC in distal pancreatic adenocarcinoma is warranted based on these findings.

Soft Tissue Sarcoma With Tongue Metastasis: A Case Report and Literature Review.

Soft tissue sarcomas are rare malignant tumors that develop from mesenchymal cells. Metastasis is predominantly hematologic, with the lungs being the most common site. Metastasis to the oral cavity is a rare occurrence. The most common primary tumors to metastasize to the oral cavity are adenocarcinoma of the lung, breast, and kidney. This report describes a case of a 41-year-old man who was diagnosed with myxofibrosarcoma of the lower extremity and underwent neoadjuvant chemoradiation followed by surgical resection. Two years later, he presented with metastasis to the tongue and lungs. The literature on tongue metastasis of soft tissue sarcoma is reviewed and discussed. Surgeons providing care to patients with a soft tissue sarcoma should maintain a strong clinical suspicion for distant metastases in patients with this type of tumor.

Epidemiology of metastatic hepatocellular carcinoma, a nationwide perspective.

BACKGROUND: Hepatocellular carcinoma (HCC) is the most common primary tumor of the liver. AIMS: The aim of this study was to describe the prevalence, trends, and predictors of metastatic HCC on a national scale. METHODS: We used two nationwide datasets for our study: the University Health Consortium (UHC) and the Nationwide Inpatient Sample (NIS) databases. We included adults with a primary diagnosis of HCC from 2000 to 2011. We collected information regarding demographics, insurance, HCC risk factors, liver decompensation, and the sites and frequencies of metastases. Multivariable regression analysis was used to examine predictors of metastatic HCC. Trend analysis was performed to examine the change in metastatic HCC prevalence over time. RESULTS: We included 25,671 and 26,054 HCC patients from UHC and NIS, respectively. Prevalence of metastatic HCC was 18 % with lung being the most frequent site (31 %). Compared with Caucasian, African American ethnicity was an independent predictor of metastasis in both the NIS [OR 1.13 (1.02-1.25)] and UHC [OR 1.4 (1.3-1.6)] databases. Lack of long-term insurance was associated with significantly higher prevalence of metastasis in both the NIS [OR 1.6 (1.4-1.9)] and UHC [OR 1.9 (1.6-2.2)] databases. There has been an increased prevalence of metastatic HCC over the last decade with an annual percentage change of +1.25 and +1.60 % (p = 0.03 and p = 0.08) for the NIS and UHC databases, respectively. CONCLUSIONS: Metastasis is not rare among HCC patients and is rising in prevalence over the last decade. Lungs were the most common metastatic site. Ethnicity and insurance status are independent predictors of metastasis.

Comorbidity and outcomes after surgery among women with breast cancer: analysis of nationwide in-patient sample database.

To examine the effect of comorbidity on risk of postoperative complications, prolonged hospitalization (defined as above median length of stay), non-routine disposition, and in-patient death among women with breast cancer after surgery. Nationwide in-patient sample is a nationwide clinical and administrative database. Discharges of patients aged 40 years and older who underwent surgery for breast cancer from 2005 to 2009 were identified. Information about patients and hospitals characteristics were obtained. Comorbidities were identified and used to calculate Charlson comorbidity index (CCI) score. We divided patients based on these scores into four groups: 0, 1, 2, and ≥3. Multivariate logistic regression analyses were used to examine risk adjusted association between CCI score and the aforementioned outcomes. We identified 70,536 patients' discharges. Compared to a CCI score of zero as a reference group, CCI scores of 1, 2, and ≥3 increased the risk of post-operative complications by 1.7-fold, 2.6-fold, and 4.6-fold, respectively (p < 0.001). Patients with CCI scores of 1, 2, and ≥3 had higher risk of non-routine disposition by 1.3-folds, 1.7-folds, and 2.2-folds, respectively (p < 0.001). Patients with CCI scores of 1, 2, and ≥3 had higher risk of prolonged hospitalization by 1.2-folds, 1.6-folds, and 2.3-folds, respectively (p < 0.001). Similarly, CCI scores of 1, 2, and ≥3 increased risk of in-patient death by 3.1-folds (p 0.05), 5.4-folds (p 0.008), and 15.8-folds (p < 0.001), respectively. Comorbidity associated with worse in-hospital outcomes among women with breast cancer after surgery. Effective control of comorbidity in breast cancer patients may reduce post-operative morbidity and mortality.

Racial disparities in clinical presentation, surgical treatment and in-hospital outcomes of women with breast cancer: analysis of nationwide inpatient sample database.

To examine racial/ethnic disparities in stage of disease and comorbidity (pre-treatment), surgical treatment allocation (breast-conserving surgery versus mastectomy), and in-hospital outcomes after surgery (post-treatment) among women with breast cancer. Nationwide inpatient sample is a nationwide clinical and administrative database compiled from 44 states representing 95 % of all hospital discharges in the Unites States. Discharges of adult women who underwent surgery for breast cancer from 2005 to 2009 were identified. Information about patients and hospitals characteristics was obtained. Multivariate logistic regression analyses were used to examine the risk adjusted association between race/ethnicity and the aforementioned outcomes (pre-treatment, treatment, and post-treatment). We identified 75,100 patient discharges. Compared to Whites, African-Americans (1.17, p < 0.001), and Hispanics (1.20, p < 0.001) were more likely to present with regional or metastatic disease. Similarly, African-American (1.58, p < 0.001) and Hispanics (1.11, p 0.003) were more likely to have comorbidity. Compared to Whites, African-Americans (0.71, p < 0.001), and Hispanics (0.77, p < 0.001) were less likely to receive mastectomy. Compared to Whites, African-Americans were more likely to develop post-operative complications (1.35, p < 0.001) and in-hospital mortality (1.87, p 0.13). Other racial groups showed no statistically significant difference compared to Whites. After controlling for potential confounders, we found racial/ethnic disparities in stage, comorbidity, surgical treatment allocation, and in-hospital outcomes among women with breast cancer. Future researches should examine the underlying factors of these disparities.

Health insurance coverage among diabetic adults from three major ethnic groups in the United States.

OBJECTIVE: The lack of adequate health insurance may result in a downward spiral of the diabetic condition, imposing an increased financial strain on family and the society as a whole. The objective of our study was to assess the insurance type and coverage among diabetic adults from three major ethnic groups. DESIGN AND SETTING: We used data of two cross-sectional national surveys to estimate insurance coverage among diabetic adults aged 20-64 years, 1988-1994 and 2003-2008. RESULTS: The prevalence of doctor-diagnosed diabetes has increased by 120%, 178% and 135% respectively among non-Hispanic Whites (NHWs), non-Hispanic Blacks (NHBs), and Mexicans & other Hispanics (M&OHs) from 1988-94 to 2003-08. However, during the same period, the percentages of diabetic adults covered by health insurance declined for all three groups. In the 2003-08 period, 15%, 19% and 40% of NHWs, NHBs and M&OHs, respectively, had no insurance. Diabetic NHBs and NHWs had an equal likelihood to be covered by government-sponsored programs. However, 70% of NHWs, in contrast to 37% of NHBs, were covered by private programs exclusively. Diabetic M&OHs remained at the lowest likelihood to be covered by government-sponsored programs. The diabetic citizen's probability of being insured was more than tripled compared with the non-citizens (OR=3.40, 95%=1.42-8.14). CONCLUSION: Increasing percentages of diabetics had no insurance. Diabetic Whites were more likely to be covered by private programs than diabetic Blacks. Hispanics were the group falling through the cracks between private programs due to low income and government programs because of immigration status.

Peritoneal Lavage Cytology Following Neoadjuvant Chemotherapy for Gastric Adenocarcinoma: Low Yield in Detecting Peritoneal Metastases.

BACKGROUND: Peritoneal lavage cytology (PLC) can detect advanced disease in gastric adenocarcinoma (GC); however, routine practice remains controversial. Furthermore, the effect of neoadjuvant chemotherapy (NAC) on cytological detection of carcinomatosis is unknown. METHODS: Using a 2012-2020 prospective database, we retrospectively reviewed patients with GC who underwent NAC followed by a staging laparoscopic peritoneal lavage with or without biopsy of suspicious peritoneal nodules. PLC results were considered discordant if they did not align with the peritoneal biopsy results. Patients with benign peritoneal cytology (Cyt-) or biopsy results who had postoperative time to carcinomatosis of <6 months were considered to have diagnostic failure of peritoneal lavage. RESULTS: Fifty-five patients with GC who underwent NAC followed by staging diagnostic laparoscopy with peritoneal lavage were identified. The majority of the patients in the cohort had Cyt- lavage (89.1%). Of the patients who underwent resection, 76.1% had T3 or greater disease on final pathology and 66% had nodal metastases. In 23 patients (41.8%) who had both peritoneal lavage and biopsy, four cases (17.4%) had discordant results. Diagnostic failure rate was 20% at 6 months and 42.2% at 12 months. The median time to carcinomatosis in patients who were Cyt- or biopsy negative was 7.9 months. CONCLUSION: PLC after NAC has a high diagnostic failure rate and inaccurately predicts carcinomatosis in 20% of patients with GC. Novel methods for identifying cytology positive GC after NAC should also be developed and evaluated, since the risk of peritoneal dissemination is high.

Prospective associations of hemoglobin A1c and c-peptide with risk of diabetes-related cancers in the Cancer Prevention Study-II Nutrition Cohort.

Self-reported type 2 diabetes mellitus (T2DM) is a risk factor for many cancers, suggesting its pathology relates to carcinogenesis. We conducted a case-cohort study to examine associations of hemoglobin A1c (HbA1c) and c-peptide with cancers associated with self-reported T2DM. This study was drawn from a prospective cohort of 32,383 women and men who provided blood specimens at baseline: c-peptide and HbA1c were assessed in 3,000 randomly selected participants who were cancer-free-at-baseline and an additional 2,281 participants who were cancer-free-at-baseline and subsequently diagnosed with incident colorectal, liver, pancreatic, female breast, endometrial, ovarian, bladder, or kidney cancers. Weighted-Cox regression models estimated hazards ratios (HRs) and 95% confidence intervals (CI), adjusted for covariates. C-peptide was associated with higher risk of liver cancer (per standard deviation (SD) HR: 1.80; 95%CI: 1.32-2.46). HbA1c was associated with higher risk of pancreatic cancer (per SD HR: 1.21 95%CI 1.05-1.40) and with some suggestion of higher risks for all-cancers-of-interest (per SD HR: 1.05; 95%CI: 0.99-1.11) and colorectal (per SD HR: 1.09; 95%CI: 0.98-1.20), ovarian (per SD HR: 1.18; 95%CI 0.96-1.45) and bladder (per SD HR: 1.08; 95%CI 0.96-1.21) cancers. Compared to no self-reported T2DM and HbA1c <6.5% (reference group), self-reported T2DM and HbA1c <6.5% (i.e., T2DM in good glycemic control) was not associated with risk of colorectal cancer, whereas it was associated with higher risks of all-cancers-of-interest combined (HR: 1.28; 95%CI: 1.01-1.62), especially for breast and endometrial cancers. Additional large, prospective studies are needed to further explore the roles of hyperglycemia, hyperinsulinemia, and related metabolic traits with T2DM-associated cancers to better understand the mechanisms underlying the self-reported T2DM-cancer association and to identify persons at higher cancer risk.

Body mass index and death rate of colorectal cancer among a national cohort of U.S. adults.

Substantial evidence suggests that increasing adiposity is associated with an increased death rate of colorectal cancer, but no studies were conducted among national representative populations in the United States. The current study examined the death rate across BMI levels in 7,016 adults who participated in the National Health and Nutrition Examination Survey in 1971-1975. BMI categories were defined as normal (18.5-24.9 kg/m(2)), overweight (25-29.9), and obese (≥30). A total of 519 cancer deaths were identified during a 17-yr follow-up with 118,998 person-years. No significantly increased death rates of total cancers, lung, breast, and prostate cancer were observed among participants with an increased BMI. However, colorectal cancer death rates were 0.39, 0.68, and 0.96/1,000 person-years, respectively, for normal weight, overweight, and obese (P value for log-rank trend test < 0.001), and the corresponding adjusted hazard ratios [95% confidence intervals (CI)] were 1.00 (reference), 1.25 (95% CI = 0.72-2.19), and 2.04 (1.08-3.83), respectively. No gender difference of the association was identified. The authors conclude that a significantly increased death rate of colorectal cancer was associated with excess body weight. The current study is an addition to the expanding body of literature indicating an increased risk of colorectal cancer development among the obese.

Fish consumption and severely depressed mood, findings from the first national nutrition follow-up study.

The evidence obtained from prospective studies to support the hypothesis that fish consumption may improve mental status remains limited. The current study prospectively assessed a low frequency of fish consumption as a risk factor for depressed mood. Included were 5068 adults aged 25-74 years examined in 1971-1975 as the baseline of the First National Health and Nutrition Examination Survey Follow-up Study. Frequency of eating fish at baseline was obtained using a 3-month food frequency questionnaire. Severely depressed mood (SDM) was defined as the Center for Epidemiologic Studies Depression Scale scores ≥22 or taking anti-depressants. After an average of 10.6 years of follow-up, among men (n=2039), the percentage of individuals with SDM was 11.7%. Compared with frequent consumers (more than once a week), the odds ratios (ORs) were 1.43 (95%CI=0.66-3.11) and 2.08 (1.08-4.09) respectively for the men eating fish once a week and less than once a week (p for trend=0.03). Among women (n=3029), the percentage of individuals with SDM was 17.89%. The ORs were 1 (reference), 0.91 (0.68-1.22) and 1.15 (0.83-1.59) respectively for the women eating fish more than once, once, and less than once a week. These estimates were obtained after adjustment for indicators of social deprivation and major physical diseases. The study concluded that independently from social deprivation and physical diseases, low fish consumption was a risk factor for SDM among men. Further studies are needed to confirm these findings and elucidate mechanisms for the difference between men and women.

The Immune Microenvironment Impacts Survival in Western Patients with Gastric Adenocarcinoma.

BACKGROUND: Expression of CD3+ T cells, CD8+ cytotoxic T cells, CD45RO+ memory T cells, and FOXP3+ regulatory T cells at the invasive margin (IM) and tumor center (TC) has correlated with survival in gastric adenocarcinoma (GA) patients from East Asia, independent of anatomic staging. The reason for improved survival in East Asians compared with Western patients is a subject of debate. This study examined the immune profiles of a cohort of Western patients with GA, and their association with overall survival (OS). METHODS: Immunohistochemistry (IHC) using antibodies to CD3, CD4, CD8, CD45RO, and FOXP3 was performed on a randomly selected resected GA specimens from 88 Western patients. Cutoffs for high or low expression of each marker were determined with maximally selected rank statistics, and multivariable Cox proportional-hazards models constructed to evaluate the relationship between OS and expression of each marker at the IM and TC. RESULTS: Immune cell density was independent of anatomic staging. High expression of CD3, CD4, CD8, and CD45RO at the IM along with CD4 and FOXP3 at the TC were associated with improved OS. A combined marker of CD3, CD8, CD45RO, and FOXP3 associated with OS in East Asian GA was also validated. DISCUSSION: This is the first report in US patients to demonstrate that high expression of multiple subsets of T lymphocytes in GA is associated with better OS independent of clinical factors and anatomic stage. Further evaluation of immune-modulating mechanisms may explain survival differences between Western and Eastern patients and provide opportunity for novel treatments.

Accuracy of nodal staging is influenced by sidedness in colon cancer.

BACKGROUND: Adequate lymph node (LN) sampling is critical for accurate nodal staging in colon cancer (CC), particularly for T3N0 disease as current guidelines recommend considering adjuvant chemotherapy when less than 12 LNs are examined. The impact of sidedness on nodal staging accuracy in patients with T3N0 disease has not been previously studied. METHODS: Patients with pathologic T3 CC were identified from a prospective multicenter international trial of ultrastaging in CC. The probability of true nodal negativity (TNN) based on the number of LN examined was calculated for right and left CC. These results were then validated in a cohort of patients with similar inclusion criteria selected from the National Cancer Database (NCDB) between 2006 and 2014. RESULTS: Three hundred and seventy patients met the inclusion criteria in the trial cohort; 48% were LN-negative. Of 153,945 patients in the NCDB, 57% were LN-negative. The probability of TNN when 12 LNs were examined was 68% for right and 64% for left CC in the trial cohort and 77% and 72% in the NCDB. The number of LNs needed to achieve any given probability of TNN was significantly different between right and left CC in both the trial (P<0.001) and the NCDB (P<0.001). CONCLUSIONS: In both a prospective multicenter trial and the NCDB, sidedness influences the number of LNs needed to predict nodal negativity in CC. Current guidelines regarding the minimum number of LNs needed to accurately stage patients with T3N0 CC may need to be re-evaluated by taking into consideration the tumor sidedness.

Current Imaging Modalities Understage One-Third of Patients with Stage I Rectal Cancer: Implications for Treatment Selection.

Accurate preoperative clinical staging is essential to optimize the treatment of rectal cancer. Primary surgical resection is typically indicated for stage I disease, whereas neoadjuvant therapy is recommended for stages II and III. The objective of this study is to examine the accuracy of clinical staging using current imaging modalities in predicting pathologic stage and, thus, selecting appropriate treatment. Adult patients with nonmetastatic rectal cancer who underwent primary surgical resection were identified from the National Cancer Database between 2006 and 2014. Data on clinical and pathologic staging was obtained. Kappa index was used to determine the correlation between clinical and pathologic staging. A total of 13,175 patients were identified. The correlation between clinical and pathologic staging was 69 per cent for stage I (31% upstaged) (Kappa 0.54, P < 0.001). One-third of patients who were clinically staged as stage I, and were therefore treated with primary surgical resection, had pathologic stage II or III disease. Based on their clinical staging, those patients did not receive the neoadjuvant therapy recommended by present guidelines. Where accurate clinical staging is in doubt, oncologists should carefully examine the quality of staging modality and perhaps consider multimodal imaging using both endorectal ultrasound and MRI.

Neoadjuvant Chemotherapy Improves Survival in Patients with Clinical T4b Colon Cancer.

BACKGROUND: In 2016, the National Comprehensive Cancer Network included neoadjuvant chemotherapy as a treatment option for patients with clinical T4b colon cancer. However, there is little published data on the survival impact of neoadjuvant chemotherapy for locally advanced colon cancer. METHODS: Adult patients with non-metastatic clinically staged T3 or T4 colon cancer who underwent surgical resection were identified from the National Cancer Data Base between 2006 and 2014. Treatment was categorized as neoadjuvant chemotherapy followed by surgery and surgery followed by adjuvant chemotherapy. Overall survival was compared between the two groups using propensity score matching. RESULTS: Of 27,575 patients that met inclusion criteria, 26,654 (97%) were treated with surgery followed by adjuvant chemotherapy and 921 (3%) received neoadjuvant chemotherapy followed by surgery. After propensity score matching, patients with T4b colon cancer treated with neoadjuvant chemotherapy had a 23% lower risk of death at 3 years compared to patients that had adjuvant chemotherapy (HR 0.77, 95% CI 0.60-0.98; p = 0.04). However, neoadjuvant chemotherapy did not demonstrate a similar significant benefit for patients with T3 and T4a disease. CONCLUSIONS: Patients with clinical T4b colon cancer treated with neoadjuvant chemotherapy may have an improved survival compared to those who receive adjuvant chemotherapy. Further prospective investigation is warranted.

Correlation Between Clinical and Pathologic Staging in Colon Cancer: Implications for Neoadjuvant Treatment.

BACKGROUND: Recent randomized trials suggest improved outcomes in patients with locally advanced colon cancer (LACC) treated with neoadjuvant chemotherapy (NAC). Optimal selection of patients for NAC depends on accurate clinical staging. The purpose of this study was to examine the degree of correlation between clinical and pathologic staging in patients with colon cancer (CC). METHODS: Adult patients with non-metastatic CC who underwent surgery were identified from the National Cancer Data Base between 2006 and 2014. Data on clinical and pathologic staging was obtained. Kappa index was used to determine the correlation between clinical and pathologic staging. RESULTS: One hundred five thousand five hundred sixty-nine patients were identified. The overall correlation rate between clinical and pathologic staging for T stage was 80% (kappa 0.7) and 83% for N stage (kappa 0.6). The correlation rate was 54% for T1, 76% for T2, 95% for T3, and 94% for T4 (P < 0.001). This compared with 81% for N0, 82% for N1, and 97% for N2 (P < 0.001). The sensitivity and specificity of clinical staging for identifying T3/T4 vs T1/T2 were 80 and 98%, respectively, compared to 60 and 98% for N1/N2 vs N0 (P < 0.001). CONCLUSIONS: Our findings suggest that current modalities used for clinical staging are accurate in predicting pathologic stage for advanced but not early T and N disease. Further optimization of clinical staging is essential for the accurate selection of patients who may benefit from neoadjuvant therapy and to avoid overtreatment of low-risk patients.