The volume-outcome relationship in robotic protectectomy: does center volume matter? Results of a national cohort study.

BACKGROUND: Utilization of robotic proctectomy (RP) for rectal cancer has steadily increased since the inception of robotic surgery in 2002. Randomized control trials evaluating the safety of RP are in process to better understand the role of robotic assistance in proctectomy. This study aimed to characterize the trends in the use of RP for rectal cancer, and to compare oncologic outcomes with center-level RP volume. MATERIALS AND METHODS: 8107 patients with rectal adenocarcinoma who underwent RP were identified in the National Cancer Database (2010-2015). Logistic regression was used to evaluate associations between center-level volume and conversion to open proctectomy, margin status, lymph node yield, 30- and 90-day post-operative mortality, and overall survival. RESULTS: The utilization of RP increased from 2010 to 2015. On multivariate regression, lower center-level volume of RP was associated with significantly higher rates of conversion to open, positive margins, inadequate lymph node harvest (≥ 12), and lower overall survival. The present study was limited by its retrospective design and lack of information regarding disease-specific survival. CONCLUSIONS: This series suggests a volume-outcome relationship association; patients who have robot-assisted proctectomies performed at low-volume centers are more likely to have poorer overall survival, positive margins, inadequate lymph node harvest, and require conversion to open surgery. While these data demonstrate the increased adoption of robot-assisted proctectomy, an understanding of the appropriateness of this intervention is still lacking. As with any new intervention, further information from ongoing randomized controlled trials is needed to better clarify the role of RP in order to optimize patient outcomes.

Operative Management of Anastomotic Leaks after Colorectal Surgery.

Anastomotic leak is associated with increased morbidity and mortality after colorectal surgery. Although surgical techniques have improved over time, anastomotic leak is still a reality in colorectal surgery with rates ranging from as low as 1% for low-risk anastomoses, such as enteroenteric or ileocolic, to 19% for high-risk coloanal anastomoses. There are many varied risk factors for anastomotic leak. However, many of the risk factors have not been definitively proven in high-quality studies. Presumably, risk factors are cumulative and every effort should be made to optimize modifiable risk factors in the perioperative period. Treatment of anastomotic leak should start with the determination of patient stability followed by resuscitation and diagnostic imaging or operative exploration. Operative findings will dictate surgical approach with the goal of controlling sepsis and stabilizing the patient. If nonoperative treatment is undertaken, close patient monitoring is necessary to ensure control of sepsis and that intervention is undertaken if the clinical picture changes. Early intervention at each stage is key to decreasing the morbidity of anastomotic leak.

Predictors of Metastases in Rectal Neuroendocrine Tumors: Results of a National Cohort Study.

BACKGROUND: Rectal neuroendocrine tumors are often found incidentally. Local excision alone has been advocated for lesions ≤2 cm; however, the evidence base for this approach is limited. OBJECTIVE: Associations among tumor size, degree of differentiation, and presence of distant metastatic disease were examined. DESIGN: This was a retrospective cohort study. SETTINGS: This study was conducted using a nationwide cohort. PATIENTS: A total of 4893 patients with rectal neuroendocrine tumors were identified in the National Cancer Database (2006-2015). MAIN OUTCOME MEASURES: Logistic regression analyses were used to evaluate associations among tumor size, degree of differentiation, and presence of regional and distant metastatic disease. Cut point analysis was performed to identify an optimal size threshold predictive of distant metastatic disease. RESULTS: Of patients included for analysis, 3880 (79.3%) had well-differentiated tumors, 540 (11.0%) had moderately differentiated tumors, and 473 (9.7%) had poorly differentiated tumors. On logistic regression, increasing size was associated with a higher likelihood of pathologically confirmed lymph node involvement (among patients undergoing proctectomy), and both size and degree of differentiation were independently associated with a higher likelihood of distant metastatic disease. The association between tumor size and distant metastatic disease was stronger for well-differentiated and moderately differentiated tumors (OR = 1.4; p < 0.001 for both) than for poorly differentiated tumors (OR = 1.1; p = 0.010). For well-differentiated tumors, the optimal cut point for the presence of distant metastatic disease was 1.15 cm (area under the curve = 0.88; 88% sensitive and 88% specific). Tumors ≥1.15 cm in diameter were associated with a substantially increased incidence of distant metastatic disease (72/449 (13.8%)). For moderately differentiated tumors, the optimal cut point was also 1.15 cm (area under the curve = 0.87, 100% sensitive and 75% specific). LIMITATIONS: This study was limited by its retrospective design. CONCLUSIONS: Tumor size and degree of differentiation are predictive of regional and distant metastatic disease in rectal neuroendocrine tumors. Patients with tumors >1.15 cm are at substantial risk of distant metastasis and should be staged and managed accordingly. See Video Abstract at http://links.lww.com/DCR/A778.

The mutual benefits of research in wild animal species and human-assisted reproduction.

Studying the reproductive biology of wild animal species produces knowledge beneficial to their management and conservation. However, wild species also share intriguing similarities in reproductive biology with humans, thereby offering alternative models for better understanding the etiology of infertility and developing innovative treatments. The purpose of this review is to raise awareness in different scientific communities about intriguing connections between wild animals and humans regarding infertility syndromes or improvement of fertility preservation. The objectives are to (1) highlight commonalities between wild species and human fertility, (2) demonstrate that research in wild species-assisted reproductive technologies can greatly enhance success in human reproductive medicine, and (3) recognize that human fertility preservation is highly inspiring and relevant to wild species conservation. In addition to having similar biological traits in some wild species and humans, the fact of sharing the same natural environment and the common needs for more options in fertility preservation are strong incentives to build more bridges that will eventually benefit both animal conservation and human reproductive medicine.

Segmental resection is a safe oncological alternative to total proctocolectomy in elderly patients with ulcerative colitis and malignancy.

AIM: The standard approach for the surgical management of colorectal cancer (CRC) in the setting of ulcerative colitis (UC) involves total proctocolectomy (TPC). However, some patients also undergo a partial resection (PR). This may be an attractive option in older patients with a high risk for surgery. The aim of this study was to compare the risk of metachronous cancer after PR or TPC for CRC in the setting of UC. METHOD: This was a retrospective cohort study conducted through the Nationwide Veterans Affairs Healthcare System (VA). Patients who had UC and underwent a PR or TPC for CRC were followed from the time of their surgery to their most recent clinical follow-up. The primary outcome was development of metachronous cancer in the PR group. Secondary outcomes included surgical and medical outcomes. RESULTS: Fifty-nine patients were included: 24 (40.7%) underwent PR and 35 (59.3%) underwent TPC. The median age at cancer diagnosis was 73.0 and 61.7 years in PR and TPC groups, respectively (P < 0.0005). Amongst patients undergoing PR, 15 (60%) had no active UC at the time of surgery, whereas in patients undergoing TPC, at the time of surgery eight (23.5%) had no active UC (P = 0.005). No patient who underwent a partial colectomy developed a metachronous cancer in the retained colonic segment during the follow-up period (median 7 years). CONCLUSION: Our study suggests that PR for CRC in the setting of UC may be a viable option in a selected cohort of patients, especially among the elderly.

A Nomogram to Predict Lymph Node Positivity Following Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer.

BACKGROUND: Patients with locally advanced rectal cancer typically receive neoadjuvant chemoradiation followed by total mesorectal excision. Other treatment approaches, including transanal techniques and close surveillance, are becoming increasingly common following positive responses to chemoradiation. Lack of pathologic lymph node staging is one major disadvantage of these novel strategies. OBJECTIVE: The purposes of this study were to determine clinicopathologic factors associated with positive lymph nodes following neoadjuvant chemoradiation for rectal cancer and to create a nomogram using these factors to predict rates of lymph node positivity. DESIGN: This is a retrospective cohort analysis. SETTINGS: This study used the National Cancer Database. PATIENTS: Patients aged 18 to 90 with clinical stage T3/T4, N0, M0 or Tany, N1-2, M0 adenocarcinoma of the rectum who underwent neoadjuvant chemoradiation before total mesorectal excision from 2010 to 2012 were identified. MAIN OUTCOME MEASURES: The primary outcome measure was lymph node positivity after neoadjuvant chemoradiation for locally advanced rectal cancer. Bivariate and multivariate analyses were used to determine the associations of clinicopathologic variables with lymph node positivity. RESULTS: Eight thousand nine hundred eighty-four patients were included. Young age, lower Charlson score, mucinous histology, poorly differentiated and undifferentiated tumors, the presence of lymphovascular invasion, elevated CEA level, and clinical lymph node positivity were significantly predictive of pathologic lymph node positivity following neoadjuvant chemoradiation. The predictive accuracy of the nomogram is 70.9%, with a c index of 0.71. There was minimal deviation between the predicted and observed outcomes. LIMITATIONS: This study is retrospective, and it cannot be determined when in the course of treatment the data were collected. CONCLUSIONS: We created a nomogram to predict lymph node positivity following neoadjuvant chemoradiation for locally advanced rectal cancer that can serve as a valuable complement to imaging to aid clinicians and patients in determining the best treatment strategy.

Colorectal specialization and survival in colorectal cancer.

AIM: It is recognized that higher surgeon volume is associated with improved survival in colorectal cancer. However, there is a paucity of national studies that have evaluated the relationship between surgical specialization and survival. METHOD: We used the Surveillance, Epidemiology, and End Results Medicare cancer registry to examine the association between colorectal specialization (CRS) and disease-specific survival (DSS) between 2001 and 2009. A total of 21,432 colon cancer and 5893 rectal cancer patients who underwent elective surgical resection between 2001 and 2009 were evaluated. Univariate and multivariate Cox survival analysis was used to identify the association between surgical specialization and cancer-specific survival. RESULTS: Colorectal specialists performed 16.3% of the colon and 27% of the rectal resections. On univariate analysis, specialization was associated with improved survival in Stage II and Stage III colon cancer and Stage II rectal cancer. In multivariate analysis, however, CRS was associated with significantly improved DSS only in Stage II rectal cancer [hazard ratio (HR) 0.70, P = 0.03]. CRS was not significantly associated with DSS in either Stage I (colon HR 1.14, P = 0.39; rectal HR 0.1.26, P = 0.23) or Stage III (colon HR 1.06, P = 0.52; rectal HR 1.08, P = 0.55) disease. When analysis was limited to high volume surgeons only, the relationship between CRS and DSS was unchanged. CONCLUSIONS: CRS is associated with improved DSS following resection of Stage II rectal cancer. A combination of factors may contribute to long-term survival in these patients, including appropriate surgical technique, multidisciplinary treatment decisions and guideline-adherent surveillance. CRS probably contributes positively to these factors resulting in improved survival.

Trends in surveillance for resected colorectal cancer, 2001-2009.

BACKGROUND: Little is known about recent trends in surveillance among the more than 1 million US colorectal cancer (CRC) survivors. Moreover, for stage I disease, which accounts for more than 30% of survivors, the guidelines are limited, and the use of surveillance has not been well studied. Guidelines were changed in 2005 to include recommendations for computed tomography (CT) surveillance in select patients, but the impact of these changes has not been explored. METHODS: A retrospective analysis of patients who were identified in the Survival, Epidemiology, and End Results-Medicare database and underwent resection of stage I to III CRC between 2001 and 2009 was performed. The receipt of guideline-determined sufficient surveillance, including office visits, colonoscopy, carcinoembryonic antigen (CEA) testing, and CT imaging, in the 3 years after resection was evaluated. RESULTS: The study included 23,990 colon cancer patients and 5665 rectal cancer patients. Rates of office visits and colonoscopy were high and stable over the study period. Rates of CEA surveillance increased over the study period but remained low, even for stage III disease. Rates of CT imaging increased gradually during the study period, but the 2005 guideline change had no effect. Stage II patients, including high-risk patients, received surveillance at significantly lower rates than stage III patients despite similar recommendations. Conversely, up to 30% of stage I patients received nonrecommended CEA testing and CT imaging. CONCLUSIONS: There continues to be substantial underuse of surveillance for CRC survivors and particularly for stage II patients, who constitute almost 40% of survivors. The 2005 guideline change had a negligible impact on CT surveillance. Conversely, although guidelines are limited, many stage I patients are receiving intensive surveillance.

Local excision for early stage rectal cancer in patients over age 65 years: 2000-2009.

BACKGROUND: Local excision of rectal cancer is an attractive option because it avoids the morbidity of radical resection. Concerns have arisen during the past decade, however, regarding substandard oncologic results. OBJECTIVE: Using the most recent Survey of Epidemiology and End Results-Medicare data, we examined the change in the use of local excision for rectal cancer from 2000 to 2009 and examined patient, surgeon, and hospital factors related to its use. DESIGN: This study is a retrospective cohort study. SETTINGS: This study was conducted at a tertiary care medical center using Survey of Epidemiology and End Results-Medicare data. PATIENTS: Patients with pathologic Tis, T1, or T2 rectal cancer who were >65 years of age and underwent primary radical resection or local excision between 2000 and 2009 were included in this study. MAIN OUTCOME MEASURES: The change in the use of local excision for rectal cancer from 2000 to 2009 was the main outcome measured. RESULTS: A total of 8966 patients were identified. The use of local excision decreased significantly between 2000 and 2009. Women and patients who were older and had more comorbidities were significantly more likely to undergo local excision. Having a colorectal surgeon perform the surgery increased the odds of local excision by 1.5 times (p < 0.001). Similar trends were seen in patients operated on at the National Cancer Institute (OR, 1.7; p <0.001) and teaching hospitals (OR, 1.2; p = 0.003). Younger surgeons were more likely to perform local excisions. For surgeons graduating in 1980-1989 or 1990 and after, the odds of local excision were 1.40 (p = 0.001) and 2.1 (p <0.001) compared with surgeons graduating before 1970. LIMITATIONS: The study was limited by the retrospective design, and the data were collected by multiple healthcare officials in their representative institutions. CONCLUSIONS: In patient >65 years of age, the odds of undergoing local excision for early stage rectal cancer decreased significantly between 2000 and 2009, coincident with evidence of oncologic inferiority. However, there was still significant variation in its use. More studies are needed to better understand these variations in an attempt to bring more uniformity to the use of local excision in early stage rectal cancer.

Surveillance after neoadjuvant therapy in advanced rectal cancer with complete clinical response can have comparable outcomes to total mesorectal excision.

PURPOSE: While the standard of care for patients with rectal cancer who sustain a complete clinical response (cCR) to chemoradiotherapy (CRT) remains proctectomy with total mesorectal excision, data suggests that non-operative management may be a safe alternative. The purpose of this study is to compare outcomes between patients treated with CRT that attained a cCR and opted for a vigilant surveillance to those of the patients who had a complete pathologic response (cPR) following proctectomy. METHOD: This is a retrospective review of patients treated for adenocarcinoma of the rectum who achieved either a cCR or a cPR following CRT. Patients with a cCR were enrolled in an active surveillance program which included regularly scheduled exams, proctoscopy, serum carcinoembryonic antigen (CEA), endorectal ultrasound, and cross-sectional imaging. Outcomes were compared to those patients who underwent proctectomy with a cPR. Our primary outcome measures were post-treatment complications, recurrence, and survival. RESULTS: We reviewed 18 patients who opted for surveillance after cCR and 30 patients who underwent proctectomy after a cPR. No non-operative patients had a documented treatment complication, while 17 patients with cPR suffered significant morbidity. There were two recurrences in the active surveillance group, one local and once distant, both treated by salvage resection with no associated mortality at 54 and 62 months. In the cPR group, one patient had a distant recurrence 24 months after surgery which was managed non-operatively. This patient died of unrelated causes 35 months after surgery. CONCLUSIONS: Active surveillance can be a safe option that avoids the morbidity associated with proctectomy and preserves oncologic outcomes.

Impact of BMI on postoperative outcomes in patients undergoing proctectomy for rectal cancer: a national surgical quality improvement program analysis.

BACKGROUND: There is a mounting body of evidence that suggests worsened postoperative outcomes at the extremes of BMI, yet few studies investigate this relationship in patients undergoing proctectomy for rectal cancer. OBJECTIVE: We aimed to examine the relationship between BMI and short-term outcomes after proctectomy for cancer. DESIGN: This was a retrospective study comparing the outcomes of patients undergoing proctectomy for rectal cancer as they relate to BMI. SETTINGS: The American College of Surgeons-National Surgical Quality Improvement Program database was queried for this study. PATIENTS: Patients included were those who underwent proctectomy for rectal neoplasm between 2005 and 2011. MAIN OUTCOME MEASURES: Study end points included 30-day mortality and overall morbidity, including the receipt of blood transfusion, venous thromboembolic disease, wound dehiscence, renal failure, reintubation, cardiac complications, readmission, reoperation, and infectious complications (surgical site infection, intra-abdominal abscess, pneumonia, and urinary tract infection). Univariate logistic regression was used to analyze differences among patients of varying BMI ranges (kg/m; ≤20, 20-24, 25-29, 30-34, and ≥35). When significant differences were found, multivariable logistic regression, adjusting for preoperative demographic and clinical variables, was performed. RESULTS: A total of 11,995 patients were analyzed in this study. The incidences of overall morbidity, wound infection, urinary tract infection, venous thromboembolic event, and sepsis were highest in those patients with a BMI of ≥35 kg/m (OR, 1.63, 3.42, 1.47, 1.64, and 1.50). Wound dehiscence was also significantly more common in heavier patients. Patients with a BMI <20 kg/m had significantly increased rates of mortality (OR, 1.72) and sepsis (OR, 1.30). LIMITATIONS: This study was limited by its retrospective design. Furthermore, it only includes patients from the American College of Surgeons-National Surgical Quality Improvement Program database, limiting its generalizability to nonparticipating hospitals. CONCLUSIONS: Obese and underweight patients undergoing proctectomy for neoplasm are at a higher risk for postoperative complications and death.

Biologic therapy and surgery for crohn disease.

In 1998, infliximab, an antitumor necrosis factor alpha (anti-TNF-α) antibody, was approved for use in the treatment of Crohn disease (CD). Since then, other biologic therapies, including adalimumab and certolizumab pegol (newer anti-TNF-α antibodies), and natalizumab, an antibody against alpha-4 integrin, have also been approved. Here, we review the published studies that examine the relationship between pre- and postoperative biologic therapy and postoperative complications in patients with CD. This body of literature is composed of numerous small, retrospective, heterogeneous studies that demonstrate conflicting and varied results. Overall, the receipt of biologic therapy in the pre- or postoperative period does not appear to significantly increase the risk of postoperative complications. It is, however, difficult to draw any firm conclusions based on the existing level of data. In the future, larger prospective studies are needed to better elucidate the true risks, if any, that the use of biologic therapy poses to patients with CD requiring operation.

In vivo determination of urinary stone composition using dual energy computerized tomography with advanced post-acquisition processing.

PURPOSE: We assessed whether dual energy computerized tomography with advanced post-image processing can accurately differentiate urinary calculi composition in vivo. MATERIALS AND METHODS: A total of 25 patients scheduled to undergo ureteroscopic/percutaneous nephrolithotomy were prospectively identified. Dual energy computerized tomography was performed using 64-slice multidetector computerized tomography. Novel post-processing (DECTSlope) used pixel by pixel analyses to generate data sets grayscale encoding ratios of relative differences in attenuation of low (DECT80 kVp) and high energy (DECT140 kVp) series. Surgical extraction and Fourier spectroscopy resulted in 82 calculi. Of these stones 51 showed minor admixtures (uric acid, ammonium urate, struvite, calcium oxalate monohydrate and brushite) and 31 were polycrystalline (mixtures of calcium oxalate monohydrate/dihydrate and calcium phosphate). Analyses identified stone clusters of equal composition and distinct attenuation descriptors on DECT140 kVp, DECT80 kVp and DECTSlope. Iterative cross-validation of the 3 dual energy computerized tomography data sets was used to identify characteristic attenuation limits for each stone type. RESULTS: Attenuatio profiles showed substantial overlap among various stones on DECT140 kVp (uric acid 427.3±168.1 HU, ammonium urate 429.9±99.7 HU, struvite 480.2±123.5 HU, calcium oxalate monohydrate 852.4±301.4 HU, brushite 863.7±180.1 HU and polycrystalline 858.1±210.5 HU) and on DECT80 kVp (uric acid 493.6±182.8 HU, ammonium urate 591.5±157.9 HU, struvite 712.4±173.9 HU, calcium oxalate monohydrate 1,240.5±494.7 HU, brushite 1,532.1±273.1 HU and polycrystalline 1,358.7±316.8 HU). Statistically spectral separation was not sufficient to characterize stones unambiguously based on DECT140 kVp/DECT80 kVp attenuation. Analysis of attenuation showed sufficient spectral separation on DECTSlope (uric acid 14.9±10.9 U, ammonium urate 56.1±1.8 U, struvite 42.7±1.4 U, calcium oxalate monohydrate 62.8±1.8 U and brushite 113.2±5.3 U). Polycrystalline stones (51.8±3.7 U) overlapped with struvite and ammonium urate stones. This overlap was resolved as all struvite/ammonium urate stones measured 900 HU or less and all polycrystalline stones measured more than 900 HU on DECT80 kVp. CONCLUSIONS: Dual energy computerized tomography with novel post-processing allows accurate discrimination among main subtypes of urinary calculi in vivo and, thus, may have implications in determining the optimum clinical treatment of urinary calculi from a noninvasive, preoperative radiological assessment.

Acuity and survival in colon cancer surgery.

PURPOSE: Reports indicate that up to 40% of patients with colon cancer require nonelective resection, which has been shown to portend worse long-term prognosis compared with elective resection. We used a national database to identify specific preoperative, perioperative, and postoperative factors mediating the acuity-survival relationship in an effort to identify areas of medical practice that can serve as targets for improvement in cancer care. METHODS: We used the Surveillance, Epidemiology and End Results-Medicare-linked database to identify non-health maintenance organization-enrolled people aged 66 years and older who were diagnosed with stages I to III colon cancer between 1996 and 2003 (N = 30,685). Using stepwise, multivariate Cox regression, disease-specific survival was compared in patients undergoing elective vs nonelective resection. Adjustment for preoperative, perioperative, and postoperative variables was performed to identify factors contributing to the acuity-survival relationship. RESULTS: Five-year disease-specific survival was 86.3% after elective and 75.4% after nonelective colon resection (hazard ratio, 1.92; P < .001). A significant proportion of this disparity was the result of differences in stage and patient characteristics, particularly age and comorbidity burden, at the time of resection. Differences in adequacy of nodal assessment and the use of surveillance colonoscopy and adjuvant chemotherapy, however, also contributed to the disparity. After adjustment for these factors, the hazard ratio for nonelective resection was 1.30 (P < .001). CONCLUSION: Nonelective resection of colon cancer is associated with poor long-term prognosis compared with elective resection. Disease-specific survival among patients undergoing nonelective surgery may be improved by addressing insufficient nodal assessment, inadequate follow-up care, and underutilization of appropriate, adjuvant chemotherapy.

An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care.

INTRODUCTION: The use of screening can prevent death from colorectal cancer, yet people without regular healthcare visits may not realize the benefits of this preventive intervention. The objective of this study was to determine the effectiveness of a mailed screening invitation or mailed fecal immunochemical test in increasing colorectal cancer screening uptake in veterans without recent primary care encounters. STUDY DESIGN: Three-arm pragmatic randomized trial. SETTING/PARTICIPANTS: Participants were screening-eligible veterans aged 50-75 years, without a recent primary care visit who accessed medical services at the Corporal Michael J. Crescenz Veteran Affairs Medical Center between January 1, 2017, and July 31, 2017. All data were analyzed from March 1, 2018, to July 31, 2018. INTERVENTION: Participants were randomized to (1) usual opportunistic screening during a healthcare visit (n=260), (2) mailed invitation to screen and reminder phone calls (n=261), or (3) mailed fecal immunochemical test outreach plus reminder calls (n=61). MAIN OUTCOME MEASURES: The main outcome under investigation was the completion of colorectal cancer screening within 6 months after randomization. RESULTS: Of 782 participants in the trial, 53.9% were aged 60-75 years and 59.7% were African American. The screening rate was higher in the mailed fecal immunochemical test group (26.1%) compared with usual care (5.8%) (rate difference=20.3%, 95% CI=14.3%, 26.3%; RR=4.52, 95% CI=2.7, 7.7) or screening invitation (7.7%) (rate difference=18.4%, 95% CI=12.2%, 24.6%; RR=3.4, 95% CI=2.1, 5.4). Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5). CONCLUSIONS: Mailed fecal immunochemical test screening promotes colorectal cancer screening participation among veterans without a recent primary care encounter. Despite the addition of reminder calls, an invitation letter was no more effective in screening participation than screening during outpatient appointments. TRIAL REGISTRATION: This study is registered at clinicaltrials.gov NCT02584998.

Risk of Persistent Opioid Use following Major Surgery in Matched Samples of Patients with and without Cancer.

BACKGROUND: The opioid crisis has reached epidemic proportions, yet risk of persistent opioid use following curative intent surgery for cancer and factors influencing this risk are not well understood. METHODS: We used electronic health record data from 3,901 adult patients who received a prescription for an opioid analgesic related to hysterectomy or large bowel surgery from January 1, 2013, through June 30, 2018. Patients with and without a cancer diagnosis were matched on the basis of demographic, clinical, and procedural variables and compared for persistent opioid use. RESULTS: Cancer diagnosis was associated with greater risk for persistent opioid use after hysterectomy [18.9% vs. 9.6%; adjusted OR (aOR), 2.26; 95% confidence interval (CI), 1.38-3.69; P = 0.001], but not after large bowel surgery (28.3% vs. 24.1%; aOR 1.25; 95% CI, 0.97-1.59; P = 0.09). In the cancer hysterectomy cohort, persistent opioid use was associated with cancer stage (increased rates among those with stage III cancer compared with stage I) and use of neoadjuvant or adjuvant chemotherapy; however, these factors were not associated with persistent opioid use in the large bowel cohort. CONCLUSIONS: Patients with cancer may have an increased risk of persistent opioid use following hysterectomy. IMPACT: Risks and benefits of opioid analgesia for surgical pain among patients with cancer undergoing hysterectomy should be carefully considered.

HER-2/neu overexpression as a predictor for the transition from in situ to invasive breast cancer.

The clinical implications of HER-2/neu (HER2) expression in ductal carcinoma in situ (DCIS) lesions have yet to be clearly elucidated; this despite the more frequent expression of HER2 in high-grade DCIS lesions compared with invasive cancers. We hypothesized that HER2 overexpression in DCIS is associated with more rapid progression to invasive disease. Immunohistochemical staining for estrogen receptor, progesterone receptor, and HER2 was done on DCIS specimens. Univariate analysis and a multivariate logistic regression were done to determine whether estrogen receptor, progesterone receptor, or HER2 status, comedo necrosis, nuclear grade, lesion size, or patient age predicted the presence of associated invasive disease in patients with DCIS. Invasive foci were found in association with HER2 overexpressing DCIS at a higher frequency than with DCIS that did not overexpress HER2. Although high nuclear grade, large lesion size, and HER2 overexpression were all associated with the presence of invasive disease on univariate analysis, HER2 was the only significant predictor for the presence of invasive disease after multivariate adjustment (odds ratio, 6.4; P = 0.01). These data indicate that HER2 overexpression in DCIS lesions predicts the presence of invasive foci in patients with DCIS and suggest that targeting of HER2 in an early disease setting may forestall or prevent disease progression.

Gender influences treatment and survival in colorectal cancer surgery.

BACKGROUND: It has been observed that survival after colorectal cancer resection is longer in women than men. The majority of these studies are in non-U.S. populations and few use appropriate multivariate adjustment. We used the Surveillance, Epidemiology and End Results- Medicare database to examine disease-specific survival in women and men undergoing colorectal cancer resection in the United States, adjusting for patient, cancer, and hospital characteristics in an effort to identify disparities, not only in survival, but also in patterns of presentation, surgical resection, and treatment. METHODS: With use of the Surveillance, Epidemiology and End Results-Medicare-linked database, we performed a retrospective cohort study of 30,975 patients with colon cancer and 8,350 patients with rectal cancer who underwent surgical resection from 1996 to 2003. Kaplan-Meier curves, the log-rank test, and Cox regression compared survival between genders. Multivariate adjustment was performed by use of patient demographics; cancer variables including stage, medical treatment, and adequacy of nodal harvest; and hospital characteristics. RESULTS: In both cancers, women presented at an older age and more emergently than men. They also underwent less aggressive medical therapy for advanced disease; in particular, in the octogenarian population. In unadjusted analysis, there was no gender difference in survival (colon hazard ratio, 0.98; P = 0.74; rectal hazard ratio, 0.95; P =0.10). After full adjustment, however, women had significantly longer survival, in particular, after rectal resection (colon hazard ratio, 0.91; P< 0.001; rectal hazard ratio, 0.82; P< 0.001). CONCLUSIONS: Women in this cohort have longer adjusted survival compared with men; however, they present more emergently and at an older age, and they receive less aggressive medical treatment. These are noticeable disparities that could serve as targets for continued improvement.

Postoperative mortality after esophagectomy for cancer: development of a preoperative risk prediction model.

BACKGROUND: Surgical resection for the treatment of esophageal cancer remains a high-risk procedure. To develop a model to predict risk of postoperative death, we sought to identify factors associated with postoperative mortality for Medicare patients undergoing esophagectomy for cancer. METHODS: We evaluated patients in the Surveillance, Epidemiology, and End Results Program (SEER)-Medicare database who underwent esophagectomy for esophageal cancer from 1997 to 2003. Variables evaluated were patient age, race, marital status, sex, tumor stage, Charlson score, and hospital volume. Hospital volume was evaluated in tertiles of even volume groups (low, < .67 cases a year; medium, .68 to 2.33 cases a year; high, > 2.33 cases a year). The primary outcome measure was postoperative mortality, defined as death within 30 days of esophagectomy or death during the hospitalization in which the primary surgical procedure was performed. In-hospital deaths more than 30 days after esophagectomy were included in the outcomes to more accurately estimate the true mortality of this procedure. Multivariable logistic regression analyses were performed to evaluate the relationship between patient and provider characteristics and postoperative mortality. Finally, characteristics identified by the regression analysis were used to generate a simplified, clinically applicable model predicting risk of postoperative mortality in the Medicare population. RESULTS: A total of 1172 patients underwent esophageal cancer surgery during this study period. Overall postoperative mortality was 14%. Multivariable logistic regression demonstrated that age, Charlson score, and hospital volume were statistically significant predictors of postoperative mortality. The other variables such as race, martial status, sex, and disease stage were not found to be significant. The odds of postoperative mortality at low-volume hospitals were almost twice those at a high-volume hospital. Age greater than 80 increased odds of mortality almost twofold. Similarly, Charlson scores of > or = 2 resulted in more than a 1.5-fold risk of postoperative mortality. Our prediction model using these variables accurately stratified postoperative mortality for this population. CONCLUSIONS: Postoperative mortality (30-day and in-hospital) remains high after esophagectomy. Age, Charlson score, and hospital volume were identified as independent predictors of postoperative mortality. A simple risk prediction model that uses preoperative clinical data accurately predicted patient postoperative mortality for this SEER-Medicare population.