Practice Patterns for Organ Preservation in US Patients With Rectal Cancer, 2006-2020.

Importance: In March 2023, the National Comprehensive Cancer Network endorsed watch and wait for those with complete clinical response to total neoadjuvant therapy. Neoadjuvant therapy is highly efficacious, so this recommendation may have broad implications, but the current trends in organ preservation in the US are unknown. Objective: To describe organ preservation trends among patients with rectal cancer in the US from 2006 to 2020. Design, Setting, and Participants: This retrospective, observational case series included adults (aged ≥18 years) with rectal adenocarcinoma managed with curative intent from 2006 to 2020 in the National Cancer Database. Exposure: The year of treatment was the primary exposure. The type of therapy was chemotherapy, radiation, or surgery (proctectomy, transanal local excision, no tumor resection). The timing of therapy was classified as neoadjuvant or adjuvant. Main Outcomes and Measures: The primary outcome was the absolute annual proportion of organ preservation after radical treatment, defined as chemotherapy and/or radiation without tumor resection, proctectomy, or transanal local excision. A secondary analysis examined complete pathologic responses among eligible patients. Results: Of the 175 545 patients included, the mean (SD) age was 63 (13) years, 39.7% were female, 17.4% had clinical stage I disease, 24.7% had stage IIA to IIC disease, 32.1% had stage IIIA to IIIC disease, and 25.7% had unknown stage. The absolute annual proportion of organ preservation increased by 9.8 percentage points (from 18.4% in 2006 to 28.2% in 2020; P < .001). From 2006 to 2020, the absolute rate of organ preservation increased by 13.0 percentage points for patients with stage IIA to IIC disease (19.5% to 32.5%), 12.9 percentage points for patients with stage IIIA to IIC disease (16.2% to 29.1%), and 10.1 percentage points for unknown stages (16.5% to 26.6%; all P < .001). Conversely, patients with stage I disease experienced a 6.1-percentage point absolute decline in organ preservation (from 26.4% in 2006 to 20.3% in 2020; P < .001). The annual rate of transanal local excisions decreased for all stages. In the subgroup of 80 607 eligible patients, the proportion of complete pathologic responses increased from 6.5% in 2006 to 18.8% in 2020 (P < .001). Conclusions and Relevance: This case series shows that rectal cancer is increasingly being managed medically, especially among patients whose treatment historically relied on proctectomy. Given the National Comprehensive Cancer Network endorsement of watch and wait, the increasing trends in organ preservation, and the nearly 3-fold increase in complete pathologic responses, international professional societies should urgently develop multidisciplinary core outcome sets and care quality indicators to ensure high-quality rectal cancer research and care delivery accounting for organ preservation.

A shortened course of Amoxicillin/Clavulanate is the preferred antibiotic treatment after surgery for perforated appendicitis in children.

BACKGROUND/PURPOSE: Despite evidence supporting short course outpatient antibiotic treatment following appendectomy for perforated appendicitis, evidence of real-world implementation and consensus for antibiotic choice is lacking. We therefore aimed to compare outpatient antibiotic treatment regimens in a national cohort. METHODS: We identified children who underwent surgery for perforated appendicitis between 2010 and 2018 using the PearlDiver database and compared 45-day disease-specific readmission between children who received shortened (5-8 days) versus prolonged (10-14 day) total antibiotic courses (inpatient intravenous and/or oral) completed with outpatient Amoxicillin/Clavulanate versus Ciprofloxacin/Metronidazole, and compared antibiotic type (5-14 days) to each other. RESULTS: 4916 children were identified, 2001 (90.0%) treated with Amoxicillin/Clavulanate (5-14 days), 381 (19.0%) with shortened (5-8 days), 1464 (73.2%) with prolonged (10-14 days) courses. 222 (10.0%) were treated with Ciprofloxacin/Metronidazole, 44 (19.8%) with shortened, 174 (78.4%) with prolonged courses. Freedom from readmission was not different between prolonged and shortened course whether they received Amoxicillin/Clavulanate (adjusted hazard ratio [AHR] 1.54, 95%CI 0.95-2.5) or Ciprofloxacin/Metronidazole (AHR 3.49, 95%CI 0.45-27.3). Antibiotic type did not affect readmission rate (Amoxicillin/Clavulanate versus Ciprofloxacin/Metronidazole, AHR 1.21, 95%CI 0.71-2.05). CONCLUSION: Prolonged antibiotic regimens are routinely prescribed despite evidence suggesting shorter courses and antibiotic choice are not associated with greater treatment failure. As it is better tolerated, we recommend a shortened course of Amoxicillin/Clavulanate for oral management of perforated appendicitis. STUDY DESIGN: Retrospective. LEVEL OF EVIDENCE: Level III.

Trends in Surgeon-Level Utilization of Sacral Nerve Stimulator Implantation for Fecal Incontinence in New York State.

BACKGROUND: There is a paucity of real-world data regarding surgeon utilization of sacral nerve stimulation for fecal incontinence compared with anal sphincteroplasty. OBJECTIVE: This study aims to examine trends in sacral nerve stimulation use compared with sphincteroplasty for fecal incontinence and surgeon-level variation in progression to implantation of the pulse generator. DESIGN: This is a population-based study. PATIENTS: Patients with fecal incontinence between 2011 and 2014 in New York who underwent stage 1 of the sacral nerve stimulation procedure were selected. For the comparison with sphincteroplasty, patients with fecal incontinence who underwent anal sphincteroplasty between 2008 and 2014 were included. MAIN OUTCOME MEASURES: The main outcomes after sacral nerve stimulation generator placement were unplanned 30-day admission, emergency department visit within 30 days, revision or explant of leads or generator, and 30-day mortality. RESULTS: Six hundred twenty-one patients with fecal incontinence underwent a stage 1 procedure with 79.7% progressing to stage 2. There has been an increase in the number of sacral nerve stimulation cases per year as well as the number of surgeons performing the procedure. The rate of progression to stage 2 among patients treated by colorectal surgeons was 80.2% compared with 77.0% among those treated by noncolorectal surgeons. Among those who completed stage 2, there were 3 (0.5%) unplanned 30-day admissions, 24 (4.4%) emergency department visits within 30 days, and 0 mortalities within 30 days. Thirty-two (6.5%) patients had their leads or pulse generator revised or explanted. There was a significant decrease in annual sphincteroplasty cases and the number of providers performing the procedure starting in 2011. LIMITATIONS: We lacked data regarding patient and physician decision making and the severity of disease. CONCLUSIONS: Sacral nerve stimulation for fecal incontinence is increasing in popularity with an increasing number of surgeons utilizing sacral nerve stimulation for fecal incontinence rather than sphincteroplasty. See Video Abstract at http://links.lww.com/DCR/A450.

Poor compliance with adjuvant chemotherapy use associated with poorer survival in patients with rectal cancer: An NCDB analysis.

BACKGROUND: National Comprehensive Cancer Network treatment guidelines for patients with locally advanced rectal cancer include neoadjuvant chemoradiation followed by total mesorectal excision and adjuvant chemotherapy. The objective of the current study was to examine the rate of adjuvant chemotherapy and associated survival in patients with stage II/III rectal cancer. METHODS: The 2006 to 2011 National Cancer Data Base was queried for patients with AJCC clinical stage II/III rectal cancer who underwent neoadjuvant chemoradiation and surgical resection. A mixed effects multivariable logistic regression identified factors associated with the receipt of adjuvant chemotherapy. A mixed effects Cox proportional hazards model was used to estimate the adjusted effect of receiving adjuvant therapy on 5-year overall survival (OS). RESULTS: A total of 14,742 patients were included; 68% of the cohort did not receive adjuvant chemotherapy. When controlled for clinical stage of disease, patients who were aged >70 years, had a higher comorbidity score, and had a pathologic complete response had lower odds of receiving adjuvant therapy. There was a 22-fold difference in the risk-adjusted rate of adjuvant therapy use among hospitals (3.1%-67.7%). Adjuvant therapy was associated with increased 5-year OS when controlled for patient factors, stage of disease, and pathologic response (hazard ratio, 0.65; 95% confidence interval, 0.59-0.71). The greatest survival benefit was noted among patients who achieved a pathologic complete response (hazard ratio, 0.40; 95% confidence interval, 0.23-0.67). CONCLUSIONS: There is poor compliance to National Comprehensive Cancer Network guidelines for adjuvant chemotherapy in patients with locally advanced rectal cancer after neoadjuvant chemoradiation and surgery. Adjuvant therapy appears to be independently associated with improved OS regardless of stage of disease, pathologic response, and patient factors. The greatest survival benefit was observed in patients who were complete responders. Age and comorbidities were found to be significantly associated with nonreceipt of adjuvant therapy. Improved rehabilitation and physical conditioning may improve the odds of patients receiving adjuvant therapy. Cancer 2017;52-61. © 2016 American Cancer Society.

Increases in ambient particulate matter air pollution, acute changes in platelet function, and effect modification by aspirin and omega-3 fatty acids: A panel study.

Increased particulate matter (PM) air pollutant concentrations have been associated with platelet activation. It was postulated that elevated air pollutant concentrations would be associated with increases in measures of platelet function and that responses would be blunted when taking aspirin and/or fish oil. Data from a sequential therapy trial (30 subjects with type 2 diabetes mellitus), with 4 clinic visits (first: no supplements, second: aspirin, third: omega-3 fatty acid supplements, fourth: aspirin and omega-3 fatty acids) per subject, were utilized. Using linear mixed models, adjusted for relative humidity, temperature, visit number, and season, changes in three platelet function measures including (1) aggregation induced by adenosine diphosphate (ADP), (2) aggregation induced by collagen, and (3) thromboxane B2 production were associated with interquartile range (IQR) increases in mean concentrations of ambient PM2.5, black carbon, ultrafine particles (UFP; 10-100 nm), and accumulation mode particles (AMP; 100-500 nm) in the previous 1-96 h. IQR increases in mean UFP and AMP concentrations were associated with significant decreases in platelet response, with the largest being a -0.43 log(pg/ml) decrease in log(thromboxane B2) (95% CI = -0.8, -0.1) associated with each 582-particles/cm(3) increase in AMP, and a -1.7 ohm reduction in collagen-induced aggregation (95% CI = -3.1, -0.3) associated with each 2097-particles/cm(3) increase in UFP in the previous 72 h. This UFP effect on thromboxane B2 was significantly muted in diabetic subjects taking aspirin (-0.01 log[pg/ml]; 95% CI = -0.4, 0.3). The reason for this finding remains unknown, and needs to be investigated in future studies.