The Rationale for and Reality of the New National Accreditation Program for Rectal Cancer.

BACKGROUND: The treatment of rectal cancer has greatly evolved because of numerous diagnostic and therapeutic advances. More accurate staging by MRI has allowed more appropriate use of neoadjuvant therapy as well as more standardized high-quality total mesorectal excision. Lower rates of perioperative morbidity, permanent colostomy creation, and improved rates of oncologically acceptable rectal excision have led to lower recurrence and greater disease-free survival rates. The recognition of the need for pathologic assessment of the quality of total mesorectal excision, the status of the circumferential resection margins, and the finding of a minimum of 12 lymph nodes as well as identification of extramural vascular invasion has improved staging. These evolutions in imaging, surgical management, and pathologic specimen assessment are interdependent and have been repeatedly shown on national levels to be best operationalized in a multidisciplinary team environment. OBJECTIVE: The aim of this article is to evaluate the evidence leading to these important changes, including the imminent launch of the National Accreditation Program for Rectal Cancer. DESIGN AND SETTING: Based on the myriad confirmatory experiences in Europe and in the United Kingdom, a multidisciplinary team rectal cancer program was designed by the Consortium for Optimizing Surgical Treatment of Rectal Cancer and subsequently endorsed and accepted by the American College of Surgeons Commission on Cancer. MAIN OUTCOME MEASURES: The primary outcome measured is the adherence to the new program standards. RESULTS: Surgical treatment of rectal cancer consortium membership rapidly increased from 14 centers in August 2011 to more than 350 centers in April 2017. LIMITATIONS: The multidisciplinary team rectal cancer program has not yet launched; thus, its impact cannot yet be assessed. CONCLUSIONS: It is our hope and expectation that the outstanding improvement in quality outcomes repeatedly demonstrated within Europe, and extensively shown as much needed in the United States, will be rapidly achieved.

Lymph node yield is an independent predictor of survival in rectal cancer regardless of receipt of neoadjuvant therapy.

AIMS: Lymph node yield (LNY) is used as a marker of adequate oncological resection. The American Joint Committee on Cancer (AJCC) currently recommends that at least 12 nodes are necessary to confirm node-negative disease for rectal cancer. A LNY of 12 is not always achieved, particularly in patients who have undergone neoadjuvant treatment. This study attempts to examine factors associated with LNY and its prognostic impact following neoadjuvant chemoradiation in rectal cancer. METHODS: The 2006-2011 National Cancer Data Base was queried for patients with clinical stage I-III rectal cancer who underwent a proctectomy. Suboptimal LNY was defined as <12 lymph nodes examined. A mixed-effects multinomial logistic regression model was used to identify independent factors associated with LNY. Mixed-effects Cox proportional hazards models were used to estimate the adjusted effect of LNY on 5-year overall survival. RESULTS: 25 447 patients met inclusion criteria. Overall, 62% of the cohort received neoadjuvant chemoradiation and 32% had suboptimal LNY. The median LNY for patients who received neoadjuvant therapy was 13 (IQR: 9-18) and for patients who did not receive neoadjuvant therapy was 15 (IQR: 12-21). After risk adjustment, there was a 3.5-fold difference in the rate of suboptimal LNY among individual hospitals (27%-95%). Suboptimal LNY was independently associated with an 18% increased hazard of death among patients who did not receive neoadjuvant treatment and a 20% increased hazard of death among those who did receive neoadjuvant treatment when controlled for adjuvant treatment, staging, proximal/distal margins and other patient factors. CONCLUSIONS: Suboptimal LNY is independently associated with worse overall survival regardless of neoadjuvant therapy, pathological staging and patient factors in rectal cancer. This finding underlies the importance and challenge of an optimal lymph node evaluation for prognostication, especially for patients receiving neoadjuvant therapy.

Variation in Hospital-Specific Rates of Suboptimal Lymphadenectomy and Survival in Colon Cancer: Evidence from the National Cancer Data Base.

BACKGROUND: Little is known about between-hospital differences in the rate of suboptimal lymphadenectomy. This study characterizes variation in hospital-specific rates of suboptimal lymphadenectomy and its effect on overall survival in a national hospital-based registry. METHODS: Stage I-III colon cancer patients were identified from the 2003-2012 National Cancer Data Base. Bayesian multilevel logistic regression models were used to assess the impact of patient- and hospital-level factors on hospital-specific rates of suboptimal lymphadenectomy (<12 lymph nodes), and multilevel Cox models were used to estimate the effect of suboptimal lymphadenectomy at the patient (yes vs. no) and hospital level (quartiles of hospital-specific rates) on overall survival. RESULTS: A total of 360,846 patients across 1345 hospitals in the US met the inclusion criteria, of which 25 % had a suboptimal lymphadenectomy. Wide variation was observed in hospital-specific rates of suboptimal lymphadenectomy (range 0-82 %, median 44 %). Older age, male sex, comorbidity score, no insurance, positive margins, lower tumor grade, lower T and N stage, and sigmoid and left colectomy were associated with higher odds of suboptimal lymphadenectomy. Patients treated at lower-volume and non-academic hospitals had higher odds of suboptimal lymphadenectomy. Patient- and hospital-level factors explained 5 % of the between-hospital variability in suboptimal lymphadenectomy, leaving 95 % unexplained. Higher suboptimal lymphadenectomy rates were associated with worse survival (quartile 4 vs. quartile 1: hazard ratio 1.19, 95 % confidence interval 1.16-1.22). CONCLUSION: Large differences in hospital-specific rates of suboptimal lymphadenectomy were observed, and this variation was associated with survival. Quality improvement initiatives targeting hospital-level adherence to the national standard may improve overall survival among resected colon cancer patients.

High Rate of Positive Circumferential Resection Margins Following Rectal Cancer Surgery: A Call to Action.

OBJECTIVES: To identify predictors of positive circumferential resection margin following rectal cancer resection in the United States. BACKGROUND: Positive circumferential resection margin is associated with a high rate of local recurrence and poor morbidity and mortality for rectal cancer patients. Prior study has shown poor compliance with national rectal cancer guidelines, but whether this finding is reflected in patient outcomes has yet to be shown. METHODS: Patients who underwent resection for stage I-III rectal cancer were identified from the 2010-2011 National Cancer Database. The primary outcome was a positive circumferential resection margin. The relationship between patient, hospital, tumor, and treatment-related characteristics was analyzed using bivariate and multivariate analysis. RESULTS: A positive circumferential resection margin was noted in 2859 (17.2%) of the 16,619 patients included. Facility location, clinical T and N stage, histologic type, tumor size, tumor grade, lymphovascular invasion, perineural invasion, type of operation, and operative approach were significant predictors of positive circumferential resection margin on multivariable analysis. Total proctectomy had nearly a 30% increased risk of positive margin compared with partial proctectomy (OR 1.293, 95%CI 1.185-1.411) and a laparoscopic approach had nearly 22% less risk of a positive circumferential resection margin compared with an open approach (OR 0.882, 95%CI 0.790-0.985). CONCLUSIONS: Despite advances in surgical technique and multimodality therapy, rates of positive circumferential resection margin remain high in the United States. Several tumor and treatment characteristics were identified as independent risk factors, and advances in rectal cancer care are necessary to approach the outcomes seen in other countries.

Acute renal failure due to phenazopyridine (Pyridium) overdose: case report and review of the literature.

Phenazopyridine (Pyridium) is a commonly used urinary tract analgesic. It has been associated with yellow skin discoloration, hemolytic anemia, methemoglobinemia, and acute renal failure, especially in patients with preexisting kidney disease. We report a 17-year-old female with vertically transmitted human immunodeficiency virus (HIV) infection, presenting with acute renal failure and methemoglobinemia following a suicidal attempt with a single 1,200 mg ingestion of Pyridium. She had no prior evidence of HIV nephropathy. The patient had a progressive nonoliguric renal failure on the 3rd day following the ingestion. She was treated with N-acetylcysteine, intravenous carnitine, and alkalinization of the urine. Her kidney biopsy revealed acute tubular necrosis with no glomerular changes. After 7 days of conservative management, she was discharged home with normal kidney function. To our knowledge, this is the second smallest amount of Pyridium overdose resulting in acute renal failure with no previous history of kidney disease.