A Pilot Study of a Screening Program for Human Papillomavirus-Related Squamous Intraepithelial Lesion and Malignancy in Gynecologic Oncology Patients.

OBJECTIVE: Human papillomavirus (HPV)-related squamous intraepithelial lesion (SIL) or malignancy is associated with a significantly increased risk of second-site SIL or malignancy. The primary objective of this study was to determine the feasibility and acceptability of concurrent anal, cervical, and vulvovaginal screening in patients with a history of HPV-related gynecologic high-grade SIL or malignancy. The secondary objective was to assess subjects' knowledge regarding HPV screening and risks. METHODS: Women with high-grade cervical, vulvar, or vaginal SIL or malignancy were enrolled during a 1-year pilot period. Subjects with cervical SIL or malignancy underwent vulvar examination and anoscopy. Subjects with vulvovaginal SIL or malignancy underwent Pap test if indicated and anoscopy. Appropriate referrals were made for abnormal findings. Feasibility was assessed by compliance using study acceptance rate, screening procedure adherence, and referral adherence. Acceptability was assessed using a Likert-scaled question after completion of screening procedures. RESULTS: One hundred three women with a diagnosis of high-grade vulvovaginal or cervical SIL or carcinoma were approached regarding study enrollment; of these, 74 (71.8%) enrolled. The median score on the HPV knowledge assessment was 8.1 ± 1.6 (max score 10). Seventy-three (98.6%) of 74 patients rated the screening procedures as acceptable (score of 5/5). On examination, 14 (18.9%) subjects had abnormalities noted; 7 (9.5%) were referred for colorectal surgical evaluation, and 6/7 (85.7%) were compliant with their referral appointments. CONCLUSIONS: Screening examinations for other HPV-related SILs and malignancies, including Pap tests, vulvovaginal inspection, and anoscopy, are acceptable to patients, with abnormal findings in almost 1 in 5 women.

Considerations in Stoma Reversal.

Temporary stomas are frequently used in the management of diverticulitis, colorectal cancer, and inflammatory bowel disease. These temporary stomas are used to try to mitigate septic complications from anastomotic leaks and to avoid the need for reoperation. Once acute medical conditions have improved and after the anastomosis has been proven to be healed, stomas can be reversed. Contrast enemas, digital rectal examination, and endoscopic evaluation are used to evaluate the anastomosis prior to reversal. Stoma reversal is associated with complications including anastomotic leak, postoperative ileus, bowel obstruction, enterocutaneous fistula, and, most commonly, surgical site infection. Furthermore, many stomas, which were intended to be temporary, may not be reversed due to postoperative complications, adjuvant therapy, or prohibitive comorbidities.

Treatment trends, risk of lymph node metastasis, and outcomes for localized esophageal cancer.

BACKGROUND: Endoscopic resection is increasingly used to treat localized, early-stage esophageal cancer. We sought to assess its adoption, characterize the risks of nodal metastases, and define differences in procedural mortality and 5-year survival between endoscopic and surgical resection in the United States. METHODS: From the National Cancer Data Base, patients with T1a and T1b lesions were identified. Treatment patterns were characterized, and hierarchical regression methods were used to define predictors and evaluate outcomes. All statistical tests were two-sided. RESULTS: Five thousand three hundred ninety patients were identified and underwent endoscopic (26.5%) or surgical resection (73.5%). Endoscopic resection increased from 19.0% to 53.0% for T1a lesions (P < .001) and from 6.6% to 20.9% for T1b cancers (P < .001). The strongest predictors of endoscopic resection were depth of invasion (T1a vs T1b: odds ratio [OR] = 4.45; 95% confidence interval [CI] = 3.76 to 5.27) and patient age of 75 years or older (vs age less than 55 years: OR = 4.86; 95% CI = 3.60 to 6.57). Among patients undergoing surgery, lymph node metastasis was 5.0% for T1a and 16.6% for T1b lesions. Predictors of nodal metastases included tumor size greater than 2 cm (vs. <2 cm) and intermediate-/high-grade lesions (vs low grade). For example, 0.5% of patients with low-grade T1a lesions less than 2 cm had lymph node involvement. The risk of 30-day mortality was less after endoscopic resection (hazard ratio [HR] = 0.33; 95% CI = 0.19 to 0.58) but greater for conditional 5-year survival (HR = 1.63; 95% CI = 1.07 to 2.47). CONCLUSIONS: Endoscopic resection has become the most common treatment of T1a esophageal cancer and has increased for T1b cancers. It remains important to balance the risk of nodal metastases and procedural risk when counseling patients regarding their treatment options.

Examination of national lymph node evaluation practices for adult extremity soft tissue sarcoma.

BACKGROUND AND OBJECTIVES: Lymph node evaluation recommendations for extremity soft tissue sarcoma (ESTS) are absent from national guidelines. Our objectives were (1) to assess rates and predictors of nodal evaluation, and (2) to assess rates and predictors of nodal metastases. METHODS: ESTS patients from the National Cancer Data Base (2000-2009) were assessed, and regression models were used to identify factors associated with nodal evaluation and metastases. RESULTS: Of 27,536 ESTS patients, 1,924 (7%) underwent nodal evaluation, and of these, 290 (15%) had nodal metastases. Nodal evaluation was most frequently performed for rhabdomyosarcoma (15.6%), angiosarcoma (10.0%), clear cell sarcoma (39.3%), epithelioid sarcoma (28.1%), and synovial sarcoma (9.3%). On multivariable analysis, factors associated with nodal evaluation included histologic subtype, tumor size, and grade. Nodal metastasis rates were highest among patients with rhabdomyosarcoma (32.1%), angiosarcoma (24.1%), clear cell sarcoma (27.7%), and epithelioid sarcoma (31.8%). On multivariable analysis, factors associated with nodal metastases included histologic subtype, tumor size, and grade. CONCLUSIONS: Nodal evaluation rates are highest among certain expected subtypes but are generally low. However, nodal metastasis rates for many histologic subtypes in patients selected for lymph node evaluation may be higher than previously reported. Multi-institutional studies should address nodal evaluation for ESTS.

Using a modification of the Clavien-Dindo system accounting for readmissions and multiple interventions: defining quality for pancreaticoduodenectomy.

BACKGROUND: The Clavien-Dindo system (CD) does not change the grade assigned a complication when multiple readmissions or interventions are required to manage a complication. We apply a modification of CD accounting for readmissions and interventions to pancreaticoduodenectomy (PD). METHODS: PDs done between 1999 and 2009 were reviewed. CD grade IIIa complications requiring more than one intervention and II and IIIa complications requiring significantly prolonged lengths of stay including all 90-day readmissions were classified severe-adverse-postoperative-outcomes (SAPO). CD IIIb, IV, and V complications were also classified SAPOs. All other complications were considered minor-adverse-postoperative-outcomes (MAPO). RESULTS: Four-hundred forty three of 490 PD patients (90.4%) had either no complication or a complication of low to moderate CD grade (I, II, IIIa). When reclassified by the new metric, 92 patient-outcomes (19%) were upgraded from CD II or IIIa to SAPO. One-hundred thirty nine patients (28.4%) had a SAPO. Multivariable regression identified age >75 years, pylorus preservation and operative blood loss >1,500 ml as predictors of SAPO. Age was not associated with poor outcome using the unmodified CD system. CONCLUSIONS: Established systems may under-grade the severity of some complications following PD. We define a procedure-specific modification of CD accounting for readmissions and multiple interventions. Using this modification, advanced age, pylorus preservation, and significant blood loss are associated with poor outcome.

Assessment of multimodality therapy use for extremity sarcoma in the United States.

BACKGROUND: Extremity sarcoma national guidelines offer several stage-specific treatment options; therefore, treatment approaches are not standardized. Our objectives were to examine multimodality treatment trends, practice patterns, and factors associated with neoadjuvant or postoperative adjuvant therapy utilization. METHODS: Using the National Cancer Data Base (2000-2009), treatment of non-metastatic extremity sarcoma was examined. Regression models were developed to identify factors associated with neoadjuvant or postoperative adjuvant therapy receipt and treatment sequence. RESULTS: Twenty-two thousand fifty-one patients underwent resection (stage I: 45.2%, stage II: 27.7%, stage III: 27.1%). Over 10 years, neoadjuvant radiation (6.4-11.6%, P < 0.001) and chemotherapy utilization (1.4-1.8%, P = 0.037) increased, while postoperative radiation (34.3-29.2%, P = 0.023) and trimodality therapy decreased (10.5-9.6%, P = 0.002). After adjusting for age, comorbidities, and histology, patients with large high-grade tumors treated at high-volume academic centers were more likely to receive neoadjuvant therapy (all P < 0.001). Postoperative chemotherapy utilization was associated with younger age, synovial histology, high grade, and surgical margins (all P < 0.001). CONCLUSIONS: Utilization of neoadjuvant therapy for extremity sarcoma has increased over time. Practice patterns are not only related to tumor size, grade, histology, and margins but also hospital type. Opportunities remain to better define the most effective multimodality treatment for extremity sarcoma.

Surgeons' perceptions of public reporting of hospital and individual surgeon quality.

BACKGROUND: Hospital-specific and surgeon-specific public reporting of performance measures is expanding largely due to calls for transparency from the public and oversight agencies. Surgeons continue to voice concerns regarding public reporting. Surgeons' perceptions of hospital-level and individual-level public reporting have not been assessed. This study (1) evaluated surgeons' perceptions of public reporting of surgical quality; and (2) identified specific barriers to surgeons' acceptance of public reporting. METHODS: All surgeons (n=185) at 4 hospitals (university, children's, 2 community hospitals), representing all surgical specialties, received a 41-item anonymous Internet-based survey. Twenty follow-up qualitative interviews were conducted to assess surgeons' interpretation of findings. RESULTS: The survey response rate was 66% (n=122). Most surgeons supported public reporting of quality metrics at the hospital level (80%), but opposed individual reporting (53%, P<0.01). Fewer surgeons expected that individual (26%) or hospital (47%) public reporting would improve outcomes (P<0.01). Few indicated that their practice would change with hospital (11%) or individual (18%) public reporting (P=0.20). Primary concerns regarding public reporting at the hospital level included patients misinterpreting data, surgeons refusing high-risk patients, and outcome metric validity. Individual-surgeon level concerns included outcome metric validity, adequate sample sizes, and patients misinterpreting data. To make public reporting more acceptable, surgeons recommended patient education, simplified data presentation, continued risk-adjustment refinement, and internal review before public reporting. CONCLUSIONS: Surgeons expressed concerns about public reporting of quality metrics, particularly reporting of individual surgeon performance. These concerns must be addressed to gain surgeons' acceptance and to use public reporting to improve health care quality.

Efficiency of colorectal cancer care among veterans: analysis of treatment wait times at Veterans Affairs Medical Centers.

PURPOSE: Timeliness of cancer treatment is an important aspect of health care quality. Veterans Affairs Medical Centers (VAMCs) are expected to treat a growing number of patients with cancer. Our objectives were to examine treatment times from diagnosis to first-course therapy for patients with colon and rectal cancers and assess factors associated with prolonged wait times. METHODS: From the VA Central Cancer Registry, patients who underwent colon or rectal resection for cancer from 1998 to 2008 were identified. Time from diagnosis to definitive cancer-directed therapy was measured, and multivariable regression methods were used to determine predictors of prolonged wait times for colon (≥ 45 days) and rectal (≥ 60 days) cancers. RESULTS: From 124 VAMCs, 14,097 patients underwent colectomy, and 3,390 underwent rectal resection for cancer. For colon cancer, the median time to treatment increased by 68% over time (P < .001). From 2007 to 2008, the median time to colectomy was 32 days. Predictors of prolonged wait times included age ≥ 55 years (v < 55 years), time period (2007 to 2008 v 1998 to 2000), black race (v white), marriage status (married v unmarried), high-volume center status (v low volume), and treatment at a different hospital (v same hospital as initial diagnosis; all P < .05). For rectal cancer, the overall median time to first-course treatment increased by 74% (P < .001). From 2007 to 2008, the median time to proctectomy was 47 days. Similar predictors of prolonged wait times were identified for rectal cancer. CONCLUSION: Time to first treatment has increased for patients with colon and rectal cancers at VAMCs. Patient, tumor, and hospital factors are associated with prolonged time to treatment.

Assessment of advanced gastric cancer management in the United States.

BACKGROUND: Increasing attention is being placed on utilization of treatment for advanced malignancies. Though some suggest it is futile, recent reports have advocated noncurative surgery for advanced gastric cancer. Our objectives were to (1) assess treatment trends, (2) identify predictors of surgery, and (3) evaluate the effect of treatment on outcomes. METHODS: Patients with stage IV gastric adenocarcinoma were identified from the National Cancer Data Base (1998-2007). Patients who underwent emergent surgery were excluded. Models were developed to identify factors associated with treatment receipt and to compare adjusted overall survival by treatment group. RESULTS: Twenty-four percent (n = 22,430) of patients presented with stage IV gastric adenocarcinoma; 1.5 % (n = 414) underwent emergent surgery. Of the remaining 21,039 patients, 62.4 % underwent treatment (87.0 % chemotherapy with or without radiotherapy (C ± RT), 5.6 % surgery, 7.2 % combined surgery and C ± RT). Over the decade, surgery rates increased by 43 %, and C ± RT use increased by 16 % while receipt of no treatment decreased by 26 % (all p < 0.001). Patients who were younger, white, and insured, as well as those with distal tumors were more likely to undergo surgery. Reasons for receiving no treatment were multifactorial but were most strongly associated with advanced age and being uninsured. Median survival was longest for patients selected to undergo surgery and C ± RT (13.5 months) versus C ± RT alone (6.1 months), surgery alone (4.8 months), or no treatment (1.7 months, all p < 0.001). CONCLUSIONS: Utilization of nonemergent surgical treatment and C ± RT for metastatic gastric adenocarcinoma has increased considerably over time, especially in certain patient populations; however, the true utility and cost of these treatments remain unknown.

Treatment trends and predictors of adjuvant and neoadjuvant therapy for gastric adenocarcinoma in the United States.

PURPOSE: Over the last decade, evidence suggesting the benefits of adjuvant therapy in the treatment of stage IB-III gastric adenocarcinoma has emerged, though the influence of these clinical trials and current treatment patterns is unknown. Our objectives were (1) to assess changes in gastric adenocarcinoma treatment over time, (2) to identify predictors of neoadjuvant or postoperative adjuvant therapy use, and (3) to identify factors associated with neoadjuvant therapy use. METHODS: Patients with stage IB-III gastric adenocarcinoma diagnosed between 1998 and 2007 in the National Cancer Data Base who underwent surgical resection were selected. Models were developed to identify factors associated with treatment. RESULTS: We identified 30,448 patients diagnosed with stage IB-III gastric adenocarcinoma who underwent surgical resection. Rates of systemic therapy receipt (either before or after surgery) increased by 71 % from 1998 to 2007 (p < 0.001). Receipt of neoadjuvant therapy receipt increased by 237 % over 10 years (p < 0.001), with the highest rate of increase seen at high-volume academic centers. American Joint Committee on Cancer (AJCC) stage and age were the strongest predictors of pre- or postoperative systemic therapy among surgical patients. Neoadjuvant therapy receipt was most strongly predicted by tumor location in the gastric cardia. CONCLUSIONS: Treatment trends over the past decade reflect rapid adoption of evidence from randomized controlled trials by increased receipt of pre- and postoperative systemic therapy in the treatment of stage IB-III gastric adenocarcinoma. Although age and AJCC stage are strongly associated with receiving systemic adjuvant therapy, tumor location is the most significant predictor of neoadjuvant therapy.

Defining quality for distal pancreatectomy: does the laparoscopic approach protect patients from poor quality outcomes?

INTRODUCTION: Established systems for grading postoperative complications do not change the assigned grade when multiple interventions or readmissions are required to manage a complication. Studies using these systems may misrepresent outcomes for the surgical procedures being evaluated. We define a quality outcome for distal pancreatectomy (DP) and use this metric to compare laparoscopic distal pancreatectomy (LDP) to open distal pancreatectomy (ODP). METHODS: Records for patients undergoing DP between January 2006 and December 2009 were reviewed. Clavien-Dindo grade IIIb, IV, and V complications were classified as severe adverse--poor quality--postoperative outcomes (SAPOs). II and IIIa complications requiring either significantly prolonged overall lengths of stay including readmissions within 90 days or more than one invasive intervention were also classified as SAPOs. RESULTS: By Clavien-Dindo system alone, 91 % of DP patients had either no complication or a low/moderate grade (I, II, IIIa) complication. Using our reclassification, however, 25 % had a SAPO. Patients undergoing LDP demonstrated a Clavien-Dindo complication profile identical to that for SDP but demonstrated significantly shorter overall lengths of stay, were less likely to require perioperative transfusion, and less likely to have a SAPO. CONCLUSIONS: Established systems undergrade the severity of some complications following DP. Using a procedure-specific metric for quality, we demonstrate that LDP affords a higher quality postoperative outcome than ODP.

Short-term outcomes after esophagectomy at 164 American College of Surgeons National Surgical Quality Improvement Program hospitals: effect of operative approach and hospital-level variation.

HYPOTHESIS: When assessing the effect of operative approach on outcomes, it may be less relevant whether a transhiatal or an Ivor Lewis esophagectomy was performed and may be more important to focus on patient selection and the quality of the hospital performing the operation. DESIGN: Observational study. SETTING: Hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program. PATIENTS: Individuals undergoing esophagectomy were identified from January 1, 2005, to December 31, 2010. The following 4 groups were created based on operative approach: transhiatal, Ivor Lewis, 3-field, and any approach with an intestinal conduit. MAIN OUTCOME MEASURES: Risk-adjusted 30-day outcomes and hospital-level variation in performance. RESULTS: At 164 hospitals, 1738 patients underwent an esophageal resection: 710 (40.9%) were transhiatal, 497 (28.6%) were Ivor Lewis, 361 (20.8%) were 3-field, and 170 (9.8%) were intestinal conduits. Compared with the transhiatal approach, Ivor Lewis esophagectomy was not associated with increased risk for postoperative complications; however, 3-field esophagectomy was associated with increased likelihood of postoperative pneumonia (odds ratio [OR], 1.88; 95% CI, 1.28-2.77) and prolonged ventilation exceeding 48 hours (OR, 1.68; 95% CI, 1.16-2.42). Intestinal conduit use was associated with increased 30-day mortality (OR, 2.65; 95% CI, 1.08-6.47), prolonged ventilation exceeding 48 hours (OR, 1.61; 95% CI, 1.01-2.54), and return to the operating room for any indication (OR, 1.85; 95% CI, 1.16-2.96). Patient characteristics were the strongest predictive factors for 30-day mortality and serious morbidity. After case-mix adjustment, hospital performance varied by 161% for 30-day mortality and by 84% for serious morbidity. CONCLUSIONS: Compared with transhiatal dissection, Ivor Lewis esophagectomy did not result in worse postoperative complications. After controlling for case-mix, hospital performance varied widely for all outcomes assessed, indicating that reductions in short-term outcomes will likely result from expanding other aspects of hospital quality beyond a focus on specific technical maneuvers.

Factors affecting selection of operative approach and subsequent short-term outcomes after anatomic resection for lung cancer.

BACKGROUND: Previous studies evaluating video-assisted thoracoscopic surgery (VATS) for lung cancer are single-institution series, suffer from small sample size, or use administrative or self-reported databases. Using a multi-institutional, standardized, and audited surgical outcomes database, our objectives were to examine preoperative factors associated with undergoing VATS vs open resection and assess subsequent perioperative outcomes. STUDY DESIGN: The American College of Surgeons National Surgical Quality Improvement Program Participant Use File was used to identify patients who underwent anatomic resection (eg, segmentectomy, lobectomy, and bi-lobectomy) for primary lung cancer (2005 to 2010). Multiple logistic regression models, including propensity scores, were developed to assess preoperative factors associated with undergoing VATS and the risk-adjusted association between operative approach and 30-day outcomes. RESULTS: Of 2,353 patients undergoing resection, 74% underwent open thoracotomy (OT) and 26% underwent VATS. After regression for confounders, factors associated with undergoing a VATS were patient age older than 75 years (odds ratio [OR] = 1.41; 95% CI, 1.05-1.90), Hispanic ethnicity (OR = 2.52; 95% CI, 1.69-3.77), and cardiothoracic surgery training (OR = 1.68; 95% CI, 1.37-2.07). Patients undergoing OT had a higher likelihood of any adverse event developing (24% vs 14%; OR = 1.76; 95% CI, 1.35-2.29), specifically pneumonia and sepsis/septic shock. Median length of stay was significantly longer in the OT group (7 vs 4 days; p < 0.001). Mortality was not significantly different for VATS vs OT after regression for confounders. CONCLUSIONS: In addition to patient factors, surgeon training can play a role in determining the operative approach offered to patients. Patients selected for VATS had a lower 30-day morbidity and shorter length of stay compared with OT anatomic resection for primary lung cancer.

Sweet's syndrome with neurologic manifestations in a patient with esophageal adenocarcinoma: case report and review of the literature.

BACKGROUND: Sweet's syndrome, also known as febrile neutrophilic dermatosis, can occur in patients with an underlying malignancy and can present with extracutaneous manifestations, including neurologic symptoms. METHODS: This report describes a 62-year-old man with adenocarcinoma of the esophagus who developed Sweet's syndrome and whose postoperative course was complicated by encephalitis. RESULTS: A diagnosis of Sweet's syndrome with neurologic manifestations was made, and the patient was treated with oral corticosteroids. His symptoms improved markedly within 12 h. CONCLUSION: Neurologic symptoms in Sweet's syndrome are infrequently reported and have not been described previously in a patient with adenocarcinoma of the esophagus.

Heparin-coated stents do not protect cancer patients from cardiac complications after noncardiac surgery.

Previous studies regarding preoperative coronary stents and antithrombotic agents have excluded patients with cancer as a result of hypercoagulability. The objective of this study is to determine whether preoperative heparin-coated coronary stents are as safe in patients with cancer undergoing surgery as patients without cancer. Between February 2003 and February 2005, 29 patients had heparin-coated coronary stents placed before noncardiac surgery. The incidence of postoperative myocardial infarction (MI) and/or death was compared in patients with and without cancer, and outcomes were further evaluated based on preoperative antithrombotic status. Postoperative MI occurred in three of 13 (23%) patients with cancer compared with zero of 16 noncancer patients. Patients with cancer were 9.6 times more likely to have a postoperative MI resulting in death compared with noncancer patients. There was a positive correlation between patients having cancer and having a postoperative MI (r = 0.38, P = 0.044) and between patients with cancer being on antithrombotic medications during surgery and having a postoperative MI (r = 0.567, P = 0.044). After stent placement, patients with cancer undergoing surgery experienced a higher incidence of postoperative MI resulting in death compared with noncancer patients despite continued antithrombotic use. In these patients, alternatives to stenting should be considered to avoid perioperative cardiac complications.