Discontinuation of surgical versus nonsurgical clinical trials: an analysis of 88,498 trials.

BACKGROUND: It has been previously reported that over 20% of surgical trials will be discontinued prematurely raising ethical and financial concerns. Previous studies have been limited in scope owing to the need for manual review of selected trials. To date, there has been no broad analysis comparing surgical and nonsurgical registered clinical trials. MATERIALS AND METHODS: ClinicalTrials.gov was queried October 7, 2017 for all US trials from 2005 to 2017. Trials were assigned to surgical or nonsurgical groups by automated sorting. The sorting algorithm was validated by comparison with manual assignments made by blinded investigators. Comparisons were made between trial status, funding sources, and trial design. The reasons for discontinuation were examined and tabulated. RESULTS: The database search yielded 82,719 nonsurgical and 5779 surgical trials after automatic assignment. The algorithm for assignments had an overall accuracy of 87.99% and a positive likelihood ratio of 6.09 and negative likelihood ratio of 0.093. Significant differences existed in trial status (nonsurgical versus surgical: completed: 55.51% versus 39.49%, P < 0.001 and discontinued: 11.07% versus 15.97%, P < 0.001). Discontinuation due to poor recruitment was more commonly cited by surgical trials (44.65% versus 34.74% P < 0.001). Industry funding predicted discontinuation for all trials (odds ratio 1.63 P < 0.001) and surgical trials independently (OR 1.25 P = 0.041). Patient enrollment, reporting results, and NIH funding were all protective against discontinuation. CONCLUSIONS: Surgical trials are more likely to prematurely discontinue than nonsurgical trials. Industry funding independently predicts trial discontinuation. Poor recruitment is a major cause of early trial discontinuation for all trials and is more pronounced in surgical trials.

Preclinical antitumor activity of a nanoparticulate SN38.

The present studies were carried out to examine the efficacy of a nanoparticulate formulation of SN38, the potent topoisomerase I inhibitor and active metabolite of irinotecan. Metabolism of irinotecan to SN38 is inefficient and subject to considerable patient-to-patient variability. One approach to more controlled administration of the anticancer agent is direct administration of the active SN38. A nanoparticulate formulation of SN38 was prepared by a method of precipitation with compressed antisolvent. Nanoparticulate SN38 efficiently inhibited the proliferation of colorectal, ovarian, and mesothelial cancer cell lines in vitro. Concentrations resulting in 50 % inhibition of proliferation were approximately 1000 fold lower for nanoparticulate SN38 compared to irinotecan. In vivo effects were examined using colorectal and ovarian mouse model systems. In a mouse model of peritoneally disseminated ovarian cancer intraperitoneal administration of irinotecan was favorable to intravenous delivery however intraperitoneal delivery of nanoparticulate SN38 was significantly more effective than intraperitoneal irinotecan. In addition, in a mouse colorectal cancer model administration of nanoparticulate SN38 once weekly exhibited greater activity compared to daily or weekly administration of irinotecan. Additional studies demonstrated nanoparticulate SN38 administered as a combination therapy with mitomycin C was more effective than the combination of irinotecan and mitomycin C. Results from the present studies using preclinical colorectal and ovarian cancer model systems demonstrate the efficacy of nanoparticulate SN38 and substantiate continued development.

Continuous manual agitation significantly improves temperature distribution during closed hyperthermic intraperitoneal chemotherapy: Results of a porcine model.

BACKGROUND: Debate persists regarding the need for shaking during hyperthermic intraperitoneal chemotherapy. Studies assessing the thermal behaviors of the perfusate throughout the abdomen during hyperthermic intraperitoneal chemotherapy are limited. METHODS: A closed hyperthermic intraperitoneal chemotherapy technique was performed in an institutional International Animal Care and Use Committee approved porcine model targeting a 41°C outflow temperature. Continuous temperature monitoring was conducted. Abdominal shaking was performed for 60 second intervals and temperatures were allowed to equilibrate without shaking between intervals. Temperature distributions and changes due to shaking were evaluated. These findings were validated against human subjects' data. RESULTS: The experimental procedure was conducted in 2 different animals and with 6 total shaking intervals assessed. Without shaking, temperatures were highly variable ranging between 38.0 to 42.2°C. Shaking the abdomen reduced the mean range of temperatures across all locations observed from 3.9°C to 0.8°C (P < .01). The locations of the most divergent temperatures varied based on perfusion cannula position. The point of minimum temperature heterogeneity was achieved in 28.3 (19.1-37.5) seconds. After shaking stopped, heterogeneity equal to the baseline measurements was seen on average within 25.7 (13.3-38.0) seconds. The outflow catheter differed from the system mean temperature by 1.4°C and from the coldest-reading probe by 2.8°C and outperformed the inflow catheter for all time points. With shaking these were significantly reduced to 0.4°C (P < .01) and 0.6°C (P < .01). The patient data mirrored that of the pig data. CONCLUSION: Shaking significantly reduces temperature variability within the abdomen during hyperthermic intraperitoneal chemotherapy, and significantly improves the ability of the outflow catheter to estimate internal temperatures.

Neoadjuvant Radiotherapy Facility Type Affects Anastomotic Complications After Esophagectomy.

BACKGROUND: Esophagectomy is a complex oncologic surgery that results in lower perioperative morbidity and mortality when performed in high-volume hospitals by experienced surgeons; however, limited data exists evaluating the importance of neoadjuvant radiotherapy delivery at high- versus low-volume centers. We sought to compare postoperative toxicity among patients treated with preoperative radiotherapy delivered at an academic medical center (AMC) versus community medical centers (CMC). METHODS: Consecutive patients undergoing esophagectomy for locally advanced esophageal or gastroesophageal junction (GEJ) cancer at an academic medical center between 2008 and 2018 were reviewed. Associations between patient factors and treatment-related toxicities were calculated in univariate (UVA) and multivariable analyses (MVA). RESULTS: One hundred forty-seven consecutive patients were identified: 89 CMC and 58 AMC. Median follow-up was 30 months (0.33-124 months). Most patients were male (86%) with adenocarcinoma (90%) located in the distal esophagus or GEJ (95%). Median radiation dose was 50.4 Gy between groups. Radiotherapy at CMCs resulted in higher rates of re-operation after esophagectomy (18% vs 7%, p = 0.055) and increased rates of anastomotic leak (38% vs 17%, p < 0.01). On MVA, radiation at a CMC remained predictive of anastomotic leak (OR 6.13, p < 0.01). CONCLUSION: Esophageal cancer patients receiving preoperative radiotherapy had higher rates of anastomotic leaks when radiotherapy was completed at a community medical center versus academic medical center. Explanations for these differences are uncertain but further exploratory analyses regarding dosimetry and radiation field size are warranted.

A phase II study of perioperative pembrolizumab plus mFOLFOX in patients with potentially resectable esophagus, gastroesophageal junction (GEJ), and stomach adenocarcinoma.

BACKGROUND: Perioperative chemotherapy/chemoradiation is standard in esophageal/gastric/gastroesophageal junction (GEJ) adenocarcinoma, immune checkpoint inhibitors (ICI) effect in setting of metastatic and postoperatively. This study is to assess ICI + chemotherapy perioperatively. METHODS: Patients with locally advanced (T1N1-3M0 or T2-3NanyM0) potentially resectable esophageal/gastric/GEJ adenocarcinoma by PET/EUS/CT and staging-laparoscopy, were treated preoperative 4 cycles mFOLFOX6 (Oxaliplatin 85 mg/m2 /Leucovorin 400 mg/m2 /5-FU bolus 400 mg/m2 then infusion 2400 mg/m2 for 46 h q2weeks) and 3 cycles pembrolizumab (200 mg q3week). Those without distal disease post-neoadjuvant and eligible for resection underwent surgery. Postoperative treatment was initiated at 4-8 weeks with 4 cycles mFOLFOX and 12 cycles pembrolizumab. The primary objective is pathological response (ypRR with tumor regression score, TRS ≤2). The expression of ICI-related markers PD-L1 (CPS), CD8, and CD20 were analyzed before and after preoperative therapy. RESULTS: Thirty-seven patients completed the preoperative treatment. Twenty-nine patients had curative R0 resection. 6/29 (21%; 95% CI: 0.08-0.40) achieved ypCR with TRS 0 in resected patients. 26/29 (90%; 95% CI: 0.73-0.98) had ypRR with TRS ≤2. Twenty-six patients finished adjuvant therapy with a median 36.3-month follow-up. Three patients had recurrence/metastatic disease (at 9-, 10-, 22 months enrollment) with one dead at 23 months, and two are still alive at 28 and 36.5 months. The remaining (23/26) are free of disease with 3 years DFS of 88.5% and 3 years OS of 92.3%. There were no unexpected toxicities. Preoperative ICI + chemotherapy enhanced immune responses significantly with increasing expression of PD-L1 (CPS ≥10, p = 0.0078) and CD8 (>5%, p = 0.0059). CONCLUSIONS: The perioperative pembrolizumab and mFOLFOX combination in resectable esophageal/gastric/GEJ adenocarcinoma is very effective with 90% ypRR, 21% ypCR, and impressive long-time survival benefits.

Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Jejunojejunal intussusception of a sutured enterotomy site after takedown and primary repair of persistent enterocutaneous fistula: a case report.

Enterocutaneous fistula (ECF) is a common complication of many abdominal surgeries. Although most ECF resolve spontaneously, there are many factors that can lead to persistence of the fistula. Management of persistent enterocutaneous fistula usually involves surgery with recurrence of fistula being the most common complication. Here we describe a case of 67-year-old female who presented with intussusception following repair of a persistent enterocutaneous. Given the rare finding of intussusception in adults, this case report presents an interesting complication.

SWOG S1820: Altering Intake, Managing Symptoms for bowel dysfunction in survivors of Rectal Cancer (The AIMS-RC intervention trial).

OBJECTIVE: To describe the study protocol of SWOG S1820, a trial of the Altering Intake, Managing Symptoms intervention for bowel dysfunction in survivors of Rectal Cancer (AIMS-RC). DESIGN: SWOG S1820 is a multi-site, randomized trial of 94 post-treatment survivors of rectal cancer, comparing the intervention and attention control arms. SETTING: Affiliated institutions of the National Cancer Institute (NCI)-supported National Community Oncology Research Program (NCORP) and the National Clinical Trial Network (NCTN). PARTICIPANTS: Survivors of rectal cancer who are between 6 and 24 months after treatment completion. INTERVENTION: AIMS-RC is a 17-week, 10 session telephone coaching program to help survivors of rectal cancer track their symptoms and improve their diets for better health and bowel function. It includes telephone-based coaching, resource manual, and personalized text/email messaging for motivation in between the telephone sessions. MAIN OUTCOME MEASURES: Bowel function, low anterior resection syndrome score, quality of life (QOL), dietary quality, motivation, self-efficacy, positive/negative affect, feasibility, adherence, retention, acceptability. ANALYSIS: Thirty-seven participants per arm (74 total) provide 80% power to detect this 0.5 standard deviation effect size, based on a two-sample t-test with a 1-sided alpha = 0.1. A total of 94 randomized participants will be accrued to account for 7% ineligibility and 15% attrition at 6 months.

System Modularity Chip for Analysis of Rare Targets (SMART-Chip): Liquid Biopsy Samples.

Liquid biopsies are becoming popular for managing a variety of diseases due to the minimally invasive nature of their acquisition, thus potentially providing better outcomes for patients. Circulating tumor cells (CTCs) are among the many different biomarkers secured from a liquid biopsy, and a number of efficient platforms for their isolation and enrichment from blood have been reported. However, many of these platforms require manual sample handling, which can generate difficulties when translating CTC assays into the clinic due to potential sample loss, contamination, and the need for highly specialized operators. We report a system modularity chip for the analysis of rare targets (SMART-Chip) composed of three task-specific modules that can fully automate processing of CTCs. The modules were used for affinity selection of the CTCs from peripheral blood with subsequent photorelease, simultaneous counting, and viability determinations of the CTCs and staining/imaging of the CTCs for immunophenotyping. The modules were interconnected to a fluidic motherboard populated with valves, interconnects, pneumatic control channels, and a fluidic network. The SMART-Chip components were made from thermoplastics via microreplication, which lowers the cost of production making it amenable to clinical implementation. The utility of the SMART-Chip was demonstrated by processing blood samples secured from colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) patients. We were able to affinity-select EpCAM expressing CTCs with high purity (0-3 white blood cells/mL of blood), enumerate the selected cells, determine their viability, and immunophenotype the cells. The assay could be completed in <4 h, while manual processing required >8 h.

Combination intraperitoneal chemotherapy is superior to mitomycin C or oxaliplatin for colorectal carcinomatosis in vivo.

BACKGROUND: Hyperthermic intraperitoneal (IP) chemotherapy after cytoreduction improves survival in patients with colorectal carcinomatosis of the peritoneal surface. Most protocols use single agents (mitomycin C or oxaliplatin) provided IP. The purpose of this study was to determine whether combination IP chemotherapy is superior to single-agent therapy in a mouse model. METHODS: Nu/Nu mice were injected IP with HT-29 colorectal cancer cells. Animals were treated with single agents or combinations. Primary end point was overall survival. Agents explored included oxaliplatin, mitomycin C, panitumumab, erlotinib, cetuximab, and irinotecan delivered IP as single agents; mitomycin C, panitumumab, and irinotecan in combination IP; and 5-fluorouracil-leucovorin-irinotecan (FOLFIRI) in combination delivered intravenously. RESULTS: Survival of mice receiving irinotecan or mitomycin C IP was greater than controls. Median survival of mice receiving intravenous FOLFIRI was also greater than control. However, survival of mice receiving IP irinotecan or mitomycin C was far greater than mice receiving intravenous FOLFIRI. For combination therapy, a positive interaction was observed with mitomycin C and irinotecan, whereas survival was greater than either agent individually. No interaction was observed between panitumumab and mitomycin C or irinotecan. However, an overall survival benefit was observed with the combination of irinotecan, mitomycin C, and panitumumab; at 120 days after cell injection, 100% of the triagent therapy group survived. CONCLUSIONS: IP therapy with mitomycin C or irinotecan provided a survival benefit compared with intravenous FOLFIRI. Combination IP therapy with mitomycin C, panitumumab, and irinotecan was superior to all other agents tested alone or in combination. This warrants further combination analysis and supports consideration for a phase I application.

Satisfaction or Distraction: Exposure to Nonpreferred Music May Alter the Learning Curve for Surgical Trainees.

OBJECTIVE: There is growing evidence supporting the benefits of preferred music on task performance, however there is a paucity of data regarding the potential impact on surgical and procedural learners. This study aims to assess the effects of nonpreferred music on surgical and procedural learners. DESIGN: This was a single-blinded, randomized crossover trial in which each participant completed a survey regarding their demographic information and music preferences. Each participant then completed 3 training tasks, and 2 repetitions of the evaluative task while listen to music. Tasks were completed using a Da Vinci Skills Simulator Si. SETTING: All tasks were completed in a live operating room at the University of Kansas Hospital, a tertiary care center. PARTICIPANTS: Medical students at the University of Kansas Medical Center were recruited by email to participate. In total, 31 medical students completed the experience. RESULTS: Thirty-one participants participated in this study. Group 2 (preferred music first, nonpreferred music second) showed no significant change in their test scores (72.73 vs 74.33, p = 0.34). However, Group 1 (nonpreferred music first, then preferred music) showed significant improvement between trial runs (70.31 vs 81.88, p < 0.001). There was no significant difference between the initial runs for each group. When analyzed irrespective of group assignment, there was a significant increase in scores for preferred music vs nonpreferred music (77.45 vs 72.26 p = 0.025). CONCLUSIONS: Participants showed expected improvement with task repetition. This improvement may have been offset by exposure to nonpreferred music during repeat runs. Our findings suggest that the impact of music was nearly as large as the impact of prior exposure to the task. This may have implications for environmental conditions during resident procedural training, especially early in residency training when new tasks are being introduced and the skill level of the learner is still low.

Intellectual Equipoise and Challenges: Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316).

BACKGROUND: Prospective, randomized trials are needed to determine optimal treatment approaches for palliative care problems such as malignant bowel obstruction (MBO). Randomization poses unique issues for such studies, especially with divergent treatment approaches and varying levels of equipoise. We report our experience accruing randomized patients to the Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (SWOG S1316) study, comparing surgical and nonsurgical management of MBO. METHODS: Patients with MBO who were surgical candidates and had treatment equipoise were accrued and offered randomization to surgical or nonsurgical management. Patients choosing nonrandomization were offered prospective observation. Trial details are listed on www.clinicaltrials.gov (NCT #02270450). An accrual algorithm was developed to enhance enrollment. RESULTS: Accrual is ongoing with 176 patients enrolled. Most (89%) patients chose nonrandomization, opting for nonsurgical management. Of 25 sites that have accrued to this study, 6 enrolled patients on the randomization arm. Approximately 59% (20/34) of the randomization accrual goal has been achieved. Patient-related factors and clinician bias have been the most prevalent reasons for lack of randomization. An algorithm was developed from clinician experience to aid randomization. Using principles in this tool, repeated physician conversations discussing treatment options and goals of care, and a supportive team-approach has helped increase accrual. CONCLUSIONS: Experience gained from the S1316 study can aid future palliative care trials. Although difficult, it is possible to randomize patients to palliative studies by giving clinicians clear recommendations utilizing an algorithm of conversation, allotment of necessary time to discuss the trial, and encouragement to overcome internal bias.

A patient with metastatic melanoma of the small bowel.

We report the case of a 74-year-old man with metastatic melanoma of the small bowel. Melanoma metastasizing to the small bowel is a rare but well described presentation of the disease, detected clinically in only 2% to 5% of these patients. Its presentation is similar to other gastrointestinal tract tumors, with symptoms of abdominal pain or anemia prevailing. Recent studies have implicated the chemokine receptor CCR9 and its ligand CCL25 as signals that allow malignant melanoma cells to preferentially metastasize to the small bowel. Common imaging modalities used to detect these small bowel lesions include contrast-enhanced computed tomography (CT) scans and upper gastrointestinal series with small bowel follow-through. Given the low sensitivity of these modalities, newer helical CT scanners, 18F-2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG PET)/CT, and capsule endoscopy are now being recommended to replace the older imaging techniques. Current treatment modalities include surgical resection, which has been shown to increase overall survival, and adjuvant immunotherapy, whose efficacy is currently being questioned. A review of the current literature describing this rare occurrence is included to compare with our patient's presentation, diagnosis, and management.

Morbidity and mortality of synchronous hepatectomy with cytoreductive surgery/hyperthermic intraperitoneal chemotherapy (CRS/HIPEC).

BACKGROUND: Liver resection in conjunction with partial colectomy for colon cancer is considered acceptable treatment for isolated metastasis to the liver. This method is unstudied in patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for carcinomatosis due to colon cancer and high grade appendiceal cancer. METHODS: A retrospective chart review included patients from 2005 to 2016 undergoing CRS/HIPEC. Cancers other than colorectal adenocarcinoma and high grade appendiceal carcinoma were excluded. Patients were divided into hepatectomy and non-hepatectomy groups. Data was collected by chart review from electronic medical records to assess morbidity and mortality, as well as oncologic outcomes of included patients. RESULTS: The average patient age, length of stay, and sex were similar between groups. For those in the hepatectomy group, 80% underwent minor hepatectomy, and 20% underwent major hepatectomy. The comprehensive complication index (CCI) scores ranged from 0 (no complications), to 100 (death). The average CCI between study groups was similar (27.29 vs. 17.41, P=0.09). Hepatectomy was associated with a higher rate of Clavien-Dindo classifications (CDCs) of III or greater. Complications included pressor requirement, renal failure, blood transfusions, TPN, pleural effusions and leaks requiring drain placement, respiratory failure, UTI, new onset atrial fibrillation, wound infections, and death. CONCLUSIONS: Patients who underwent CRS/HIPEC and hepatectomy for colorectal and high grade appendiceal carcinomatosis had more severe complications at similar rates to non-hepatectomy patients. Complication rates should be considered when selecting patients for aggressive surgical intervention.

Comparison of postoperative venous thromboembolism incidence in gastrointestinal and gynecologic solid tumors.

INTRODUCTION: Studies have shown the benefit of 28days of extended postoperative venous thromboembolism (VTE) prophylaxis for patients undergoing major cancer surgery in the abdomen or pelvis. We retrospectively evaluated the VTE incidence at the University of Kansas Hospital between gynecologic (GYN) cancer patients, who receive extended prophylaxis, and gastrointestinal (GI) cancer patients, who do not. METHODS: Patients were evaluated between January of 2010 and December of 2013, and VTE data for eligible patients were collected for 30 and 90days postoperatively. RESULTS: The study population composed of 190 GYN and 204 GI patients. Colon and endometrial cancers were the most common diagnoses. For GYN and GI patients respectively, VTE occurred in 4.2% and 5.4% at 30days (p=0.584) and 7.4% and 7.8% at 90days (p=0.514). One VTE-related death occurred in the GI group. GI patients underwent more open surgeries, 77.9% versus 66.3% (p=0.010) and had longer postoperative hospital stay, median of 7 versus 4days (p<0.0001). Out of all cancer patients combined, 40% versus 17.9% had stage IV disease and 10.2% versus 0.9% had open surgery in the VTE and non-VTE groups, respectively. CONCLUSIONS: There were no significant differences in overall VTE incidence between the two patient groups at 30 and 90days postoperatively. A majority of VTEs occurred in stage IV patients and patients who underwent open surgeries regardless of diagnosis.

Breast cancer in Native American women treated at an urban-based Indian health referral center 1982-2003.

BACKGROUND: Breast cancer incidence and survival varies by race and ethnicity. There are limited data regarding breast cancer in Native American women. METHODS: A retrospective chart review was performed of 139 women diagnosed with breast cancer and treated at Phoenix Indian Medical Center in Phoenix, AZ between January 1, 1982 and December 31, 2003. Data points included tribal affiliation, and quantum (percentage American Indian Heritage) along with patient, tumor, and treatment characteristics. RESULTS: Most patients (79%) presented initially with physical symptoms. There were no significant differences based on tribal affiliation; however, higher quantum predicted both larger tumor size and more advanced stage at diagnosis. Obesity also significantly correlated with larger tumor size and more advanced stage. Treatment was inadequate in 21%; this was attributed to traditional beliefs, patient refusal, or financial issues. CONCLUSIONS: When compared to national averages, Native American women presented at a later stage, underutilized screening, and had greater delays to treatment.

Bronchogenic cyst presenting as a symptomatic neck mass in an adult: case report and review of the literature.

We report the unusual clinical manifestation and subsequent management of a symptomatic congenital bronchogenic cyst that connected to the trachea and presented in the neck of an adult. The embryology, clinical presentation, diagnostic evaluation, and management options of this rare aberration are discussed.

Is Glucagonoma of the Pancreas a Curable Disease?

Glucagonomas are rare tumors that arise from thepancreatic islet cell of Langerhans. Because of theuncommon occurrence of these tumors, the naturalhistory is not well defined and has largely been basedon case reports or small series. Less than 250 casesof glucagonomas have been reported in the Englishliterature. To our knowledge, the largest single institutionalexperience is from the Mayo Clinic where 21 cases were reported (1). We report one of thelargest series of 12 patients with a diagnosis ofglucagonomas treated at our institution.