Quality of life and fear of cancer recurrence in patients and survivors of non-Hodgkin lymphoma.

Non-Hodgkin lymphoma (NHL) is a common haematological cancer that is comprised of approximately 30 subtypes, of which Waldenström Macroglobulinemia (WM) is a rare incurable form. It is typically managed using a watch-and-wait strategy that can contribute to illness uncertainty which may result in fear of cancer recurrence (FCR) and poor health-related quality of life (QOL). However, few studies have examined the correlates of FCR and QOL in NHL patients, including WM patients. One-hundred males and 92 females with a mean age of 62.7 years who were an average of 6.8 years from diagnosis completed the online questionnaire which asked about demographics, medical history, QOL, FCR, stress, anxiety and depression. Few NHL patients reported significant stress or affective distress, most had moderate-high QOL and 41% experienced recent FCR, relative to published cut-off scores. Poorer QOL was related to depression symptoms, FCR, higher illness burden (i.e. comorbidity) and fewer personal resources (i.e. unemployed), whereas FCR was related to shorter time since diagnosis and more depressive symptoms. Results suggest that FCR and depressive symptoms may adversely impact QOL, whereas a recent cancer diagnosis and depression-related pessimism may contribute to FCR.

Mode of Delivery: Development and Implementation of an Obstetrical In Situ Simulation Program.

OBJECTIVE: Simulation is increasingly valued as a learning tool in obstetrical practice. In situ simulation assesses the hands-on and critical thinking skills of a health care team within their clinical setting. We aimed to create an in situ simulation program to promote skills acquisition, enhance teamwork, and identify system limitations. METHODS: Key obstetrical emergencies were identified through a needs assessment. In situ simulations were developed to address these clinical presentations. During simulations, organizers and participants identified latent safety threats. Medical management was evaluated through comprehensive emergency-specific checklists. Leadership attitudes were assessed using the modified Perinatal Emergency Team Response Assessment tool. Following each simulation, team members were debriefed, and qualitative and quantitative feedback was solicited and aggregated by specialty and discipline. RESULTS: Simulations were conducted monthly at two academic centers over 14 months. Participation was interdisciplinary, including learners, staff physicians, nursing, and allied health team members from the departments of obstetrics, anesthesia, emergency medicine, and neonatology. Participants reported their involvement was enjoyable. Participants reported improvements in communication skills, content knowledge, and procedural knowledge. Participants favourably rated the spontaneity of simulations, clinically relevant scenarios, safe environment, and use of realistic equipment. Latent safety threats, related to equipment, medication, personnel, resources, and technical skills, were identified. CONCLUSION: We present the successful implementation of a comprehensive in situ simulation program. In situ simulation allows for deliberate practice of obstetrical emergencies and promotes a culture of patient safety. Lessons learned provide valuable data to identify limitations within our current practices and inform future policy change.

A multiple-trainee, multiple-level, multiple-competency (multi-TLC) simulation-based approach to training obstetrical emergencies.

Competency-based education requires that programs increase the breadth of direct observation and assessment to improve resident training. To achieve these goals, the authors developed and executed a multiple-trainee, multiple-level, multiple-competency (Multi-TLC) obstetrical emergencies simulation curriculum. Depending upon their training level (PGY1-PGY5), obstetrics and gynaecology residents participated in various roles (i.e., first responder, second responder, confederates, and evaluators) within four simulation scenarios designed to provide opportunities for education, direct observation, and assessment across a number of competencies (i.e., medical expert, communicator, collaborator, leader, advocate, and scholar). The curriculum was carried out over 8 h spread evenly across 2 days (i.e., 4 h/day) and involved periods of pre-briefing, live simulation, and debriefing. An evaluation of the Multi-TLC was operationalised via a context-input-process-product model. This report presents the outcomes of that evaluation derived from quasi-experimental comparisons of the new and previous curricula across four priorities for simulation-based education identified by the Department of Obstetrics and Gynecology at McMaster University (Hamilton, ON, Canada): increasing learning opportunities, maintaining or improving resident learning, maintaining or reducing program costs, and improving resident satisfaction. The evaluation revealed that the Multi-TLC curriculum permitted a greater breadth of direct observation and assessment across competencies, maintained the previous learning objectives while also addressing additional ones, and was done so in a way that reduced the overall financial and human resource costs associated with the department's obstetrical emergency simulation curriculum. A Multi-TLC organisation of simulation curricula can facilitate efficient application of competency-based education principles.

Novel Use of Ultrasound to Teach Reproductive System Physical Examination Skills and Pelvic Anatomy.

OBJECTIVES: To determine whether integration of ultrasound (US) into a reproductive system examination clinical skills lab can increase confidence in palpating key reproductive structures during testicular and bimanual pelvic examinations, reduce anxiety about conducting testicular and bimanual pelvic examinations, and improve performance on multiple-choice questions based on structure identification using US images. METHODS: Second-year medical students enrolled in the Life Cycle preclinical course participated in this cross-sectional study. A single learning activity was developed to pair the teaching of the reproductive system physical examination with the use of US in the clinical skills lab. The evaluation of the teaching session consisted of a pre-post analysis of student self-reported knowledge, confidence, and anxiety. RESULTS: The response rate for the pre survey was 82% (n = 96), and the rate for the post survey was 79% (n = 93). Students' confidence in their ability to identify reproductive system structures on US images increased from pre to post survey. Their confidence in their ability to palpate the epididymis, uterus, and ovary during a physical examination improved, and their anxiety about conducting testicular and bimanual pelvic examinations decreased. Student satisfaction with the session was high. Students' performance on multiple-choice questions based on structure identification using US images was at 96% or higher. CONCLUSIONS: Our study findings support the integration of US into a reproductive system examination clinical skills lab. Medical students acquire competency and confidence in reproductive system physical examination skills with US integration.

Irreversible electroporation of unresectable soft tissue tumors with vascular invasion: effective palliation.

BACKGROUND: Irreversible electroporation (IRE) has recently been added as an additional therapeutic ablative option in patients with locally advanced cancers (LAC) involving vital structures. IRE delivers localized electric current by peri-tumoral discrete probes to attain irreversible changes in cell membrane leading to cell death. The aim of this study was to evaluate the long-term effects of IRE in the treatment of locally advanced tumors. METHODS: A prospective IRB approved evaluation of 107 consecutive patients from 7 institutions with tumors that had vascular invasion treated with IRE from 5/2010 to 1/2012. LAC was defined as primary tumor with <5 mm from major vascular structure based on pre-operative dynamic imaging or intra-operative criteria. RESULTS: IRE as utilized in LAC in the liver (N = 42, 40%) and pancreas (N = 37, 35%), with a median number of lesions being 2 with a mean target size of 3 cm. IRE attributable morbidity rate was 13.3% (total 29.3%) with high-grade complications seen in 4.19% (total 12.6%). No significant vascular complications were seen, and of the high-grade complications, bleeding (2), biliary complications (3) and DVT/PE (3) were the most common. Complications were more likely with pancreatic lesions (p = 0.0001) and open surgery (p = 0.001). Calculated local recurrence free survival (LRFS) was 12.7 months with a median follow up of 26 months censured at last follow up. The tumor target size was inversely associated with recurrence free survival (b = 0.81, 95% CI: 1.6 to 4.7, p value = 0.02) but this did not have a significant overall survival impact. CONCLUSIONS: IRE represents a novel therapeutic option in patients with LAC involving vital structures that are not amenable to surgical resection. Acceptable to high local disease control and the long LRFS can be achieved with this therapy in combination with other multi-disciplinary therapies.

Evaluation of quality of life following placement of self-expanding plastic stents as a bridge to surgery in patients receiving neoadjuvant therapy for esophageal cancer.

PURPOSE: To determine whether self-expanding plastic stent (SEPS) placement significantly improves quality of life and maintains optimal nutrition while allowing full-dose neoadjuvant therapy (NAT) in patients with esophageal cancer. PATIENTS AND METHODS: A prospective, dual-institution, single-arm, phase II (http://ClinicalTrials.gov: NCT00727376) evaluation of esophageal cancer patients undergoing NAT prior to resection. All patients had a self-expanding polymer stent placed prior to NAT. The European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OG25, Functional Assessment of Cancer Therapy-Anorexia, and Functional Assessment of Cancer Therapy-General surveys were administered prior to stenting, within 1 week post-stent placement, and at the completion of neoadjuvant therapy. RESULTS: Fifty-two patients were enrolled; 3 (5.8%) had stent migrations requiring replacement. There were no instances of esophageal erosion or perforation. All patients received some form of neoadjuvant therapy. Thirty-six (69%) received chemoradiation; 34 (93%) of these patients received the planned dose of chemotherapy, and 27 (75%) received the full planned dose of radiotherapy. There were 16 (31%) patients receiving chemotherapy alone; 12 (74%) of patients in the chemotherapy-alone group completed the planned dose of therapy. CONCLUSION: Placement of SEPS appears to provide significant improvement in quality of life related to dysphagia and eating restriction in patients with esophageal cancer undergoing neoadjuvant therapy. Consideration of SEPS instead of percutaneous feeding tube should be initiated as a first line in dysphagia palliation and NAT nutritional support.

Health-related quality of life changes following major and minor hepatic resection: the impact of complications and postoperative anemia.

BACKGROUND: Few studies have evaluated the health-related quality-of-life (QOL) changes in patients following major liver resection for malignancy. METHODS: QOL parameters were recorded prospectively at baseline (preoperative), and through 6 months of follow-up using various instruments. RESULTS: Major complications occurred in 10 of 41 patients. At the initial outpatient visit, patients reported decreased global QOL with increased fatigue compared with baseline, which normalized at 6 weeks' follow-up and remained stable at 6 months. Those with major complications reported increased severity of pain over baseline at initial follow-up and at 6 months. Patients anemic at the time of discharge had worse physical QOL at 6 weeks, but levels similar to nonanemic patients at 3 months. CONCLUSIONS: Major complications are associated with increased reporting of pain persisting at 6 months. Attention to pain control, especially among patients with major complications, may improve QOL after major hepatic resection.

Safety and early efficacy of irreversible electroporation for hepatic tumors in proximity to vital structures.

INTRODUCTION: Irreversible electroporation (IRE) has shown promise for ablation of lesions in proximity to vital structures in the preclinical setting. This study aims to evaluate the safety and efficacy of IRE for hepatic tumors in the clinical setting. METHODS: An IRB approved prospective registry of patients undergoing IRE for hepatic tumors over a 2-year period. Factors analyzed included patient and tumor characteristics, treatment related complications, and local recurrence free survival (LRFS) for ablated lesions. LRFS was calculated according to Kaplan-Meier, with secondary analyses stratified by procedural approach (laparotomy, laparoscopy, and percutaneous) and tumor histology. RESULTS: There were 44 patients undergoing 48 total IRE procedures, 20 colorectal mets, 14 hepatocellular, and 10 other metastatsis. Initial success was achieved in 46 (100%) treatments. Five patients had 9 adverse events, with all complications resolving within 30 days. LRFS at 3, 6, and 12 months was 97.4%, 94.6%, and 59.5%. There was a trend toward higher recurrence rates for tumors over 4 cm (HR 3.236, 95% CI: 0.585-17.891; P = 0.178). CONCLUSIONS: IRE appears to be a safe treatment for hepatic tumors in proximity to vital structures. Further prospective evaluation is needed to determine the optimal effectiveness of IRE in relation to size and technique for IRE of the liver.

Irreversible electroporation in locally advanced pancreatic cancer: potential improved overall survival.

BACKGROUND: Locally advanced unresectable pancreatic adenocarcinoma (LAC) is characterized by poor survival despite chemotherapy and conventional radiation therapy. We have recently reported on the safety of using irreversible electroporation (IRE) for the management of LAC. The purpose of this study was to evaluate the overall survival in patients with LAC treated with IRE. METHODS: A prospective, multi-institutional evaluation of 54 patients who underwent IRE for unresectable pancreatic cancer from December 2009 to October 2010 was evaluated for overall survival and propensity matched to 85 matched stage III patients treated with standard therapy defined as chemotherapy and radiation therapy alone. RESULTS: A total of 54 LAC patients have undergone IRE successfully, with 21 women, 23 men (median age, 61 (range, 45-80) years). Thirty-five patients had pancreatic head primary and 19 had body tumors; 19 patients underwent margin accentuation with IRE and 35 underwent in situ IRE. Forty-nine (90 %) patients had pre-IRE chemotherapy alone or chemoradiation therapy for a median duration 5 months. Forty (73%) patients underwent post-IRE chemotherapy or chemoradiation. The 90 day mortality in the IRE patients was 1 (2 %). In a comparison of IRE patients to standard therapy, we have seen an improvement in local progression-free survival (14 vs. 6 months, p = 0.01), distant progression-free survival (15 vs. 9 months, p = 0.02), and overall survival (20 vs. 13 months, p = 0.03). CONCLUSIONS: IRE ablation of locally advanced pancreatic tumors remains safe and in the appropriate patient who has undergone standard induction therapy for a minimum of 4 months can achieve greater local palliation and potential improved overall survival compared with standard chemoradiation-chemotherapy treatments. Validation of these early results will need to be validated in the current multi-institutional Phase 2 IDE study.

Impact of post-operative complications on quality of life after pancreatectomy.

CONTEXT: Pancreatectomies for malignant and benign diseases are increasingly being performed worldwide. Recent studies, that have evaluated quality of life in pancreatectomy, have reported conflicting outcomes. OBJECTIVE: This study was undertaken to analyze the quality of life changes reported by patients with pancreatic cancer undergoing pancreatectomy. DESIGN: Post-hoc analysis was performed of a clinical trial examining the safety of intraoperative autotransfusion during oncologic resections. MAIN OUTCOME MEASURES: Perioperative (90-day) complications were graded prospectively using a validated 5-point scale. Quality of life parameters were recorded prospectively by a single trained interviewer preoperatively, at the first post-operative outpatient visit, and at 6 weeks, 3 months, and 6 months follow-up using the EORTC QLQ-C30 and FACT-An instruments. RESULTS: Pancreatectomy for adenocarcinoma was performed in 34 patients with a median follow-up of 2 years (range: 1-1.5 years). Major (grade≥3) complications occurred in 12 (35.3%) of patients. Early (<6 month) recurrence was noted in 2 patients (5.9%). Increased severity of fatigue, pain, dyspnea, and loss of appetite over baseline were noted at initial follow-up (P<0.05); however, symptom scores normalized at 6-week follow-up, and remained stable at 6 months. No significant difference was noted in quality of life metrics between patients with or without major complications (P>0.11). A significant (P=0.023) decline in cognitive function vs. baseline was noted at 6-month follow-up after pancreatectomy. Using a repeated-measures generalized linear model, neither age, nor complication occurrence, nor adjuvant therapy, nor early recurrence accounted for this cognitive decline (P>0.10). CONCLUSION: Quality of life metrics tend to normalize to preoperative levels after pancreatectomy at 6 weeks post-operatively. The occurrence of major complications does not predict a decreased quality of life. The decrease in self-reported cognitive function at six months in this cohort merits further study.

Irreversible electroporation therapy in the management of locally advanced pancreatic adenocarcinoma.

BACKGROUND: Locally advanced pancreatic cancer patients have limited options for disease control. Local ablation technologies based on thermal damage have been used but are associated with major complications in this region of the pancreas. Irreversible electroporation (IRE) is a nonthermal ablation technology that we have shown is safe near vital vascular and ductal structures. The aim of this study was to evaluate the safety and efficacy of IRE as a therapy in the treatment of locally advanced pancreatic cancer. STUDY DESIGN: We performed a prospective multi-institutional pilot evaluation of patients undergoing IRE for locally advanced pancreatic cancer from December 2009 to March 2011. These patients were evaluated for 90-day morbidity, mortality, and local disease control. RESULTS: Twenty-seven patients (13 women and 14 men) underwent IRE, with median age of 61 years (range 45 to 80 years). Eight patients underwent margin accentuation with IRE in combination with left-sided resection (n = 4) or pancreatic head resection (n = 4). Nineteen patients had in situ IRE. All patients underwent successful IRE, with intraoperative imaging confirming effective delivery of therapy. All 27 patients demonstrated nonclinically relevant elevation of their amylase and lipase, which peaked at 48 hours and returned to normal at 72 hour postprocedure. There has been one 90-day mortality. No patient has shown evidence of clinical pancreatitis or fistula formation. After all patients have completed 90-day follow-up, there has been 100% ablation success. CONCLUSIONS: IRE ablation of locally advanced pancreatic cancer tumors is a safe and feasible primary local treatment in unresectable, locally advanced disease. Confirming these early results must occur in a planned phase II investigational device exemption (IDE) study to be initiated in 2012.

A prospective phase II evaluation of esophageal stenting for neoadjuvant therapy for esophageal cancer: optimal performance and surgical safety.

BACKGROUND: Many surgeons are reluctant to use esophageal stents during neoadjuvant therapy for esophageal cancer because of concerns about nutritional status, stent-related complications, or added difficulties during esophagogastrectomy. We hypothesized that esophageal stenting during neoadjuvant therapy allows for optimal nutritional intake without adversely affecting perioperative outcomes. STUDY DESIGN: This study is a prospective, dual-institution, single-arm, phase II evaluation of esophageal cancer patients undergoing neoadjuvant therapy before resection. All patients had a self-expanding polymer stent placed before neoadjuvant therapy. We monitored dysphagia symptoms, nutritional status, stent-related complications, and perioperative complications during the course of therapy and 90 days postoperatively. RESULTS: We enrolled 32 patients with dysphagia and weight loss who were eligible for neoadjuvant therapy. After stent placement, 2 patients had stent migrations requiring replacement. No erosive complications were observed. During the course of neoadjuvant therapy, we noted improvement in dysphagia, mild weight loss, and maintenance of performance status. At a median of 50 days (range 18 to 92 days) after completion of neoadjuvant therapy, 20 patients underwent margin-negative esophagogastrectomy (16 Ivor Lewis, 4 minimally invasive) without problems with stent removal or difficulty in surgical dissection. Twelve patients did not undergo resection due to development of metastases (n = 8) or rapid decline in functional status (n = 4). Major perioperative complications included pulmonary embolism (n = 2), chyle leak (n = 1), and bronchial injury (n = 1). No surgical complications were attributed to stent placement. CONCLUSIONS: Use of esophageal stents during neoadjuvant therapy is safe and results in resolution of dysphagia, mild weight loss, and maintenance of performance status without an effect on intraoperative dissection, perioperative complications, or delay in resection after neoadjuvant therapy.

Phase II comparison study of intraoperative autotransfusion for major oncologic procedures.

BACKGROUND: Intraoperative autotransfusion (IOAT) has been avoided in oncologic surgery because of possible tumor cell dissemination. Through a prior Phase I study, we demonstrated that malignant cells are not present in blood filtered for IOAT. We hypothesized that autotransfusion could be safely used for patients undergoing major oncologic procedures and reduce the need for allogeneic blood. MATERIALS AND METHODS: A Phase II, IRB-approved, prospective evaluation was conducted of patients undergoing gastrointestinal oncologic procedures. All procedures were conducted with blood salvaged for IOAT, and the collected volume was autotransfused if it was >100 ml. Quality of life (QoL) was assessed by questionnaire at regular intervals. RESULTS: A total of 92 patients were enrolled with median age of 56 years. The most commonly performed procedures were hepatectomy (47%) and pancreaticoduodenectomy (26%). The median preoperative hemoglobin (Hgb) was 13.1 (range, 9-16), and the median estimated blood loss was 350 ml (range, 20-4000 ml). Of the 92 total patients, 32 (35%) received IOAT with a median volume of 255 ml (range, 117-1499 ml). Multivariate analysis identified that patients with preoperative Hgb >11 g/dl (P = .02), and blood loss of 400-900 ml (P = .03) benefited from IOAT with a reduction in postoperative blood transfusion rate. Patients with discharge Hgb >10 g/dl showed higher mean QoL scores throughout their recovery. At a median follow-up of 18 months, the rates of recurrence in the IOAT and the non-IOAT groups were equivalent (38 vs. 39%, P = .9). CONCLUSIONS: Intraoperative autotransfusion can be used safely and effectively for major oncologic procedures. Furthermore, degree of discharge anemia is associated with lower quality of life in patients undergoing oncologic gastrointestinal surgery.

Safety of hepatic resection in metastatic disease to the liver after yttrium-90 therapy.

BACKGROUND: Unresectable hepatic metastases from aerodigestive cancers are common and in most cases herald a poor prognosis. A small percentage of patients maybe amenable to surgical resection or ablation once the biology of the disease and the burden of hepatic disease are better understood. The use of hepatic arterial resin microspheres containing the ß emitter, yttrium-90, has been reported in the treatment of unresectable hepatic metastases. The goal of this review was to evaluate the use of yttrium-90 hepatic arterial therapy in the management of hepatic metastases and surgical downstaging. METHODS: We reviewed our prospective hepatic arterial therapy registry and found 44 patients who had received Sir Sphere treatment for unresectable hepatic malignancies from 11/06 to 7/08. Response was assessed by using CT-imaging and characterized using modified response evaluation criteria in solid tumors (RECIST). All patients were managed in a multidisciplinary tertiary referral center specializing in hepatic malignancies. RESULTS: A total of 44 patients, 34 men and 10 women, with a median age of 60 y (range 44-8), received 67 treatments. The disease types treated were one adenosquamous tongue, one adrenal, nine carcinoid, three cholangiocarcinoma, four esophageal, one gastric, one gastrinoma, one GIST, four HCC, 15 colorectal, one melanoma, one non-small-cell lung, one occular, and one sarcoma. Four patients treated proceeded to resection because of downstaging of disease or no evidence of extrahepatic progression. The median age in these patients was 61 y (range 49-62). All of the patients had less than 25% tumor burden in the liver. Surgical therapy consisted of two patients undergoing right hepatic lobectomy, one patient who also underwent two wedge resections of segment 3, and one patient who had a left lateral hepatectomy with right lobe microwave ablation. The median length of postoperative stay was 7 d. There was no evidence of liver dysfunction following resection in any of the patients. None of the patients show evidence of recurrence in the liver following resection. One patient has had progression of disease in the lungs following resection, histologically confirmed as metastatic rectal carcinoma. All of the patients are currently alive with a median survival of 2 y. CONCLUSION: Hepatic directed yttrium-90 is a minimally invasive, highly effective therapy that can be utilized to downstage the hepatic burden and/or assess the biology of the disease to allow for appropriate treatment. The use of yttrium-90 microspheres for radio-embolization of metastases in the liver can successfully downstage the lesions to allow for surgical resection in patients with amenable predictors, and can provide a significantly better prognosis in these patients. This form of therapy for the purposes of downstaging tumors for resection merits more extensive study in order to provide the best possible outcomes for patients with metastatic liver disease.

Role of dynamic MRI in surgical decision-making for a postpartum woman with a prolapsed degenerating uterine leiomyoma.

BACKGROUND: Surgical decision-making in the case of postpartum complications affecting fibroids can be difficult. We present a case that illustrates the potential role of MRI in assisting these decisions. CASE: A 28-year-old woman with a known uterine leiomyoma presented on postpartum day 10 with abdominal pain, fever, and foul-smelling vaginal discharge. Her condition improved after antibiotic therapy, but she subsequently returned to hospital with a liquefied fibroid filling the vagina and a solid mass palpable above the dilated cervix. Pelvic ultrasound did not conclusively identify the vascular supply or myometrial involvement of the mass. MRI identified one fundal vascular pedicle and a very thin posterior uterine wall. At abdominal myomectomy, the myometrium was found to be only minimally involved, and the fundal vascular pedicle was easily cross-clamped. CONCLUSION: When available, MRI can be used to clarify the location of vascular pedicles and the extent of myometrial involvement of uterine fibroids, and it can assist in fibroid-related surgical decision-making.

Is selective internal radioembolization safe and effective for patients with inoperable hepatocellular carcinoma and venous thrombosis?

BACKGROUND: The goal of this study was to examine the safety and efficacy of selective internal radioembolization (SIR) for hepatocellular carcinoma (HCC) with portal vein or caval thrombosis (VT), or both. Recent reports have demonstrated that SIR is safe for patients with HCC, but the impact on efficacy of venous thrombosis is unknown. STUDY DESIGN: Prospective single-arm study of the use of Therasphere in patients with unresectable HCC enrolled from January 2004 to June 2007. Patients were categorized into three groups based on VT status and therapy. RESULTS: Fifty-two patients were enrolled: 20 patients without VT who received SIR, 15 patients with VT who were treated, and 17 patients (10 with VT) who were not treated because of preprocedure screening failure. Fifty-eight treatments were administered, with a median of two treatments per patient (range of one to three treatments). Child's score was different between groups. Of the VT patients treated, 67% had portal VT, 7% had cava VT, and 26% had both. There were no treatment-related deaths. There was no difference in complications among groups (p = 0.34). Treated patients without thrombosis had a median overall survival of 13.9 months versus 2.7 months for those treated with thrombosis and 5.2 months for the untreated group given best supportive care only (p = 0.01). CONCLUSIONS: SIR is safe in patients with HCC. Although SIR can be delivered with minimal morbidity, there might be no benefit for patients with VT. Continued emphasis on multimodality therapy in this population is needed to improve survival.

The use of self-expanding silicone stents in esophageal cancer care: optimal pre-, peri-, and postoperative care.

BACKGROUND: Preoperative nutritional supplementation, management of esophageal leaks, and postoperative anastomotic strictures still remain common problems in the management of esophageal cancer. Jejunal feeding tubes, total parenteral nutrition (TPN) with nasogastric suction, and repeated esophageal dilations remain the most common treatments, respectively. The aim of this study was to evaluate the use of removable silicone stents in (1) the preoperative nutritional optimization during neoadjuvant therapy, (2) the management of perioperative anastomotic leak, and (3) the management of postoperative anastomotic strictures. METHODS: Review of our prospectively maintained esophageal database identified 15 patients who had removable self-expanding silicone stents placed in the management of one of these three management problems from July 2004 to August 2006. RESULTS: Preoperative therapy: Five patients underwent initial stent placement in preparation for neoadjuvant therapy. Dysphagia relief was seen in 100% of patients, with optimal caloric needs taken within 24 h of placement. All patients tolerated neoadjuvant therapy without delay from dehydration or malnutrition. One stent migration was found at the time of operation, which was removed without sequelae. Perioperative therapy: Five patients developed delayed (>10 days) esophageal leaks that were managed with removable esophageal stent and percutaneous drainage (in three patients). All patients had successful exclusion of the leak on the day of the procedure with resumption of oral intake on the evening of procedure. All five healed leaks without sequelae. Postoperative therapy: Five patients developed postoperative anastomotic strictures that required dilation and placement of removable esophageal stent. The median number of dilations was 1 (range 1-2), with all stents placed for approximate 3 months duration. All patients had immediate dysphagia relief after stent placement. CONCLUSION: Removable esophageal stents are novel treatment option to optimize relief of symptoms and return the patients back to a more normal oral intake. Continued evaluation is needed to consider stent use as first-line therapy.

Prevention of anastrozole-induced bone loss with monthly oral ibandronate during adjuvant aromatase inhibitor therapy for breast cancer.

PURPOSE: The aromatase inhibitor anastrozole is a highly effective well-tolerated treatment for postmenopausal endocrine-responsive breast cancer. However, its use is associated with accelerated bone loss and an increase in fracture risk. The ARIBON trial is a double-blind, randomized, placebo-controlled study designed to evaluate the impact of bisphosphonate treatment on bone mineral density (BMD) in women taking anastrozole. EXPERIMENTAL DESIGN: BMD was assessed in 131 postmenopausal, surgically treated women with early breast cancer at two U.K. centers. Of these, 50 patients had osteopenia (T score -1.0 to -2.5) at either the hip or lumbar spine. All patients were treated with anastrozole 1 mg once a day and calcium and vitamin D supplementation. In addition, osteopenic patients were randomized to receive either treatment with ibandronate 150 mg orally every month or placebo. RESULTS: After 2 years, osteopenic patients treated with ibandronate gained +2.98% (range -8.9, +19.9) and +0.60% (range -9.0, +6.9) at the lumbar spine and hip, respectively. Patients treated with placebo, however, lost -3.22% (range -16.0, +4.3) at the lumbar spine and -3.90% (range -12.3, +7.2) at the hip. The differences between the two treatment arms were statistically significant at both sites (P < 0.01). At 12 months, urinary n-telopeptide, serum c-telopeptide, and serum bone-specific alkaline phosphatase levels declined in patients receiving ibandronate (30.9%, 26.3%, and 22.8%, respectively) and increased in those taking placebo (40.3%, 34.9%, and 37.0%, respectively). CONCLUSIONS: Monthly oral ibandronate improves bone density and normalizes bone turnover in patients treated with anastrozole.

Prolonged efficacy of a single dose of the bisphosphonate zoledronic acid.

PURPOSE: Bisphosphonates play a central role in the management of bone loss due to a range of disorders, including metastatic bone disease, cancer treatment-induced bone loss, and postmenopausal osteoporosis. With potent bisphosphonates, such as zoledronic acid, it may be possible to maintain efficacy with relatively infrequent administration. EXPERIMENTAL DESIGN: Sixty-six patients who were osteopenic at >1 year following curative cancer therapy received a single i.v. 4 mg dose of the bisphosphonate zoledronic acid. Bone mineral density (BMD) was measured using double-beam X-ray absorptiometry scan and the bone resorption marker N-telopeptide of type II collagen was determined using a chemiluminescence ELISA assay. RESULTS: The single dose of zoledronic acid induced mean increases in bone BMD at the lumbar spine of 3.1%, 5.2%, and 5.3% and at the total hip of 2.7%, 3.5%, and 4.3% after 12, 24, and 36 months of follow-up, respectively (P < 0.001 at all time points). By 36 months, 84% of patients had achieved increase in BMD at the spine and 90% at the hip. The mean percentage decrease in the bone resorption marker N-telopeptide was approximately 58% at 6 weeks and 42%, 33%, and 31% at 12, 24, and 36 months, respectively (P < 0.001). CONCLUSIONS: A single dose of zoledronic acid in patients with low BMD results in a sustained increase in BMD and a corresponding decrease in bone resorption. Very infrequent administration of zoledronic acid may have clinical benefits in terms of convenience, reduced toxicity, improved compliance, and cost.