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.

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.

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.

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.