Relationship Between Quality of Life and Health-Related Measures Including Symptoms, Biochemical Markers And Tumor Burden

s Presented at the 2 Annual Meeting of the North American NeuroEndocrine Tumor Society, October 2Y3, 2009, Charlotte, North Carolina An Open-Label, Phase II Study Evaluating the Safety and Efficacy of PTK787/ZK222584 in Patients With Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms Lowell B. Anthony, Maria M. Chester, Bernard J. Brown, Stacy L. Michael, Jacky R. Seward, M. Sue O_Dorisio, Thomas M. O_Dorisio. LSUHSC New Orleans, LA; University of Iowa, Iowa City, IA. Background: Vatalanib inhibits endothelial growth factor receptor (VEGFR) by binding to the intracellular kinase domain of all 3 VEGFRs. Neuroendocrine tumors (NETs) express VEGF receptors. Inhibiting VEGF with bevacizumab, sorafenib, and sunitinib reduced time to progression or tumor size in some NET patients (pts). To determine vatalanib_s tolerability and efficacy in NET pts, a trial was performed. Methods: Eligibility criteria included NET pts with biopsy-proven metastatic disease and rising biomarkers on somatostatin analog therapy. Eligible pts had measurable lesions, a KPS 9 60%, and normal hematologic, renal, and hepatic functions. A stable octreotide LAR dose, not exceeding 30 mg monthly, was required. Initial total daily dosing of vatalanib was 1,250 mg. Biochemical responses within a 90 day interval were the primary response criteria. Secondary endpoints included radiographic/scintigraphic scan changes and safety. Results: Twenty-four pts (12males) were enrolled between 5/20/05 to 5/28/09. The median age (range) was 60.4 (25Y74). Eighteen pts were evaluable for efficacy and safety. Four pts continue on therapy. One pt withdrew consent; 2 pts died of disease prior to first cycle initiation; 1 pt was allergic tovatalanib. Six pts required a 10Y28 day discontinuation for rising SGOT/SGPT, alkaline phosphatase, G2 proteinuria, G2 headache, and G3 nausea/vomiting. Resumption of vatalanib at 1,000 mg daily was well tolerated in 2 pts and 750 mg in another. One pt developed carcinoid crisis with fever, flushing, and rising 5HIAA. Grade 1 nausea occurred in 15 pts with antiemetics required for 4 pts. A partial (9 50% decrease) biochemical response occurred in 4 pts. The observed radiographic and scintigraphic responses in 16 pts have shown progressive disease in 6 and stable/minimal response in 10 pts. Accrual continues. Conclusions: Vatalanib is well tolerated in most pts and results in a 24% biochemical partial response rate in NET pts with rising biochemical markers on somatostatin analog therapy. Health-Related Quality of Life of Patients With Neuroendocrine Tumor Compared to the United States General Population Jennifer L. Beaumont, Zhimei Liu, Seung Choi, James C. Yao, David Cella. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, US Oncology Health Economics & Outcomes Research, Novartis Pharmaceuticals Corporation, GI Medical Oncology Department, MD Anderson Cancer Center, Houston, TX. Background: Health-related quality of life (HRQL) can be disrupted in patients with chronic illnesses such as cancer. The study evaluated the HRQL burden of patients with neuroendocrine tumor (NET), testing the hypothesis that NET patients have reduced HRQL compared to the general United States population. Methods: NET patients were invited via email to participate in an online, anonymous survey. This survey consisted of a brief set of demographic and disease-related items, the RAND-36 and the PROMIS-29, the latter two of which are standardized measures of HRQL with general population normative values available for comparison. Norm-based scores were calculated for all subscales, such that a score of 50 represents the mean of the general population (standard deviation = 10). For the anxiety and fatigue subscale, higher scores (9 50) represent worse outcome. Results are presented as means and 95% confidence intervals. Results: Data collection is currently ongoing but at the time of this writing 565 eligible participants have completed the survey. Demographics: 66% were female, 91% white, 3% Hispanic, 40% 60 years or older. 25% require some amount of bed rest during the day, 35% have diarrhea and 51% experienced at least one flushing episode in the past two weeks. NET patients demonstrated worse HRQL scores compared to the general population mean of 50 on all subscales of the RAND-36 and PROMIS-29. For example, mean scores (95% confidence interval) in NET patients were: physical function = 45.2 (44.4Y46.0); anxiety = 54.2 (53.4Y55.0); fatigue = 54.7 (53.8Y55.6); and general health = 40.0 (39.0Y41.0). Conclusion: In this preliminary evaluation of the survey results, NET patients reported worse HRQL outcomes compared to the general population on all subscales of the RAND-36 and PROMIS-29. Symptom management and/or psychosocial interventions may be warranted to ease the HRQL burden experienced by patients with NETs. Gluteal Intramuscular Injections: Techniques Associated With Successful Octreotide LAR Injection April E. Boyd, Colleen C. Leary, James P. Brook, Valentine G. Boving, Cecile G. Dagohoy, Linda L. DeFord, Jeana L. Garris, Jeannette E. Mares, Alexandria T. Phan, James C. Yao. Departments of Gastrointestinal Medical Oncology, the Gastrointestinal Center, and the Office of Performance Improvement, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX. Background: Gluteal intramuscular injection remains an important method for delivery of a variety of medications including octreotide LAR. In one study, only 32% of gluteal injections were delivered into the intramuscular space (Chan et al, Eur J Radiol. 2006). We examined nursing factors that are associated with successful gluteal intramuscular injections. Methods: Patients receiving intramuscular injection of octreotide LAR at the Gastrointestinal Center, University of Texas M. D. Anderson Cancer Center were identified. Pelvic CTs were reviewed for evaluation of injection success, measurement of injection depth, and skin to muscle depth. Results: 22 Nurses were interviewed. 251 intended intramuscular injections between 12/21/2005 and 6/25/2008 were evaluable by CT. 105 (42%) Were The Publication of Abstracts is Sponsored by NANETS and Molecular Insight Pharmaceuticals. TABLE 1. Self-Reported Parameters With Intramuscular Injection Self-Reported Parameter Group IM Success Rate P Indicators of experience Experience with IM injection Moderate 44% 0.008