Efficacy and Safety of Sunitinib as First-Line Treatment in Patients with Metastatic Renal Cell Carcinoma: Systematic Review

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PCN197 Predictors of NGS Testing in Metastatic Colorectal Cancer Biltaji E1, Stenehjem D1, Schiffman J2, Brixner D3 1University of Utah, Pharmacotherapy Outcomes Research Center, Program in Personalized Health, Salt Lake City, UT, USA, 2University of Utah, Salt Lake City, UT, USA, 3Personalized Health Care, University of Utah Health Sciences Center, Salt Lake City, UT, USA

Objectives: Guidelines recommend routine KRAS testing among patients with metastatic colorectal cancer (mCRC) to determine eligibility for targeted therapies. Genomic profiling, using next generation sequencing (NGS) based technology, identifies multiple mutations simultaneously. Understanding potential predictors of NGS testing is crucial to assess clinical utility of the test.  Methods: Electronic health records and tumor registry data of mCRC patients were accessed. Baseline characteristics of patients tested with NGS panel or KRAS mutation detection test (timeframe: Jan 1, 2010 – April 10, 2015) were compared. Colorectal cancer was defined by ICD-O codes for site and histology. Metastatic stage was identified using ICD-9 codes for metastases, initial cancer stage reported, or chemotherapies received. Analysis was limited to mCRC diagnosis after Jan 1st, 2010. Predictive univariate logistic regression models were used to control for potential confounding.  Results: Of 584 patients meeting eligibility criteria, 60 patients were NGS ± KRAS tested and 140 patients were KRAS-only test. Median (mean) age at diagnosis was 61(58) year for NGS group vs. 57(58) year in KRAS-only group (p= 0.399). For NGS and KRAS-only groups, majority of mCRC patients were white (80% and 81%, respectively; p= 0.772), males (59% and 52%, respectively; p= 0.403), and initially diagnosed at stage IV (53% and 65%, respectively; p= 0.490). Metastatic sites or their number were not different between groups (p= 0.348 for number of metastatic sites), but year of mCRC diagnosis was different (p< 0.0001). Univariate analysis showed increased use of NGS panels with more recent diagnoses (p < 0.0001).  Conclusions: Patients tested with NGS were similar to KRAS-only tested patients. The only predictor of NGS testing was the year of mCRC diagnosis. As NGS testing cost is almost 10 times KRAS testing cost, an ongoing cost-effectiveness analysis is being conducted to assess the value of NGS testing in mCRC patients. PCN198 Temporal Trends in Utilization of Pancreatectomy Procedures in New York State: 1999-2014 Nair AA1, Gumustop SB1, Racz MJ1, O’Grady TJ1, Polimeni JM1, Gumustop B2, Meek PD1 1Albany College of Pharmacy and Health Sciences, Albany, NY, USA, 2Albany Gastroenterology Consultants, Albany, NY, USA

Objectives: Pancreatic resection is performed for a wide range of malignant (e.g., pancreatic cancer) and non-malignant indications (e.g., traumatic injury). This research aims to determine the temporal trends in utilization of the three most commonly used pancreatectomy procedures (Whipple, distal pancreatectomy and total pancreatectomy) in New York State for a 16-year period from 1999-2014.  Methods: Inpatient administrative data from the New York Statewide Planning and Research Cooperative System (SPARCS) was utilized to identify cases of pancreatic surgery based on ICD-9-CM procedure codes. Residents of New York State aged 18 years and over were eligible for inclusion in the analysis. Age-sex standardized rates (per 1 million adult residents) were calculated to evaluate temporal trends in surgical utilization for each type of pancreatectomy. Rates were stratified by malignancy indication. Utilization in 1999 was compared with utilization in 2014 to calculate a percentage change (Δ ) during the study period.  Results: There were 15,409 cases that matched our inclusion criteria. For malignancy (n= 11,119), increase in rates of Whipple procedures (28.4 to 38.5, Δ = 35.6%), distal pancreatectomies (8.1 to 13.4, Δ = 53.6%) and total pancreatectomies (1.4 to 2.1, Δ = 65.1%) were observed from 1999 to 2014. Similarly for non-malignancy (n= 4,290), increase in rates of Whipple procedures (6.4 to 9.1, Δ = 42.9%), distal pancreatectomies (8.5 to 12.6, Δ = 48.0%), and total pancreatectomies (0.9 to 1.1, Δ = 20.4%) were observed from1999-2014.  Conclusions: A gradual increase in utilization was observed for each of the three pancreatectomy procedures over the study period. Earlier diagnosis of malignant tumors as a result of improved diagnostic procedures such as endoscopic ultrasound guided-fine needle aspiration and improved neoadjuvant chemotherapy using FOLFIRINOX and nabpaclitaxel-gemcitabine for tumor down-staging pre/post-resection are plausible explanations that may explain the increasing trends. Moreover improved operative techniques and reduced complication rate may have resulted in increased use for non-malignant indications like cystic neoplasms and pancreatitis. However further exploration of these and other factors is warranted. PCN199 Marital Status, Stage of Diagnosis, and Survival in Younger Women with Breast Cancer Hinyard L, Schwartz T Saint Louis University, St. Louis, MO, USA

Objectives: Marital status has been shown to affect outcomes in patients with multiple types of malignance, including breast cancer in women over the age of 65. The purpose of this study is to investigate the effect of marital status on diagnosis, treatment, and survival of women with breast cancer under the age of 65.  Methods: The Survey of Epidemiology and End Results (SEER) database was queried for all women ages 25-64 with a diagnosis of invasive breast cancer from the years 2004-2009. Chi-square analysis was used to examine the association of marital status and age, race, stage, estrogen receptor positivity, tumor size, tumor grade, and choice of breast operation. Logistic regression was used to predict late stage diagnosis by marital status and Cox proportional hazards models were used to compare survival by marital status classification adjusting for age, race, AJCC stage, and ER positivity.  Results: Unmarried women were more likely to be older, Black, diagnosed at a later stage, and with larger tumors. There was no difference in choice of breast surgery between married and unmarried women. Unmarried women were 1.18 times more likely to be diagnosed at a later stage (stage 2 or higher) than married women after adjusting for age, race, and ER positivity (OR =  1.18, 95% CI 1.15, 1.20). Unmarried women were 1.33 times more likely to die compared

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to married women after adjusting for age, race, AJCC stage, and ER positivity (HR 1.33, 95% CI 1.29, 1.37).  Conclusions: Unmarried women are more likely to present with more advanced disease and have a higher risk of death from breast cancer. Attention should be paid to marital status in young women at the time of diagnosis. Unmarried women may benefit from additional counseling, psychosocial support, and case management to ensure their overall outcomes are optimized. PCN200 Breast Cancer Hospital Discharges in Chilean Women: 10 Years Analysis Gutierrez-Ardila MV, Solar Tobar F Pfizer Chile S.A., Santiago, Chile

Objectives: Breast cancer is the most frequently diagnosed cancer and is the leading cause of death among Chilean women. Health policies implemented to improve access to mammography were incorporated in 2005, which has led to detecting more cases of breast cancer at earlier stages. This analysis characterizes hospital discharge patterns over the last 10 years among Chilean women with breast cancer.  Methods: Annual governmental reports [Superintendent of Health] (20052014) were analyzed to examine hospital discharge patterns among the Chilean population with breast cancer. Analyses included examining the number of hospital discharges overall and for women only, number of discharges due to breast cancer in women, hospital discharge rate per 100,000 women, average days of hospitalization per discharge, and average discharges per patient-year.  Results: Tumors are the leading cause of hospitalization in Chile due to disease reported in the past ten years (12.5% to 14.3% of all causes); most of the reported hospital discharges occurred in women (53,6% to 59,0%). Five to seven percent of all female hospital discharges are due to malignant tumors; most of these are for breast tumors (37,3% to 42,6%). For the overall female population, the rate of hospital discharges due to breast cancer has increased from 336 per 100,000 women in 2005 to 641 per 100,000 women in 2014. For women with breast cancer between 45 and 64 years and > 65 years, the hospital discharge rate increased to 1,702 and 2,275 per 100,000, respectively. For the whole population (male and female) with breast cancer, the average hospital length-of-stay per discharge was 2,0 days and the average number of hospital discharges was 3,5 per patient-year.  Conclusions: The hospital discharge rate per 100,000 women due to breast cancer has an upward trend and has doubled in the last 10-years. Greater investment in healthcare resources may be needed to treat this patient population appropriately. PCN201 Efficacy and Safety of Sunitinib as First-Line Treatment in Patients with Metastatic Renal Cell Carcinoma: Systematic Review Huerfano C1, NinoNiño CP1, Davila F1, Reyes JM2, Diaz JA3 1Universidad Nacional de Colombia, Bogota, Colombia, 2Pfizer SAS, Bogota, Colombia, 3Universidad Nacional de Colombia, Bogotá D.C., Colombia

Objectives: To review the efficacy and safety of sunitinib in comparison with other drugs for first-line treatment in metastatic renal cell carcinoma.  Methods: We performed a systematic review that evaluated sunitinib compared to bevacizumab plus interferon alfa, pazopanib, and sorafenib in patients with metastatic renal cell carcinoma without previous treatment. The search was performed using Medline, EMBASE, Cochrane, LILACS, and DARE databases and was restricted to randomized clinical trials (RCT). The RTCs were selected and extracted, and risk of bias was assessed, using the Cochrane checklist by two researchers independently. Bayesian mixed treatment comparison (MTC) method was applied for the pairwise comparisons among treatments. The outcomes were: overall survival (OS), progression free survival (PFS), response rate and serious adverse events (SAE).  Results: We found 166 references, from which 5 RCTs met the inclusion criteria. The principal comparator in the studies was interferon alfa with the exception of one study (Motzer 2013) with a direct comparison between sunitinib and pazopanib. For PFS, sunitinib showed better results than bevacizumab plus interferon alfa (HR 0.79; 95% CrI 0.66-0.96), and sorafenib (HR 0.60; 95% CI 0.44-0.84); PFS in comparison to pazopanib was similar (HR 0.94; 95% CrI 0.81 – 1.10). Sunitinib was similar in terms of OS to bevacizumab plus interferon alfa (HR 0.93; 95% CrI 0.76 – 1.13), and pazopanib (HR 0.91; 95% CrI 0.78 – 1.06). In terms of proportions of SAE, sunitinib was safer than bevacizumab plus interferon alfa (OR 0.35; 95%CrI 0.12 – 0.97), tends to be safer but without statistically significant difference than pazopanib (OR 0.76; 95% CrI 0.33-1.74), and similar than sorafenib (OR 1.03; 95% CrI 0.25 -4.28).  Conclusions: The MTC suggests that sunitinib as first line of treatment of metastatic renal cell carcinoma is a reliable option due to its efficacy and safety profile compared with other alternatives. PCN202 A Multi-Criteria Decision Making Approach for Selecting an Optimal Therapy for Metastatic Colorectal Cancer Adunlin G1, Diaby V2, Campbell ES3, Xiao H4, Montero AJ5, Dranitsaris G6 1Virginia Commonwealth University, Richmond, VA, USA, 2Florida A & M University, Tallahassee, FL, USA, 3Florida A&M University, Tallahasse, FL, USA, 4University of Florida, Gainesville, FL, USA, 5Cleveland Clinic, Cleveland, OH, USA, 6Augmentium Pharma Consulting Inc., Toronto, ON, Canada

Objectives: The decision-making process for selecting optimal cancer therapy has become more complex due to several factors including the proliferation of therapy options, variations in sequence, timing of therapy, different side-effect profiles, and rising cost. Such decision problems are suited to the use of Multi-criteria Decision Analysis (MCDA).While MCDA has practical implications for structuring the decision-making process, the method has not yet been fully developed in the healthcare setting. This study assesses the feasibility and benefits of using MCDA for selecting optimal cancer therapy. Methods: A case study for the selection the optimal monoclonal antibody combination for the first-line therapy of patients with Kirsten Rat Sarcoma Virus Oncogene Homologue gene (KRAS) wild-type metastatic colorectal cancer (mCRC) was used for the application. This application details the main