Prevalence Of Autoimmune Comorbidities In Patients With Metastatic Melanoma In The United States

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8

Objectives: Natalizumab is an effective therapy for multiple sclerosis. Its most notable toxicity is progressive multifocal leukoencephalopathy (PML). The FDA mandated registry, TOUCH, focuses on reporting PML cases. SONAR identified an unusual case of natalizumab associated urethral melanoma and queried FDA databases for all natalizumab associated melanoma events reported to the FDA. We evaluated if safety reports were more complete among natalizumab associated melanoma cases when the safety report was reported from the TOUCH registry (“heavy TOUCH”), or when data from TOUCH was used in the safety report sent to the FDA (“light TOUCH”), or if no data from TOUCH was included in the safety report ( “no TOUCH”).  Methods: Case details were obtained from MedWatch reports: 2005-2014. A completeness score was developed, consisting of clinical (8 items), demographic (4 items), and pharmacy (3 items) - related items. Clinical items include melanoma site, existence of pre-existing nevi etc. Total completeness scores ranged from 0 (lowest) to 15 (highest). Optimal discriminant analysis (ODA) was used to compare completeness across TOUCH groups. As the TOUCH Registry is for the United States only, cases from outside the United States were evaluated separately.  Results:: Overall, 137 melanoma cases were identified in MedWatch. Of the US cases, 73% were categorized as light, 15% as heavy, and 13% as no TOUCH. All median clinical completeness scores were low: 2.0, 4.0, 3.5, and 4.0 for heavy, light, no TOUCH, and non-US cases, respectively. Statistical analysis revealed lower clinical completeness scores for heavy cases compared to the light cases (p< .0007).  Conclusions: FDA reports of natalizumab associated melanoma cases from the US generally contain 50% or less relevant clinical information. The “heavy TOUCH” of the FDA-mandated registry did not facilitate improved completeness of reporting of natalizumab-associated melanoma, reflecting the focus on PML for the TOUCH program. PCN9 Prevalence Of Autoimmune Comorbidities In Patients With Metastatic Melanoma In The United States Ma Q1, Shilkrut M2, Li M3, Barber BL1, Zhao Z1 Inc, Thousand Oaks, CA, USA, 2Amgen, Thousand Oaks, CA, USA, 3University of Massachusetts at Amherst, Amherst, MA, USA

1Amgen

A135

head & neck cancer (HR 2.44, 95%CI, 1.34-4.47; p= 0.004), musculoskeletal cancer (HR 5.74, 95%CI, 2.56-12.86; p< 0.0001), and atherosclerosis (HR 3.08, 95%CI, 1.12-8.41; p= 0.029).  Conclusions: Depression had a significant impact of health service utilizations in cancer patients. Clinicians and health systems should recognize the importance of providing care in cancer patients with depression and managing comorbid conditions. PCN11 Prevalence Of Cancer Types In Patients Attending Cenar Cancer Hospital Quetta, Pakistan ul Haq N1, Watan Pal A1, Nasim A1, Razaque G1, Riaz S1, Zeeshan M2 1University of Balochistan, Quetta, Pakistan, 2University of The Punjab, Lahore, Pakistan

Objectives: This study aimed to assess the prevalence of cancer types in patients attending CENAR cancer hospital Quetta, Pakistan. Methods: A retrospective study was conducted in CENAR hospital Quetta which is cancer hospital in the Balochistan. Data was obtained from the medical record of the hospital for period of 5 years that is from 2010 to 2015. Predetermined scheme of analyzing individual files of patients attending the hospital for the study period. All data was collected by using standardized data collection Performa. Data was analyzed and presented in the form of percentage and frequencies. All analysis was done by using SPSS20.  Results: During the study period a total of 6577 patients were registered in the hospital. The demographics result showed that majority of patients 1459 (21.43%) were from age group 41-50 years. Three thousand seven hundred and twenty-three (56.60%) were male. Number of patients diagnosed throughout the study period was dominated in year 2010 where 1449 (22.31%) patients. Fifteen hundred and thirty-four (23.3%) cases were from GIT Tumors followed by carcinomas of breast 762 (11.6%). Malignant lymphomas were 630 (9.6%). Skin cancer highlighted 609 cases (9.3%). Head and Neck tumors were 519 (7.9%). Hematological malignancies were recorded 466 (7.1%) cases  Conclusions: The study concluded that incidence rate of GIT tumors are highest among all cancer during the study period. Further investigation should be done to find out the cause of cancer so that better prevention should be done.

Objectives: Immunotherapies have advanced the treatment of metastatic melanoma (MM); however they are associated with frequent immune-related toxicities. As a result, patients with pre-existing autoimmune conditions were commonly excluded from clinical trials studying immunotherapies in metastatic melanoma. Since limited information is available on pre-existing autoimmune comorbidities in “real-world” patients with MM, we sought to estimate prevalence of autoimmune comorbidities and the change over time in this population.  Methods: Definitions of autoimmune disorders included in this study were obtained from the American Autoimmune-Related Diseases Association. Prevalence of autoimmune disorders and time trend over a period of 10 years from 2004 to 2014 were estimated in patients with newly diagnosed MM as well as in patients with newly diagnosed non-MM, and in the general population. Prevalence rates and trends were compared among these 3 populations to delineate the potential role of disease vis-à-vis time on prevalence trends. Data were obtained from MarketScan®, a large US claims database. Logistic regression analyses were performed to evaluate the relationship between risk factors and pre-existing autoimmune disorders in MM.  Results: A list of 147 autoimmune disorders was examined in this study. Among 12,028 patients with newly-diagnosed MM, the prevalence rate for autoimmune disorders increased 1.7-fold from 17.1% in 2004 to 28.3% in 2014 (P< 0.001). The prevalence rates were lower in patients with non-MM (11.7% in 2004 to 19.8% in 2014) and in the general population (7.9% in 2004 to 9.2% in 2014), but the rates increased 1.7- and 1.2-fold over time, respectively. Additionally, female, bone or gastrointestinal metastasis, and high comorbid disease burden were found to be associated with higher risk of autoimmune disorders.  Conclusions: Prevalence of autoimmune comorbidities is high and increases over time in patients with newly diagnosed metastatic melanoma. Comorbid autoimmune disorders should be taken into consideration when treatment decisions are made.

PCN12 Hypofractionated Radiotherapy For Low-Intermediate Risk Prostate Cancer: Clinical And Economic Evaluation In A Real-Life Setting

PCN10 A Pilot Study Using Electronic Medical Records To Evaluate The Mortality And Health Service Utilization In Cancer Patients With Depression At A Medical Teaching Oncology Center

PCN13 Rolapitant For Prevention Of Chemotherapy-Induced Nausea And Vomiting In Patients Receiving Moderately Emetogenic Chemotherapy In The United States: Subgroup Analysis From A Randomized Phase Iii Trial

Yeung P1, Vaida F2, Mausbach B1 of California San Diego, La Jolla, CA, USA, 2University of California San Diego, San Diego, CA, USA

1University

Objectives: The implementation of EMR allowed us to evaluate the impact of depression on cancer patients.  Methods: A retrospective review of EMR of cancer patients in UC San Diego Moores Cancer Center (2011-2013). All diagnoses were defined by ICD-9 codes at the date of cancer diagnosis. Cox proportional hazard analysis and negative binomial modeling were performed to evaluate predictors of mortality, number of emergency room (ER) visits, hospitalizations, readmissions and length of stay in the hospital (LOS). The analyses were adjusted for race, age of diagnosis with cancer, gender, number of cancers, cancer type, comorbidity conditions, status of metastasis, insurance types, and Charlson Comorbidity Index (CCI).  Results: 9429 cancer patients of whom 8.9% had depression were compared to non-depressed cancer patients. In patients with CCI >  6 (n= 558), depression did not increase mortality (HR 0.62, 95%CI, 0.32-1.23; p=  0.17). However, depression was a significant predictor for ER visits (incident rate ratio [IRR] 1.31, 95% CI, 1.03-1.67; p= 0.017), frequent hospitalization (IRR 1.36, 95%CI 1.09-1.71; p< 0.014) and longer LOS (IRR 1.34, 95%CI 1.05-1.71; p< 0.0001), and frequent readmission (IRR 1.44, 95%CI 1.03-2.00; p= 0.024). In cancer patients with CCI ≤  6 (n= 8871), depression increased ER visits (IRR 1.71, 95%CI, 1.53-1.90; p< 0.0001), hospitalization (IRR 1.70, 95CI%, 1.55-1.88; p< 0.0001), LOS (IRR 1.35, 95%CI, 1.21-1.50; p< 0.01), but not with readmission (IRR 1.05, 95%CI, 0.86-1.24; p= 0.24). Mortality did not increase with depression (HR 1.51, 95%CI, 0.72-1.84; p= 0.56) but increased with CCI (HR 1.58, 95%CI, 1.44-1.72; p< 0.0001), age of diagnosis (HR 1.02, 95%CI, 1.01-1.03; p= 0.003),

Hu J, Cury F, Aprikian A, Dragomir A McGill University Health Centre, Montreal, QC, Canada

Objectives: Hypofractionated radiotherapy (HypoRT) uses larger daily fractions and shortens the overall treatment time compared to conventionally fractionated radiotherapy (ConvRT). This can improve therapeutic outcomes in prostate cancer and reduce the costs associated with radiotherapy. The objective is to evaluate clinical outcomes and perform an economic evaluation of HypoRT versus ConvRT regimens.  Methods: The cohort consists of low- and intermediate-risk prostate cancer patients treated at the McGill University Health Center Radiation Oncology Department from Nov. 2002 to Jul. 2013. Biochemical failure was the main clinical outcome and defined as the nadir PSA level plus 2ng/ml. Kaplan-Meier analyses were performed to evaluate the time to clinical outcomes. Cox proportional hazards model was used to evaluate the association between the clinical outcomes of HypoRT versus ConvRT, adjusted for covariables.  Results: With a median follow-up of 90 months, the 8- year biochemical relapse-free survival rates were 93% for low risk patients treated with the HypoRT regimen, compared to 82% among intermediate risk patients receiving the HypoRT regimen, and to 67% for intermediate risk patients in the ConvRT group. A significant association was found between type of regimen and biochemical failure (HRHypo/Conv =  0.495; 95% CI 0.256-0.996). In addition, the cost estimates for the HypoRT regimen ranged from $5,718.80 to $6,254.00; compared to ConvRT, which ranged from $8,802.70 to $9,614.40.  Conclusions: This study highlights the potential therapeutic gains and cost savings of using a HypoRT regimen in patients with low and intermediate risk prostate cancer, versus ConvRT.

Schwartzberg LS1, Powers D2, Arora S2, Harrow B2, Schnadig ID3 Clinic, Memphis, TN, USA, 2TESARO, Inc., Waltham, MA, USA, 3Compass Oncology, US Oncology Research, Tualatin, OR, USA 1The West

Objectives: Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect, impairing quality of life (QoL) and increasing healthcare resource utilization. In a global phase 3 trial in patients administered moderately emetogenic chemotherapy (MEC), addition of rolapitant, a long-acting, selective neurokinin-1 receptor antagonist, to standard antiemetic therapy improved CINV control. To evaluate rolapitant outcomes in US medical practices, this post-hoc subgroup analysis assessed US patients administered MEC (n= 278).  Methods: Patients were randomized 1:1 to receive a single 180-mg oral dose of rolapitant or placebo ~1-2 hours before chemotherapy on day 1; all patients received 2 mg oral granisetron plus 20 mg oral dexamethasone 30 minutes before chemotherapy on day 1 and 2 mg oral granisetron once daily on days 2 and 3. Endpoints included complete response (CR; no emesis or use of recuse medication) in the delayed (> 24-120 hours), acute (≤ 24 hours), and overall (0-120 hours) phases post-chemotherapy. Healthrelated QoL was assessed using the Functional Living Index-Emesis (FLIE) questionnaire.  Results: The CR rate was significantly higher with rolapitant (n= 139) than with control (n= 139) in the delayed phase (66.2% vs 51.1% [P= 0.011]), acute phase (89.2% vs 77.7% [P= 0.010]), and overall phase (64.0% vs 47.5% [P= 0.006]). Rolapitant significantly improved QoL versus control based on mean FLIE total scores (117.7 vs 108.1 [P< 0.001]) and nausea and vomiting domain subtotal scores (56.5 vs 51.2 [P= 0.002] and 61.2 vs 56.9 [P< 0.001], respectively). A greater proportion of patients