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427 Background: Data on HCRU and costs in US UC patients treated with ICIs is in its infancy, as there is little information by LOT or focused on irAEs due to ICI use. In addition, the relationship between irAEs and mortality is controversial, with some studies suggesting lower risk of mortality in pts with irAEs, whereas others have found no association between irAEs and mortality. We assessed the associations of 1) irAEs and 2) LOT with HCRU, costs, and mortality in UC pts treated with ICI monotherapy. Methods: This retrospective cohort study used administrative claims data linked with mortality data from the National Death Index and Social Security Death Index to identify US commercial and Medicare Advantage plan members with UC treated with ICI monotherapy between 1 Sep 2014 and 30 Apr 2019. The LOT number of ICI therapy was captured. Twenty-one irAEs were chosen a priori based on ASCO and NCCN guidelines and clinical input. Based on ICD codes from claims, newly occurring irAEs were captured from ICI initiation to the earliest of 6 months after initial ICI LOT ended, start of new treatment, death, disenrollment, or 30 Apr 2019; HCRU and costs were assessed during same time. Using Cox regression with ICI LOT and time-varying irAEs as the exposures, we computed adjusted hazard ratios (HRs). Lin’s regression analysis was used to calculate adjusted 6-month all-cause costs by irAE. Results: Among UC pts treated with ICI monotherapy (N=417; mean age 74 ± 10 years; 72% male; 17% received prior systemic steroids; 32% initiated ICI as LOT 1, 43% as LOT 2), 22% (n=90) had an irAE. Pts who received ICIs as 2L therapy were 1.5 (95% CI: 1.1-2.0) and 1.7 (95% CI: 1.2-2.4) times more likely to have an all-cause ER visit and inpatient stay, respectively, than those who received 1L. There was no difference in mortality risk between 2L and 1L subgroups (HR, 1.2 [95% CI: 0.9-1.6]). Pts with irAEs had a 60% higher risk of an all-cause ER visit (95% CI: 1.0-2.5) and more than double the risk of an all-cause inpatient stay (HR, 2.6 [95% CI: 1.7-4.0]) than pts without irAEs. Pts who experienced an irAE had higher mean all-cause healthcare costs over 6 months vs those without irAEs ($98,415 vs $75,300; p

e19319 Background: Prostate cancer (PC) is the most common cancer among men in the United States. Once the disease progresses to mCRPC, initial castration modalities may not be sufficient. This real-world data study describes the treatment patterns and pharmacy costs of US-insured patients with mCRPC. Methods: Adult males in an administrative claims database who had ≥1 claim for PC (ICD-9: 185 or 233.4; ICD-10: C61 or D075), had undergone pharmacologic or surgical castration, and had a code for metastatic disease during the identification period were included in the analysis. A minimum of 6 months of continuous enrollment (CE) pre- and post-index date (first metastatic claim) was required. Patients with metastatic claims at baseline were excluded. Patients were followed until the earliest of death (unless prior to 6-month CE), end of study period, or disenrollment. Claims-based algorithms were used to identify locally advanced and distant mCRPC patients and lines of therapy (LOT). The entire study period (baseline period through follow-up) was January 2008-March 2018. Results: 3690 patients with mCRPC were identified, of which 3150 received at least one LOT; 85.4% had ≥1 LOT, 69.4% had ≥2 LOTs, and 50.7% had ≥3 LOTs following metastatic diagnosis (Table). The average duration of treatment was similar across groups: 83.8, 86.5, 71.7, and 70.2 days for LOTs 1–4, respectively. The five most common LOTs were leuprolide (36.6%), bicalutamide-leuprolide (6.6%), abiraterone (5.9%), bicalutamide (5.0%), and enzalutamide (4.7%). Mean monthly per-patient pharmacy costs increased with each LOT ($2683, $2654, $2911, $2924, $3611, for LOTs 1–5, respectively). Conclusions: This is the first study to examine treatment patterns and drug costs of patients with mCRPC. Given the large number of LOTs this population moves through and the increasing costs associated with each, the development of more efficacious novel therapies for use earlier in the metastatic treatment regimen to prolong life is warranted. [Table: see text]

e17017 Background: Anti-PD-1/PD-L1 agents are US FDA-approved for patients with advanced or metastatic UC, but limited information exists on real world irAEs among this patient population. We examined the rates and time to onset of select irAEs in UC patients receiving PD-L1s vs PD-1s in the real world. Methods: This observational study included US commercial and Medicare Advantage health plan members from Optum Research Database with UC and treated with a PD-1 or PD-L1 agent between 01-Sep-14 and 30-Apr-19. Baseline characteristics were assessed ≤ 6-months prior to the first claim for anti-PD-1/PD-L1. 21 irAEs were chosen a priori based on the ASCO clinical guideline on irAE management, clinical input, frequency, and cost of treatment. Patients were followed for newly occurring irAEs, based on claims ICD codes, during the PD-1/PD-L1 therapy and up to 180 days after if no new treatment, study period end, death, or disenrollment. Kaplan-Meier method was utilized to calculate time to onset of irAEs. Results: The study included 240 patients receiving PD-L1s and 317 receiving PD-1s. Baseline demographics were similar (Table). The most common irAEs were 1) thyroid disorders, 2) impaired ventricular function with heart failure and vasculitis, 3) rash, and 4) nephritis. UC patients receiving PD-L1s had a lower rate of irAEs vs PD-1s, mainly driven by lower rates of hematologic and endocrine toxicities (Table). UC patients receiving a PD-L1 also had longer time to irAE onset (p-value = 0.05). Conclusions: UC patients receiving PD-L1s had a lower incidence rate of irAEs and longer time to irAE onset than patients on PD-1s. Findings suggest patients receiving PD-1s may require more intense monitoring for irAEs than patients taking PD-L1s. [Table: see text]

e20655 Background: Chemotherapy and immunotherapy (IO) are associated with increased overall survival in patients with mNSCLC, yet real-world data on AE-associated healthcare utilization are sparse. This study assessed incidence and utilization associated with AEs among patients initiating first-line treatment for mNSCLC with IO, IO with chemotherapy (IC), or chemotherapy alone (CH). Methods: Data were claims from commercial and Medicare Advantage patients (Jan 2008-Feb 2018). Inclusion criteria were mNSCLC, health plan enrollment for ≥6 months pre- (baseline) and ≥1 month post-index date; initiation of recommended systemic therapy for mNSCLC. Excluded were targeted or small-cell lung cancer therapy, and baseline surgery or other systemic therapy. AE incidence and healthcare utilization were measured from start of 1st line therapy until earliest of start of 2nd line therapy or 180 days. AEs evaluated included hematologic, GI, endocrine, infections, infusion reactions, muscle, neurological, and respiratory. Results: Cohorts were 8,818 CH, 482 IO, and 412 IC. Mean age was older for IO (72 yrs, vs. 69 IC, 68 CH; P < 0.001). IOs used were atezolizumab (n = 12), nivolumab (n = 148), and pembrolizumab (n = 673). Common chemotherapies were carboplatin (74%), pemetrexed (30%), and paclitaxel or etoposide (22%). Overall, 74% had ≥1 AE; incidence rate ratios (IRR) vs. IO (95% CI) were IC 1.36 (1.15-1.60) and CH 1.43 (1.28-1.61). Frequent AEs were blood conditions (43%), GI (32%), and infections (29%). IRR vs. IO included infections (1.94 CH), GI (1.71 IC, 1.90 CH), anemia (4.05 IC, 5.68 CH), leukopenia (5.69 IC, 22.28 CH), and thrombocytopenia (3.70 CH). CH had lower rates vs. IO for hyperthyroidism (2% IO; IRR 0.16 CH) and hypothyroidism (12% IO; IRR 0.19 CH). AE overlaps with infection were common; 61% of patients with infection had a hospitalization that involved both infection and another AE. AE-associated visits varied by cohort; ambulatory: 46% (IO), 50% IC, 61% CH; ER: 25% IO, 27% IC, 30% CH; inpatient: 29% IO, 35% IC, 37% CH (P < 0.05 for all CH vs IO). Conclusions: AE-associated visits in mNSCLC were lower for IO-treated than for CH or IC-treated patients.

6570Background: Cancer is the second leading cause of death in the United States and also one of the most expensive diseases to treat. End of life care is often low in quality despite the availabil...

e16539 Background: SREs are associated with increased mortality and costs for mCRPC patients. The impact of mCRPC oral therapies on SREs is not well understood in the real world. This study examined the occurrence of and health care costs associated with SREs among mCRPC patients treated with abiraterone acetate + prednisone (ABI) or enzalutamide (ENZ). Methods: A retrospective study of a large national health claims database identified patients initiated on ABI or ENZ from 9/2012- 6/2015. Patients included had: ≥1 claim with prostate cancer diagnosis (ICD-9-CM 185.x) from 6 mo. pre- to 30 days post-index; ≥6 mo. pre- + ≥3 mo. post-index health plan enrollment. Index was date initiated on first oral therapy (ABI/ENZ). SREs (spinal cord compression, radiation to bone, pathological fracture, bone surgery) were assessed and health care cost calculated for patients with/without SREs in baseline/follow-up. Descriptive analyses and Cox proportional hazards examined SREs; generalized linear models assessed costs. Models adjusted for ABI/ENZ, age, region, baseline comorbidities, bone/brain/visceral metastases, docetaxel, and statin use. Results: The table below summarizes unadjusted results. Total all-cause per patient per month (PPPM) costs of 1,516 patients were highest for those with follow-up SREs. A significant difference in cost exists when comparing across all groups. Among patients without baseline SREs, adjusted analysis found greater hazards of follow-up SREs for baseline bone metastases (HR: 1.62, P = 0.003), baseline visceral metastases (HR: 1.68, P < 0.001), prior docetaxel (HR: 1.46, P = 0.004), and ENZ (vs. ABI) as first treatment (HR: 1.35, P = 0.013). Patients with follow-up SREs (with/without baseline SREs) had 19% higher adjusted costs compared to those without baseline or follow-up SREs (P < 0.001 each). Conclusions: SREs were common among mCRPC patients and associated with a significant financial burden. [Table: see text]

e16534 Background: mCRPC patients are likely to receive oral therapies such as ABI or ENZ prior to hospice care. Payers and clinicians perceive hospice care as improving the quality of life for advanced prostate cancer patients dying of cancer, but literature suggests that it may be underutilized. A previous study found a longer time to starting hospice for patients initiated on ABI (vs. ENZ) with no significant difference in time spent in hospice. Understanding the active-treatment period prior to hospice may shed light on the overall burden of treatment without discounting the benefits of hospice. This study examined total pre-hospice per patient per month (PPPM) costs among mCRPC patients who utilized hospice care and treated with ABI or ENZ. Methods: A retrospective study of a large national health claims database identified patients initiated on ABI or ENZ from 09/2012 to 06/2015. Patients included had: ≥1 claim with a prostate cancer diagnosis (ICD-9-CM 185.xx) from 6 mo. pre- to 30 days post-index; ≥6 mo. pre- and ≥3 mo. post-index health plan enrollment. Index was date initiated on first oral therapy (ABI/ENZ). The subset of patients who entered hospice care were identified. Descriptive analyses assessed total PPPM costs (pharmacy, ambulatory, ER, inpatient, other medical costs) for subset of pre-hospice patients and all patients. Generalized linear model (GLM) assessed adjusted pre-hospice costs. Since the GLM used a log-link function with cost as a dependent variable, results are interpreted as a ratio of costs. Results: Among 1,516 mCRPC patients, 213 had utilized hospice care (ABI: 161, ENZ: 52). Total pre-hospice PPPM cost was greater for patients initiated on ENZ (ENZ = $19,485 ABI = $13,252; p = 0.048). Adjusted analysis found a 25.8% greater PPPM cost for those patients (Cost Ratio = 1.26, p = 0.038). Among all 1,516 patients, total all-cause PPPM cost was higher in ENZ but not statistically significant (ENZ = $11,268 ABI = $10,520; p = 0.090). Total prostate cancer related PPPM cost was statistically significant (ENZ = $10,327 ABI = $9,477, p = 0.038). Conclusions: Total pre-hospice PPPM cost is 26% lower for mCRPC patients initiated on ABI vs. ENZ.

24 Background: Impact of strategies for evaluating value and quality of cancer care may vary for patients with metastatic tumors, particularly for strategies considering lines of treatment therapy as distinct events. To aid in evaluating the value and quality of care in patients’ overall trajectory of disease, this study examined disease progression, mortality, hospice, and treatment patterns in patients (pts) with metastatic breast (mBC), lung (mLC), and colorectal cancers (mCRC). Methods: Included were commercially insured and Medicare Advantage adults from a large US health plan administrative claims database (2007-2014); pts had ≥ 2 claims for BC, CRC, or LC, and ≥ 2 claims for metastases. Index date was defined as the first post-metastatic systemic anti-cancer therapy (TX). Health plan enrollment for 6 mo pre- and post-index date was required; pts with < 6 mo of follow-up due to death were included. Pts with other primary cancers were excluded. A line of therapy (LOT) algorithm was developed and outcomes assessed over a variable follow-up. Progressive disease (PD) was defined as: start of a new LOT, where 1) previous LOT duration > 60 days, and 2) ≥ 1 imaging/lab test occurred between previous LOT and new LOT; receipt of hospice care; or death. Results: Among 7070 mBC, 4767 mCRC and 6994 mLC patients, 73%, 72%, and 84% respectively progressed during the study period (incidence rates: 7, 7, and 13 per 10-pt-years). Mean (median) time in months to PD was 9.5 (6.5) for mBC, 9.0 (7.0) for mCRC and 6.3 (5.0) for mLC. For all cancers, median number of LOT over 1 year was 2, with means of 1.8 (mBC), 1.7 (mCRC), and 1.7 (mLC). Compared to patients without PD, patients with PD had shorter LOT1. Mortality was highest among mLC patients (50%) compared to mCRC (27%) and mBC (22%), with rates per 100-pt-years of 50, 16, and 11 respectively. Hospice rates varied by tumor type. Conclusions: The high level of progression and use of multiple lines of therapy in the metastatic setting suggests a need to delay progression with effective treatments for breast, lung, and colorectal cancers. The value and quality of cancer care should be evaluated across the entire span of patients’ disease.

e11504 Background: Although clinical outcomes have been described for patients with early versus late recurring metastatic breast cancer, little information is available on the impact of the timing...

164 Background: National Comprehensive Cancer Network breast cancer guidelines suggest sequencing of systemic therapy. This study examined sequencing of endocrine and chemotherapy treatments to better understand real-world treatment patterns for HR+/HER2- advanced breast cancer. Methods: A proprietary clinical cancer database with physician-reported clinical data on patients with breast cancer was linked to medical and pharmacy claims (2008-2012) from a national US health plan. Study patients had HR+ and HER2- status. Advanced cancer cohorts were defined: stage III (SIII) or IV (SIV) at initial diagnosis, or developed metastases following initial diagnosis (MET). Index date was the first date of advanced cancer diagnosis or date of metastases following initial diagnosis. Health plan enrollment for 3 months pre- and ≥ 3-months post- index date was required; patients who died within 3 months after index date and were continuously enrolled were retained. A 3-month baseline period assessed prior treatment; a variable follow-up (until disenrollment or 31 Oct 2012) assessed patterns of endocrine and chemotherapy treatments following index date. Results: A total of 954 breast cancer patients met study inclusion criteria and were HR+/HER2- with ≥ 3 months of continuous enrollment after index date, with 369 of the 954 (38.68%) SIII, 117 (12.26%) SIV, and 469 (49.16%) MET patients. In the study population, 83.65% were treated with endocrine therapy, starting an average of 179 days after index date. A total of 80.29% were treated with chemotherapy, starting an average of 53 days following the index date; 65% of patients initiated chemotherapy after index date without prior endocrine treatment. Rates varied by cohort: 90% of SIII, 57% of SIV, and 48% of MET patients had no evidence of endocrine treatment prior to initiating chemotherapy. Conclusions: This study found large proportions of HR+/HER2- advanced breast cancer patients initiated chemotherapy without prior endocrine therapy. Further investigation of patient characteristics and outcomes by therapy sequencing patterns will help illuminate the extent to which patterns adhere to NCCN guidelines.

6063 Background: Differences in BC outcomes have been noted between rural and urban women. The influence of tumor biology vs treatment factors as the driver of these differences remains unclear. The Oncotype Dx 21-gene assay RS predicts distant recurrence risk for HR+BC; a RS>18 indicates possible chemotherapy benefit. We assessed rural vs urban differences in RS and therapies received (endocrine therapy; chemotherapy for RS>18). Methods: Retrospective chart review was conducted on BC pts diagnosed 2005–2010 with a 21-gene assay RS. Stage, grade, medications and receptor status were abstracted; RS information was obtained from Genomic Health. Rural-Urban Commuting Area (RUCA) codes defined rural vs urban status. Comparisons between rural vs urban pts were made using two-sample tests, chi-square or Fisher’s exact test for discrete data such as RS (≤ 18 vs > 18), stage and ER status. T- or Wilcoxon rank sum test were used for continuous data (RS 0-100 and age.) All tests were at a two-sided significance level of 0.05. Results: Of 495pts with RS, 488 had RUCA codes (91% white, 61% postmenopausal). For rural vs urban pts, mean RS was 18 vs 19, p=0.15. The table shows univariate analysis for other predictors. For treatment, 321/354 (97%) rural vs 118/134 (94%) urban pts started endocrine therapy (p=0.2). For RS>18, 17/55 (31%) rural vs 83/165 (50%) urban pts received chemotherapy (p=0.02, Chi-square test). Conclusions: Rural pts did not have significantly different RS compared with urban pts, but received significantly less chemotherapy for RS>18. This suggests that for HR+ BC, rural vs urban discrepancies may be explained in part by treatment factors. We suggest prospective comparison or confirmation in another cohort. [Table: see text]

555 Background: Obesity at diagnosis has been associated with poorer overall survival in BC patients. The Oncotype Dx 21-gene assay RS has been shown to predict the risk of distant recurrence in estrogen receptor (ER) positive BC. This study aimed to evaluate if an association exists between body mass index (BMI) and RS. Methods: Retrospective chart review of patients (pts) with BC diagnosed 2005-2010 and a 21-gene assay was performed. Risk factors including BMI, hormone use, and menopausal status were collected as well as tumor characteristics such as ER/PR/HER2 status, stage, and grade. Univariate analysis of the association between BMI level (18), stage (I vs II), and grade (1 vs 2 vs 3) was conducted using Chi square test. Correlation of BMI with RS (0-100) was also assessed via Spearman’s correlation. All tests were at a two sided significance level of 0.05. Results: Of 495 pts with a RS value, 482 had a BMI within 6 months of diagnosis. Median BMI was 27.7 kg/m2 (range 17-63). BMI for pts presenting with stage 2 disease is significantly higher (30±6.9) than those with stage 1 (29±7.8), p=0.04 (Wilcoxon rank sum test). No association was found between BMI level and stage, grade or RS. See Table. Mean RS was 18.8 vs 18.2 (BMI

563 Background: Observational studies suggest that EHU, such as oral contraceptive (OCPs) or postmenopausal hormone replacement therapy (HRT), increases the risk of developing BC. However, the prognosis of women taking EHU compared to nonusers remains controversial. The Oncotype Dx 21-gene assay RS predicts the distant recurrence risk for early stage, HR+ BC. We assessed RS in patients (pts) on EHU at diagnosis (users) vs nonusers. Methods: Retrospective chart review was conducted on BC pts with a RS, diagnosed 2005–2010. Stage, grade, estrogen (ER), progesterone (PR) and HER2 receptor status were abstracted. Manual review of medications, as well as electronic data pull within ≤5yrs of diagnosis, defined users as pts on EHU within 1 yr of diagnosis for ≥1 yr. Nonusers had been on EHU > 5 yrs before diagnosis or never. Comparisons between EHU users and nonusers were made using two-sample tests; chi-square or Fisher’s exact test for discrete data such as stage and ER status and t-test or Wilcoxon rank sum test for continuous data such as RS. All tests were at a two-sided significance level of 0.05. Results: 495 pts had RS. EHU was documentable for 475, 77 were using exogenous hormone at diagnosis. Type of hormone use included systemic HRT (48%), OCPs (36%), other (4%), and unknown (12%). For users vs nonusers, mean RS was 17 vs 19, (p=0.007, t-test). See table for other predictors. Conclusions: Prior study shows21-gene assay predict distant recurrence risk for HR+BC. In our study, an association existed between EHU and lower RS, suggesting that BC developing on EHU may have less risk of recurrence. Prospective evaluation is warranted. [Table: see text]

e16586 Background: Little is known about real-world usage of TPO-RAs and treatment patterns for patients with cITP. Methods: Using medical/pharmacy claims and enrollment data of a large US managed ...

6083 Background: The literature reports little on the frequency of hormonal treatment in CRPC or on the variation by specialty of treating physician. This study compared patients treated by oncolog...

22181 Background: Immunohistochemical (IHC) classification for breast cancer subtypes correlates with intrinsic gene expression microarray categorization: estrogen/progesterone receptor positive, h...

15051 Background: In the majority of patients with esophageal carcinoma curative treatment proves to be impossible when establishing the diagnosis. While adenocarcinomas (ac) of the oesophago-gastric junction are increasingly treated in the same way as gastric carcinomas, the most frequently applied palliative chemotherapy regimen for both advanced squamous epithelial carcinomas (sec) of the oesophagus and gastric carcinomas is a combination of 5-FU and cisplatin. The question should be answered whether the AIO regimen plus irinotecan may achieve similarly positive results in esophageal carcinomas such as in gastric carcinomas (median survival (ms) up to 11 months). Methods: Prospective phase II trial, patients: n=25, trial start: 11/2002, chemotherapy: Irinotecan (80 mg/m2 i.v. as 1h-infusion; d 1, 8, 15, 22, 29, 36, qd 57) as well as sodium folinic acid (500 mg/m2 i.v.) together with 5-FU (2000 mg/m2 i.v.; d 1, 8, 15, 22, 29, 36, qd 57) as 24h-infusion via a miniature pump system. Results: Last date of evaluation: 31/12/2006: n=25; ac: n=13, sec: n=12; UICC III: n=3, UICC IV: n =22; grading G1/G2/G3/G4: 0/10/10/5; median age: 58 (44- 77) years; men/women: 20/5; ECOG 0/1/2/3: 3/17/4/1; chemotherapeutic applications: 429. Evaluable in terms of toxicity: n=25. Higher grade toxicity: grade (g) III diarrhea: n=2, g III hyponatremia: n=1, g III stomatitis: n=1, g III fatigue: n=1, g III vomiting: n=1, g IV nausea: n=1, g IV elevation of creatinine: n=1, thrombosis of the vena subclavia: n=1, ischemic lesion of the brain stem: n=1. 4 patients died after 2 chemotherapeutic applications due to known peritoneal carcinomatosis and high tumour burden. Evaluable in terms of response: n=25. PR: n=7 (28%), SD: n=10 (40%), PD: n=2 (8%), not evaluable: n=6 (24%). Cases of death: n=18. Total ms: 13 months (95% CI 3,9–22,1). ms of ac: 20 months (95% CI 8,6–31,4). ms of sec: 8 months (95% CI 0,0–17). Secondary resection (R0): n=2. Conclusion: In oesophageal carcinomas the AIO regimen plus irinotecan is excellently manageable on an outpatient basis and shows high efficacy in both adenocarcinomas and squamous epithelial carcinomas of the oesophagus. No significant financial relationships to disclose.