United States real-world drug utilization patterns …

1 United States real-world drug utilization patterns and associated overall survival in Medicare patients with newly-diagnosed metastatic triple negative breast cancer using Surveillance, Epidemiology, and End Results-Medicare data Aly A1; Shah R1; Hill K2; Botteman M11. PharmeritInternational, Bethesda, MD, USA. 2. CelldexTherapeutics, Hampton, NJ, USABACKGROUND Triple negative breast cancer (TNBC) refers to patients not expressing the estrogen receptor (ER), progesterone receptor (PR) or Her2/neu(HER2) gene1 TNBC accounts for approximately 15% of all breast cancer cases1 As most chemotherapies target one of the receptors, TNBC is more difficult to treat2 Resistance to standard therapies, such as anthracyclines or taxanes, limits treatment options for previously treated patients with metastatic TNBC (mTNBC)

2 To a small number of non-cross-resistant regimens3 Limited information exist regarding treatment patterns for elderly patients with mTNBC. The analysis characterized treatment patterns and associated survival among Medicare patients with mTNBC in a real-world settingMETHODS Patients 66 years of age who were newly diagnosed with mTNBC between 2004 and 2011 were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. Triple negative status was obtained from the SEER registry Since HER2 was unavailable from 2004-2009, patients with claim for a HER2 test followed by no hormonal therapy were assumed to be HER2 negative Patients were followed from diagnosis to the first of death, Medicare disenrollment, HMO enrollment, or 12/31/2013 to characterize the sequence of chemotherapy received as first (1R), second (2R), or third or more regimens (3R+)

3 OS estimates based on drug utilization patterns were reported using the Kaplan-Meier methodRESULTSV ariableStatistic or CategoryAll Patients(N=625)Untreated(N=308)Treated (N=317)1R(N=161)2R (N= 88)3R+(N= 68)PFollow-up period, monthsMean/Median (SD) (19) (14) (20) (23) (18)< at diagnosis, yearsMean/Median (SD) (7) (8) (7) (5) (6)< , N (%)Hispanic38 ( )11 ( ) Black119 ( )65 ( )30 ( )11 ( )13 ( )Non-Hispanic White454 ( )221 ( )115 ( )69 ( )49 ( )Other14 ( )11 ( )NRNRNRM arital status, N (%)Married184 ( )67 ( )48 ( )35 ( )34 ( )< married351 ( )188 ( )91 ( )42 ( )30 ( )Census Location, N (%)Midwest98 ( )56 ( )18 ( )12 ( ) ( )75 ( )37 ( )18 ( )NRSouth171 ( )75 ( )49 ( )30 ( )17 ( )West217 ( )102 ( )57 ( )28 ( )30 ( )CCI, N (%)0331 ( )95 ( )51 ( )44 ( )141 ( ) ( )29 ( )23 ( )18 ( )70 ( )273 ( )19 ( )NRNR46 ( )3+81 ( )18 ( )NRNR51 ( )Poor performance, N (%)Yes130 ( )28 ( )19 ( )NR77 ( ) Size, mmMean/Median (SD) (243) (268) (257) (314) (202) 1.

4 Baseline characteristics of patients with of therapy, monthsTime from end of previousregimen, monthsTime from mTNBC diagnosis tostart of current regimen, monthsMonthsFigure 3: Duration of each regimen and timing in the mTNBC Cohort Table 2: Treatment groups received by mechanism of action and single vs combination regimensCONCLUSIONS Half of Medicare patients with mTNBC do not receive chemotherapy Older and unmarried patients tend not to receive 3+ regimens and are more likely to not receive chemotherapy Paclitaxel and capecitabine were the most commonly used single agents and taxane-based combination therapy was the most commonly used combinationSPONSORSHIPR eceive an electronic PDF of this poster on your mobile to to download the free barcode reader the code and get access

5 To the WD et al. New England Journal of (2010): Clinical cancer Research. 2008 Mar 1;14(5) , et al. breast cancer : basic and clinical research. 2016;10 DescriptionStatistic or Category1R(N= 317)2R(N= 156)3R+(N= 68)Age at diagnosis, ( to ) ( to ) ( to ) ( to ) ( to ) ( to )80+ ( to ) ( to ) ( to )Marital status at diagnosis, Single (never married) ( to ) ( to ) ( to ) ( to ) ( to ) ( to )Census ( to ) ( to ) ( to ) ( to ) ( to ) ( to ) ( to ) ( to ) ( to )CCI, ( to ) ( to ) ( to ) ( to ) ( to ) ( to )3+ ( to ) ( to ) ( to )Poor performance status, ( to ) ( to ) ( to )

6 Tumor size (Categorical), <50 mmReference50 -70 ( to ) ( to ) ( to )>70 ( to ) ( to ) ( to ) ( to ) ( to ) ( to )Table 3: Factors associated with receipt of first, second, and third or more regimens Treatment1R(n=317)2R(n=156)3R +(n=68)Single Agent 205 (65%)74 (47%)40 (59%)Microtubule inhibitors 80 (39%)23 (31%)NRPaclitaxel 72 (35%)18 (24%)NRAnthracyclines 29 (14%)13 (18%)NRDoxorubicin 27 (13%)13 (18%)NRAntimetabolites/Others 96 (47%)38 (51%)27 (73%)Capecitabine 51 (25%)20 (27%)NRGemcitabine NRNR13 (35%)Combination Regimens 112 (35%)82 (53%)28 (41%)Taxane-based 64 (57%)57 (70%)

7 NRTreatment patterns The proportion of patients using combination chemotherapy was higher in 2R and 3R+ vs 1R; The most common combination regimen was taxane-based in 1R (57%) and 2R (70%; Table 2) The 2 most commonly prescribed single agents were: 1R, paclitaxel and capecitabine; 2R, capecitabine and paclitaxel; and 3R+, gemcitabine and capecitabine (Figure 2) Median duration of each regimen was (Figure 3) months (1R), months (2R), and months (3R) Median time from diagnosis to the start of the 1R was months Median time to start of 2R and 3R after the end of 1R and 2R was and monthsFigure 1.

8 Patient attrition flowchartExcluded Patients <66 years of age (n=96,844) Patients enrolled in an HMO in the2 months prior to diagnosis (n=44,409) Patients with no continuous enrollment in Medicare Parts A/B in the 12 months prior to month of diagnosis (N=10,158)Excluded Patients with unknown diagnosis month or year (n=1,119)Patients with ICD-O-3 codes for breast cancer (BC) (N=267,034)Known diagnosis date (N=265,915)Patients with de novoMetastatic breast cancer (N=5,849)Patients with de novoMetastatic Triple Negative breast cancer (mTNBC)(N=625)Excluded Non Triple Negative breast cancer (n=5,191) Patients who died within 30 days of diagnosis of de novomTNBC (n=69)Patient Characteristics and Comorbidities (Table 1) Median age was 75 years, median follow-up was months, and >25% of patients had Charlson Comorbidity Index of 2 308 of 625 patients with mTNBC did not receive chemotherapy (older at diagnosis, higher CCI, and had poor performance indicators compared to treated patients)

9 Among 317 treated patients, those who received more regimens had higher CCI and poor performance indicators Of the 317 treated patients, 50%, 28%, and 22% received 1R, 2R, and 3R+ (Table 1). Compared to 1R patients, 2R patients were significantly younger (median 72 vs 75 years), more frequently married (40% vs 30%), had lower CCI. (Not reported per data user agreement [DUA])RESULTS (CONTINUED)RESULTS (CONTINUED)RESULTS (CONTINUED)Predictors of number of regimens received Multinomial logistic regression revealed that (Table 3) patients who were-Older (>80 years) were less likely to receive 1R, 2R, or 3R+ vs.

10 Younger (66-70 years) patients -Married patients were times more likely to receive 2R and times more likely to receive 3R+ compared to single patients. Separated/divorced patients were less likely to receive 3R+-Sicker (CCI=2) were less likely to receive 2R compared to patients without comorbidities (CCI=0) -with tumor size 70mm were times more likely to receive 3R+ tvsthose with tumor size <70 mmSurvival based on drug utilization patterns Median (12-month) OS was 7 months (34%) for all patients and ranged from (17%) in the untreated to (88%) months in 3R+ patients (Figure 4)Figure 4: Overall survival of patients with mTNBC by number of ProbabilityTime (Months)Figure 2.