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This retrospective chart review examined real-world healthcare resource utilization (HRU) in patients with AML ineligible for intensive therapy who received first-line systemic therapy or best supportive care (BSC).Data were collected anonymously on patients with AML who initiated first-line hypomethylating agents (HMA), low-dose cytarabine (LDAC), other systemic therapy, or BSC. HRU endpoints included hospitalizations, outpatient consultations, transfusions, and supportive care.Of 1762 patients included, 46% received HMA, 11% received LDAC, 17% received other systemic therapy, 26% received BSC; median treatment durations were 118, 35, 33, and 57 days, respectively. Most patients were hospitalized, most commonly for treatment administration, transfusion, or infection (HMA 82%, LDAC 93%, other systemic therapy 83%, BSC 83%). A median number of hospitalizations were 2-6 across systemic groups and two for BSC, with median durations of 8-18 days. Transfusion rates and outpatient consultations were highest for HMA (80% and 79%) versus LDAC (57% and 53%), other systemic therapy (57% and 63%), and BSC (71% and 66%). Antivirals/antibiotics and antifungals were used more frequently than growth factors (72-92%, 34-63%, and 7-27%, respectively).Patients with AML ineligible for intensive therapy have high HRU; novel therapies are needed to alleviate this burden.

Background Treatment with venetoclax + hypomethylating agents (HMAs) is standard-of-care for newly diagnosed (ND) patients with acute myeloid leukemia (AML) aged ≥75 years, or with comorbidities precluding intensive chemotherapy. We describe real-world venetoclax + HMA treatment practices and outcomes in patients with ND AML in the US. Patients and Methods This retrospective cohort study used an electronic health record-derived, US nationwide, de-identified database, and included adults with ND AML, initiating venetoclax + HMA treatment ≤30 days from diagnosis (June 1, 2018-January 31, 2020). Venetoclax treatment variables included dosing information, schedule modifications, and drug–drug interactions. The median venetoclax + HMA treatment duration and overall survival (OS) from venetoclax initiation to discontinuation, death, or end of follow-up (August 31, 2020) were examined by Kaplan-Meier analyses. Results Overall, 169 patients were included. The median age at diagnosis was 77 years; 85.2% of patients were treated in community practice. Ninety-five of 169 patients (56.2%) had evaluable bone marrow response data following the start of treatment; 53.7% were assessed approximately at the end of cycle 1. Following the first treatment cycle, treatment schedule modifications were recorded in 101 patients and dose changes in 56, primarily due to toxicity. The median treatment duration was 5.2 months; the median OS was 8.6 months (median follow-up was 7.2 months). Venetoclax dose changes did not modify efficacy outcomes, but longer median OS was associated with venetoclax treatment schedule modifications (P = .02). Conclusions This study reflects early real-world experience with venetoclax + HMAs in a predominantly community setting and emphasizes the importance of appropriate venetoclax management in optimizing patient outcomes.

Introduction: Venetoclax (VEN), a novel BCL-2 inhibitor, received accelerated FDA approval for the treatment of newly diagnosed (ND) acute myeloid leukemia (AML) in adults aged 75 years or older, or who have comorbidities precluding use of intensive chemotherapy, in combination with hypomethylating agents (HMAs: azacitidine [AZA] or decitabine [DEC]), or low-dose cytarabine (LDAC). As Phase III trials have demonstrated relative efficacy of VEN combinations, this real-world initiative provides insight into the characteristics and outcomes of ND AML patients (pts) treated with VEN combinations vs non-VEN-based regimens in clinical practice. Methods: The AML Real world evidenCe (ARC) Initiative is a multicenter chart review study of adult pts with ND AML treated with VEN ≥ 4-11-2016 (VEN cohort) or non-VEN-based regimens ≥ 5-15-2015 (control cohort) from different academic sites in the US. Pts in the control cohort were matched to pts in the VEN cohort based on age ( Results: At time of interim data analysis, 33 VEN and 33 control ND AML pts were included. Combinations in the VEN cohort included HMA (AZA [26 pts, 78.8%], DEC [6 pts, 18.2%]) or LDAC (1 pt, 3.0%); the control cohort received high- (18 pts, 54.5%) or low-intensity regimens (15 pts, 45.5%; HMA: 12 pts; enasidenib: 2 pts; LDAC: 1 pt). Median age was 75 years in both VEN and control cohorts, 39.4% and 42.4% were female, respectively, and 63.6% had de novo AML in both cohorts. The majority had ECOG performance status of 1 (VEN: 66.7%; control: 63.3%) and adverse-risk ELN classification (66.7% in both cohorts). All pts with favorable-risk in the VEN cohort (100.0%) had mutated NPM1 without FLT3-ITD or with low allelic ratio ( In the high-intensity therapy matched subgroup (VEN: n=18; control: n=18), median age was 74 and 69 in VEN versus control, respectively. The majority of pts had ECOG performance status of 1 (VEN: 76.5%; control: 75.0%) and adverse-risk ELN classification (61.1% in both cohorts). High-intensity treatment regimens used for the control group were: CPX-351 (n=10; 55.6%), 7+3 (n=4; 22.2%), 7+3 + gemtuzumab ozogamicin (n=3; 16.7%), cytarabine + mitoxantrone (n=1; 5.6%). In the VEN matched high-intensity subgroup, 15 (83.3%) received VEN + AZA, 2 (11.1%) received VEN + DEC, and 1 (5.6%) received VEN + LDAC. Ten (55.6%) initiated VEN as an inpatient treatment. Outcomes for the full sample and subgroup are presented in Table 1. In the full sample, the overall response rate (ORR: CR+CRi+CRh) was 69.7% in the VEN cohort and 45.5% in the control cohort. The 1-year OS was 67.0% in the VEN cohort and 44.2% in the control cohort for the full sample; and 71.3% and 55.4%, respectively, in the high-intensity therapy matched subgroups. Conclusions: The ongoing ARC Initiative demonstrates real-world treatment effectiveness of VEN combinations in clinical practice. The real-world outcomes for VEN combinations for ND AML pts appear consistent with results reported from clinical trials, though a small number of pts were assessed. Further analyses of comparisons to matched controls, both overall and in the high-intensity therapy matched subgroup, and continuing data collection will allow a more robust assessment of the comparative effectiveness of VEN combinations in the real-world setting. Disclosures Pollyea: Syndax: Consultancy; Syros: Consultancy; Novartis: Consultancy; Karyopharm: Consultancy; Janssen: Consultancy; 47: Consultancy, Research Funding; Genentech: Consultancy; Takeda: Consultancy; Celgene/BMS: Consultancy; Agios: Consultancy; Glycomimetics: Other; Amgen: Consultancy; Abbvie: Consultancy, Research Funding; Daiichi Sankyo: Consultancy; Pfizer: Consultancy. Talati:BMS: Honoraria; Jazz: Speakers Bureau; AbbVie: Honoraria; Pfizer: Honoraria; Astellas: Speakers Bureau. Lai:Abbvie: Consultancy; Jazz: Speakers Bureau; Astellas: Speakers Bureau; Macrogenics: Consultancy; Agios: Consultancy. Abedin:Helsinn Healthcare: Honoraria; Agios: Honoraria; Jazz Pharmaceuticals: Honoraria; Pfizer: Research Funding; Helsinn Healthcare: Research Funding; Actinium Pharmaceuticals: Research Funding. Zeidner:Sumitomo Dainippon Pharma Oncology, Inc.: Research Funding; Merck: Research Funding; Forty-Seven: Other: Travel Reimbursement, Research Funding; AROG: Research Funding; AsystBio Laboratories: Consultancy; Daiichi Sankyo: Honoraria; Takeda: Consultancy, Honoraria, Other: Travel Reimbursement, Research Funding; Pfizer: Honoraria; Genentech: Honoraria; Celgene: Consultancy, Honoraria, Research Funding; AbbVie: Honoraria, Other: Independent Review Committee; Agios: Honoraria. Xavier:Kite/Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Morphosys: Honoraria, Membership on an entity's Board of Directors or advisory committees; TG therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Verastem: Honoraria, Membership on an entity's Board of Directors or advisory committees; Acrotec: Consultancy, Speakers Bureau; Biegene: Speakers Bureau; Genentech: Speakers Bureau; Seattle Genetics: Speakers Bureau; Celgene/BMS: Speakers Bureau; Epizyme: Speakers Bureau; Astellas: Speakers Bureau; Incyte: Speakers Bureau. Wolach:AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Fees for lectures and Consultancy, Research Funding; Pfizer: Consultancy, Honoraria; Janssen: Other: Fees for lectures and Consultancy; Amgen: Other: Fees for lectures and Consultancy; Astellas: Consultancy, Honoraria, Other: Fees for lectures and Consultancy; Novartis: Consultancy, Honoraria, Other: Fees for lectures and Consultancy. Moshe:Novartis: Membership on an entity's Board of Directors or advisory committees, Other: Lecturer; Astellas: Membership on an entity's Board of Directors or advisory committees, Other: lecturer; AbbVie: Membership on an entity's Board of Directors or advisory committees, Other: Fee for lec. Choi:AbbVie: Current Employment, Current equity holder in publicly-traded company. Bui:AbbVie: Current Employment, Current equity holder in publicly-traded company. Svensson:AbbVie: Current Employment, Current equity holder in publicly-traded company. Kye:AbbVie: Current Employment, Other: may hold stock or other options. Burne:Analysis Group, Inc., which has received consultancy fees from AbbVie: Current Employment. Guerin:Abbvie: Consultancy, Other; Sanofi Genzyme: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Novartis Pharmaceuticals Corporation: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Ma:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Montez:Genentech, Inc.: Current Employment; F. Hoffmann-La Roche: Current equity holder in publicly-traded company. Goldberg:Dava Oncology: Honoraria; Pfizer: Research Funding; Celularity: Research Funding; AROG: Research Funding; Aprea: Research Funding; ADC Therapeutics: Research Funding; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Aptose: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Background : For patients (pts) with acute myeloid leukemia (AML), preserving and measuring perceptions of health-related quality of life (HRQoL) is important, particularly for those ineligible for intensive chemotherapy and with a poor prognosis, especially when evaluating new treatment regimens. This analysis from 2 Phase 3 trials, Viale-A (NCT02993523) and Viale-C (NCT03069352), evaluated HRQoL, including key symptoms and aspects of functioning, in pts with AML receiving venetoclax (VEN) co-administered with azacitidine (AZA) (Viale-A) or low-dose cytarabine (LDAC) (Viale-C). Methods: Viale-A and Viale-C included treatment-naïve pts with AML, ≥18 years of age, and ineligible to receive intensive chemotherapy. Pts were randomized 2:1 to receive VEN +AZA or placebo (PBO)+AZA in Viale-A, and VEN+ LDAC or PBO+LDAC in Viale-C. Pt-reported outcome (PRO) measures included the PROMIS Cancer Fatigue Short Form 7a, the EORTC QLQ-C30 global health status (GHS)/QoL and physical functioning [PF] subscales, and the EQ-5D-5L health status visual analog scale (VAS). PRO data were collected on Day 1 of every 28-day cycle throughout both trials. Time to deterioration (TTD) was assessed to quantify differences between treatment groups. TTD was defined as worsening from baseline in PRO-specific meaningful change thresholds of ≥10, 7, or 5 points for the EORTC-QLQ-C30, EQ-5D-5L VAS, and PROMIS Fatigue, respectively. TTD differences between treatment arms were analyzed using Kaplan-Meier curves, unadjusted log-rank tests, and Cox PH models adjusted for key covariates (age, baseline ECOG and PRO scores, AML type, and cytogenetic risk category). TTD analyses were conducted for all pts in the full dataset who survived up to a given assessment with available data on ≥1 PRO measures from baseline. Results: Viale-A included 431 pts (VEN+AZA: 286, PBO+AZA: 145), of whom 60% were male; median age was 76 years. Compared with PBO+AZA pts, VEN+AZA pts had a non-statistically significant trend to longer TTD in GHS/QoL (median in months [95% CI]: 16.5 [95% CI: 9.8, NE] vs. 9.3 [95% CI: 4.7, 16.6], P=0.066) and fatigue (9.3 [7.2, 16.6] vs. 8.6 [4.2, 16.6], P=0.189) (Figure 1A, B). VEN+AZA pts had significantly longer TTD in PF (9.7 [6.7, 16.0] vs. 6.2 [4.7, 9.5], P=0.028) and health status VAS (10.7 [7.5, 18.6] vs. 3.9 [2.4, 7.4], P Conclusions: Results showed a longer TTD in PRO measures of global health status, VAS, fatigue, and PF for pts receiving VEN combinations vs AZA or LDAC monotherapy, with significantly longer TTD observed for all PRO measures from the unadjusted and adjusted analyses in Viale-C, and for PF and health VAS in Viale-A. These results suggest that VEN conveys meaningful benefit in terms of HRQoL. Limitations included the small sample size beyond early cycles in these studies; however, the early separation of the TTD curves with the initial larger sample size, suggests that these results are not due to chance variability and are statistically valid. Overall the improvements in PROs with VEN are consistent with previous efficacy reports. In summary, VEN appears to have a positive impact on the HRQoL of pts with AML who are ineligible for intensive chemotherapy, leading to a longer preservation of functioning and overall health status. Disclosures Pratz: Millennium: Research Funding; Daiichi Sankyo: Research Funding; Agios: Other: Scientific Advisory Board, Research Funding; Celgene: Other: Scientific Advisory Board; Boston BioMedical: Consultancy; AbbVie: Other: Scientific Advisory Board, Research Funding; Astellas: Other: Scientific Advisory Board, Research Funding; Jazz Pharmaceutical: Consultancy. Panayiotidis:AbbVie: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Genesis: Honoraria, Research Funding; Takeda: Honoraria; Phizer: Honoraria; ASH: Honoraria; Janssen: Honoraria; Gilead: Honoraria. Jonas:AbbVie: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Tolero: Consultancy; Treadwell: Consultancy; Forty Seven: Research Funding; Daiichi Sankyo: Research Funding; Genentech/Roche: Research Funding; Amgen: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; GlycoMimetics: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Accelerated Medical Diagnostics: Research Funding; AROG: Research Funding; LP Therapeutics: Research Funding; Forma: Research Funding; Pharmacyclics: Research Funding; Pfizer: Research Funding; Jazz: Consultancy, Research Funding; Sigma Tau: Research Funding; Celgene: Consultancy, Research Funding; F. Hoffmann-La Roche: Research Funding; Incyte: Research Funding; Hanmi: Research Funding; Takeda: Consultancy. Dinardo:Takeda: Honoraria; Celgene: Research Funding; Agios: Consultancy, Research Funding; AbbVie: Consultancy, Research Funding; Notable Labs: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy; Daiichi Sankyo: Consultancy, Research Funding; Calithera: Research Funding; ImmuneOnc: Honoraria. Novak:Janssen: Other: Travel expenses; Novartis: Consultancy; Roche: Consultancy; Pfizer: Consultancy; Amgen: Consultancy, Other: Travel expenses; Takeda: Consultancy. Pejsa:Oktal Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sandoz: Honoraria, Membership on an entity's Board of Directors or advisory committees; Alvogen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pliva: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees. Stevens:Amgen, MorphoSys: Consultancy. Yeh:Amgen: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Astex: Membership on an entity's Board of Directors or advisory committees. Kim:AbbVie: Other: Clinical trials investigator. Fracchiolla:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Yamamoto:Takeda: Consultancy, Honoraria, Research Funding; Yakult: Research Funding; Zenyaku: Research Funding; SymBio: Research Funding; Solasia Pharma: Research Funding; Aichi Cancer Center: Current Employment; AbbVie: Consultancy, Honoraria, Research Funding; Astra-Zeneca: Consultancy, Research Funding; Bayer: Research Funding; Bristol-Myers Squibb: Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Chugai: Consultancy, Honoraria, Research Funding; Eisai: Consultancy, Honoraria, Research Funding; Daiichi Sankyo: Consultancy; IQIVA/HUYA: Honoraria; HUYA: Consultancy; IQIVA/Incyte: Research Funding; Gilead Sciences: Research Funding; Janssen: Honoraria; Kyowa Kirin: Honoraria; Meiji Seika Pharma: Consultancy, Honoraria; Mochida: Honoraria; MSD: Consultancy, Honoraria, Research Funding; Mundipharma: Consultancy, Honoraria, Research Funding; Nippon Shinyaku: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Ono: Consultancy, Honoraria, Research Funding; Otsuka: Consultancy, Honoraria, Research Funding; Pfizer: Honoraria; Sanofi: Honoraria; Sumitomo Dainippon: Honoraria; Stemline Therapeutics: Consultancy. Ofran:AbbVie: Membership on an entity's Board of Directors or advisory committees. Wei:Astra Zeneca: Honoraria, Research Funding; Walter and Eliza Hall Institute of Medical Research: Patents & Royalties: AW is eligible for royalty payments related to venetoclax; Novartis: Honoraria, Research Funding, Speakers Bureau; Amgen: Honoraria, Research Funding; Macrogenics: Honoraria; Roche: Honoraria; Servier: Consultancy, Honoraria, Research Funding; Pfizer: Honoraria; Janssen: Honoraria; Abbvie: Honoraria, Research Funding, Speakers Bureau; Bristol Myers Squibb: Honoraria, Research Funding, Speakers Bureau. Bui:AbbVie: Current Employment, Current equity holder in publicly-traded company. Benjamin:AbbVie: Current Employment, Current equity holder in publicly-traded company. Kamalakar:AbbVie: Current Employment, Other: may hold stock or other options. Potluri:AbbVie: Current Employment, Other: may hold stock or stock options. Mendes:AbbVie: Current Employment, Current equity holder in publicly-traded company. Devine:Genentech: Current Employment, Current equity holder in publicly-traded company. Fiedler:Daiichi Sankyo: Other: support for meeting attendance; Gilead: Other: support for meeting attendance; Jazz Pharmaceuticals: Honoraria, Other: support for meeting attendance; Abbvie: Membership on an entity's Board of Directors or advisory committees; Morphosys: Consultancy, Honoraria; Celgene: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Honoraria; ARIAD/Incyte: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Other: support for meeting attendance, Patents & Royalties, Research Funding.

Objectives To assess real‐world treatment patterns and healthcare resource utilization (HRU) among patients with FLT3–mutated (FLT3 mut) and FLT3–wild‐type (FLT3 wt) acute myeloid leukemia (AML). Methods Data were abstracted from medical charts of patients with AML from 10 countries. Patients were grouped based on their FLT3 mutation status, age (18‐64 or ≥65), and whether they were newly diagnosed (ND) or relapsed/refractory (R/R). Results Charts of 1027 AML patients were included (183 FLT3 mut 18‐64 ND; 136 FLT3 mut ≥65 ND; 181 FLT3 mut R/R; 186 FLT3 wt 18‐64 ND; 159 FLT3 wt ≥65 ND; 182 FLT3 wt R/R). Substantial heterogeneity was observed in treatment patterns for AML. Among ND patients 18‐64, the most common initial treatment was standard‐to‐intermediate dose cytarabine‐based therapies (43.2% for FLT3 mut and 55.9% for FLT3 wt); among ND patients ≥65, the most common initial treatment was hypomethylating agent‐based therapies (36.0% and 47.2%). Among R/R patients, the most common initial treatment after R/R was best supportive care only (39.8% and 24.7%). HRU was substantial across cohorts during both event‐free and post‐event periods. Conclusions Treatment patterns of AML were heterogeneous and FLT3 mut AML was treated more aggressively than FLT3 wt disease. HRU was substantial for all cohorts, particularly after relapse or treatment failure.

Introduction: Venetoclax (VEN) is a BCL-2 inhibitor FDA approved in combination with azacitidine (AZA), decitabine (DEC), or low-dose cytarabine (LDAC) for newly diagnosed (ND) acute myeloid leukemia (AML) in adults aged ≥75 or those with comorbidities precluding intensive chemotherapy. We explored real-world practices and clinical outcomes of patients (pts) treated with VEN-based vs. non-VEN-based regimens in the AML Real world evidenCe (ARC) Initiative. Methods: This multicenter chart review study includes adult pts with ND AML treated with VEN (VEN cohort) after 11 April 2016 matched to pts with non-VEN-based regimens (control cohort) after 15 May 2015 from 10 academic sites in the US and 4 in Israel. Pts were randomly selected and matched on age ( Results: Select results are shown in Table 1. 133 VEN and 133 control ND AML pts were included. Median age was 73 years (Range: 34-89) in the VEN cohort and 71 years (Range: 40-89) in the control cohort; 60.9% of matched pts were The mean duration of follow-up was 9.2 months in the VEN cohort and 14.6 months in the control cohort and the mean duration of treatment was 6.9 months and 4.3 months. Composite complete remission (CCR: CR+CRi) rate was 60.4% in the VEN cohort and 50.0% in the control cohort and rate of MLFS was 7.2% and 3.4%, respectively; among the pts who achieved a response (CR, CRi, CRh, or MLFS; 81 VEN and 68 control pts), median time to best response was 1.7 months and 1.3 months, respectively. The 1-year KM DOR for patients who achieved CCR was 57.7% in the VEN cohort and 53.1% in the control cohort. After initial therapy, 5.3% of pts in the VEN cohort and 15.0% of pts in the control cohort were referred to HCT. The 1-year KM OS was 62.6% in the VEN cohort and 49.8% in the control cohort and the 1-year KM EFS was 41.4% and 31.5%. In the Conclusions: The current analyses support real-world treatment effectiveness of VEN combinations and are consistent with data reported from clinical trials, despite the relatively short follow-up at the time of interim analyses. The outcomes, including OS at 1 year, for VEN combinations in ND AML pts appear similar to matched control pts, including the subgroup of pts Figure 1 Figure 1. Disclosures Garcia: AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; Pfizer: Research Funding; Prelude: Research Funding; AstraZeneca: Research Funding. Wolach: Neopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Research Funding. Vachhani: Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Blueprint Medicines: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees. Talati: Jazz: Speakers Bureau; BMS: Honoraria; Pfizer: Honoraria; AbbVie: Honoraria; Astellas: Speakers Bureau. Pollyea: Karyopharm: Consultancy; Syndax: Consultancy; Amgen: Consultancy; AbbVie: Consultancy, Research Funding; Novartis: Consultancy; Genentech: Consultancy; Janssen: Consultancy; Celgene/BMS: Consultancy; Pfizer: Consultancy; Takeda: Consultancy; Daiichi Sankyo: Consultancy; Agios: Consultancy; Glycomimetics: Other. Lai: Jazz Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Speakers Bureau; Macrogenics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Jazz Pharma: Speakers Bureau; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Agios: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees. Moshe: Astellas: Membership on an entity's Board of Directors or advisory committees, Other: Lectures; AbbVie: Membership on an entity's Board of Directors or advisory committees, Other: Lectures; Novartis: Membership on an entity's Board of Directors or advisory committees, Other: Lectures. Abedin: Astellas Pharma Inc.: Research Funding; Amgen: Honoraria; Pfizer: Research Funding; Actinium: Research Funding; AltruBio: Research Funding; Agios: Honoraria; Helsinn: Research Funding. Lavie: AbbVie: Membership on an entity's Board of Directors or advisory committees, Other: Fees for lectures; BMS: Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Other: Fees for lectures; Roche: Other: Fees for lectures; Novartis: Other: Fees for lectures. Zuckerman: AbbVie: Honoraria; Orgenesis Inc.: Honoraria; BioSight Ltd: Honoraria; Janssen: Honoraria; Novartis: Honoraria; Gilead Sciences: Honoraria, Speakers Bureau; Cellect Biotechnology: Honoraria. Xavier: ADC Therapeutics: Speakers Bureau; Epizyme: Speakers Bureau; Celgene/BMS: Speakers Bureau; Seattle Genetics: Speakers Bureau; Morphosys/Incyte: Speakers Bureau; Beigene: Speakers Bureau; Acrotec: Consultancy; Genentech: Honoraria; Kite/Gilead: Honoraria; Jansen/Pharmacyclics: Honoraria; AstraZeneca: Honoraria, Speakers Bureau; Verastem: Honoraria; AbbVie: Consultancy, Speakers Bureau. Lee: AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Innate: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pin Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees. Bui: Abbvie: Current Employment, Other: May hold equity. Svensson: AbbVie: Current Employment, Current equity holder in publicly-traded company, Current holder of individual stocks in a privately-held company. Burne: Analysis Group Inc: Current Employment, Other: Analysis Group Inc received consulting funds from AbbVie. Kye: AbbVie: Current Employment, Other: May hold equity. Maitland: Analysis Group Inc: Current Employment, Other: Analysis Group Inc received consulting funds from AbbVie. Ma: Genentech, Inc.: Current Employment, Other: May hold equity. Montez: Genentech, Inc: Current Employment, Other: May hold equity. Grunspan: AbbVie: Current Employment, Other: May hold equity. Goldberg: Aptose: Consultancy, Research Funding; Arog: Research Funding; Pfizer: Research Funding; Prelude Therapeutics: Research Funding; Aprea: Research Funding; Celularity: Research Funding; DAVA Oncology: Honoraria; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Background: Ven+HMA is now a standard treatment (Tx) for newly diagnosed (ND) AML in patients (pts) aged ≥75 years (y), or with comorbidities precluding intensive chemotherapy. The Phase 3 VIALE-A trial demonstrated clinical benefit and longer overall survival (OS) for Ven+azacitidine (Aza) vs Aza alone; however, frequent Ven dose modifications (mods) occurred due to cytopenias (DiNardo et al. NEJM 2020). We describe real world (RW) Tx practices and outcomes in ND AML pts treated with Ven+HMA in the US. Methods: This retrospective cohort study used the Flatiron Health electronic health record (EHR)-derived, nationwide, de-identified database. Pts aged ≥18 y with ND AML, initiating Ven+HMA Tx ≤30 days (d) from diagnosis, from Jun 1, 2018 to Jan 31, 2020, were included (i.e., prior to VIALE-A data availability, reflecting early experience). Ven Tx data and Tx mods (Ven dose and Tx schedule changes [in-cycle interruptions, cycle delays, schedule per cycle changes]) were abstracted from the EHR, including frequency of and reasons (where documented) for Tx mods and discontinuations (d/c). Timing of bone marrow (BM) biopsy and response to Tx were measured. BM response was defined as ≤5% blasts by BM biopsy. RW complete response/complete response with partial hematologic recovery (rwCR/CRh) was defined as ≤5% BM blasts, with platelet count >50 × 10 9/L and absolute neutrophil count >0.5 × 10 9/L, within 14 d of BM biopsy. Tx mods post-rwCR/CRh are described. Median Ven+HMA Tx duration, and OS from start of Ven Tx to d/c, death, or censoring at the last EHR activity before data cutoff (Aug 31, 2020) were examined by Kaplan-Meier analyses. Time-varying survival analyses assessed the effect of Ven Tx mods on Tx duration and OS. Results: A total of 169 eligible pts treated with Ven+HMA were included. Median age at diagnosis was 77 y, 27% of pts had an ECOG performance status ≥2, 44% had secondary AML, and the overall majority (85%) were treated in community practice. European LeukemiaNet (ELN) classification was 13% favorable, 22% intermediate, 39% adverse, and 26% unknown. By Day 7 of Tx (after ramp-up), Ven dose was 400 mg in 49% of pts, 300 mg in 3%, 200 mg in 20%, and ≤100 mg in 20%. Dose was not recorded in 8% of pts. Of 72 pts with doses At 7.2 months (mo; range 0.6-24.8) median follow-up, median Tx duration was 5.2 mo (95% CI 4.0-7.7) and median OS (mOS) was 8.4 mo (95% CI 7.2-11.1). Of the 95 pts with BM data during follow-up, 51 (54%) had their first biopsy by Day 28 (±14) of Tx (proxy for BM around Tx Cycle 1), with the majority of pts (41/51; 80%) achieving a BM response at that time. Of the 82% (78/95) of pts who had a BM response at any time, 47% (45/95) had a rwCR/CRh. Three of 95 (3%) pts with documented BM biopsy had early mortality (≤60 d of starting first-line Tx) vs 14/74 (19%) pts without documented BM biopsy. Tx mods post-rwCR/CRh occurred in 25/45 (56%) pts; dose holds occurred in 7/25 pts, cycle delays in 8/25, Tx schedule changes in 6/25, dose changes and d/c in ≤4/25. Within the entire cohort, time-varying adjusted analyses showed that, compared with pts with no Tx schedule changes, those with Tx schedule changes had a longer median Tx duration (4.2 vs 6.0 mo, respectively; non-significant) and longer mOS (7.2 vs 10.0 mo, respectively; p=0.02; Figure). Conclusions: This study reflects early RW experience with Ven+HMA Tx in a predominantly community setting, ahead of Phase 3 VIALE-A data availability. Around half of pts started on full-dose Ven, suggesting that azole prophylaxis was either deferred or not received in many pts, although not all pts on lower doses had documented CYP3A4 inhibitor Tx. Only half of pts had a documented BM biopsy at approx. Cycle 1, but a high response rate was observed in evaluated pts. While the RW cohort reported here had a shorter follow-up time and mOS than reported in clinical trials, pts with Tx schedule mods had longer OS vs those without. These observations highlight, among other points, the importance of appropriate Ven management, including early BM assessment, to optimize pts' outcomes. Figure 1 Figure 1. Disclosures Vachhani: CTI BioPharma Corp: Consultancy; O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham: Current Employment; Abbvie: Consultancy; Agios: Consultancy; Pfizer: Consultancy; Incyte: Consultancy, Speakers Bureau; Jazz Pharmaceuticals: Consultancy; Novartis: Consultancy; Astellas Pharma: Speakers Bureau; Seattle Genetics: Research Funding; Blueprint Medicines: Consultancy. Abbas: Tennessee Oncology: Current Employment; Jazz: Consultancy, Speakers Bureau; TG: Consultancy, Speakers Bureau; Bristol Myers Squibb: Speakers Bureau; Incyte: Speakers Bureau; Amgen: Speakers Bureau; Takeda: Speakers Bureau. Flahavan: Roche Products Ltd. UK: Current Employment; Roche: Current equity holder in publicly-traded company. Ma: Genentech, Inc.: Current Employment, Other: May hold equity. Xu: F. Hoffmann-La Roche AG: Current Employment. Jin: Roche: Current equity holder in publicly-traded company; Genentech Inc: Current Employment. Montez: Genentech, Inc: Current Employment, Other: May hold equity. Huang: Genentech: Current Employment; University of Washington: Ended employment in the past 24 months. Gershon: Genentech: Current Employment; F. Hoffmann-La Roche Ltd: Current holder of stock options in a privately-held company. Ku: Genentech: Current Employment, Other: TRAVEL, ACCOMMODATIONS, EXPENSES; Roche: Current Employment, Current equity holder in publicly-traded company, Other: TRAVEL, ACCOMMODATIONS, EXPENSES. Flores: Genentech: Current Employment; Roche: Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company, Divested equity in a private or publicly-traded company in the past 24 months. Onishi: Genentech: Current Employment; Roche: Current Employment, Current equity holder in publicly-traded company. Bui: Abbvie: Current Employment, Other: May hold equity.

Introduction: Venetoclax (VEN) is a novel BCL-2 inhibitor indicated in the US for treatment of newly-diagnosed (ND) acute myeloid leukemia (AML) in adults ≥75 years or with comorbidities precluding use of intensive chemotherapy, in combination with azacitidine (AZA), decitabine (DEC), or low-dose cytarabine (LDAC). Despite widespread clinical use of VEN combinations in ND AML, real-world practice patterns are largely unknown. We set out to explore real-world outcomes and treatment paradigms in ND AML patients treated with VEN-based regimens. Methods: The AML Real world evidenCe (ARC) Initiative is a multicenter chart review study of adult pts with ND AML treated with VEN-based regimens and matched control pts (by age and ELN risk) from different academic sites in the US (10 sites) and Israel (4 sites), assessing real-world outcomes as well as VEN treatment practices. Interim descriptive results with data cutoff of 17 May 2021 are presented; data collection is ongoing, with a targeted sample size of over 250 VEN pts and further global expansion planned. Descriptive results are presented here on VEN-related treatment practices overall, and separately in the US and Israel. Results: At data cutoff, 133 VEN ND AML pts were included. The majority of pts were treated at US sites (102 pts, 76.7%). Regimens administered were VEN+AZA (106 pts, 79.7%), VEN+DEC (24 pts, 18.0%), and VEN+LDAC (3 pts, 2.3%). In Israel, all pts were treated with VEN+AZA (31 pts, 100.0%). Median age was 73.2 years, and the majority of pts (64.7%) had adverse ELN risk. Common genetic mutations observed included TP53 (30 pts, 22.7%), RUNX1 (21 pts,15.9%), IDH1/IDH2 (22 pts, 16.5%), NPM1 (15 pts, 11.4%), and FLT3 ITD (12 pts, 9.1%). Mean [median] duration of follow-up was 9.2 months [7.1] and duration of VEN-based treatment was 6.9 months [4.1]. 27.8% of pts had discontinued VEN. Among those who discontinued (37 pts), reasons for discontinuation included intolerance (13/37 pts, 35.1%), relapse (8/37 pts, 21.6%), and insufficient response (7/37 pts, 18.9%; results not shown). Unplanned dose interruptions during therapy were observed for 40 pts (30.1%) with common reasons including severe febrile neutropenia (13/40 pts, 32.5%), neutropenia (severe: 10/40 pts, 25.0%; non-severe: 5/40 pts, 12.5%), and patient request (6/40 pts, 15.0%). Venetoclax ramp-up was performed for 74.4% of pts overall and was more common in Israel (29 pts, 93.5%) than US sites (70 pts 68.6%). Among pts with venetoclax ramp-up performed, the majority received initial VEN treatment in the inpatient setting (US: 47/70 pts, 67.1%; Israel: 25/29 pts 86.2%), median starting and ending doses were 100mg and 400mg respectively, and median ramp-up duration was 3 days; which was similar in the US and Israel. Antifungal use during the first cycle, either prophylactically or in response to an infection, was observed in two-thirds of pts (88 pts, 66.2%) and was more common in the US (72 pts, 70.6%). Among pts with prophylactic antifungal use of a strong CYP3A4 inhibitor (33 pts, 24.8%), 42.4% of pts did not ramp-up and started and maintained a venetoclax dose of 100mg. At data cutoff, 120 pts had laboratory testing and bone marrow assessment results available in the full sample. Of these pts, timing of first bone marrow biopsy assessments varied, with 44.5% of pts having an assessment in their first cycle of venetoclax and 11.8% of pts having an assessment after the first two cycles. In Israel, a higher proportion of pts had a bone marrow assessment during their first cycle of venetoclax (18 pts, 58.1%). Out of those with response assessed (111 pts, 90.2%), 65.8% of pts achieved a response of CR, CRh, or CRi (US: 54/86 pts, 62.8%; Israel: 19/25 pts, 76.0%). Conclusions: The ongoing ARC Initiative provides insights on real-world treatment practices and management of ND AML pts treated with VEN-based regimens from academic sites. The ramp-up and dosing patterns appear consistent with label, with some variation. Delay in timing of bone marrow assessments may affect the assessment of time to response and post-response management in the real-world. Additional data collection in the ARC Initiative will provide more robust and valuable insights into VEN-based treatment practices and management in the real world. Figure 1 Figure 1. Disclosures Vachhani: Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Blueprint Medicines: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees. Wolach: AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Neopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding. Garcia: AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; Pfizer: Research Funding; Prelude: Research Funding; AstraZeneca: Research Funding. Talati: Pfizer: Honoraria; AbbVie: Honoraria; BMS: Honoraria; Jazz: Speakers Bureau; Astellas: Speakers Bureau. Pollyea: Takeda: Consultancy; Daiichi Sankyo: Consultancy; Syndax: Consultancy; Karyopharm: Consultancy; Novartis: Consultancy; AbbVie: Consultancy, Research Funding; Agios: Consultancy; Glycomimetics: Other; Amgen: Consultancy; Janssen: Consultancy; Genentech: Consultancy; Celgene/BMS: Consultancy; Pfizer: Consultancy. Lai: Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Jazz Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Macrogenics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Speakers Bureau; Jazz Pharma: Speakers Bureau; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Agios: Consultancy, Membership on an entity's Board of Directors or advisory committees. Moshe: Novartis: Membership on an entity's Board of Directors or advisory committees, Other: Lectures; Astellas: Membership on an entity's Board of Directors or advisory committees, Other: Lectures; AbbVie: Membership on an entity's Board of Directors or advisory committees, Other: Lectures. Abedin: Agios: Honoraria; Actinium: Research Funding; AltruBio: Research Funding; Helsinn: Research Funding; Pfizer: Research Funding; Amgen: Honoraria; Astellas Pharma Inc.: Research Funding. Lavie: AbbVie: Membership on an entity's Board of Directors or advisory committees, Other: Fees for lectures; BMS: Membership on an entity's Board of Directors or advisory committees; Takeda: Other: Fees for lectures; Roche: Other: Fees for lectures; Novartis: Other: Fees for lectures; Takeda: Consultancy. Zuckerman: Cellect Biotechnology: Honoraria; Gilead Sciences: Honoraria, Speakers Bureau; Novartis: Honoraria; Janssen: Honoraria; BioSight Ltd: Honoraria; Orgenesis Inc.: Honoraria; AbbVie: Honoraria. Xavier: AbbVie: Consultancy, Speakers Bureau; Morphosys/Incyte: Speakers Bureau; Jansen/Pharmacyclics: Honoraria; ADC Therapeutics: Speakers Bureau; Epizyme: Speakers Bureau; Genentech: Honoraria; Kite/Gilead: Honoraria; Beigene: Speakers Bureau; Acrotec: Consultancy; Seattle Genetics: Speakers Bureau; AstraZeneca: Honoraria, Speakers Bureau; Verastem: Honoraria; Celgene/BMS: Speakers Bureau. Lee: Pin Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Innate: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees. Bui: Abbvie: Current Employment, Other: May hold equity. Svensson: AbbVie: Current Employment, Current equity holder in publicly-traded company, Current holder of individual stocks in a privately-held company. Kye: AbbVie: Current Employment, Other: May hold equity. Burne: Analysis Group Inc: Current Employment, Other: Analysis Group Inc received consulting funds from AbbVie. Maitland: Analysis Group Inc: Current Employment, Other: Analysis Group Inc received consulting funds from AbbVie. Ma: Genentech, Inc.: Current Employment, Other: May hold equity. Montez: Genentech, Inc: Current Employment, Other: May hold equity. Grunspan: AbbVie: Current Employment, Other: May hold equity. Goldberg: AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Arog: Research Funding; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Research Funding; Aptose: Consultancy, Research Funding; Aprea: Research Funding; DAVA Oncology: Honoraria; Celularity: Research Funding; Prelude Therapeutics: Research Funding; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Objective: To estimate the healthcare costs and characteristics of docetaxel chemotherapy episodes of care for men with metastatic castration-resistant prostate cancer (mCRPC). Methods: This study used the Medicare 5% sample and MarketScan Commercial (2010–2013) claims data sets to identify men with mCRPC and initial episodes of docetaxel treatment. Docetaxel episodes included docetaxel claim costs from the first claim until 30 days after the last claim, with earlier termination for death, insurance disenrollment, or the end of a 24-month look-forward period from initial docetaxel index date. Docetaxel drug claim costs were adjusted for 2011 generic docetaxel introduction, while other costs were adjusted to 2015 values using the national average annual unit cost increase. Results: This study identified 281 Medicare-insured and 155 commercially insured men, with 325 and 172 docetaxel episodes, respectively. The average number of cycles (unique docetaxel infusion days) per episode was 6.9 for Medicare and 6.3 for commercial cohorts. The average cost per episode was $28,792 for Medicare and $67,958 for commercial cohorts, with docetaxel drug costs contributing $2,588 and $13,169 per episode, respectively. The average cost per episode on docetaxel infusion days was $8,577 (30%) for Medicare and $28,412 (42%) for commercial. Non-docetaxel infusion day costs included $7,074 (25%) for infused or injected drugs for Medicare, $10,838 (16%) for commercial cohorts, and $6,875 (24%) and $9,324 (14%) for inpatient admissions, respectively. Limitations: The applicability is only to the metastatic castration-resistance clinical setting, rather than the metastatic hormone-sensitive setting, and the lack of data on the cost effectiveness of different sequencing strategies of a range of systemic therapies including enzalutamide, abiraterone, radium-223, and taxane chemotherapy. Conclusion: The majority of docetaxel episode costs in Medicare and commercial mCRPC populations were non-docetaxel drug costs. Future research should evaluate the total cost of care in mCPRC.

Objective: The aim of this analysis was to examine treatment patterns in patients with acute myeloid leukemia (AML) in routine clinical practice in the United States, including factors influencing the choice of front-line treatment intensity and the effect of age and treatment line. Methods: We used data from the Adelphi AML Disease Specific Programme, a real-world, cross-sectional survey conducted in 2015. Physicians completed patient record forms providing patients’ demographic and clinical characteristics. Results: In total, 61 academic, non-academic, and office-based hematologists and hematology/oncology specialists provided data on 457 patients with AML; 284 had ≥20% blasts (World Health Organization-defined AML) and were included in the analysis. In the front-line setting, 60% of patients received high-intensity therapy, most commonly cytarabine plus anthracycline; the most common low-intensity treatments were hypomethylating agents. Primary drivers for selecting high-intensity versus low-intensity treatment were age, performance status, and comorbidities; 67%, 64%, and 61% of physicians stated they would prescribe high-intensity treatment to patients aged p0001). In a selected cohort of relapsed/refractory patients, 69% of patients received high-intensity therapy (78% of patients aged Conclusions: Most patients in this analysis of real-world survey data received well-established, front-line induction therapies. Treatment intensity was determined by age, comorbidities, and performance status, as recommended by guidelines.

Enzalutamide (ENZA) and abiraterone acetate plus prednisone (AA) are approved second-generation hormone therapies for chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). This study compared ENZA with AA in chemotherapy-naïve mCRPC by calculating the number needed to treat (NNT) and associated incremental costs to achieve one additional chemotherapy-naïve patient with mCRPC free of radiographic progression, chemotherapy, or death over a 1-year time horizon.Clinical outcomes were obtained from the PREVAIL and COU-AA-302 trials. Three outcomes were evaluated: radiographic progression-free survival, time to cytotoxic chemotherapy initiation, and overall survival at 1 year. NNT was calculated as the reciprocal of the outcome event rate difference for ENZA compared with AA. The incremental costs to achieve one additional outcome at 1 year were calculated as the difference in cost per treated patient multiplied by the NNT. Per-treated-patient costs were considered from a US payer perspective and included medications, monitoring, adverse events, post-progression treatments, and end-of-life care.Within a 1-year time horizon, the total cost per treated patient for ENZA was $2,666 less than AA. Compared with AA, treating 14 patients with ENZA resulted in one additional patient free of progression or death over 1 year; treating 26 patients with ENZA resulted in one additional patient with chemotherapy delayed over 1 year; and treating 91 patients with ENZA resulted in one additional patient free of death over 1 year. Therefore, ENZA is cost-effective compared with AA for all three outcomes evaluated, and the modeled results suggest ENZA is associated with potentially improved clinical outcomes in delaying chemotherapy initiation and disease progression for chemotherapy-naïve patients. The results are robust in sensitivity analyses, where the effect of changes in key model inputs and assumptions were tested.The results modeled in the present study suggest ENZA is cost-effective compared with AA for treating chemotherapy-naïve patients with mCRPC.

Prostate cancer is expected to account for approximately one quarter of all new diagnoses of cancer in American men in 2015. The cost of prostate cancer care is expected to reach $15.1 billion by the year 2020, up from $11.9 billion in 2010. Given the high burden of prostate cancer, health care payers are interested in quantifying the potential budget impact of new therapies.To estimate the budget impact of enzalutamide for the treatment of chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) from a U.S. payer perspective.A model was developed to assess the budget impact of enzalutamide for treatment of chemotherapy-naïve mCRPC patients in a hypothetical 1-million-member U.S. health plan over a 1-year time horizon. Comparators included abiraterone acetate, sipuleucel-T, radium Ra 223 dichloride, and docetaxel. Epidemiologic data, including National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) incidence rates, were used to estimate the number of chemotherapy-naïve mCRPC patients. Dosing, administration, duration of therapy, and adverse event rates were based on package inserts and pivotal studies. Drug costs were obtained from RED BOOK and Centers for MedicareMedicaid Services (CMS) average sales price pricing files, costs of administration and monitoring from the CMS physician fee schedule, and adverse events from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project and published literature. Market shares were estimated for each comparator before and after adoption of enzalutamide. The incremental aggregate budget impact, per patient per year (PPPY), per patient per month (PPPM), and per member per month (PMPM), was calculated. One-way sensitivity analyses were performed.In a population of 115 chemotherapy-naïve mCRPC patients, adopting enzalutamide had an annual incremental budget impact of $510,641 ($4,426 PPPY, $369 PPPM, and $0.04 PMPM). Results were most sensitive to enzalutamide drug cost, size of the chemotherapy-naïve mCRPC patient population, and enzalutamide adoption rate.Results indicate a modest 1-year budget impact of adopting enzalutamide for chemotherapy-naïve mCRPC patients, partly because of the cost offset of a moderate incidence of adverse events and lack of additional required monitoring.

e19513 Background: Treatment options for AML patients ineligible for intensive chemotherapy are limited. This study aims to describe demographic and clinical characteristics, outcomes, and HCRU in this patient population. Methods: This was a retrospective observational study of patients aged > 60 years who received first-line (1L) treatment within 60 days of AML diagnosis between 1/1/2011 – 1/1/2018 and had > 2 visits at US Oncology Network (USON) clinics. Patients were followed until 6/30/2018, last visit, or death, whichever came first. Data were sourced from structured fields of the USON database and chart reviews. Patient characteristics and HRU were assessed using descriptive statistics while overall survival (OS), time-to-treatment failure (TTF), and progression-free survival (PFS) from 1L treatment initiation were assessed using the Kaplan-Meier method. Results: 378 patients were included with median age of 79 years; 62.7% were male, 29.3% had an ECOG score > 2, and 38.4% had poor cytogenetic risk profile. Most patients received 1L hypomethylating agent (HMA) monotherapy: azacitidine (AZA, 57.9%) or decitabine (DEC, 25.9%). Few patients received best supportive care only (7.1%) or other AML treatment (9.1%). Median (range) durations of 1L treatment among patients receiving AZA and DEC were 2.9 (0.0, 46.9) and 2.5 (0.1, 26.4) months, respectively. Median (95% CI) OS, TTF, and PFS in the AZA and DEC cohorts were 7.5 (5.7, 9.6) and 7.3 (4.8, 8.8) months, 3.4 (2.8, 4.4) and 3.7 (2.4, 5.2) months, and 6.7 (5.0, 8.0) and 5.7 (3.4, 7.4) months, respectively. Among patients receiving HMAs, 84.5% received at least one transfusion. Median number of red blood cell and platelet transfusions was 4.0. Hospitalization rates in the AZA and DEC cohorts were 79.9% and 83.7%; proportions with hospitalization > 2 days duration were 64.4% and 66.3%, respectively, with median (range) durations of 6.5 (3.0, 34.0) and 7.0 (3.0, 26.0) days, respectively. Conclusions: The low TTF and OS and high HRU in this real-world community oncology study indicates an unmet need to improve outcomes among AML patients ineligible for intensive chemotherapy. NCCN guidelines were updated since this study and future real-world studies are warranted to evaluate impact of novel therapies on treatment patterns and outcomes.

Corticosteroids (CSs) are used concomitantly with life-extending therapies (LETs) in patients with castration-resistant prostate cancer (CRPC). This study examined time to LETs, LETs and concomitant CS adherence, and monthly all-cause healthcare utilization and costs in patients with CPRC with and without CS-sensitive comorbidities in the Veterans Health Administration population.Patients had CRPC if records showed prostate cancer diagnosis, medical/surgical castration and ≥2 prostate-specific antigen increases through 1 June 2007-31 May 2012. CS-sensitive comorbidities were assessed 6 months prior to the index date. Adherence, defined as medication possession ratio (MPR) ≥0.8, among patients initiating LETs (cabazitaxel, docetaxel, or abiraterone acetate) before 30 November 2011, resource utilization and costs among patients with concomitant CS were assessed. Statistical analysis included descriptive, Cox proportional hazards, and logistic regression models.Common CS-sensitive conditions among 12,128 patients with CRPC included hypertension (75.74%) and hyperlipidemia (54.69%). Those with glaucoma (hazard ratio [HR] = 0.67), ischemic heart disease (HR = 0.78), and peripheral vascular disease (PVD) (HR = 0.78) were less likely to be prescribed LETs (all p 0.01). Duration of LET was shorter among patients with CS-sensitive comorbidities (125.02 vs 133.08 days; p = 0.04) in the 6 month follow-up period. Among LET-treated patients with and without CS-sensitive comorbidities, less than half had MPR ≥ 0.8 (LET: 48.72% vs 54.05%; concomitant CS: 42.19% vs 40.54%, respectively). Cerebrovascular disease (odds ratio = 0.107; 95% confidence interval = 0.012 to 0.966) and PVD (odds ratio = 0.523; 95% confidence interval = 0.276 to 0.991) were associated with reduced CS adherence. Among patients with concomitant CS, those with CS-sensitive comorbidities had more inpatient stays than those without (20.45% vs 12.88%; p = 0.033), incurring higher monthly inpatient costs ($1157 vs $342; p 0.0001) and total costs ($5725 vs $4772; p = 0.036).CS-sensitive conditions influence initiation and duration of LETs, concomitant CS adherence, inpatient stays, and total costs. Future efforts should focus on specific strategies for treating prostate cancer patients with CS-sensitive comorbidities to ensure that they have appropriate access to LETs and to reduce costs and inpatient stays. Study limitations include the use of retrospective claims data and the relatively restricted subpopulation of older North American males.

Background: Newly diagnosed acute myeloid leukemia (ND AML) patients (pts) ineligible for intensive chemotherapy have limited treatment options. Most commonly used low intensity regimens are azacitidine (AZA), decitabine (DEC), or low-dose cytarabine (LDAC). These patients often have low blood counts that may contribute to poor quality of life (QoL) due to high risk for infections and may require transfusion of blood products. The objective of this study was to describe the patient characteristics, treatment patterns, and quantify the clinical outcomes (i.e., transfusion requirements infections and hospitalizations (hosp) among ND AML pts ineligible for intensive chemotherapy who received currently available therapies as first-line (1L) treatment in a real-world cohort. Methods: Eligible pts were found in the de-identified Optum© Clinformatics® Data Mart between 1/1/2010 and 6/30/2017 and had the following: AML at ≥2 encounters (ICD-9/10 codes) at least 30 days apart, ≥ 60 yrs. at diagnosis (dx), and ≥6 months (mo) benefit coverage before and ≥ 3 mo post dx. 1L treatment date (tx-index) was the date of first monotherapy (AZA, DEC, or LDAC) after AML diagnosis. 1L treatment duration was from tx-index to the end of study (EOS) defined as either end of 1L treatment, end of benefit coverage, relapse, or 12/31/2017. Transfusion independence (TI) during 1L treatment was defined as having neither platelets nor red blood cells (RBC) for ≥56 consecutive days (56-day TI). Patients with < 56 days of observation time from tx-index were not classified as achieving ≥56-day TI. During 1L treatment, transfusion support was defined as patients receiving either platelets and/or RBC regardless whether or not patients achieved ≥56-day TI. Sample selection and creation of analytic variables were performed using the Instant Health Data (IHD) platform (BHE, Boston, MA). Statistical analyses were undertaken with SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA). Results: Among 785 eligible pts, 82.0% had Medicare Advantage, 59.2% were male, and the mean (median; range) age was 74.7 (75.0; range 60.0-89.0) yrs. The mean (median; range) baseline comorbidity score (measured by Quan Charlson Comorbidity Index, CCI) was 1.5 (1.0; 0-11), with an available follow-up period of 13.6 (10.6; 3.0-88.5) mo. As1L treatment, majority of pts received AZA (n=422, 53.8%) followed by DEC (n=337, 43.0%) and LDAC (n=26, 3.3%) and the mean (median; range) duration of treatment was 5.6 (3.7; 0.03-52.0) mo. A total of 4.5% (35) patients had major or minor GI hemorrhage, 1.9% (15) brain hemorrhage, and 48.7% (382) had infections of all grades (AZA: 202/422, 47.9%; DEC: 170/337, 50.5%; LDAC: 10/26, 38.5%). Prior to receiving 1L treatment, 48.0% (377/785) of patients required transfusion of either platelets and/or RBC (Table 1). During 1L treatment, 73.3% (575) of pts received transfusion support with a mean (median; range) of 8.5 (5.0; 1-181) transfusions of either platelets and/or RBC. Among 377 patients with transfusion support prior to 1L treatment, 33.7% (127/377) of patients achieved ≥ 56-day TI during 1L treatment (Table 1). Multivariate logistic regression showed pts with baseline transfusion requirement were less likely to achieve ≥56 consecutive day TI during 1L treatment vs. pts without baseline transfusion requirements (33.7% vs. 58.6%; OR = 0.37; 95% CI = 0.27 - 0.50; P < 0.001) with the current treatments. Among 785 patients during 1L treatment, the mean (median; range) number of hospitalizations was 0.91 (1.0; 0-8). A total of 53.1% (417) had ≥ 1 hospitalization; the mean (median; range) length of an inpatient stay was 10.9 (7.0; 1-97) days for these patients; and 49.4% (206), 75.1% (313), and 87.3% (364) of patients were admitted within 30, 60, 90 days of tx-index, respectively. Conclusions: This real-world study in ND AML patients showed transfusion burden on patients with the currently available non-intensive treatment with AZA and DEC being the most commonly used agents. Most (61.5%-80.1%) of the pts required transfusions for platelets and /or RBC and less than 40% (0%-38.6%) of the patients with baseline transfusion requirement achieved ≥56 consecutive days of transfusion independence anytime while receiving their 1L treatment. Additional research is warranted to understand the correlation between response to treatment and transfusion independence and subsequent impact on hospitalization and infections. Disclosures Bui: AbbVie: Employment. Marshall:AbbVie: Employment, Equity Ownership. Kamalakar:AbbVie: Employment. Posadas:AbbVie: Employment. Potluri:AbbVie: Employment, Equity Ownership.

To assess appropriateness of antimuscarinic use in long-term care facilities (LTCFs) among treated and untreated urinary incontinence (UI) residents from 2007 to 2009.We conducted a retrospective analysis using the AnalytiCare(SM) database consisting of minimum data sets (MDS) assessments and prescription records of 90,660 residents from 2007 to 2009. UI (MDS H1b ≥ 1) residents with ≥ 14-day LTCF stay were identified and categorized as treated if they had ≥ 1 antimuscarinic prescription and untreated if they had no antimuscarinics. A random sample of untreated residents was matched based on treated residents' type of MDS assessment. We defined appropriate antimuscarinic use if residents had adequate cognitive function [≤ 4 on the cognitive performance scale (0 = intact to 6 = very severe impairment)] and mobility [scoring4 on mobility for toileting scale (MDS item G1iA 0 = independent to 4 = total dependent)]. Chi-square tests were used to detect statistical difference between cohorts.A total of 5,327 residents (2,840 treated; 2,487 untreated) were selected [mean age (standard deviation) 80 (8), 81 (8) years; female (76, 65 %), respectively]. On study-defined MDS assessment, 63 % of treated and 69 % of untreated residents had UI (P0.01). Approximately 84 % of treated and 74 % of untreated residents may have had cognitive function and mobility sufficient for appropriate antimuscarinic use (P0.01).Our study identified a high percentage of LTCF residents with UI who may have been candidates for antimuscarinics. However, due to the MDS limitation, we were unable to identify overactive bladder patients among these untreated residents with UI. It is possible that untreated control residents had UI due to other factors not amenable to treatment with antimuscarinic agents. Therefore, choice of treatment for each resident needs to be individualized and carefully monitored for efficacy and adverse effects. This retrospective analysis requires prospective confirmation. Proper patient selection for antimuscarinic treatment requires careful assessment of underlying physical status including cognitive function, mobility, and comorbidities.

e18525 Background: There is currently limited data on the quality-of-life (QoL) of patients with acute myeloid leukemia (AML) in the real-world setting. The objective of this analysis was to understand the impact of AML on patients receiving first-line treatment vs those who were relapsed/refractory to first-line treatment and therefore on later lines of therapy. Methods: The Adelphi AML Disease-Specific Programme, a real-world, cross-sectional survey involving 61 US hematologists/hemato-oncologists and their consulting AML patients, was conducted between February–May 2015. Physicians provided details on patient demographics and clinical information. Each patient was asked to complete both the EQ-5D-3L and Functional Assessment of Cancer Therapy Leukemia (FACT-Leu). Scores range from −1.09–1 (EQ-5D-3L) and 0–176 (FACT-Leu), where a higher score indicates a better QoL. Data from physician-completed record forms and corresponding patient self-completion forms on a matched sample of 75 patients were analyzed. Results: Of the patients who took part in the survey, 75% (n = 56) were receiving first-line treatment for AML and 25% (n = 19) were relapsed/refractory to first-line treatment and had progressed to later lines of therapy. The first-line patients had a mean age of 56.6 years and an average of 2.1 symptoms whereas the relapsed/refractory patients had a mean age of 56.9 years and an average of 2.4 symptoms, according to the physician. First-line patients may have a directionally better QoL scores than those on later lines of therapy, according to both the EQ-5D (0.75 and 0.71 respectively, P= .51) and the FACT-Leu (103.7 and 92.5 respectively, P= .098) measures. Results from the FACT-Leu-Physical Well-Being sub-domain show that relapsed/refractory patients were significantly more likely than first-line patients to be affected physically by their AML condition (13.0 and 17.6 respectively, P= .005). Conclusions: AML patients who have relapsed or become refractory to first-line treatment report worse QoL than those still on first-line treatments. These observational data shows a need for effective and tolerable treatments that can maintain or improve patients’ QoL, especially for patients with relapsed or refractory disease.

261 Background: Acute myeloid leukemia (AML) is a rare, but deadly hematological, disease with 20,830 new cases estimated in 2015 in the United States (US). As new treatments emerge, quality measures (QMs) will become important to assess the value of care. Our aim was to evaluate the current US AML QM landscape. Methods: We reviewed literature and online resources (eg, National Quality Measures Clearinghouse, Centers for Medicare & Medicaid Services, etc.) published within the last 5 years to identify AML-specific and AML-related QMs. All QMs were categorized using a “continuum of care” framework according to the 5 stages of AML: 1) symptom assessment, 2) diagnosis/risk stratification, 3) initial treatment, 4) monitoring/additional treatment, and 5) advanced/late stage care. Quality measures were categorized by the measure type (eg, process or outcome measure) and use by the Centers for Medicare & Medicaid Services (CMS). Results: In total, 30 QMs were identified: 1 leukemia-specific QM and 29 general oncology QMs. The leukemia-specific QM is a clinician-level process measure that evaluates the percentage of patients aged ≥ 18 years with a diagnosis of myelodysplastic syndrome or acute leukemia who had baseline bone marrow cytogenetic testing performed. Among the 29 general QMs: 8 are specific to stem cell transplantation, 13 are specific to chemotherapy, and 8 are general to oncology. Across the AML continuum of care: 2 QMs focus on symptom assessment, 1 supports diagnosis/risk stratification, 11 are for initial treatment, 9 for monitoring/additional treatment, and 7 for late-stage care. Twenty-seven QMs are based on process of care: 1 addresses resource utilization and 2 are outcomes based. The single leukemia-specific QM is used in CMS quality improvement programs, along with 3 other oncology-related QMs. Conclusions: While only one identified QM was specific to leukemia, other general oncology QMs may also apply. Unfortunately, QMs addressing AML-related morbidity and mortality are still lacking. Research into patient-centered communication, shared decision-making, patient-reported outcomes and resource use by AML patients may inform development of new QMs. Sponsorship: This research was funded by Astellas Pharma, Inc.

262 Background: Docetaxel (DTX) is commonly used to treat metastatic prostate cancer, yet little data is available about the cost of a DTX chemotherapy episode of care (DEC) for treating mCRPC. This study analyzes DEC cost and health service utilization for men with mCRPC. Methods: We performed a claims-based analysis using Truven MarketScan and Medicare 5% sample data sets. Eligibility was required in all months of 2010 and ≥ 1 month of 2011, along with ≥ 1 2011 claim coded with prostate cancer and ≥ 1 DTX claim. Initial 2011 DECs required no DTX claim in the prior 12 months while subsequent DECs required a 60-day gap between DTX claims. DEC costs included all paid claims, except prescription drugs, from the 1st DTX claim to 30 days after the last DTX claim with early termination for death, insurance disenrollment or the end of a 24-month look-forward period. DTX drug costs were adjusted for 2011 generic DTX introduction while all other DEC costs were adjusted to 2015 using national average unit cost increase. Results: 155 commercially insured patients (COMM) and 281 Medicare patients (MDCR) were identified with 172 and 325 DECs, respectively. The average number of DTX cycles per DEC was 6.3 for COMM and 6.9 for MDCR, with 105 and 102 average days between the 1st and last infusion, respectively. The average DEC cost was $63,788 for COMM and $28,742 for MDCR with DTX drug costs contributing $13,169 (21%) and $2,588 (9%) per DEC, respectively. The average cost per DEC contributed by DTX-infusion days was $27,900 (44%) for COMM and $8,577 (30%) for MDCR. Non-DTX-infusion day costs per DEC included $10,838 (17%) for infused/injectable drugs for COMM and $7,074 (25%) for MDCR, along with $9,324 (15%) and $6,875 (24%) for inpatient admissions, respectively. 29% of COMM-DECs and 40% of MDCR-DECs had ≥ 1 inpatient admissions while 22% and 25% had ≥ 1 emergency room (ER) visit, respectively. 22% of COMM and 28% of MDCR inpatient costs and 15% of COMM and 33% of MDCR ER costs were chemotherapy related. Conclusions: Non-DTX drug costs including infusion day services, infused/injectable drugs administered on non-DTX days and inpatient admissions contributed the majority of DEC costs in COMM and MDCR mCRPC populations.

To determine the cost-effectiveness of pharmacologic treatments for overactive bladder (OAB) in the US.A decision model was constructed based on studies of effectiveness, adverse consequences, co-morbid conditions, and medical costs for the treatment of OAB. Treatment success was defined as no incontinence episodes for 3-7 days or 3-7 consecutive dry days. Estimates of treatment success were obtained from clinical trials and included darifenacin, fesoterodine, oxybutynin immediate release (IR), oxybutynin extended release (ER), oxybutynin topical gel, oxybutynin transdermal patch, solifenacin, tolterodine IR, tolterodine ER, trospium IR, and trospium ER. Probabilistic sensitivity analysis was conducted using Monte Carlo simulation.A total of 51 OAB studies were identified and 11 reported treatment success. Mean continence rates varied in the literature from 21.0% with trospium IR to 51.0% with solifenacin. The 95% CI for solifenacin's success rate was statistically higher than other regimens due to the higher continence rates from the clinical trials. Oxybutynin IR and oxybutynin ER were significantly less costly than other products. The product with the lowest incremental cost-effectiveness ratio (ICER) relative to oxybutynin IR was solifenacin at $1338 (± 168) per additional continent patient. The cost-effectiveness acceptability curve indicated that oxybutynin IR was the most cost-effective regimen when willingness-to-pay values were less than $10,000 per additional continent patient. Solifenacin was most cost-effective at higher willingness-to-pay values.There was broad overlap in effectiveness among the anti-muscarinic products, except solifenacin had a significantly higher continence rate. Oxybutynin IR and oxybutynin ER were significantly less costly than other anti-muscarinic regimens, and these two products have a useful role to play in the management of OAB. However, for patients unable to tolerate the lower cost products, formularies benefit from solifenacin among branded products since the cost-effectiveness acceptability curve demonstrated it was the product most likely to be cost-effective after oxybutynin IR.

e16080 Background: Corticosteroids (CS) have been integral in metastatic castration-resistant prostate cancer (mCRPC) treatment and can be used alongside life-extending therapies (LETs), despite potential toxicity effects. LET and CS timing and adherence were examined in CRPC patients in the Veterans Health Administration (VHA) dataset with conditions sensitive to CS use. Methods: Diagnosed prostate cancer patients with evidence of medical/surgical castration, at least two following prostate-specific antigen (PSA) increases (third PSA value date was the index), and ≥1 claim for cabazitaxel, docetaxel, or abiraterone acetate 06/2007-05/2012 were examined. Adherence was the total overlapping days of CS and LET prescriptions divided by total LET prescription days (≥0.8). Comorbid conditions were measured for 6 months pre-index date. Descriptive analysis, Cox proportional hazards, and logistic regression models summarized therapeutic/clinical features of CRPC or the CS-adherent patient subset. Results: Common CS-sensitive conditions among 15,585 mCRPC patients included hypertension (58.94%) and hyperlipidemia (42.56%). Fewer glaucoma (hazard ratio [HR]: 0.67), ischemic heart disease (HR: 0.78), and peripheral vascular disease (HR: 0.78) patients were prescribed LETs (all p

17 Background: In the AFFIRM trial, enzalutamide (ENZ), an oral androgen receptor inhibitor, was superior to placebo (PBO) in overall survival (HR=0.63 [0.53, 0.75], p

198 Background: Prostate cancer is the most commonly diagnosed malignancy among men in the US; mortality rates are highest among those with castration-resistant prostate cancer (CRPC). Observational data on CRPC are limited. This study examined CRPC treatment patterns relative to NCCN guidelines in a large US health plan. Methods: This was a retrospective claims database analysis of commercial and Medicare Advantage enrollees with evidence of prostate cancer (ICD-9: 185.xx) between 07/01/06 – 03/31/11. CRPC patients were then identified based on prostate-specific antigen (PSA) progression (≥2 PSA increases based on ≥3 PSA values) and/or use of chemotherapy: docetaxel (DOC), mitoxantrone (MIT), estramustine (EST), or cabazitaxel (CAB). The CRPC index date was the first date of PSA progression or chemotherapy. Patients were continuously enrolled for 6 months before (baseline) and ≥6 months after the index date until 09/30/2011 or until death, if sooner (follow-up). Results: A total of 1651 patients met the CRPC selection criteria. Mean (SD) age was 70 ± 9 years, 1085 (66%) received DOC on the index date, and 467 (28%) died during follow-up. A third of patients with DOC received additional CRPC therapy during follow-up: 160 (15%) received MIT, EST, or CAB, and 239 (22%) received a secondary hormonal therapy (SHT: antiandrogens, aminoglutethimide, GnRH/LHRH antagonists, estrogen, or abiraterone acetate). Among 566 patients without DOC, 99 (17%) received a different chemotherapy (MIT = 45; EST = 52; CAB = 2), and 178 (31%) received a SHT. More than half 311 (55%) without DOC did not receive any other CRPC therapy during follow-up, of which 40 (13%) received bone-directed therapy (BDT: denosumab = 0; bisphosphonates = 27; radiation = 13). Conclusions: Consistent with NCCN guidelines, DOC was the most commonly used therapy. However, two-thirds of patients with DOC and over half of patients without DOC did not receive additional CRPC therapy after the index date. In addition, only 13% of patients with no CRPC therapy received any follow-up BDT. Additional research is warranted to understand whether clinical rationale, patient preference, or access to care may have resulted in patients not receiving additional therapy.