Treatment patterns in men with metastatic castration sensitive prostate cancer (mCSPC) in the United States (US).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19131-e19131
Author(s):  
Xuehua Ke ◽  
Marie-Hélène Lafeuille ◽  
Hela Romdhani ◽  
Frederic Kinkead ◽  
Peter St. John Francis ◽  
...  

e19131 Background: Given recent advances in treatment options for mCSPC, this study assessed US real-world treatment patterns of mCSPC patients over time. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for PC, ≥1 claim for metastasis, ≥1 castration sensitivity (CS) indicator (CS diagnosis code [dx]; castration and no prostate-specific antigen [PSA] rise; or hormone/castration naive for ≥18 months [mo] before metastasis). Index (idx) date was the 1st metastasis dx date on or after 1st PC dx and from 2015-2018. Patients were excluded if they had a pre-idx castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-idx or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from idx until CR (i.e., any post-idx CR indicator or initiation of abiraterone acetate [ABI] or docetaxel [DOC] ≥12 mo after post-idx androgen deprivation therapy [ADT] initiation or ≥12 mo post-idx for those with no ADT) or end of data. mCSPC treatment patterns in F/U were assessed overall and in patients with idx years (yrs) in 2015-2016 and in 2017-2018, separately. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: In the 2,825 mCSPC patients identified (age: 75 [9] yrs; F/U: 10.9 [9.0] mo), 43% were in the 2015/16 cohort (age: 75 [9] yrs; F/U: 15.8 [10.2] mo); and 57% were in the 2017/18 cohort (age: 75 [9] yrs; F/U: 7.2 [4.7] mo). The most common first-line (1L) mCSPC therapy was ADT only (Table), but patients in the 2017/18 cohort had fewer ADT only as 1L (43% vs. 52%) and more 1L ABI (10% vs. 4%) compared to the 2015/16 cohort. About 4% (2015/16: 5%; 2017/18: 3%) of patients received second-line (2L) mCSPC therapies, with ABI (74%) and DOC (25%) as the main 2L therapies observed. In patients receiving 2L mCSPC therapies, the 2017/18 cohort had more 2L ABI (81% vs. 68%) and fewer 2L DOC (19% vs. 30%) compared to the 2015/16 cohort. Conclusions: A large proportion of men with mCSPC were untreated/deferred treatment or were treated with ADT only, highlighting unmet needs in this patient group. As additional therapies for mCSPC become available, this trend is expected to improve, as supported by more recent treatment patterns. [Table: see text]

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19138-e19138
Author(s):  
Xuehua Ke ◽  
Marie-Hélène Lafeuille ◽  
Hela Romdhani ◽  
Frederic Kinkead ◽  
Peter St. John Francis ◽  
...  

e19138 Background: mCSPC is clinically complex. Although consensus on treatments are evolving, ADT remains the backbone of therapy. This study assessed the proportion of mCSPC patients treated with ADT only or remaining untreated and their HRU during the mCSPC period in the US. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for prostate cancer (PC), ≥1 claim for metastasis, ≥1 castration sensitivity (CS) indicator (CS diagnosis code [dx]; castration and no prostate-specific antigen [PSA] rise; or hormone/castration naive for ≥18 months [mo] before index [date of 1st metastasis dx on or after 1st PC dx and between 2015-2018]). Patients were excluded if they had a pre-index castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-index or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from index until CR (i.e., any post-index CR indicator or initiation of abiraterone acetate or docetaxel ≥12 mo after post-index ADT initiation or ≥12 mo post-index for those with no ADT) or end of data. The proportion of patients receiving ADT only or no mCSPC treatment during F/U was reported. Per-patient-per-year (PPPY) all-cause HRU were evaluated during baseline (12 mo pre-index) and F/U. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: A total of 2,825 mCSPC patients were identified (age: 75 [9] years). Of these, 2,181 (77%) received ADT only or no treatment in a F/U of 10.9 [9.0] mo. Among them, there were more patients with ≥1 inpatient (IP) stay or ≥1 emergency room (ER) visit (F/U vs. baseline; IP: 50% vs. 20%; ER: 57% vs. 44%), and patients had more IP stays and ER visits (IP: 2.0 [4.0] vs. 0.3 [0.7] stays; ER: 3.2 [7.1] vs. 1.1 [2.2] visits) and more IP days (27 [61] vs. 3 [11] days) PPPY in F/U vs. baseline. Trends were similar among patients receiving ADT only (N=1,252 [44%]; F/U of 12.6 [9.0] mo; Table). Conclusions: The majority of mCSPC patients were treated with ADT only or remained untreated and incurred substantial HRU. These findings suggest that improvements in therapy and prompt treatment initiation in men with mCSPC are needed to improve outcomes. [Table: see text]


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 291-291
Author(s):  
Jinan Liu ◽  
Eric M Maiese ◽  
Bruno Émond ◽  
Marie-Hélène Lafeuille ◽  
Patrick Lefebvre ◽  
...  

291 Background: Among patients (pts) with endometrial cancer (EC), response rates for platinum-based regimens in the first-line (1L) setting range from 40% to 62% in clinical trials. This study describes patient characteristics, treatment patterns, time to next treatment (TTNT), and overall survival (OS) among pts with advanced/recurrent EC treated with a platinum-based regimen in a real-world setting in the US. Methods: This retrospective study used Optum Clinformatics Extended Data Mart de-identified databases from January 1, 2007, to December 31, 2019. Adult pts with advanced/recurrent EC who initiated a 1L platinum-based regimen and subsequently initiated second-line (2L) antineoplastic therapy were identified. Prior to initiation of 1L, a 12-month washout period of continuous enrollment without use of antineoplastic agents (except hormonal agents) was imposed. Kaplan-Meier (KM) rates were used to report TTNT and OS from 2L, third line (3L), and fourth line (4L), separately. Results: A total of 1878 pts with advanced/recurrent EC initiated 2L therapy following a platinum-based regimen in 1L. Among them, 739 (39.4%) pts initiated 3L and 330 (17.6%) initiated 4L or later (4L+) therapy. Median pt age was 68.0 years. More pts received platinum-based regimens (56.4%) in 2L than other options (Table). Few pts (3.3%) received immunotherapy. Among pts receiving 3L, a similar percentage of pts were treated with platinum-based (33.2%) and other chemotherapy regimens (33.8%); few pts received immunotherapy (3.0%). Among pts receiving 4L+, the most frequent treatment option was other chemotherapy (46.1%). Median TTNT was 17.7, 10.6, and 8.4 months for 2L, 3L, and 4L pts, respectively. KM rates of OS following initiation of 2L therapy at 1, 2, 3, and 4 years were 68.4%, 49.6%, 41.3%, and 33.6%, respectively, with a median OS of 23.5 months. Conclusions: Among pts with advanced/recurrent EC treated with platinum-based therapy in 1L, platinum-based regimens remain prevalent treatment choices in later lines of therapy. In this study, immunotherapy was used infrequently in 2L, 3L, and 4L+. The median TTNT decreased in later lines of therapy. This study highlights a critical need for novel, more effective treatment options in later lines of therapy to optimize outcomes among pts with advanced/recurrent EC.[Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18693-e18693
Author(s):  
Eric M. Maiese ◽  
Bruno Émond ◽  
Jinan Liu ◽  
Marie-Hélène Lafeuille ◽  
Patrick Lefebvre ◽  
...  

e18693 Background: Among patients (pts) with endometrial cancer (EC), response rates for platinum-based regimens in the first-line (1L) setting range from 40% to 62% in clinical trials. This study describes patient characteristics, treatment patterns, time to next treatment (TTNT), and overall survival (OS) among pts with advanced/recurrent EC treated with a platinum-based regimen in a real-world setting in the US. Methods: This retrospective study used Optum Clinformatics Extended Data Mart de-identified databases from January 1, 2007, to December 31, 2019. Adult pts with advanced/recurrent EC who initiated a 1L platinum-based regimen and subsequently initiated second-line (2L) antineoplastic therapy were identified. Prior to initiation of 1L, a 12-month washout period of continuous enrollment without use of antineoplastic agents (except hormonal agents) was imposed. Kaplan-Meier (KM) rates were used to report TTNT and OS from 2L, third line (3L), and fourth line (4L), separately. Results: A total of 1878 pts with advanced/recurrent EC initiated 2L therapy following a platinum-based regimen in 1L. Among them, 739 (39.4%) pts initiated 3L and 330 (17.6%) initiated 4L or later (4L+) therapy. Median pt age was 68.0 years. More pts received platinum-based regimens (56.4%) in 2L than other options (Table). Few pts (3.3%) received immunotherapy. Among pts receiving 3L, a similar percentage of pts were treated with platinum-based (33.2%) and other chemotherapy regimens (33.8%); few pts received immunotherapy (3.0%). Among pts receiving 4L+, the most frequent treatment option was other chemotherapy (46.1%). Median TTNT was 17.7, 10.6, and 8.4 months for 2L, 3L, and 4L pts, respectively. KM rates of OS following initiation of 2L therapy at 1, 2, 3, and 4 years were 68.4%, 49.6%, 41.3%, and 33.6%, respectively, with a median OS of 23.5 months. Conclusions: Among pts with advanced/recurrent EC treated with platinum-based therapy in 1L, platinum-based regimens remain prevalent treatment choices in later lines of therapy. In this study, immunotherapy was used infrequently in 2L, 3L, and 4L+. The median TTNT decreased in later lines of therapy. This study highlights a critical need for novel, more effective treatment options in later lines of therapy to optimize outcomes among pts with advanced/recurrent EC.[Table: see text]


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
David M. Kern ◽  
M. Soledad Cepeda ◽  
Frank Defalco ◽  
Mila Etropolski

Abstract Background Understanding how patients are treated in the real-world is vital to identifying potential gaps in care. We describe the current pharmacologic treatment patterns for the treatment of depression. Methods Patients with depression were identified from four large national claims databases during 1/1/2014–1/31/2019. Patients had ≥2 diagnoses for depression or an inpatient hospitalization with a diagnosis of depression. Patients were required to have enrollment in the database ≥1 year prior to and 3 years following their first depression diagnosis. Treatment patterns were captured at the class level and included selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, other antidepressants, anxiolytics, hypnotics/sedatives, and antipsychotics. Treatment patterns were captured during all available follow-up. Results We identified 269,668 patients diagnosed with depression. The proportion not receiving any pharmacological treatment during follow-up ranged from 29 to 52%. Of the treated, approximately half received ≥2 different classes of therapy, a quarter received ≥3 classes and more than 10% received 4 or more. SSRIs were the most common first-line treatment; however, many patients received an anxiolytic, hypnotic/sedative, or antipsychotic prior to any antidepressive treatment. Treatment with a combination of classes ranged from approximately 20% of first-line therapies to 40% of fourth-line. Conclusions Many patients diagnosed with depression go untreated and many others receive a non-antidepressant medication class as their first treatment. More than half of patients received more than one type of treatment class during the study follow up, suggesting that the first treatment received may not be optimal for most patients.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S249-S249
Author(s):  
Tanya Burton ◽  
Amy Anderson ◽  
Jerry Seare ◽  
Ryan J Dillon ◽  
Eilish McCann

Abstract Background Infections caused by carbapenem non-susceptible (C-NS) Gram-negative (GN) organisms pose a major threat, due in part to limited treatment options. The aim of this study was to assess treatment patterns for these infections in a large US electronic health record database. Methods A retrospective cohort study of hospitalized adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), bacterial pneumonia (BP), or bacteremia (BAC) due to C-NS (resistant/intermediate susceptibility to carbapenem) GN organisms from January 2013 to March 2018. Patients with inherently C-NS organisms (e.g., Pseudomonas aeruginosa to ertapenem) were only included if resistance to another carbapenem was identified. The index date was the date of first C-NS culture in a qualifying hospitalization (±3 days from admission/discharge). Clinical characteristics and administered treatments were assessed from admission to discharge with variables summarized descriptively and stratified by infection type. Results 7,702 patients met inclusion criteria: 31% cUTI ± BAC, 24% BP ± BAC, 21% cUTI + BP ± BAC, 17% cIAI ± BAC, cUTI, or BP, 7% BAC only. The median age was 66 years, ranging from 60 (BAC) to 69 (cUTI) years; male, 57%. The most common pathogens were Pseudomonas aeruginosa (64%) and Klebsiella pneumoniae (15%). Antibiotics were administered to the majority of patients (87%); of which, 79% received combination therapy (median classes: 3, maximum: 7), the remainder received monotherapy. For antibiotic-treated patients, 93% initiated an antibiotic before the non-susceptibility status of the underlying organism was known. The most common classes given during the index hospitalization were: penicillin (49%), fluoroquinolone (44%), carbapenem (40%), cephalosporin (39%), aminoglycoside (28%) (by infection type, Figure 1). Eleven percent of patients received colistin/polymyxin B. Conclusion Varied antibiotic use was observed in this cohort, with carbapenems frequently detected despite the C-NS nature of the underlying GN organisms. The use of antibiotics to which organisms are non-susceptible could lead to poor health outcomes, supporting the need for new targeted therapies to treat C-NS infections. Disclosures All authors: No reported disclosures.


BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e019955 ◽  
Author(s):  
Xiaomei Ma ◽  
David P Steensma ◽  
Bart L Scott ◽  
Pavel Kiselev ◽  
Mary M Sugrue ◽  
...  

ObjectivesTreatment patterns for patients with myelodysplastic syndromes (MDS) outside clinical trials are not well described. Our objective was to evaluate treatment patterns and patient characteristics that influence time to disease-modifying therapy in patients with MDS in the USA.Design, participants and outcome measuresPatients with MDS treated with erythropoiesis-stimulating agents (ESAs), iron chelation therapy, lenalidomide (LEN) and the hypomethylating agents (HMAs) azacitidine and decitabine, were retrospectively identified in the GE Centricity Electronic Medical Record database between January 2006 and February 2014; LEN and HMAs were defined as ‘disease-modifying’ therapies. Multivariable Cox regression models were used to ascertain patient characteristics associated with time to disease-modifying therapy.ResultsOf the 5162 patients with MDS, 35.7%, 40.3% and 4.6% received 1, ≥1 and ≥2 therapies, respectively. ESAs were the first-line (72.5%) and only (64.0%) treatment in the majority of patients who received ≥1 therapy. ESA-only patients were older and had more comorbidities, including isolated anaemia. LEN and HMAs were first-line treatment in 12.4% of patients each; 32.7% received LEN or HMAs at any time. The majority of del(5q) patients (77.6%) received ≥1 therapy, most commonly LEN, compared with 40% of patients without del(5q). A shorter time to disease-modifying therapy was significantly associated with absence of comorbidities, diagnosis after February 2008, lower baseline haemoglobin level, age <80 years and male gender (p<0.002 for all).ConclusionsA high proportion of patients diagnosed with MDS in the USA do not receive approved disease-modifying therapies. It is important to improve access to these therapies.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15201-e15201
Author(s):  
Celestia S. Higano ◽  
Yoshito Hirata ◽  
Koichiro Akakura ◽  
Nicholas Bruchovsky ◽  
Kazuyuki Aihara

e15201 Background: Recently a phase III trial demonstrated that IAS was non-inferior to continuous AS in men with M0 disease after primary or salvage radiation and quality of life was better in the intermittent arm (Crook ASCO 2011). In that trial, men were treated with 8 months of AS followed by a variable time off AS driven by the absolute PSA value. The Hirata mathematical model describes the dynamics of prostate cancer treated with IAS (Hirata et al, J of Theoretical Biol 2010). In the model, there are three classes of cancer cells: a class of androgen dependent (AD) cells and two classes of androgen independent (AI:X1 and AI:X2) cells. During AS, AD cells will change to the two AI classes, and during the off treatment period, AI:X1 cells will revert to AD cells whereas AI:X2 cells cannot revert to either AD or AI:X1 cells. Methods: After IRB approval, we applied the Hirata model using serial monthly PSAs from men with M0 disease treated with IAS from Japan, Canada, and the United States. The proportions of men from each country who fell into the 3 categories of patients previously defined by the Hirata model were compared. Results: Serial PSAs from 26 men from Japan, 72 from Canada, and 79 from US were put into the model. The 3 categories of patients from the model include: (i) those with disease that will remain androgen sensitive and will respond to IAS without development of castration resistance (CRPC) (ii) those who will benefit from IAS but will develop CRPC sooner than those in group (i), (iii) those for whom continuous AS is superior to IAS. The datasets from each country show a similar distribution among the categories, and overall there were 42%, 51%, and 7% falling into groups i, ii, and iii respectively. Conclusions: This retrospective analysis shows that men with M0 disease treated with IAS fall into the 3 categories predicted by the Hirata model in similar proportions, regardless of country of origin. The ability to apply this model to the individual patient in the clinic is currently under development. The model may ultimately be able to optimize both the on and off treatment durations of IAS and to predict those patients who will most benefit from this approach.


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 248-248
Author(s):  
Orazio Caffo ◽  
Antonello Veccia ◽  
Francesca Maines ◽  
Alberto Bonetta ◽  
Gilbert Spizzo ◽  
...  

248 Background: Abiraterone acetate (AA) and enzalutamide (ENZ) are new generation hormonal agents (NHA) which demonstrated a survival gain in patients (pts) with castration-resistant prostate cancer (CRPC) pre-treated with docetaxel. Although all patients eventually became resistant to these NHAs, some of them show primary resistance, defined as an early progression within the first 3 months, which leads to an early treatment interruption. In the present analysis we have tried to identify which factor, if any, may predict primary resistance to AA and ENZ. Methods: We evaluated a consecutive series of 57 pts, treated in our hospital in two successive named patient programs conducted in our hospital to allow pre-treated CRPC patients to receive NHAs before their approval in Italy: 26 received AA (1,000 mg po + prednisone 10 mg po daily) and 31 ENZ (160 mg po daily). For each pt we have recorded the pre- and post-NHA clinical history, the treatment details and outcomes. We have also assessed the ability of a series of 24 selected clinical factors to predict NHAs resistance, through a logistic regression analysis. Continuous variables were categorized by quartiles and chosen for the initial model after a univariate chi-square analysis. Results: Among the 24 factors, the presence of pain at baseline, high baseline lactate dehydrogenase levels and prostate-specific antigen (PSA) levels after one month of treatment were predictive of primary NHA resistance at the univariate analysis. However, only PSA levels were confirmed at the multivariate analysis [exp(beta) 0.115; p = 0.007], as patients failing to achieve a 50% or more reduction in baseline PSA levels, were more likely to show primary NHA resistance (48% vs. 15%). Conclusions: Our results suggest that PSA trend may represent a simple and rapid method of identifying patients with primary resistance to NHAs, so patients failing to achieve a 50% or more reduction within the first month of treatment should undergo intensive investigations, to verify whether they have primary resistance to NHAs. These data should be confirmed in a larger patient population.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 220-220
Author(s):  
Elizabeth Henry ◽  
Abigail Silva ◽  
Elizabeth Tarlov ◽  
Ellen R. Gaynor

220 Background: Therapeutic options for men with metastatic castrate resistant prostate cancer (mCRPC) have expanded significantly over the past 5 years with several new agents demonstrating improved survival, including two oral agents. Abiraterone acetate (AA), a CYP-17 androgen synthesis inhibitor, obtained initial FDA approval in 2011 for post-docetaxel (D) use, and gained expanded approval in 2012 for pre-D use. Enzalutamide (ENZ), an androgen receptor signaling inhibitor, also gained FDA approval in 2012 (post-D) and indication was expanded in 2014 (pre-D). Due to the relatively recent approvals of these agents, there is limited data on rates of uptake and prescribing patterns for patients (pts) with mCRPC. Methods: For this observational study, Veterans Affairs (VA) healthcare system data (including hospitalizations, outpatient visits, and pharmacy) were used to identify male veterans who received treatment for mCRPC between fiscal years 2008 and 2014. Descriptive statistics were used to classify treatment patterns. Results: During the time period, 75,199 pts with prostate cancer were medically or surgically castrated. Of those, 43,805 were treated with anti-androgens and 7,890 went on to receive advanced lines of therapy associated with mCRPC. The median age at the time of mCRPC treatment was 73y. Between 2008-2010 (pre-AA) and 2011-2014 (post-AA), the proportion of mCRPC pts treated with ketoconazole or D dropped from 95% to 59% (p < 0.0001). Conversely, the proportion of pts who received AA or ENZ increased from 19% to 68% (p < 0.0001). Among the 3,763 pts treated with AA or ENZ between 2011 and 2014, the proportion treated with first-line D decreased, while the proportion treated with first-line AA increased (p < 0.00001). Conclusions: The FDA approval of AA and ENZ has had a significant impact on treatment patterns for men with mCRPC within VA, with decreased use of ketoconazole and delayed use of chemotherapy. Further information regarding patient and disease characteristics is needed. The rapid uptake of these novel agents has significant implications for disease-related outcomes as well as anticipated pharmacy costs within the VA.


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