Treatment patterns and outcomes among patients with microsatellite stable (MSS) advanced endometrial cancer in the United States: Endometrial Cancer Health Outcomes (ECHO) retrospective chart review Study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5581-5581
Author(s):  
Shelby Corman ◽  
Sneha Kelkar ◽  
Shardul Odak ◽  
Jingchuan Zhang ◽  
Vimalanand S. Prabhu ◽  
...  

5581 Background: Traditional platinum-based systemic chemotherapy continue to be the SOC for aEC in the first line. Phase 2 clinical trials of chemotherapy (GOG 129 series) and some targeted therapies (229 series) for second line advanced endometrial cancer (aEC) have proved disappointing. Recently the treatment landscape for aEC patients has significantly changed with newer targeted therapies focusing on the microsatellite instability (MSI) status of endometrial tumors. The objective of the ECHO study was to describe real-world treatment patterns and outcomes in non-MSI-high or DNA mismatch repair proficient (pMMR) aEC patients in clinical practice in the United States (US) prior to 2019. Methods: The ECHO study is a multicenter, retrospective chart review study in women diagnosed with aEC in the US. Data were obtained from medical records of adult women (≥18 years) diagnosed with advanced or inoperable aEC (stages III or IV) with known MSI status, who had received at least one prior systemic therapy and progressed between July 1, 2016 – June 30, 2019. De-identified patient data extracted by treating oncologists included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed to estimate real-world progression-free survival (rwPFS) and overall survival (OS). Results: A total of 124 non-MSI-high or pMMR aEC patients who had progression following first line therapy were included in this interim analysis. Average age was 63 years, 62.9% White/Caucasian, 16.9% Hispanic/Latino, and 86% had ECOG ≤1. Metastases were observed in 70% of patients at diagnosis, with the most common metastatic sites being lung (47.6%), liver (32.3%), and distant lymph nodes (29%). As 2nd line therapy, 69% of patients received mono or combination chemotherapy (primarily with doxorubicin), 13% hormonal therapy, and 18% targeted therapy ± chemotherapy. Median duration of 2nd line therapy was 4 months. The majority (86.3%) discontinued 2nd line therapy, with disease progression the most common reason (66.4%). A quarter (26.6%) of patients initiated an additional line of therapy. Median rwPFS from initiation of 2nd line therapy was 5 months (95% confidence interval [CI]: 4-9). Median OS from initiation of 2nd line therapy was 12 months (95%CI: 9-18). Estimated OS rates from initiation of 2nd line therapy at 6, 12, and 24 months were 66%, 47%, and 30%, respectively. Conclusions: In this retrospective, chart review study, patients with non-MSI-high/pMMR aEC in the US who failed at least one systemic therapy had poor prognosis on subsequent therapies. There continues to be a significant unmet need in this group of women. Novel therapies are needed that delay progression and/or improve overall survival and further research is indicated to explore this.

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4787-4787 ◽  
Author(s):  
Brandon Arnieri ◽  
Coen Bernaards ◽  
Kenneth Wilhelm ◽  
James Black ◽  
Ceri Hirst ◽  
...  

Abstract Introduction: Approximately 18,960 new cases of CLL and 4,660 deaths from CLL are estimated in the US in 2016, with an overall estimated 5-year survival rate of 82%. Despite this, CLL patients with unfavorable genetic features such as 17p deletion have relatively poor outcomes when treated with conventional chemoimmunotherapy (e.g. fludarabine and cyclophosphamide, or bendamustine plus rituximab); however, several new treatments have been approved by the FDA for the treatment of previously untreated CLL in the past 3 years, including obinutuzumab with chlorambucil and ibrutinib. The aim of this analysis was to assess demographics and treatment patterns in patients with previously untreated CLL since the introduction of new treatment options using a novel oncology electronic health record (EHR) database. Methods: A cohort of CLL patients was selected by identifying patients within Flatiron's real-world oncology database. The Flatiron provider network comprises 230 clinics, 2,000 clinicians, and more than 1 million cancer patients throughout the United States (US). Patients included in the cohort were required to meet the following criteria: ≥2 clinic encounters on different days occurring on or after January 1, 2011; ≥1 medication order for an antineoplastic occurring on or after January 1, 2013; physician documentation of CLL; and, evidence in unstructured documents (ie, information not organized in a pre-existing data model, such as free text from a physician note/lab report) of having been treated specifically for CLL. The latter two criteria were assessed based on technology-enabled abstraction of unstructured data (e.g., pathology reports, clinician notes). Patients who lacked unstructured documents, absence of evidence of first-line treatment, or received CLL treatment at a practice outside of the Flatiron network were excluded. The cohort included patients of all ages treated between 2011 and 2015 from all 50 states of the US. The index date was defined as the date of the patient's CLL treatment initiation. Start of first-line therapy after January 1, 2011, was defined as the first episode of an eligible therapy given after or up to 14 days before the date of the patient's CLL treatment initiation. Line of therapy was the first eligible drug episode plus other eligible drugs given within 28 days. Therapies eligible for inclusion in lines of therapy were systemic treatment, as evidenced by an order or administration of an antineoplastic agent recorded in the EHR; radiotherapy and surgery were not included. For patients with documented transformation of CLL, the abstracted date of transformation ended any active line of therapy, and the patient was not considered eligible for any subsequent CLL lines of therapy. Any treatment that occurred after the date of transformation was not included as a CLL line of therapy (steroids were not included in the definition of CLL lines of therapy). Results: As of June 2016, the cohort consisted of 766 eligible CLL patients with a median age of 71 years, and 64% were male (Table 1). While distribution of first-line therapies initiated in 2011 to 2013 remained relatively constant by year, changes were observed during 2014 and 2015 following the introduction of obinutuzumab and ibrutinib (Figure 1); obinutuzumab monotherapy as first-line therapy increased from 8.2% in 2014 to 14.5% in 2015, and ibrutinib monotherapy or ibrutinib + rituximab increased from 10.5% in 2014 to 13.6% in 2015. Of note, fludarabine containing regimens declined from 19.8% in 2012 to 8.8% in 2015. Decreases were also observed with rituximab monotherapy from 21.0% to 16.2%, bendamustine + rituximab (BR) from 36.1% to 31.6%, and rituximab + fludarabine + cyclophosphamide (RFC) from 11.0% to 8.8%. Factors associated with chlorambucil treatment (as monotherapy or in combination) vs. chemoimmunotherapy included older age (75.9 years vs. 68.7 years and 62.6 years for BR and RFC, respectively) and Rai stage (78.1% of patients treated with chlorambucil had Rai stage 0-I disease vs. 70.1% and 71.7% treated with BR and RFC, respectively). A fifth of patients with 17p deletion were treated with ibrutinib. Updated data inclusive of 2016 treatments will be presented. Conclusion: Using a novel EHR database, the marked change in CLL treatments from 2011 to 2015 shows increased utilization of newer agents. Further follow-up and analysis will contrast treatment patterns beyond RCT data in a real-world setting. Disclosures Arnieri: F. Hoffmann La-Roche Ltd: Employment. Bernaards:F. Hoffmann La-Roche Ltd: Employment. Wilhelm:Roche: Equity Ownership; Genentech: Employment. Black:F. Hoffmann La-Roche Ltd: Employment. Hirst:F. Hoffmann La-Roche Ltd: Employment; AstraZeneca: Other: Previous employment . Taylor:F. Hoffmann La-Roche Ltd: Employment. Lambert:F. Hoffmann La-Roche Ltd: Employment. Green:F. Hoffmann La-Roche Ltd: Employment. Lu:F. Hoffmann La-Roche Ltd: Employment. Humphrey:Genentech, Inc.: Employment.


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 77 (3) ◽  
pp. 1181-1194
Author(s):  
Myrlene Sanon Aigbogun ◽  
Martin Cloutier ◽  
Marjolaine Gauthier-Loiselle ◽  
Annie Guerin ◽  
Martin Ladouceur ◽  
...  

Background: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). Objective: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. Methods: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. Results: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%) were initiated within 3 months of the onset of their studied agitation episode, and 62.8% experienced multiple agitation episodes before initiation. While non-pharmacological therapies are recommended first-line approach for agitation in dementia, use of non-pharmacological therapy before initiation of antipsychotics was reported for only 37.8% of patients in residential care and 21.3% in community-based settings. Conclusion: Most patients were initiated on an antipsychotic treatment after multiple episodes of agitation and largely without initial non-pharmacological therapy, suggesting that current treatment guideline recommendations for first-line non-pharmacological intervention may not be adequately followed in clinical practice. Understanding the clinical burden and treatment patterns among dementia patients with agitation is imperative for effective disease management.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18727-e18727
Author(s):  
Robert Smith ◽  
Mei Xue ◽  
Natalie Dorrow ◽  
Prateesh Varughese ◽  
Cosima Hogea ◽  
...  

e18727 Background: Treatment for multiple myeloma (MM) over the past decade has significantly improved survival. In particular, 3 drug classes have altered the treatment paradigm for MM patients: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and CD38 monoclonal antibodies (anti-CD38s). Despite these advances, the majority of patients with MM will become refractory to PIs, IMiDs, and anti-CD38s, and limited evidence indicates these patients have poor outcomes. A retrospective study in the US showed that 275 patients treated at 14 academic institutions with prior exposure to a PI, IMiD, and anti-CD38 had median overall survival of 9.2 months. The aim of this study was to evaluate real-world treatment patterns and outcomes (duration of therapy and overall survival) of patients who had been treated with a PI, IMiD, and anti-CD38 in community practices in the US. Methods: This retrospective observational study was conducted using the Integra Connect (IC) database. The IC database includes electronic health data from structured and unstructured fields from 12 community practices on the East and West Coast of the US. Adult patients with ≥2 ICD-9/ICD-10 codes for MM on at least 2 separate dates, who received MM treatment between Jan 1, 2016, and Dec 31, 2019, with treatment history that included at least one PI, one IMiD, and one anti-CD38 (triple exposed), and initiated a subsequent line of therapy (s-LOT) after becoming triple exposed, were included. Duration of length of s-LOT was defined as number of days from start of s-LOT to last-day supply of s-LOT. Overall survival was defined as the length of time from start of s-LOT through death or the date of the last office visit. Results: A total of 501 patients were included in this analysis. The median age of patients was 64.9 years; 50% were male; 50% had commercial insurance. 82.8% of patients had ECOG 0 or 1 at diagnosis and had received a median of 3 prior lines of therapy (LOTs) before initiating s-LOT. Prior to initiating s-LOT, 91% had been exposed to bortezomib, 81% to carfilzomib, 94% to lenalidomide, 82% to pomalidomide, and 100% to daratumumab. In s-LOT, 95% received treatment that included same drug or same drug class (30% received bortezomib, 48% carfilzomib, 31% lenalidomide, 47% pomalidomide, and 31% daratumumab). The median duration of s-LOT was 78 days and median survival was 10.3 months (308 days) from initiation of s-LOT. Conclusions: For triple-class exposed patients, there is a lack of consensus on the most efficacious approach to subsequent treatment. The present study shows a significant amount of retreatment with previously used agents or classes among these patients with short duration of therapy and poor survival. As has been previously noted, new strategies and agents targeting novel aspects of MM are needed to improve outcomes for these patients. Disclosures: This study (213286) was sponsored by GlaxoSmithKline.


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