15 results on '"Prateesh Varughese"'
Search Results
2. HSR21-047: Tumor Lysis Syndrome Risk Analysis in a US Community Oncology Setting: A Retrospective Observational Study in Integra Connect Network
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Mei Xue, Simon Blanc, Edward Drea, Jeffrey A. Scott, Robert E. Smith, John Verniero, Prateesh Varughese, Hunter Lambert, Kaustav Chatterjee, and Sorena Nadaf
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Tumor lysis syndrome ,Risk analysis ,medicine.medical_specialty ,Oncology ,business.industry ,Emergency medicine ,medicine ,Retrospective cohort study ,business ,medicine.disease - Published
- 2021
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3. Abstract 920: Real-world biomarker testing patterns in metastatic castration-resistant prostate cancer patients
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Simon Blanc, Gboyega Adeboyeje, Liam Lee, Mike Gart, William Saunders, Brandon Wang, Poras Dave, Sandy English, Prateesh Varughese, and Arthur Sillah
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Cancer Research ,Oncology - Abstract
Introduction: Homologous recombination repair mutations (HRRm) result in an accumulation of genetic aberrations and genomic instability. HRRm are estimated to be present in up to 28% of patients (pts) with advanced prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC). Testing for HRRm may inform treatment choice in pts with mCRPC. The aim of the study was to assess HRRm testing rate and describe pts factors associated with testing in treated mCRPC pts. Methods: We identified pts with mCRPC on treatment from 5/1, 2020 through 3/31, 2022 from the Integra Connect PrecisionQ de-identified database, an electronic medical record (EMR) and claims database of US cancer pts in community oncology. We defined HRRm testing as the receipt of any test for alterations in 1 or more of the following genes: BRCA 1/2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54. We described age and race at diagnosis (dx), cancer stage and Gleason score at staging, and line of therapy (LOT), Eastern Cooperative Oncology Group (ECOG) performance status, metastatic sites and prostate-specific antigen (PSA) values at date closest to mCRPC diagnosis. Categorical data were reported as counts and percentages, and continuous data were summarized as medians (IQR). Results: The study cohort comprised 798 pts (HRRm tested, n=389, 48.7%). Most pts were white (81.7%), with a median (IQR) age of 68 (54-82) years at dx. Most pts had high-grade mCRPC, with Gleason scores of 7-8 (43.3%) or 9-10 (47.9%). The majority of pts were stage IV (74.0%), and on their first LOT (44.6%) at mCRPC diagnosis. A higher proportion of pts ≥80 years were not HRRm-tested (61.5%) vs. pts ≤59 (46.6%). Compared to white pts, a higher proportion of black/African American pts were HRRm non-tested (48.6% vs 41.5%). Tested pts had better ECOG status compared to non-tested pts (0 - 1: 91.0% vs 86.8%). 77.1% of tested pts had a bone metastasis compared to 73.4% of non-tested. A higher proportion of tested pts were diagnosed with mCRPC in a later LOT than those not tested. Conclusion: We found a testing rate for HRRm of 49% in US mCRPC pts receiving routine care. There were modest unadjusted differences in demographic and clinical features between tested and non-tested pts. There is a need for further research to examine the value of HRRm testing in mCRPC pts. Citation Format: Simon Blanc, Gboyega Adeboyeje, Liam Lee, Mike Gart, William Saunders, Brandon Wang, Poras Dave, Sandy English, Prateesh Varughese, Arthur Sillah. Real-world biomarker testing patterns in metastatic castration-resistant prostate cancer patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 920.
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- 2023
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4. Real-world treatment patterns and outcomes of triple-class treated patients with multiple myeloma in the United States
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Prateesh, Varughese, Robert, Smith, Mei, Xue, Natalie, Dorrow, Cosmina, Hogea, Eric M, Maiese, and Trudy, Buckingham
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Hematology - Abstract
Although multiple myeloma (MM) survival has improved following the introduction of proteosome inhibitors, immunomodulatory drugs, and anti-CD38 therapies, patients become refractory to these agents. Real-world outcomes of triple-class exposed patients are limited and were investigated in this study. The Integra Connect Database was used to assess the treatment patterns of triple-class exposed patients with relapsed/refractory MM (RRMM) (January 2016–December 2019). During this period, patients (N = 501) reached triple exposure in a median of three lines of therapy (LOTs) over 995 days. A new LOT was started in a median of 18 (1–691) days after triple exposure; 71% of the patients started a new LOT within 30 days. Throughout the follow-up period, 8% of the patients had a therapy gap greater than 90 days. Following triple exposure, 103/501 patients (21%) received only triple-class agents in subsequent LOTs, while 24 (4.8%) patients received only non–triple-class agents. The median apparent survival from initiation of first therapy after triple exposure was 308 days. These results indicate that recycling of triple-class agents after previous exposure is widespread and prognosis in the RRMM population remains poor, highlighting the continuing unmet need for new agents with novel mechanisms to improve patient outcomes.
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- 2022
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5. Quality initiative (QI) to improve molecular testing in newly diagnosed (ND) stage 4 non-small cell lung cancer (NSCLC-4): An Integra Connect (IC) database study
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Mike Gart, Rushir J. Choksi, Daniel P. Petro, Jeffrey A. Scott, Prateesh Varughese, Matt Stockton, and Robert E. Smith
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Cancer Research ,Oncology - Abstract
e13507 Background: In August 2019 IC partnered with University of Pittsburg Medical Center (UPMC) on a QI aimed at improving outcomes in stages 3 and 4 NSCLC. This report details the findings, interventions, and results in the stage 4 cohort to date. Guidelines advocate broad molecular profiling and completion of biomarker testing prior to initiation of initial therapy (KF Mileham,2022). However, real world data has shown a high rate of treatment initiation without biomarker testing due to low rate of testing and, if tested, treatment prior to results reporting (H West,2021; J Nicholas, 2021) in this disease state having a 5-year survival of only 7% (N Howlander). Based on analysis of the US Oncology Network it was found that only 46% of patients (pts) with metastatic NSCLC received testing for PD-L1, EGFR, ALK, ROS1, and BRAF-V600E (J Nicholas, 2021). Methods: By querying the UPMC and IC databases, 847 patients (pts) with ND NSCLC-4 were identified who received an initial line of therapy, excluding squamous carcinoma pts unless documented never-smokers, during 1/1/2017- 12/31/2021. Date of EGFR test ordered, date of test result report to electronic health record, and date of treatment initiation were captured. Also included were test orders for the NCCN recommended biomarker panel of PD-L1, ALK, ROS1, BRAF, RET, MET, and NTRK. The data were evaluated in three time periods for the QI: Phase 1 of 1339 days (1/1/2017-8/31/2020) for baseline, Phase 2 of 122 days (9/1/2020-12/31/20) post physician leadership intervention, and Phase 3 of 272 days (1/1/2021-9/30/2021) performance measurement period. Baseline and on-going measurement of testing metrics was performed with physician leadership intervention for identified gaps in care. Additionally, surveys were implemented to assess caregiver perceptions. The use of chart curation and software-based monitoring tools powered by IC enabled providers to understand current levels of testing and track performance over time. Results: Median age was 68 (range 36 - 89) and 49% male. As shown in Data Table, EGFR testing at baseline was 94% and increased to 96%. Testing of the entire biomarker panel noted above increased from 52% baseline to 76% at this point in Phase 3. While only 72% had treatment initiated after EGFR result at baseline, this improved to 88% during Phase 3. Conclusions: This QI led to improvement in rates of broad biomarker testing and initiation of treatment only after results were made available in this NSCLC-4 population. While this initiative was not designed to evaluate outcomes, one would expect outcome improvement over baseline with higher guideline adherence.[Table: see text]
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- 2022
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6. Evaluation of outcomes in patients (pts) with stage 4 non-small cell lung cancer (NSCLC 4) harboring actionable oncogenic drivers (AOD) when treated prior to report of mutation without tyrosine kinase inhibitors (TKI): An Integra Connect Database (ICD) retrospective observational study
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Robert E. Smith, Melissa Lynne Johnson, Lucio N. Gordan, Mei Xue, Prateesh Varughese, Natalie A. Dorrow, Brandon Wang, Varun Vaidya, Mike Gart, Hinco J. Gierman, and Jeffrey A. Scott
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Cancer Research ,Oncology - Abstract
1530 Background: In a prior analysis, we identified 525 pts with newly diagnosed NSCLC 4 harboring AOD in the ICD. Of these, 141 were treated prior to the reporting of AOD with chemotherapy (C), immune checkpoint inhibitor (ICI), or both. This report details the clinical outcomes of these 141 compared to the 384 treated after AOD reported. Methods: Real world data (RWD) were obtained from a curated ICD for pts with NSCLC 4 diagnosed 1/1/2018-12/31/2020 with cutoff of data 3/31/2021. Pts with EGFR, ALK, ROS1, BRAF, MET, RET, HER2, and NTRK were included if their treatment record were captured. Also included were demographics, ECOG score, date of first report of AOD and dates of initiations of first and any second line of therapy and date of apparent death (AD). Outcome measures were time to next treatment or apparent death (TTNT) and apparent survival (AS) (ICD model does not allow date of death per HIPAA de-identified Expert Determination). Descriptive statistics were used with Kaplan-Meier (K-M) estimates and Hazard Ratios (HR) by Cox regression. 3 cohorts were defined: Group (Gr) A with 384 pts treated after AOD reported and used as the comparator; the 141 pts treated before AOD with C, ICI or both were divided into Gr B (n = 51) who subsequently switched to TKI within 35 days and Gr C (n = 90) who did not switch. Results: As shown in data table, AS was significantly worse in Gr B and Gr C, TTNT was significantly worse in Gr C and with worsening trend in Gr B. Two potential confounders were identified: higher ECOG scores might indicate more urgency to assign treatment, but pts with ECOG ≥ 2 were similar in all 3 groups; also, difference in proportion of EGFRm by Group (Gr A 62%, Gr B 57%, and Gr C 29%), but separating cohorts by EGFR mutation status did not alter results. Conclusions: While subject to the limitations of a retrospective observational RWD study, this study strongly suggests outcomes are significantly compromised in pts harboring AOD but who are treated initially with C, ICI or both, even in pts quickly switched to TKI. Since a prospective clinical trial is not ethically feasible, these findings may stimulate review of current guidelines, fuel optimization of universal testing in NSCLC 4, and encourage utilization of liquid or ultra-fast NGS with their rapid turnaround times in order to improve survival in this setting. [Table: see text]
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- 2022
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7. Impact of turnaround time (TAT) of molecular testing on initial treatment (Tx) in newly diagnosed stage 4 non-small cell lung cancer (NSCLC 4): An Integra Connect (IC) retrospective observational study
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Mike Gart, Lucio N. Gordan, Rushir J. Choksi, Daniel P. Petro, Jeffrey A. Scott, Prateesh Varughese, Erin Alwon, and Robert E. Smith
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Cancer Research ,Oncology - Abstract
e13510 Background: Broad molecular profile-based initiation of Tx in newly diagnosed NSCLC 4 (KF Mileham, Cancer Med, 2022) is advocated by NCCN guidelines. Despite this, Tx is often started prior to, and without knowledge of, an actionable oncogenic driver (AOD), and often without subsequent switch to appropriate tyrosine kinase inhibitor (TKI). In this study we sought to assess the impact of TAT of genomic testing on Tx in patients harboring a potentially actionable EGFR mutation. Methods: By interrogating the IC curated database, we identified 2,357 newly diagnosed NSCLC 4 patients (pts) who started an initial line of therapy (LOT 1) between 1/1/2019 and 12/31/2021. Squamous carcinoma pts were excluded unless documented to be never smokers or st Tx start. From this, we calculated TAT and whether Tx was initiated after genomic results. In addition, we captured whether testing was in-house or by reference lab (RL). We looked at the RLs that comprise of the top 85% of NGS test sources, where the testing source was known. We removed records where test order dates and results dates were the same date, where test order dates or results dates were unknown, and where TAT > 90 days. EGFR Effective Testing Rate (EETR) is defined as EGFR result prior to line 1 Tx start. Results: Median age was 70 (range 40 - 89) and 50% male. Pts with TAT of ≤7 days had an 82% EETR vs. Pts with TAT of >29 days had a 61% EETR. Overall, RLs had a median TAT of 19 days with a 72% EETR, whereas in-house labs had a median TAT of 15 days with a EETR of 80%. Conclusions: When providers and patients can obtain test results within 21 days of test order there is a higher likelihood of waiting for the test result to start Tx. Many community oncology practices are contemplating implementing in-house testing solutions to improve rates of testing and turnaround time of testing. This may prove to be an effective strategy given the better TAT for in-house testing. When there is faster TAT, patients and providers wait to start initial Tx. Getting patients on appropriate therapy based on their biomarker status can improve overall survival.[Table: see text]
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- 2022
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8. MM-079: Real-World Treatment Patterns and Outcomes of Triple-Exposed Multiple Myeloma (MM) Patients Treated in Community Oncology Practices in the US
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Eric M. Maiese, Robert S. Smith, Shannon Ferrante, Prateesh Varughese, Natalie Dorrow, Trudy Buckingham, Cosmina Hogea, Leah Sansbury, and Mei Xue
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Cancer Research ,medicine.medical_specialty ,business.industry ,Bortezomib ,Daratumumab ,Retrospective cohort study ,Context (language use) ,Hematology ,medicine.disease ,Pomalidomide ,Carfilzomib ,chemistry.chemical_compound ,Oncology ,chemistry ,Internal medicine ,medicine ,business ,Multiple myeloma ,medicine.drug ,Lenalidomide - Abstract
Context Most patients with MM become refractory to proteasome inhibitors (PIs), immunomodulatory drugs, and anti-CD38 monoclonal antibodies; limited evidence indicates these patients have poor outcomes. A US retrospective study showed that 275 patients treated at 14 academic institutions with prior exposure to these 3 agents (triple-exposed) had median overall survival (OS) of 9.2 months. Objective To evaluate real-world treatment patterns and outcomes (duration of therapy and OS) of patients previously treated with a PI, immunomodulatory drug, and anti-CD38 in US community practices. Methods This retrospective observational study used the Integra Connect (IC) database, which includes electronic health data from structured and unstructured fields from 12 community practices on both US coasts. Included were adults with ≥2 ICD-9/ICD-10 codes for MM on ≥2 separate dates who received MM treatment from 2016–2019 with treatment history including triple exposure and who initiated a subsequent line of therapy (s-LOT) after becoming triple-exposed. Outcomes included s-LOT length duration (days from s-LOT start to last-day supply of s-LOT) and OS (time from s-LOT start through death or last office visit date). Results This analysis included 501 patients (median age, 64.9 years; 50% male; 50% with commercial insurance); 82.8% had ECOG 0 or 1 at diagnosis and received a median of 3 prior lines of therapy (LOTs) before initiating s-LOT. Exposures prior to s-LOT included bortezomib (91%), carfilzomib (81%), lenalidomide (94%), pomalidomide (82%), and daratumumab (100%). In s-LOT, 95% received treatment that included the same drug/drug class (bortezomib [30%], carfilzomib [48%], lenalidomide [31%], pomalidomide [47%], and daratumumab [31%]). Median s-LOT duration was 78 days, and median survival was 10.3 months from s-LOT initiation. Conclusions For triple-class-exposed patients, there is lacking consensus on the most efficacious approach to subsequent treatment. This study shows significant retreatment with previously used agents/classes among these patients with short therapy duration and poor survival. New strategies and agents targeting novel aspects of MM are needed for these patients. ©2021 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2020 ASCO Annual Meeting. All rights reserved. Funding GlaxoSmithKline (213286).
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- 2021
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9. Poster: MM-079: Real-World Treatment Patterns and Outcomes of Triple-Exposed Multiple Myeloma (MM) Patients Treated in Community Oncology Practices in the US
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Shannon Ferrante, Prateesh Varughese, Leah Sansbury, Natalie Dorrow, Trudy Buckingham, Cosmina Hogea, Mei Xue, Robert E. Smith, and Eric M. Maiese
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Internal medicine ,medicine ,Hematology ,business ,medicine.disease ,Multiple myeloma - Published
- 2021
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10. Daratumumab Dose Analysis Among Patients with Multiple Myeloma in a US Community Oncology Setting: A Retrospective Observational Study in Integra Connect Network
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Stanley M. Marks, Hunter Lambert, Robert E. Smith, Neil Nagovski, Prateesh Varughese, Mei Xue, Simon Blanc, and Jeffrey A. Scott
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Oncology ,medicine.medical_specialty ,business.industry ,Immunology ,Daratumumab ,Retrospective cohort study ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Internal medicine ,Medicine ,business ,Multiple myeloma - Abstract
BACKGROUND Since the FDA's initial indication for the use of daratumumab in relapsed/refractory multiple myeloma (RRMM) in November 2015, usage has been expanded by subsequent approvals in newly diagnosed, transplant-ineligible MM patients, and more recently in newly diagnosed transplant-eligible patients. Real World Data (RWD) has been published demonstrating daratumumab's efficacy in RRMM settings[1]and its utility of split dosing for the initial dose[2]. However, no study has been published to examine the real-world dosing patterns of daratumumab compared to the FDA standard dosing schedule. While there are minimal variations in the approved dosing schedule of daratumumab, generally accepted dosing is weekly in week 1 through week 8, q 2 Wks in week 9 through week 24, and q 4 Wks after week 24, all at the standard 16 mg/kg dosage[3]. In its approved dosing schedule, adjustments are made in the frequency of administration, but not in the standard weight-based dosing. METHODS Utilizing the Integra Connect database which contains 17 community oncology network accounts and over 1,900 providers in US, we collected all MM patients treated with daratumumab between January 1, 2016 and March 31, 2020. We then excluded any patient whose first line of therapy (LOT) was ambiguous, in order to correctly identify the daratumumab-containing LOTs. We also excluded LOT 1 daratumumab transplant induction due to the wide variation in daratumumab dosing schedules in clinical trials in the transplant eligible patient[4]. LOTs were determined based on International Myeloma Working Group guidelines[5]. Data were collected on the date of each individual daratumumab administration, counting initial split dose, if utilized, as 1 dose. The duration of daratumumab and number of doses administered were calculated and corrected for any time on treatment breaks. The study was conducted per individual patient by LOT cohorts, and for the entire cohort of patients. We utilized the standard dose schedule for daratumumab noted above to establish the expected doses of daratumumab and calculated the compliance dose ratio (ratio of actual doses to expected doses per time on therapy) to evaluate how closely real-world treatment adhered to the standard dosing schedule. RESULTS 1037 MM patients were included with at least 6 doses of daratumumab administration and without stem cell transplant or uncertain LOT. Across all LOTs, the mean duration of daratumumab treatment was 5.6 months with a median duration of 9.8 months. After week twenty-four, 671 (65%) patients remained on daratumumab-containing regimens, with 330 patients continuing q 1 Wk or q 2 Wks dosing, whereas the standard would employ a switch to q 4 Wks dosing (Figure 1). Overall compliance dose ratio was consistently above 100%, implying a significant proportion of patients were receiving more frequent dosing than expected under the standard dosing schedule (Figure 2). We carefully evaluated patients in various LOTs and combination therapies. Drug combination was not found to exert a significant impact on the daratumumab dosing pattern. Compliance dose ratio of daratumumab is slightly higher in RRMM compared to the dose ratio in LOT 1 newly diagnosed MM, but even LOT 1 has a ratio greater than 1 (Figure 3). It should be noted that this increased compliance dose ratio is present in all LOT cohorts despite 25% of patients being started on doses less frequent than weekly (Figure 1). CONCLUSIONS In real-world community oncology practices, daratumumab is utilized in a more frequent dosing schedule than the FDA approved standard dosing. With standard dosing there are 23 daratumumab doses in the first 52 weeks. The compliance dose ratio found in our RWD implies 27.3 doses in the first year for the entire cohort and 26.9 and 28.3 doses in LOTs 2 and 3 respectively. Thus, significantly increased drug and administrative costs are incurred over those anticipated in respect to daratumumab dosing utilization. This study is limited to the EMR and administrative claims data of those individuals who are being treated in a community oncology setting. Residual confounding and bias may exist due to entry error and unobserved patient characteristics. References [1] Gergely Varga, et al; Blood 2018; 132:3257 [2] Rifkin R, et al; Clin Ther. 2019;41(5):866-881 [3] DARZALEX® [Prescribing Information] [4] Abdallah N, et al. Ther Adv Hematol. 2019 Dec 23 [5] Rajkumar SV, et al Blood. 2015;126(7):921-922 Disclosures Smith: Integra Connect: Current Employment; Sanofi: Research Funding. Xue:Sanofi: Research Funding; Integra Connect: Current Employment. Marks:Sanofi: Research Funding. Scott:Integra Connect: Current Employment; Sanofi: Research Funding. Blanc:Sanofi: Research Funding. Nagovski:Sanofi: Research Funding. Lambert:Sanofi: Research Funding; Integra Connect: Current Employment. Varughese:Integra Connect: Current Employment; Sanofi: Research Funding.
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- 2020
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11. Quality initiative (QI) in unresectable stage III non-small cell lung cancer (NCSLC): Impact on time-to-treatment (TTT) for immunotherapy post chemoradiation (CRT)
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Robert E. Smith, Mike Gart, Jeffrey A. Scott, Prateesh Varughese, Daniel P. Petro, Elvis Marshall, Rebecca Tarlazzi, Elizabeth Botts, Greg Brown, Sarah Quatela, Sandy English, Hinco J. Gierman, Monica Labrador, and Rushir J. Choksi
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Time to treatment ,Immunotherapy ,Stage III Non-Small Cell Lung Cancer ,Internal medicine ,medicine ,In patient ,Stage (cooking) ,business - Abstract
e18780 Background:In August 2019 Integra Connect (IC) partnered on a QI with University of Pittsburgh Medical Center (UPMC) to improve outcomes in patients with stage 3 and 4 NSCLC. This report details the findings and interventions in the unresectable stage 3 cohort of the QI. The addition of durvalumab (D) in the PACIFIC trial (Antonia et al. NEJM 2017) after completion of CRT in stage 3 patients who had not progressed showed significant Progression Free Survival and Overall Survival (OS) benefit with Food and Drug Administration approval on 2/16/2018 in this setting. An update (Gray et al. Thoracic Oncol 2020) on 10/14/2019 noted superior OS in patients in whom randomization to D occurred 1-14 days post CRT vs. those with interval 15-42 days (HR 0.43 vs. 0.79). Data suggest that CRT renders tumors more responsive to immunotherapy (McCall et al. Clin Can Res 2018). As part of the QI, we explored the question whether time from CRT to D (TTT) could be shortened. Methods:From the UPMC and IC real-world-data (RWD) databases, we identified 182 patients with Stage 3 unresectable NSCLC treated with CRT between 2/16/18 (D approval) and 11/16/20 for manual chart abstraction. We calculated the TTT from the latest day of radiation or chemotherapy to the first D dose. Time-to-scan (TTS) used a similar methodology. If post-CRT scan data was not found, those patients were excluded from TTS analysis. We captured caregiver perception with surveys and used RWD to determine the proportion of eligible patients treated with D, categorizing the data into 3 successive time periods: Phase 1 (240 days): 2/16/18 approval of D to Gray update 10/14/19, Phase 2 (321 days): 10/15/19 to physician leadership intervention 8/31/20, Phase 3 (76 days): 9/1/20 to 11/16/20. Patients were excluded in phase 3 who started CRT after 11/16/20 to allow for up to 2 months to start D. Our plan included baseline and ongoing monitoring of metrics complemented with physician leadership intervention to address identified gaps in care. Results: Median age of the 182 patients was 68 (range 46-87) with 60% male. Of eligible patients, 121 (66.5%) received at least 1 dose of D. Median TTS improved 16 days from Phase 1 to Phase 3 while TTT concomitantly improved 17 days (Table ). Conclusions: This QI resulted in simultaneous shortening of TTS and TTT following physician intervention with establishment of TTS as a key potential driver of TTT which ultimately may result in improved OS. To do so required overcoming the traditional paradigm of imaging 4-6 weeks post-CRT to capture maximal response with that of early imaging aimed at assuring no progression had occurred. This, as well as proportion treated with D and its resulting duration, plus any subsequent treatments that might indicate relapse, continue to be monitored in a real-time dashboard.[Table: see text]
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- 2021
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12. Real-world treatment patterns and outcomes of triple-exposed multiple myeloma patients treated in community oncology practices in the United States
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Robert S. Smith, Leah Sansbury, Eric M. Maiese, Shannon Ferrante, Mei Xue, Prateesh Varughese, Cosima Hogea, Natalie Dorrow, and Trudy Buckingham
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Oncology ,Drug ,Cancer Research ,medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,Improved survival ,medicine.disease ,Internal medicine ,medicine ,business ,Multiple myeloma ,media_common - Abstract
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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- 2021
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13. Real-world data analysis of ovarian cancer (OC) maintenance utilization among maintenance eligible patients
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Prateesh Varughese, Ebru Aydin, Monica Labrador, Greg Brown, Joseph Donaldson, David Garofalo, Hinco J. Gierman, Jeffrey A. Scott, Ash Malik, and Jennifer Webster
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Oncology ,Cancer Research ,medicine.medical_specialty ,Chemotherapy ,business.industry ,medicine.medical_treatment ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,Ovarian cancer ,business ,Real world data ,030215 immunology - Abstract
5579 Background: Approximately 1% of US women will be diagnosed with epithelial OC during their lifetime. OC patients who achieve a response to platinum-based chemotherapy may benefit from maintenance therapy, with the goal of inducing a lasting remission or extending the time interval before progression without any deleterious impact on quality of life1. This analysis, based on real world data sourced from US community oncology practices, was designed to assess the current utilization of maintenance therapy among maintenance eligible patients. Methods: This analysis utilized the Integra Data Exchange (DTX) database, a deidentified data source from community oncology practice systems (EMR, practice management, paid claims). This retrospective study included 3,629 OC patients with at least two visits between 7/16/16 and 4/16/18. 398 patients who completed 2nd line or later platinum-based chemotherapy for 4-9 cycles and/or had a complete/partial response between 1/1/17 and 7/31/18 were included. Potential maintenance therapy options were monotherapy of PARP inhibitors, bevacizumab, and non-platinum-chemotherapy agents. Rate of maintenance therapy after platinum-based treatment was assessed. Results: Our real-world analysis found that 49% of 398 maintenance eligible patients received maintenance therapy at least once following response to 2nd line or later platinum chemotherapy. Among those that received maintenance, 46% received PARPi, 28% bevacizumab, and 26% non-platinum chemotherapy. Further, 56% of women with BRCA mutations received maintenance treatment, compared with 49% of women without BRCA mutations. Conclusions: Though there are several options available, 51% of OC women studied who could potentially benefit from maintenance treatment did not receive maintenance. Only 56% of BRCA mutation carriers were targeted for maintenance in the real world. Among patients that receive maintenance therapy following 2nd line or later platinum chemotherapy 46% received a PARPi based regimen. 1) Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomized controlled trial. Lancet Oncol. 2018 Aug;19(8).
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- 2019
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14. Real-world duration of maintenance therapy in 2nd-line and later ovarian cancer (OC)
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Monica Labrador, Jeffrey A. Scott, David Garofalo, Joseph Donaldson, Jennifer Webster, Prateesh Varughese, Melissa Hagan, Ebru Aydin, Helen Smith, and Ash Malik
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Oncology ,Cancer Research ,medicine.medical_specialty ,Maintenance therapy ,business.industry ,Duration (music) ,Internal medicine ,medicine ,Line (text file) ,Ovarian cancer ,medicine.disease ,business - Abstract
e17103 Background: Recurrent OC patients may benefit from maintenance therapy, with the goal of inducing a lasting remission or extending the time interval before progression without any deleterious impact on quality of life1. This analysis, based on real world data sourced from US community oncology practices, was designed to compare the time to next treatment of available maintenance treatment options in recurrent OC. Methods: This analysis utilized the Integra Data Exchange (DTX) database, a deidentified data source from community oncology practice systems (EMR, claims). This retrospective study included 3,629 OC patients with at least two visits between 7/16/16 and 4/16/18. 1,767 patients started at least one 2nd line or later line of therapy and 577 of these patients had at least one line of maintenance treatment. Maintenance options were monotherapy PARP inhibitors, Bevacizumab, or non-platinum-chemotherapy. Patients who did not receive maintenance were categorized as observation. Time to next treatment (start of maintenance to start of next line of therapy) was compared through ANOVA and paired T-test analyses. Results: A statistically significant difference was seen in time to next treatment between PARPi (n = 151) and bevacizumab maintenance (n = 212) (p = < 0.0125) and between PARPi and cytotoxic maintenance (n = 163) (p = < 0.0001). Bevacizumab and PARPi maintenance had significantly longer duration when compared to observation (n = 1,626) (p = < 0.0001). Cytotoxic maintenance duration was not significantly different than observation (p = 0.93). Conclusions: Our real world analysis found that there was a statistically significant increase in time to subsequent lines of therapy when certain maintenance treatment (PARPi, Bevacizumab) is utilized following 2nd line and later treatment in OC. Further, between available maintenance options, PARPi had the longest time to next treatment when compared to other maintenance options.[Table: see text]
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- 2019
- Full Text
- View/download PDF
15. Polymorphisms in TPMT and TYMS may predict severe toxicity in DPYD wild-type patients receiving fluoropyrimidine (FP) chemotherapy for colorectal cancer
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Kevin P. Rosenblatt, Roisin O Sullivan, Laura McGrath, Pratheesh Sathyan, Kristen C. Floyd, Patrick F. Forde, Aine Mary Peoples, Elisabete Amaral-Trusty, Prateesh Varughese, Mehdi Dehghani, Conleth G. Murphy, Raimundas Galiauskas, Brian Richard Bird, and Gul Ahmed
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Oncology ,Cancer Research ,Chemotherapy ,medicine.medical_specialty ,Thiopurine methyltransferase ,biology ,business.industry ,Colorectal cancer ,medicine.medical_treatment ,Wild type ,food and beverages ,Pharmacology ,medicine.disease ,Internal medicine ,Toxicity ,biology.protein ,Medicine ,DPYD ,business ,Severe toxicity - Abstract
e13018Background: Approx 20% of patients receiving FP chemotherapy experience grade 3-5 toxicity. Known deleterious DPYD mutations account for 20% of these toxicities. We set out to examine whether...
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- 2016
- Full Text
- View/download PDF
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