Abstract P212: Benchmark Analysis of Genetic Testing Practice Patterns in a Real-World Population of Patients Receiving Clopidogrel or Prasugrel Therapy

2011 ◽  
Vol 4 (suppl_2) ◽  
Author(s):  
Cynthia H Ewel ◽  
Barnabie C Agatep ◽  
Vivian Herrera ◽  
Nathan J Markward ◽  
Eric J Stanek ◽  
...  
Keyword(s):  
Genetic Testing ◽  
Real World ◽  
Cohort Analysis ◽  
Routine Practice ◽  
World Population ◽  
Provider Education ◽  
Stroke Event ◽  
Pharmacy Claims ◽  
Prescription Date ◽  
The Impact

BACKGROUND: Cytochrome P450 2C19 genotype has been shown to modify cardiovascular outcomes on clopidogrel therapy in patients post-acute coronary syndromes or percutaneous coronary interventions. Recent clopidogrel label changes have incorporated this information; however real-world application of genetic testing in patients receiving thienopyridine antiplatelet therapy is unknown. METHODS: A retrospective, integrated medical and pharmacy claims database, cohort analysis was conducted in patients with new clopidogrel or prasugrel prescriptions between 7/1/08-6/30/10, and continuous eligibility for 6 months pre- and 3 months post-initiation. Genetic testing was identified using CPT-4 codes present 1 month prior and 3 months post the index prescription date. Genetic testing incidence was calculated, and univariate comparisons of prescriber information, and patient demographic and clinical characteristics in cases tested vs not tested were performed. RESULTS: The analysis included 95,381 clopidogrel and 1,819 prasugrel patients. Genetic testing was recorded in 522 (0.6%) clopidogrel and 15 (0.8%) prasugrel patients, rendering the latter sample too small for detailed analysis. Clopidogrel patients receiving genetic testing (vs patients not tested) were a mean age of 58±13 yrs (68±13 yrs, p<0.001), 29% were ≥65 yrs old (61%, p<0.001), 56% were male (59%), 33% were Western US residents (18%, p<0.001), 35% were recently hospitalized for stroke (8%, p<0.001), and were less often prescribed clopidogrel by a cardiologist (22% vs 32%, p<0.001) and more often by a neurology specialist (8% vs 2%, p<0.001). The incidence of genetic testing did not vary over time. CONCLUSION: Although the FDA has provided numerous advisories that have lead to changes in clopidogrel provider information sheets, genetic testing is rarely employed in routine practice in patients prescribed clopidogrel or prasugrel therapy. Testing was biased toward younger clopidogrel patients with a recent stroke event, and non-cardiologist prescribers. While these data establish a national benchmark for future comparison, further exploration of barriers to testing, provider education and patient selection, and the impact of programmatic approaches to testing are warranted.

2848 The Impact of Multitarget Stool DNA (Cologuard) Testing in a Real World Population

2019 ◽  
Vol 114 (1) ◽  
pp. S1565-S1565
Author(s):  
Erica Turse ◽  
Francis Dailey ◽  
Veysel Tahan ◽  
John Turse
Keyword(s):  
Real World ◽  
World Population ◽  
Stool Dna ◽  
The Impact

scholarly journals 599 Gender-based differences in TAVI outcomes: report from a large contemporary real-world population of self-expandable valves

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Alessandro Sticchi ◽  
Francesco Gallo ◽  
Vincenzo De Marzo ◽  
Kim Won-keun ◽  
Tobias Zeus ◽  
...  
Keyword(s):  
Risk Factors ◽  
Acute Kidney Injury ◽  
Primary Endpoint ◽  
Major Bleeding ◽  
Real World ◽  
Vascular Complications ◽  
Kidney Injury ◽  
World Population ◽  
Gender Based ◽  
The Impact

Abstract Aims Small sub-study data derived from randomized clinical trials suggest a gender-based disparity in TAVI outcomes. However, large real-world contemporary data is missing. The aim of this study is to compare the risk factors, procedural characteristics and clinical outcomes of male and female patients who underwent transcatheter aortic valve implantation (TAVI) using two next-generation self-expandable bioprostheses (ACURATE neo and Evolut R/Pro valves). Methods We performed a first unmatched comparison and a propensity score-matched analysis (PSM) to assess the outcomes derived by the sex difference beyond the impact of pre-procedural risk factors in a large, contemporary, real-world, multicentre, international, retrospective registry of 3862 consecutive patients. The primary endpoint was a composite of all-cause death or any stroke (disabling and non-disabling) at 1 year. Results Sixty-four per cent (2162/3353 patients) of the study cohort was female and was older (mean age 82.3 years vs. 81.1 years for men (P&lt;0.001)) had a higher BMI (27.7±5.7 for women vs. 27.2±4.5 for men), and lower prevalence of dyslipidaemia (50.2% vs. 54.7, P=0.037), diabetes (26.8% vs. 33.7, P&lt;0.001), smoking (10.0% vs. 24.3%, P&lt;0.001), COPD (17.4% vs. 21.9%, P=0.002), pacemaker/ICD (9.6% vs. 14.0%, P&lt;0.001), previous cardiac surgery (8.6% vs. 18.8%, P&lt;0.001), previous PCI (23.0% vs. 36.8%, P&lt;0.001). Mean STS score for women was higher 5.2±3.9% vs. 4.5±3.4% (P&lt;0.001). Women had higher mean valve gradients (45.4±17.1 vs. 42.7±14.7 mmHg; P&lt;0.001), smaller valve areas (mean 0.7 cm2 vs. 0.9 cm2, P=0.037) and smaller annular perimeters (56.8±23.0 vs. 62.0±23.8, P&lt;0.001). The primary endpoint was resulted in a rate of 7.9% vs. 6.9% (P=0.337) in the unmatched population and 9.4% vs. 6.0% (P=0.014) after the PSM, respectively for women and for men. Independently, there was no difference in mortality (5.9% vs. 5.6%; P=0.786) and stroke (2.5% vs. 1.8%; P=0.243) rates between women and men in the un-matched groups. Rates of cardiac tamponade (1.5% vs. 0.4%, P=0.008), major vascular complications (7.7% vs. 4.1%, P&lt;0.001), life-threatening bleeding (2.8% vs. 1.4%, P=0.016), major bleeding (5.1% vs. 2.9%, P=0.004), need of transfusion (8.9% vs. 4.6%, P&lt;0.001) and acute kidney injury (8.5% vs. 5.7%, P=0.009), were all significantly higher in women. After PSM, mortality was similar between the two groups (11.3% for women vs. 9.5% for men, P=0.264) but strokes were more prevalent in women (2.8% vs. 1.2%, P&lt;0.024). Furthermore, in the matched population, major vascular complications (6.8% vs. 4.1%, P=0.024), need of transfusion (9.1% vs. 4.6%, P&lt;0.001) and acute kidney injury (8.7% vs. 5.6%, P=0.009) remained significantly different between women and men, respectively. Conclusions In this large real-world contemporary TAVI registry, female gender was associated with higher rates of stroke, vascular complications, major bleeding, and acute kidney injury. Further studies are required to explore the underlying pathophysiological mechanisms for these observations.

Abstract TMP40: Impact of Age on Atrial Fibrillation Detection among a Large, Real-World Population of Cryptogenic Stroke Patients with Insertable Cardiac Monitors

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Mark Richards ◽  
John D Rogers ◽  
Scott W Ferreira ◽  
Allan J Nichols ◽  
Jodi L Koehler ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Median Time ◽  
Real World ◽  
Detection Rate ◽  
Recurrent Stroke ◽  
Anticoagulation Therapy ◽  
Cryptogenic Stroke ◽  
World Population ◽  
Time To Detection ◽  
The Impact

Introduction: Detection of atrial fibrillation (AF) in patients with a cryptogenic stroke (CS) is critical for reducing the risk of recurrent stroke by enabling oral anticoagulation therapy. However, the impact of age on AF detection and the optimum duration of AF monitoring in patients following a CS is not well characterized. We investigated the impact of age on AF detection among a large, real-world cohort of unselected patients with an implantable cardiac monitor (ICM) placed following CS. Methods: Patients in the de-identified Medtronic Discovery™ Link database who received an ICM (Reveal LINQ™) for AF detection following CS were included and monitored for up to 182 days. All AF episodes were adjudicated. We compared the mean age between patients with vs. without AF detected and compared the median time to detection of the first AF episode between younger (age ≤65) and older (age >65) patients. Results: Among 1247 patients (mean age 65.3±13.0, 53% male) followed for 182 [IQR 182-182] days, 1521 AF episodes were detected in 147 patients and resulted in an AF detection rate of 12.2%. Patients with AF detected were significantly older than patients without AF detected (71.3±10.9 vs. 64.5±13.1 years, respectively; p<0.001). The median time to detection of the first AF episode was shorter for older vs. younger patients (43 [10-91] vs. 89 [29-127] days, respectively; p=0.016; Figure). Conclusion: Continuous monitoring of CS patients with an ICM resulted in an AF detection rate of 12.2% within the initial 6 months. Patients with AF detected were older and patients >65 years of age had shorter times to initial AF detection. However even among older patients, the majority of AF occurred outside the range of external monitoring devices and thus highlights the importance of long-term monitoring with ICMs in the management of CS patients.

scholarly journals Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada

2020 ◽  
Author(s):  
Wei Fang Dai ◽  
Jaclyn Beca ◽  
Ruth Croxford ◽  
Wanrudee Isaranawatchai ◽  
Ines B. Menjak ◽  
...  
Keyword(s):  
Real World ◽  
Comparative Effectiveness ◽  
Cox Regression ◽  
Population Based ◽  
Administrative Databases ◽  
Routine Practice ◽  
World Population ◽  
Second Line ◽  
Drug Databases ◽  
Historical Controls

Abstract Background For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment’s real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments). Methods We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting. Results We identified 329 patients with MM who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27%-41%), 20.6% (15%-27%), and 15.2% (9.6%-21%) for ipilimumab and 17.1% (11%-23%), 7.1% (2.9%-11%), and 4.7% (1.2%-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR=0.62; 95% CI: 0.49-0.78; p <0.0001). Conclusions This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.

scholarly journals CRT-8 Final Results of the Deliver Study - The Impact of the New Resolute Integrity Stent Platform in a Real-world Population With 7740 Patients

2013 ◽  
Vol 6 (2) ◽  
pp. S3-S4
Author(s):  
Jochen Wöhrle ◽  
Jawed Polad ◽  
Balbir Singh ◽  
Milan Chag ◽  
Seung-Woon Rha ◽  
...  
Keyword(s):  
Real World ◽  
World Population ◽  
The Impact

scholarly journals Overall Survival Benefit of Ixazomib, Lenalidomide and Dexamethasone (IRD) over Lenalidomide and Dexamethasone (RD) in RRMM Patients Treated in Routine Clinical Practice: Results from the Czech Registry of Monoclonal Gammopathies (RMG)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3139-3139 ◽  
Author(s):  
Jiri Minarik ◽  
Tomas Pika ◽  
Jakub Radocha ◽  
Alexandra Jungova ◽  
Jan Straub ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Survival Benefit ◽  
Cohort Analysis ◽  
Progression Free Survival ◽  
Routine Practice ◽  
Monoclonal Gammopathies ◽  
Extramedullary Disease ◽  
Overall Survival Benefit ◽  
Reported Data

Background : Outcomes reported in real-world practice versus controlled clinical trials show markedly shorter treatment durations, progression free survival (PFS) and overall survival (OS). Understanding effectiveness of therapeutic regimens in routine practice is critical for treating physicians as well as for regulatory and reimbursement authorities. We have performed a real-world comparison of two regimens, ixazomib, lenalidomide and dexamethasone (IRD) triplet and lenalidomide and dexamethasone (Rd) doublet in patients with relapsed and/or refractory multiple myeloma (RRMM) treated in seven Czech and one Slovak hematology-oncology centers. Patients and methods: Between 3/2015 and 5/2017, 344 patients with RRMM were treated with either IRD (N=127) or RD (N=217). Patients selected for both cohorts had the same inclusion and exclusion criteria. Patient baseline characteristics were well balanced. The data were collected through the Czech Registry of Monoclonal Gammopathies (RMG), which is an international database gathering data from patients with monoclonal gammopathies within Central Europe. Results: The median follow-up in the IRD vs RD arm was 20.8 vs 15.5 months, respectively. Median PFS in pts with 1-3 prior lines for the IRD cohort was 23.1 months (95% CI 11.8-34.5 months) and 11.6 months (95% CI 8.4-11.8 months) for the RD cohort favoring the all-oral triplet (p=0.001). The median PFS for all patients including 4+ line of therapy was 17.5 months (95% CI 10.3-24.7) in the IRD cohort versus 11.5 months (95% CI 8.6-14.3) in the RD group (p=0.005). Median OS for pts with 1-3 prior lines for IRD cohort was not reached, and was 27.1 months (95% CI 23.1-31.1 months) in the RD cohort (p=0.002). Median OS for all patients, including 4+ lines of treatment was 36.6 months in the IRD vs 26.0 months in the RD cohort (p=0.008). The PFS benefit of IRD over RD was observed in most of the assessed subgroups; in younger pts ≤65 years with hazard ratio (HR) 0.58, in pts 66-75 years HR 0.64. There was a trend towards better PFS in patients with lower ISS stage; ISS1 HR 0.53, ISS2 HR 0.58 and ISS3 the HR was 0.87. Patients in the 1st relapse (HR 0.53) benefited most from the IRD, followed by the 2nd relapse (HR 0.58), 3rd relapse (HR 0.90) and pts relapsing after 4+ therapies (HR 0.88). The PFS benefit of IRD regimen was observed in pts regardless of previous stem cell transplantation; transplant-eligible patients HR 0.51 and transplant-ineligible HR 0.71. Patients who did not benefit from the triplet regimen were those over 75 years of age and pts with the presence of extramedullary disease. The IRD treatment was well tolerated. The safety profile was concordant with previously reported data. Conclusions: This RMG comparative cohort analysis shows PFS benefit of all-oral IRD regimen over RD in the real world setting, and confirms growing evidence that long term outcomes with IRD triplet are comparable with phase 3 TOURMALINE-MM1 trial. Our analysis also shows an overall survival benefit of IRD over RD treatment. Patients older than 75 years, with 4+ lines of therapy and presence of extramedullary disease did not profit from addition of ixazomib to RD doublet.Additional data with larger patient populations confirming RWE effectiveness are warranted. With support of AZV 17-29343A, NV18-03-00500, FNOl 00098892, IGA-LF-2019-001, PROGRES Q40/08, MH CZ-DRO (UHHK, 00179906) Disclosures Minarik: Celgene: Consultancy, Honoraria, Research Funding; Amgen, BMS, Janssen-Cilag, Takeda: Consultancy, Honoraria. Straub:Amgen, Takeda, Celgene: Consultancy. Spicka:Celgene: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Sanofi: Consultancy; Takeda: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Janssen-Cilag: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Janssen-Cilag: Consultancy, Honoraria; Sanofi: Consultancy. Skacel:Millennium Pharmaceuticals, Inc., subsidiary of Takeda Pharmaceutical Company Limited: Employment. Maisnar:Janssen, Amgen, Celgene, Takeda, BMS: Consultancy, Honoraria.

scholarly journals Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada

2020 ◽  
Author(s):  
Wei Fang Dai ◽  
Jaclyn Beca ◽  
Ruth Croxford ◽  
Wanrudee Isaranawatchai ◽  
Ines B. Menjak ◽  
...  
Keyword(s):  
Real World ◽  
Comparative Effectiveness ◽  
Cox Regression ◽  
Population Based ◽  
Administrative Databases ◽  
Routine Practice ◽  
World Population ◽  
Second Line ◽  
Drug Databases ◽  
Historical Controls

Abstract Background For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment’s real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments). Methods We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW). Results We identified 329 patients with MM who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27%-41%), 20.6% (15%-27%), and 15.2% (9.6%-21%) for ipilimumab and 17.1% (11%-23%), 7.1% (2.9%-11%), and 4.7% (1.2%-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR=0.62; 95% CI: 0.49-0.78; p <0.0001). Conclusions This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.

Encorafenib plus Binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma: First data of the multicenter, multinational, prospective, non-interventional longitudinal study BERINGMELANOMA.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9555-9555
Author(s):  
Erika Richtig ◽  
Ralf Gutzmer ◽  
Carmen Loquai ◽  
Jochen Utikal ◽  
Christoph Hoeller ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real World ◽  
Interim Analysis ◽  
Treatment Duration ◽  
World Population ◽  
Mek Inhibition ◽  
Organ Systems ◽  
Prospective Longitudinal ◽  
The Impact

9555 Background: For the treatment of advanced BRAFV600-mutated melanoma, targeted therapy (BRAF/MEK-inhibition) is a standard of care. Encorafenib + binimetinib (EB) were approved in the EU in Sep 2018 and in Switzerland in Nov 2019, based on positive results from COLUMBUS (NCT01909453), with a median progression-free survival (PFS) of 14.9 mo (4-year PFS: 26%) and overall survival (OS) of 33.6 mo (4-year OS: 39%). As data from controlled trials are based on selected populations, BERINGMELANOMA investigates the use of EB under real-world conditions in a broader population. Methods: BERINGMELANOMA is an ongoing, multi-national, multi-center, prospective, longitudinal, non-interventional study. It analyzes the effectiveness, quality of life and tolerability of EB-treatment under real-world conditions (primary endpoint: 1-year PFS-rate), focusing on the first- (1L) and second-line setting and including an evaluation of the impact of prognostic factors. The project aims to enroll up to 750 patients (pts) in a total of 80 German, Austrian and Swiss sites with a study duration of 8 yrs. So far, from Oct 2019 to Jan 2021, 153 pts have been included. Pts with prior BRAF-/MEK-inhibition (except adjuvant use completed > 6 mo) and > 1 prior treatment line were excluded. Results: Here we present the first planned interim analysis based on the initial 100 enrolled pts (91 treated / 89 evaluable; median follow-up: 8.1 mo). This analysis set shows a median age of 63.0 yrs (range 29.0-88.0), 52% of pts were female. 81% presented with distant metastases (brain: 31%), with an involvement of ≥3 organ systems in 51% and an elevated LDH in 42%. 54% of pts underwent prior systemic therapy (adjuvant: 28%; 1L: 24%, with ipilimumab + nivolumab as main 1L-treatment: 52%). EB was mainly administered in the 1L-setting (65%). Main reasons for EB-selection were: physician's preference (37%), efficacy (34%), quality of life (21%). Median estimated EB treatment duration was 12.7 mo (95%CI 8.3-NE), median relative dose intensity was 100% for both drugs. Treatment adaptations were required in 34% of pts. Adverse events (AE) were reported in 76% of pts (grade 3/4: 26%). Main AE (≥10%, all grades) were: nausea (18%), diarrhea (17%), CK increase (15%), fatigue (11%), gamma-GT increase (11%). No fatal toxicities were observed. Conclusions: This first interim analysis of BERINGMELANOMA shows an investigation of EB in a real-world population with advanced disease. Despite the poorer prognosis configuration as compared to the pivotal study, the observed treatment duration and tolerability profile are largely consistent with data derived from COLUMBUS without any new safety signals. The second interim analysis will be performed after enrollment of 200 pts and will include an initial analysis of effectiveness data. Clinical trial information: NCT04045691.

scholarly journals The Impact of Minimal Residual Disease (MRD) Status at Day 28 in Predicting Relapse in Adults with Acute Lymphoblastic Leukemia in the Real World Setting

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4027-4027
Author(s):  
Bradley Walker Christensen ◽  
Daniel C Pipilas ◽  
Olalekan O. Oluwole
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Minimal Residual Disease ◽  
Real World ◽  
Residual Disease ◽  
Lymphoblastic Leukemia ◽  
Cohort Analysis ◽  
Real World Setting ◽  
Retrospective Cohort Analysis ◽  
The Impact ◽  
Minimal Residual

Abstract Background Acute lymphoblastic leukemia (ALL) requires intensive systemic and intrathecal (IT) therapy for a prolonged period to prevent relapse [1, 2]. MRD negativity has been associated with long-term disease-free survival.[3] However, most published data are in patients treated in a clinical trial setting. Real-world data are lacking. We performed a retrospective cohort analysis of our database of ALL patients to determine the impact of MRD measurement on the pattern of relapse.[3-5] Methods We conducted a retrospective cohort analysis of patients with ALL treated at our institution between December 2001 and September 2015. We interrogated the database for patient and disease characteristics, treatment protocols, and outcomes. In all cases, MRD reported was obtained by way of multi-color flow cytometry on bone marrow biopsy samples. Data were stored in the RedCap database and simple, descriptive statistics were utilized for analysis. Chemotherapy consisted of standard regimens including E2993, Hyper-CVAD, the Vanderbilt ALL protocol, multiple pediatrics protocols, and multiple regimens not otherwise specified. [3-5] Results We identified 147 patients over the time period specified, consisting of 91 males and 56 females. The median age of the cohort was 42 years. The most common chemotherapy regimens used included Hyper-CVAD (31%), E2993 (24%), the Vanderbilt ALL protocol (23%) and pediatric protocols (19%). Among the patients in morphologic CR, 55 (37%) had MRD measured at day 28 (+/- 7 days). Of those patients, 38 (83%) were MRD-negative and 17 (13%) were MRD-positive. In the MRD-negative cohort, 2 (5.3%) relapses occurred within the first year while 8 (21%) ocured later. In the MRD-positive cohort, 3 (38%) relapsed within the first while 2 (12%) occurred later. Discussion Our results underscore the importance of early measurement of MRD in ALL patients in predicting early relapse. In those patients with no detectable MRD on flow cytometry of the bone marrow at day 28, only 5.3% relapsed within one year compared to 38% of those with detectable MRD. This difference is actually more pronounced than those observed in some clinical trials, validating early MRD measurement across treatment regimens in the real world setting. Notably, 2 patients with detectable MRD at day 28 were continued on the same protocol and did not relapse at 7-year follow-up. This suggests a potential role for serial MRD measurement in select, low-risk patients with MRD close to negative. Our study is limited as it is a retrospective analysis with a small sample size and at a single tertiary academic medical center which may diminish its applicability to other practice settings. References 1. Bruggemann, M., et al., Clinical significance of minimal residual disease quantification in adult patients with standard-risk acute lymphoblastic leukemia. Blood, 2006. 107(3): p. 1116-23.Cassaday, R.D., et al., Description and prognostic significance of the kinetics of minimal residual disease status in adults with acute lymphoblastic leukemia treated with HyperCVAD. Am J Hematol, 2018. 93(4): p. 546-552.Mortuza, F.Y., et al., Minimal residual disease tests provide an independent predictor of clinical outcome in adult acute lymphoblastic leukemia. J Clin Oncol, 2002. 20(4): p. 1094-104.Patel, B., et al., Minimal residual disease is a significant predictor of treatment failure in non T-lineage adult acute lymphoblastic leukaemia: final results of the international trial UKALL XII/ECOG2993. Br J Haematol, 2010. 148(1): p. 80-9.Winter, S.S., et al., Safe integration of nelarabine into intensive chemotherapy in newly diagnosed T-cell acute lymphoblastic leukemia: Children's Oncology Group Study AALL0434. Pediatr Blood Cancer, 2015. 62(7): p. 1176-83. Disclosures No relevant conflicts of interest to declare.

scholarly journals Pathologic Complete Response Rates After Neoadjuvant Pertuzumab and Trastuzumab with Chemotherapy in Early Stage HER2-Positive Breast Cancer - Increasing Rates of Breast Conserving Surgery: A Real-World Experience

2021 ◽  
Vol 27 ◽  
Author(s):  
Katalin Boér ◽  
Zsuzsanna Kahán ◽  
László Landherr ◽  
Tibor Csőszi ◽  
Károly Máhr ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Survival Data ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Breast Conserving Surgery ◽  
World Population ◽  
Her2 Breast Cancer ◽  
Neoadjuvant Systemic Therapy ◽  
The Impact

Purpose: The neoadjuvant use of pertuzumab and trastuzumab with chemotherapy improves the pathologic complete response (pCR) in early HER2+ breast cancer. The aim of this study was to determine the pCR rate obtained with dual HER2 blockade in routine clinical practice. The secondary and tertiary objective was to investigate the impact of neoadjuvant systemic therapy (NST) on performing breast-conserving surgery and survival data.Methods: This was a multicentre, retrospective, observational study in patients with stage II and III HER2+ early breast cancer who received pertuzumab and trastuzumab-based NST. Data were collected from patients’ medical records.Results: Eighty-two patients were included in the study treated in 8 cancer centers in Hungary between March 2015 and January 2020. The study included women with a median age of 50.3 years. The majority of the patients (95%) received a sequence of anthracycline-based chemotherapy followed by docetaxel. pCR was achieved in 54% of the cases. As a result of NST a significant increase of conservative breast surgeries (33% vs. 3.6% planned, p = 0.0001) was observed. Ki67 expression and neutrophil-to-lymphocyte ratio (NLR) significantly predicted pCR. None of the variables were independent predictors of DFS.Conclusion: The pCR rate achieved in our study demonstrates the reproducibility of trial data in a real-world population. The rate of breast-conserving surgery was significantly increased.

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