Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9004-9004
Author(s):  
Nicholas J. Robert ◽  
Esmond D. Nwokeji ◽  
Janet L. Espirito ◽  
Liwei Chen ◽  
Mandar Karhade ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Real World ◽  
Performance Status ◽  
The United States ◽  
Molecular Testing ◽  
Ecog Performance Status ◽  
Biomarker Testing ◽  
L1 Use ◽  
The Individual ◽  
Cancer Network

9004 Background: Given the importance of molecular testing and targeted therapy for mNSCLC, the MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) consortium pragmatic study assessed real-world biomarker testing rates and turnaround times (TAT) within The US Oncology Network of over 1,000 providers across the United States. Methods: This was a retrospective observational chart review study of pts with mNSCLC initiating first-line (1L) systemic therapy between 04/01/2018 and 03/31/2020. iKnowMed electronic health records were used to examine timing of biomarker testing: before 1L therapy (cohort 1), after 1L therapy (cohort 2) or no testing (cohort 3). We assessed testing rates for ALK, BRAF, EGFR, ROS1, and PD-L1; use of full next-generation sequencing panel (NGS); time from mNSCLC diagnosis (dx) to 1L therapy; TAT from biomarker orders to results; and time from mNSCLC dx to test results. Results: We identified 3474 adults. Median age was 69 years (range 23-90), 51% female, 74% with adenocarcinoma and 76% with a documented ECOG performance status of 0 or 1. Testing rates are shown in table: 90% of pts had at least one biomarker test and 46% received all 5 biomarker tests. Changes in testing rates from 2018 to 2020 were 51% to 59% for BRAF, 71% to 71% for EGFR, 71% to 70% for ALK, 69% to 67% for ROS1, 82% to 84% for PD-L1, and 42% to 49% for pts tested for all 5 biomarkers. NGS testing increased from 33% to 44% (p<0.0001). The median (interquartile range [IQR]) time from mNSCLC dx to 1L therapy for all pts was 35 (22, 55) days. Median (IQR) TAT from biomarker testing orders to results ranged from 10 (6, 17) to 15 (10, 22) days for the individual biomarkers; and time from mNSCLC dx to biomarker results ranged from 14 (7, 26) to 21 (12, 36) days by biomarker. Conclusions: This real-world study showed that most pts received at least one biomarker test prior to 1L, but <50% received all 5 tests. NGS testing occurred in <50% of pts but increased over the periods examined. Median time from dx to 1L therapy was about 5 weeks and TAT from orders to results about 2 weeks. Analyses by histology and other trends will be reported. These data will be compared to the next phase of the MYLUNG study, which will evaluate contemporary ordering practices and TATs prospectively[Table: see text]

Real-world outcomes in patients (pts) with metastatic urothelial carcinoma (mUC) who received first- or second-line immunotherapies (IO) in the United States (US).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 457-457
Author(s):  
Marley Boyd ◽  
Srinivas Annavarapu ◽  
Gurjyot K. Doshi ◽  
Kentaro Imai ◽  
Eric Sbar ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Performance Status ◽  
The United States ◽  
Future Research ◽  
Second Line ◽  
Ecog Performance Status ◽  
Using Data ◽  
Line Of Therapy

457 Background: Benefit of IO (PD1 and PD-L1 inhibitors) for mUC was observed in clinical trials but real-world evidence for benefit and clinical outcomes is limited. Methods: This was a retrospective study of adult pts with mUC who initiated IO regardless of PD-L1 expression in the first- (1L cohort) or second-line (2L cohort) setting between 5/1/2016-1/31/2019 in the US Oncology Network (USON), a network of community oncology practices. Descriptive and Kaplan-Meier analyses to evaluate baseline characteristics, treatment patterns and clinical outcomes were conducted using data from USON’s electronic heath record. Results: Among 393 pts in the 1L cohort, median (range) age at IO initiation was 77 (42, 90+), 74% were male, 69% were White, and 19.1% and 4.1% had ECOG performance status (PS) 2 and 3/4, respectively. Among the 366 pts in the 2L cohort, median (range) age at IO initiation was 70 (29, 90+), 74% were male, 71% were White, and 19.7% and 1.4% had ECOG PS 2 and 3, respectively. Median (range) follow-up durations from IO initiation were 4.2 (0, 34.1; 1L cohort) and 4.1 (0, 31.3; 2L cohort) months (mo), during which time 43.1% (1L cohort) and 44.4% (2L cohort) of pts died. Median overall survival (OS) from IO initiation (95% confidence interval [CI]) was 10.6 (9.7, 13.2) mo for the 1L cohort and 9.4 (7.1, 11.5) mo for the 2L cohort; 1-year survival probabilities (95% CI) were 46.6% (40.1%, 52.8%; 1L cohort) and 43.4% (36.8%, 49.8%; 2L cohort). By the end of the follow-up, 48.1% of 1L pts and 47.8% of 2L pts were alive and did not advance to next line of therapy, and 13.5% of 1L and 13.4% of 2L cohort pts advanced to the next line of therapy. Median (95% CI) treatment durations were 2.6 (2.1, 2.9) and 2.8 (2.2, 3.5) mo for the 1L and 2L cohorts, respectively; 6-mo ongoing treatment probabilities (95% CI) were 26.6% (22.2%, 31.2%; 1L cohort) and 31.4% (26.4%, 36.4%; 2L cohort). Conclusions: OS of pts in the real world receiving 1L and 2L IO appears consistent with clinical trial results, although survival follow-up is limited. A minority of pts received post-IO therapy. Future research should examine influence of pt characteristics and PD-L1 expression on treatment choice and outcomes.

Real-world outcomes of metastatic urothelial carcinoma (mUC) patients (pts) treated with first or second-line immunotherapies (IO) in the United States (US).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16025-e16025
Author(s):  
Marley Boyd ◽  
Srinivas Annavarapu ◽  
Gurjyot K. Doshi ◽  
Kentaro Imai ◽  
Eric Sbar ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Performance Status ◽  
The United States ◽  
Current Treatment ◽  
Future Research ◽  
Second Line ◽  
Ecog Performance Status ◽  
Using Data ◽  
Line Of Therapy

e16025 Background: While clinical trials have affirmed benefit of IO for mUC, limited real-world evidence exists to describe the current treatment landscape and clinical outcomes. This study evaluated these trends in a network of community oncology practices, the US Oncology Network (USON). Methods: This was a retrospective study of adult mUC pts who initiated IO regardless of PD-L1 expression in the first- (1L cohort) or second-line (2L cohort) setting between 5/1/2016-1/31/2018. Using data from USON’s electronic heath record, descriptive and Kaplan-Meier analyses were conducted to evaluate baseline characteristics, treatment patterns and clinical outcomes. Results: Among the 254 pts in the 1L cohort, median (range) age at IO initiation was 74 (42, 90+), 71% were male, 77% were Caucasian, and 18.1% and 5.9% had ECOG performance status (PS) 2 and 3/4, respectively. Among the 179 pts in the 2L cohort, median (range) age at IO initiation was 71 (29, 90+), 76% were male, 76% were Caucasian and 20.7% and 2.2% had ECOG PS 2 and 3/4, respectively. Nearly all pts received IO monotherapy. Median (range) follow-up durations from IO initiation were 4.3 (0, 22; 1L cohort) and 3.6 (0, 19; 2L cohort) months (mo), during which time 39% (1L cohort) and 37% (2L cohort) of pts died. Median overall survival (95% confidence interval [CI]) was 9.9 (7.5, 15.7) mo for the 1L IO cohort and 8.3 (6.4, not reached) mo for the 2L IO cohort. Six-mo survival probabilities (95% CI) were 61.6% (54.5%, 67.9%; 1L cohort) and 60.7% (51.4%, 68.8%; 2L cohort). In total, 52.8% of 1L pts and 53.6% of 2L pts were alive and did not advance to next line of therapy, and 11% of 1L and 13% of 2L cohort pts advanced to the next line of therapy. Median (95% CI) treatment durations were 2.3 (1.9, 3.0) and 3.3 (2.7, 3.9) mos for the 1L and 2L cohorts, respectively. Six-mo ongoing treatment probabilities (95% CI) were 28.9% (23.3%, 34.7%; 1L cohort) and 34.0% (26.1%, 42.1%; 2L cohort). Conclusions: Outcomes of real-world mUC pts receiving IO were as expected, with majority of pts alive and a small minority receiving post-IO therapy. Future research should examine how pt and tumor (PD-L1 expression) characteristics influence treatment and outcomes.

scholarly journals Real-world biomarker testing rate and positivity rate in NSCLC in Spain: Prospective Central Lung Cancer Biomarker Testing Registry (LungPath) from the Spanish Society of Pathology (SEAP)

2021 ◽  
pp. jclinpath-2020-207280
Author(s):  
Clara Salas ◽  
Javier Martín-López ◽  
Antonio Martínez-Pozo ◽  
Teresa Hernández-Iglesias ◽  
David Carcedo ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Real World ◽  
Cancer Biomarker ◽  
The Other ◽  
Molecular Testing ◽  
Sample Type ◽  
Anaplastic Lymphoma ◽  
Testing Rate ◽  
Biomarker Testing ◽  
Lung Cancer Biomarker

AimThe aim of this study was to describe the testing rate and frequency of molecular alterations observed in the Lung Cancer Biomarker Testing Registry (LungPath).MethodsA descriptive study of NSCLC biomarker determinations collected from March 2018 to January 2019, from 38 Spanish hospitals, was carried out. Only adenocarcinoma and not otherwise specified histologies were included for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1) and programmed death ligand-1 (PD-L1) expression. The testing rate and the positivity rate were calculated. Multivariate logistic regression was used to explore the joint relationship between independent explanatory factors and both testing and positivity rates. Two models were adjusted: one with sample type and histology as independent factors, and the other adding the testing rate or the positivity rate of the other biomarkers.Results3226 patient samples were analysed, where EGFR, ALK, ROS1 and PD-L1 information was collected (a total of 12 904 determinations). Overall, 9118 (71.4%) determinations were finally assessed. EGFR (91.4%) and ALK (80.1%) were the mainly tested biomarkers. Positivity rates for EGFR, ALK, ROS1 and PD-L1 were 13.6%, 3.4%, 2.0% and 49.2%, respectively. Multivariate models showed a lower testing rate for ALK in surgical pieces, fine-needle aspiration or other types of samples versus biopsies.ConclusionsDespite the high testing rate in EGFR and ALK in NSCLC, the real-world evidence obtained from the LungPath demonstrates that ROS1 and PD-L1 were not determined in a significant portion of patients. LungPath provides crucial information to improve the coverage in molecular testing in lung cancer, to monitor the positivity rate and the introduction of new biomarker testing in clinical practice.

Biomarker testing patterns and actionability in advanced non-small cell lung cancer (aNSCLC) at OneOncology (OneOnc).

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 287-287
Author(s):  
Ari M. Vanderwalde ◽  
Esprit Ma ◽  
Elaine Yu ◽  
Tania Szado ◽  
Richard Price ◽  
...  
Keyword(s):  
Performance Status ◽  
Ecog Performance Status ◽  
Personalized Care ◽  
Specimen Collection ◽  
Targeted Treatments ◽  
Biomarker Testing ◽  
Next Generation Sequencing Ngs ◽  
To Receive ◽  
Testing Patterns ◽  
Test Result

287 Background: Recent approvals of targeted treatments (tx) have improved personalized care in aNSCLC. Biomarker testing is crucial for patients (pts) to receive optimal tx expeditiously. This study examined aNSCLC biomarker testing and tx patterns at OneOnc. Methods: Pts diagnosed with aNSCLC (stage ≥ IIIb) from 1/1/2015 to 5/31/2020, aged ≥ 18 years, and with ≥ 1 visit ≤ 90 days of advanced (Adv) diagnosis (Dx) were retrospectively evaluated using the nationwide Flatiron Health electronic health record derived de-identified database from selected OneOnc sites. Descriptive analyses were conducted to evaluate testing patterns for ALK, BRAF, EGFR, KRAS, PD-L1, and ROS-1 biomarkers and actionable mutation tx pattern. Results: Overall 3,860 aNSCLC pts were included, median age was 69 years, 47% females, 66% non-squamous, 29% squamous, 4% histology NOS, and 23% with ECOG performance status 0-1. Of the 3,152 (82%) pts tested for any biomarker, 64% received next-generation sequencing (NGS) vs. 36% received other biomarker tests only. Testing rates varied by biomarker: EGFR (74%), ALK (72%), ROS-1 (66%), PD-L1 (57%), BRAF (56%), KRAS (54%). Pts who received all 6 biomarker tests increased from 12% (2015), 23% (2016), 40% (2017), 41% (2018), 48% (2019) to 56% (2020). Among the tested pts, the median time from Adv Dx to the first test result was 20 days (d) and from specimen collection after Adv Dx to the first test result was 12 d. Pts tested and treated before test result available declined from 28% (2015) to 16% (2020). Of 1,207 pts with actionable mutations, 390 (32%) received tx before the test result: 35% chemotherapy (chemo) only, 28% chemo + cancer immunotherapy (CIT), and 15% CIT only. After the test result, 26% to 81% of pts received no or other tx not specific to actionable mutations [Table]. Conclusions: Findings from this study demonstrated an increase in aNSCLC biomarker testing at OneOnc over time, while 44% pts in 2020 did not receive testing on all 6 biomarkers. Some pts had tx prior to the test result, but this trend appeared to decline. Further studies are warranted to better understand the reasons for pts receiving tx that were not specific to their actionable mutations.[Table: see text]

Initial experience of TAS-102 chemotherapy in Australian patients with chemorefractory metastatic colorectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 71-71
Author(s):  
Azim Jalali ◽  
Hui-Li Wong ◽  
Rachel Wong ◽  
Margaret Lee ◽  
Lucy Gately ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Febrile Neutropenia ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Performance Status ◽  
Progression Free Survival ◽  
Median Number ◽  
Ecog Performance Status ◽  
Number Of Patients

71 Background: For patients with refractory metastatic colorectal cancer (mCRC) treatment with Trifluridine/Tipiracil, also known as TAS-102, improves overall survival. In Australia, TAS-102 was initially made available locally through patients self-funding, later via an industry sponsored Medicine Access Program (MAP) and then via the Pharmaceutical Benefits Scheme (PBS). This study aims to investigate the efficacy and safety of TAS-102 in real world Australian population. Methods: A retrospective analysis of prospectively collected data from the Treatment of Recurrent and Advanced Colorectal Cancer (TRACC) registry was undertaken. The characteristics and outcomes of patients receiving TAS-102 were assessed and compared to all TRACC patients and those enrolled in the registration study (RECOURSE). Results: Across 13 sites, 107 patients were treated with TAS-102 (non-PBS n = 27, PBS n = 80), The median number of patients per site was 7 (range: 1-17). The median age was 60 years (range: 31-83), compared to 67 for all TRACC patients and 63 for RECOURSE. Comparing registry TAS-102 and RECOURSE patients, 75% vs 100% were ECOG performance status 0-1, 74% vs 79% had initiated treatment more than 18 months from diagnosis of metastatic disease and 39% vs 49% were RAS wild type. Median time on treatment was 10.4 weeks (range: 1.7-32). Median clinician assessed progression-free survival was 3.3 compared to RECIST defined PFS of 2 months in RECOURSE study, while median overall survival was the same at 7.1 months. Two patients (2.3%) had febrile neutropenia and there were no treatment-related deaths in the real-world series, where TAS102 dose at treatment initiation was at clinician discretion. In the RECOURSE study there was a 4% febrile neutropenia rate and one treatment-related death. Conclusions: TRACC registry patients treated with TAS102 were younger than both TRACC patients overall and those from the RECOURSE trial. Less strict application of RECIST criteria and less frequent imaging may have contributed to an apparently longer PFS. However overall survival outcomes achieved with TAS102 in real world patients were comparable to findings from this pivotal trial with an acceptable rate of major adverse events.

Predictors of early hospice or death in patients with inoperable lung cancer treated with curative intent.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20525-e20525
Author(s):  
Anna Mary Brown Laucis ◽  
Kimberly A. Hochstedler ◽  
Thomas Pence Boike ◽  
Benjamin Movsas ◽  
Craig William Stevens ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Logistic Regression ◽  
Predictive Model ◽  
Performance Status ◽  
Ecog Performance Status ◽  
Curative Intent ◽  
Heart Dose ◽  
Patient Reported ◽  
Mean Heart Dose ◽  
Nsclc Patients

e20525 Background: Treatment for inoperable stage II-III non-small cell lung cancer (NSCLC) involves aggressive chemo-radiotherapy (CRT). While outcomes have improved with immunotherapy, some patients transition to hospice or die early in their treatment course. To help identify these patients, we developed a predictive model for early poor outcomes in NSCLC patients treated with curative intent. Methods: In a statewide consortium involving 27 sites, information was collected prospectively on stage II-III NSCLC patients who received curative CRT from April 2012 to November 2019. We defined an early poor outcome as termination of treatment due to hospice enrollment or death within 5 months of initiating radiation therapy. Potential predictors included clinical characteristics and patient reported outcomes (PROs) from validated questionnaires. Logistic regression models were used to assess potential predictors and build predictive models. Multiple imputation was used to handle missing data. We used Lasso regularized logistic regression to build a predictive model with multiple predictor variables. Results: Of the total of 2267 included patients, 128 patients discontinued treatment early due to hospice enrollment or death. The mean age of the 128 patients was 71 years old (range 48-91) and 59% received concurrent chemotherapy. Significant uni-variable predictors of early hospice or death were advanced age, worse ECOG performance status, high PTV volume, short distance to normal tissue critical structures, high mean heart dose, uninsured status, lower scores on the Functional and Physical Well-Being scale and the Lung Cancer Symptoms sub-scale of the FACT-L quality of life instrument, as well as higher levels of patient-reported lack of energy, cough, and shortness of breath. The best predictive model included age, ECOG performance status, PTV volume, mean heart dose, patient insurance status, and patient-reported lack of energy and cough. The pooled estimate of area under the curve (AUC) for this multivariable model was 0.71, with a negative predictive value of 95%, specificity of 97%, positive predictive value of 23%, and sensitivity of 16% at a predicted risk threshold of 20%. Conclusions: Our models identified a combination of clinical variables and PROs that may help identify individuals with inoperable NSCLC undergoing curative intent chemo-radiotherapy who are at a high risk of early hospice enrollment or death. These preliminary results are encouraging and warrant further evaluation in a larger cohort of patients.

OP208 Did Health Technology Assessments Make the Wrong Call? Quantitative Bias Analysis: Alectinib versus Ceritinib in Non-Small Cell Lung Cancer

2021 ◽  
Vol 37 (S1) ◽  
pp. 6-6
Author(s):  
Samantha Wilkinson ◽  
Alind Gupta ◽  
Eric Mackay ◽  
Paul Arora ◽  
Kristian Thorlund ◽  
...  
Keyword(s):  
Real World ◽  
Performance Status ◽  
Missing At Random ◽  
Health Technology ◽  
Bias Analysis ◽  
Ecog Performance Status ◽  
Unmeasured Confounding ◽  
Unmeasured Confounder ◽  
Innovative Therapies ◽  
Quantitative Bias Analysis

IntroductionThe German health technology assessment (HTA) rejected additional benefit of alectinib for second line (2L) ALK+ NSCLC, citing possible biases from missing ECOG performance status data and unmeasured confounding in real-world evidence (RWE) for 2L ceritinib that was submitted as a comparator to the single arm alectinib trial. Alectinib was approved in the US and therefore US post-launch RWE can be used to evaluate this HTA decision.MethodsWe compared the real-world effectiveness of alectinib with ceritinib in 2L post-crizotinib ALK+ NSCLC using the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database. Using quantitative bias analysis (QBA), we estimated the strength of (i) unmeasured confounding and (ii) deviation from missing-at-random (MAR) assumptions needed to nullify any overall survival (OS) benefit.ResultsAlectinib had significantly longer median OS than ceritinib in complete case analysis. The estimated effect size (Hazard Ratio: 0.55) was robust to risk ratios of unmeasured confounder-outcome and confounder-exposure associations of <2.4.Based on tipping point analysis, missing baseline ECOG performance status for ceritinib-treated patients (49% missing) would need to be more than 3.4-times worse than expected under MAR to nullify the OS benefit observed for alectinib.ConclusionsOnly implausible levels of bias reversed our conclusions. These methods could provide a framework to explore uncertainty and aid decision-making for HTAs to enable patient access to innovative therapies.

Sign in / Sign up

Export Citation Format

Share Document