Real World Anaplastic Lymphoma Kinase (ALK) Rearrangement Testing Patterns, Treatment Sequences and Survival of ALK-Inhibitor Treated Patients

Davies, Jessica; Martinec, Michael; Coudert, Mathieu; Delmar, Paul; Becker, Ursula; Crane, Gracy

doi:10.1016/j.jval.2016.09.2390

Cited by 5 publications

(7 citation statements)

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“…Similar to results from previously conducted studies of real‐world treatment patterns for ALK + NSCLC [25, 26, 36–39], we found that crizotinib was the most commonly prescribed first‐line ALK TKI therapy in clinical practice. In the second‐line ALK TKI setting (post crizotinib), our results showed that ceritinib was the most commonly prescribed therapy, which is consistent with the approval timelines and similar to the results of other real‐world studies [24, 25, 37–42]. These results are not surprising, as crizotinib was initially approved by the FDA in 2011 and was the first commercially available ALK TKI therapy in the U.S. [43].…”

Section: Discussionsupporting

confidence: 87%

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

et al. 2020

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Background. Little is known about real-world treatment and outcomes of patients with anaplastic lymphoma kinasepositive (ALK+) advanced non-small cell lung cancer (NSCLC). Patients and Methods. This retrospective study of the Flatiron Health EHR-derived deidentified database included patients with a lung cancer diagnosis and confirmed advanced NSCLC who received ALK tyrosine kinase inhibitor (TKI) therapy (January 1, 2011, through June 30, 2018). Patient characteristics and treatment patterns were characterized. Real-world progression-free survival (rwPFS) and time to discontinuation were calculated using the Kaplan-Meier method. Results. First-line ALK TKI therapy was administered to 581 patients (27.5% had brain metastasis on or prior to initiation) and second-line ALK TKI therapy to 254 patients post crizotinib (45.7% had brain metastasis on or prior to second-line ALK TKI initiation). Crizotinib (84.6%; n = 492) was the most commonly administered first-line ALK TKI therapy. For second-line ALK TKI post crizotinib (n = 254), 49.6% received ceritinib, 41.7% received alectinib, 5.9% received crizotinib retreatment, and 2.8% received brigatinib. Median (95% confidence interval [CI]) rwPFS was 7.47 (6.48-8.32) months for first-line and 7.30 (5.72-8.42) months for second-line ALK TKI. Median (95% CI) rwPFS was significantly longer among first-line ALK TKI patients without than with brain metastasis (8.52 [7.57-10.59] vs. 4.97 [3.75-5.99] months; p < .0001) and patients with brain metastasis on or prior to first-line ALK TKI therapy had a significantly increased risk of progression (hazard ratio AE SE, 1.976 AE 0.112; p < .0001). Conclusion. Median rwPFS in patients with advanced ALK+ NSCLC was < 8 months for firstand second-line ALK TKI therapy and was even shorter in patients with brain metastasis, highlighting the need for more effective treatments in this patient population. The Oncologist 2020;25:867-877 Implications for Practice: Results presented herein describe real-world treatment of advanced ALK+ NSCLC with ALK TKI therapies from January 2011 through June 2018. Crizotinib was the most commonly prescribed first-line ALK TKI therapy in this patient population, but the majority of data analyzed were obtained prior to Food and Drug Administration approval of alectinib and ceritinib in the first-line ALK TKI setting. Physicians should monitor patients closely to help identify when a change in treatment should occur.

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Section: Discussionsupporting

confidence: 87%

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

et al. 2020

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“…We focused on community centers, where the majority of cancer care in this country is provided. Therefore, we believe this study provides a robust view of oncology practice in the real world and continues to advance the current knowledge around ALK testing patterns [21]. However, the standard limitations inherent to retrospective real‐world data studies also apply to this study, such as the potential for coding errors in oncology practices and missing data if procedures or treatments occurred outside the specific oncology practice.…”

Section: Discussionmentioning

confidence: 96%

“…Therefore, we believe this study provides a robust view of oncology practice in the real-world and continues to advance the current knowledge around ALK testing patterns. 21 However, the standard limitations inherent to retrospective real world data studies also apply to this study, such as the potential for coding errors in oncology practices and missing data if procedures or treatments occurred outside the specific onocology practice. As an example, patients' ALK testing status might not be captured in the database if the testing was performed outside the Flatiron Health network or was not recorded in the EHR system.…”

Section: Discussionmentioning

confidence: 99%

Adherence to National Comprehensive Cancer Network ALK Testing Guidelines for Patients with Advanced Non-Small Cell Lung Cancer in U.S. Community Medical Centers

Bernicker

Xiao

Abraham³

et al. 2021

The Oncologist

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Background. NCCN guidelines recommend biomarker testing as the first step in the management of patients with advanced non-small cell lung cancer (aNSCLC). We assessed ALK testing rates and factors related to underutilization in community medical systems between 2012 and 2019 to understand guideline adoption. Methods. A retrospective observational study utilizing a nationwide electronic health record (EHR)-derived deidentified database was conducted. Patients with aNSCLC diagnosed in community medical centers from January 2012 to May 2019 were included to describe the ALK testing trend. This cohort was further restricted to patients diagnosed after 2015 to understand factors associated with testing underutilization, using mixed-effects multivariable logistic regression models. Results. Trends for increased ALK testing rates by year were observed in both NCCN guideline eligible patients (59.5% in 2012 to 84.1% in 2019) and ineligible patients (15.6% to 50.8%) in a cohort of 41,728 patients. Histology type and smoking status had the greatest impact on test utilization. Compared to patients with non-squamous histology and no smoking history, patients with squamous histology and no smoking history (adjusted odds ratio (aOR), 95% confidence interval (95%CI): 7.6, 5.6-10.4), NSCLC histology not otherwise specified (NOS) with smoking history (3.4, 2.8-4.2); NSCLC NOS/nonsmoker (1.8, 1.1-3.2), and non-squamous/ smoker (1.5, 1.3-1.7) were less likely to be tested. Factors related to underutilization also included ECOG performance status, stage at initial diagnosis and demographics. Conclusions. This analysis of real-world data shows increasing test utilization by year; however, one fifth of patients eligible for ALK testing still remain untested and potentially missing therapeutic options. The Oncologist 2021;9999:• • Implications for Practice: Advancement in treatment of lung cancer is accompanied by an increasing number of tests that should be run to determine potential therapy options for each patient. We assessed adoption of testing recommendations for ALK rearrangements in a national database. While test utilization increased over the time period studied (2012-2019), there is still room for improvement. Efforts are needed to increase test utilization in under-tested groups, thus enabling eligible patients to benefit from novel lung cancer therapies.

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“…Previous studies have similarly shown an increasing rate of biomarker testing in the US over the past decade. [25][26][27][28][29][30][31][32] In a survey conducted in 2015, 38% of newly diagnosed patients with NSCLC, including 32% of those treated in a community-based center, were tested for ROS1, 20 lower than rates observed from 2016 to 2018 in this study of patients with advanced NSCLC.…”

Section: William Wong Et Almentioning

confidence: 94%

Utilization Trends and Factors Associated With ROS1 Testing Among Patients With Advanced Non–small-cell Lung Cancer in US Community Practices

Wong¹,

Wu²,

Gupta³

et al. 2021

Clinical Lung Cancer

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Testing patients with advanced nonesmall-cell lung cancer for relevant biomarkers, including ROS1, supports selection of appropriate targeted therapy. Among 11,409 patients in the United States with advanced nonesmall-cell lung cancer in 2016 to 2018, patients with certain characteristics (including being older, male, or black) were less likely to receive ROS1 testing, highlighting current gaps and opportunities to improve identification of appropriate treatment for all eligible patients. Background: Targeted therapy for patients with nonesmall-cell lung cancer (NSCLC) harboring ROS proto-oncogene 1 (ROS1) rearrangements was approved in 2016. However, little is known about real-world ROS1 testing practices in United States community practice. We aimed to characterize ROS1 testing rates and identify potential barriers to ROS1 testing. Patients and Methods: Flatiron Health's de-identified electronic health record-derived database was used to identify patients diagnosed with advanced NSCLC from July 2016 through December 2018 who received systemic treatment in a community practice setting. ROS1 and other biomarker testing was recorded. Regression analysis identified demographic and clinical characteristics associated with occurrence of ROS1 testing, longer time ( 25 days) from diagnosis to ROS1 result, and initiation of therapy prior to ROS1 result. Results: Among 11,409 patients, documented ROS1 testing rates increased during the study period in squamous (from 30% to 48%) and nonsquamous (63% to 78%) histologies. Patients who were older, male, black, or with squamous histology, higher Eastern Cooperative Oncology Group score, recurrent disease, or history of smoking were significantly less likely to be tested. Among patients not tested for ROS1, 63% were tested for other biomarkers. Use of next-generation sequencing, older age, Hispanic/Latino ethnicity, squamous histology, de novo disease, and smoking history predicted longer time to test result post-diagnosis. Patients with delayed results were 9.7 times more likely to receive treatment prior to ROS1 test result. Conclusion: In real-world practice, some patient subgroups may be less likely to receive timely ROS1 testing and to be identified for potential targeted therapy.

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Real World Anaplastic Lymphoma Kinase (ALK) Rearrangement Testing Patterns, Treatment Sequences and Survival of ALK-Inhibitor Treated Patients

Cited by 5 publications

References 0 publications

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

Adherence to National Comprehensive Cancer Network ALK Testing Guidelines for Patients with Advanced Non-Small Cell Lung Cancer in U.S. Community Medical Centers

Utilization Trends and Factors Associated With ROS1 Testing Among Patients With Advanced Non–small-cell Lung Cancer in US Community Practices

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