scholarly journals Data Integration to Improve Real-world Health Outcomes Research for Non–Small Cell Lung Cancer in the United States: Descriptive and Qualitative Exploration (Preprint)

2020 ◽  
Author(s):  
Michael Grabner ◽  
Cliff Molife ◽  
Liya Wang ◽  
Katherine B Winfree ◽  
Zhanglin Lin Cui ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Data Integration ◽  
Clinical Data ◽  
Real World ◽  
Administrative Claims ◽  
Data Set ◽  
Health Outcomes Research ◽  
Data Source ◽  
The Mean

BACKGROUND The integration of data from disparate sources could help alleviate data insufficiency in real-world studies and compensate for the inadequacies of single data sources and short-duration, small sample size studies while improving the utility of data for research. OBJECTIVE This study aims to describe and evaluate a process of integrating data from several complementary sources to conduct health outcomes research in patients with non–small cell lung cancer (NSCLC). The integrated data set is also used to describe patient demographics, clinical characteristics, treatment patterns, and mortality rates. METHODS This retrospective cohort study integrated data from 4 sources: administrative claims from the HealthCore Integrated Research Database, clinical data from a Cancer Care Quality Program (CCQP), clinical data from abstracted medical records (MRs), and mortality data from the US Social Security Administration. Patients with lung cancer who initiated second-line (2L) therapy between November 01, 2015, and April 13, 2018, were identified in the claims and CCQP data. Eligible patients were 18 years or older and received atezolizumab, docetaxel, erlotinib, nivolumab, pembrolizumab, pemetrexed, or ramucirumab in the 2L setting. The main analysis cohort included patients with claims data and data from at least one additional data source (CCQP or MR). Patients without integrated data (claims only) were reported separately. Descriptive and univariate statistics were reported. RESULTS Data integration resulted in a main analysis cohort of 2195 patients with NSCLC; 2106 patients had CCQP and 407 patients had MR data. The claims-only cohort included 931 eligible patients. For the main analysis cohort, the mean age was 62.1 (SD 9.27) years, 48.56% (1066/2195) were female, the median length of follow-up was 6.8 months, and for 37.77% (829/2195), death was observed. For the claims-only cohort, the mean age was 66.6 (SD 12.69) years, 52.1% (485/931) were female, the median length of follow-up was 8.6 months, and for 29.3% (273/931), death was observed. The most frequent 2L treatment was immunotherapy (1094/2195, 49.84%), followed by platinum-based regimens (472/2195, 21.50%) and single-agent chemotherapy (441/2195, 20.09%); mean duration of 2L therapy was 5.6 (SD 4.9, median 4) months. We describe challenges and learnings from the data integration process, and the benefits of the integrated data set, which includes a richer set of clinical and outcome data to supplement the utilization metrics available in administrative claims. CONCLUSIONS The management of patients with NSCLC requires care from a multidisciplinary team, leading to a lack of a single aggregated data source in real-world settings. The availability of integrated clinical data from MRs, health plan claims, and other sources of clinical care may improve the ability to assess emerging treatments.

scholarly journals Data Integration to Improve Real-world Health Outcomes Research for Non–Small Cell Lung Cancer in the United States: Descriptive and Qualitative Exploration

JMIR Cancer ◽  
10.2196/23161 ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e23161
Author(s):  
Michael Grabner ◽  
Cliff Molife ◽  
Liya Wang ◽  
Katherine B Winfree ◽  
Zhanglin Lin Cui ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Data Integration ◽  
Clinical Data ◽  
Real World ◽  
Administrative Claims ◽  
Data Set ◽  
Health Outcomes Research ◽  
Data Source ◽  
The Mean

Background The integration of data from disparate sources could help alleviate data insufficiency in real-world studies and compensate for the inadequacies of single data sources and short-duration, small sample size studies while improving the utility of data for research. Objective This study aims to describe and evaluate a process of integrating data from several complementary sources to conduct health outcomes research in patients with non–small cell lung cancer (NSCLC). The integrated data set is also used to describe patient demographics, clinical characteristics, treatment patterns, and mortality rates. Methods This retrospective cohort study integrated data from 4 sources: administrative claims from the HealthCore Integrated Research Database, clinical data from a Cancer Care Quality Program (CCQP), clinical data from abstracted medical records (MRs), and mortality data from the US Social Security Administration. Patients with lung cancer who initiated second-line (2L) therapy between November 01, 2015, and April 13, 2018, were identified in the claims and CCQP data. Eligible patients were 18 years or older and received atezolizumab, docetaxel, erlotinib, nivolumab, pembrolizumab, pemetrexed, or ramucirumab in the 2L setting. The main analysis cohort included patients with claims data and data from at least one additional data source (CCQP or MR). Patients without integrated data (claims only) were reported separately. Descriptive and univariate statistics were reported. Results Data integration resulted in a main analysis cohort of 2195 patients with NSCLC; 2106 patients had CCQP and 407 patients had MR data. The claims-only cohort included 931 eligible patients. For the main analysis cohort, the mean age was 62.1 (SD 9.27) years, 48.56% (1066/2195) were female, the median length of follow-up was 6.8 months, and for 37.77% (829/2195), death was observed. For the claims-only cohort, the mean age was 66.6 (SD 12.69) years, 52.1% (485/931) were female, the median length of follow-up was 8.6 months, and for 29.3% (273/931), death was observed. The most frequent 2L treatment was immunotherapy (1094/2195, 49.84%), followed by platinum-based regimens (472/2195, 21.50%) and single-agent chemotherapy (441/2195, 20.09%); mean duration of 2L therapy was 5.6 (SD 4.9, median 4) months. We describe challenges and learnings from the data integration process, and the benefits of the integrated data set, which includes a richer set of clinical and outcome data to supplement the utilization metrics available in administrative claims. Conclusions The management of patients with NSCLC requires care from a multidisciplinary team, leading to a lack of a single aggregated data source in real-world settings. The availability of integrated clinical data from MRs, health plan claims, and other sources of clinical care may improve the ability to assess emerging treatments.

scholarly journals Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040819
Author(s):  
Pontus Rygh ◽  
Ina Asklund ◽  
Eva Samuelsson
Keyword(s):  
Urinary Incontinence ◽  
Cohort Study ◽  
Real World ◽  
Short Form ◽  
Pelvic Floor Muscle ◽  
Controlled Trial ◽  
Healthcare Services ◽  
International Consultation ◽  
The Mean

ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months’ use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance

2021 ◽  
pp. 193229682110075
Author(s):  
Rebecca A. Harvey Towers ◽  
Xiaohe Zhang ◽  
Rasoul Yousefi ◽  
Ghazaleh Esmaili ◽  
Liang Wang ◽  
...  
Keyword(s):  
Data Integration ◽  
Patient Experience ◽  
Real World ◽  
Data Availability ◽  
Post Processing ◽  
Sensor Error ◽  
The Mean ◽  
The Difference ◽  
Data Gap ◽  
Improve Patient

The algorithm for the Dexcom G6 CGM System was enhanced to retain accuracy while reducing the frequency and duration of sensor error. The new algorithm was evaluated by post-processing raw signals collected from G6 pivotal trials (NCT02880267) and by assessing the difference in data availability after a limited, real-world launch. Accuracy was comparable with the new algorithm—the overall %20/20 was 91.7% before and 91.8% after the algorithm modification; MARD was unchanged. The mean data gap due to sensor error nearly halved and total time spent in sensor error decreased by 59%. A limited field launch showed similar results, with a 43% decrease in total time spent in sensor error. Increased data availability may improve patient experience and CGM data integration into insulin delivery systems.

scholarly journals Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study

2020 ◽  
Vol 9 (7) ◽  
pp. 2275
Author(s):  
Juan J. Gorgojo-Martínez ◽  
Manuel A. Gargallo-Fernández ◽  
Alba Galdón Sanz-Pastor ◽  
Teresa Antón-Bravo ◽  
Miguel Brito-Sanfiel ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Real World ◽  
Primary Outcome ◽  
Baseline Hba1c ◽  
Real World Setting ◽  
Antihyperglycemic Therapy ◽  
The Mean ◽  
Hba1c Levels

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Juan Vivanco‐Suarez ◽  
Alan Mendez‐Ruiz ◽  
Farooqui Mudassir ◽  
Cynthia B Zevallos ◽  
Milagros Galecio‐Castillo ◽  
...  
Keyword(s):  
Real World ◽  
Intracranial Aneurysms ◽  
The United States ◽  
Chromium Alloy ◽  
Cobalt Chromium ◽  
Anterior Circulation ◽  
Safety And Efficacy ◽  
Post Marketing ◽  
The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

A-136 The Transfer of Cognitive Training to Real-World Functioning: Results of our First Six Pilot Subjects at Six-Month Follow-Up

2021 ◽  
Vol 36 (6) ◽  
pp. 1187-1188
Author(s):  
Jason A Blake ◽  
Brandon Mitchell ◽  
Staci McKay ◽  
Gitendra Uswatte ◽  
Edward Taub
Keyword(s):  
Cognitive Training ◽  
Real World ◽  
Cognitive Task ◽  
Case Series ◽  
Performance Measure ◽  
The Real ◽  
Cognitive Activities ◽  
The Mean ◽  
Laboratory Measures

Abstract Objective Currently, the majority of cognitive training research measures treatment efficacy using in-laboratory measures, with minimal focus on real-world treatment changes. This case series demonstrates the feasibility of transferring cognitive improvements from the laboratory into the everyday life setting. Method This case series includes 6 chronic post-stroke participants; mild to moderate cognitive impairment. The intervention combines cognitive training with behavioral techniques, known as the Transfer Package (TP). The TP involves components that target functionality on IADLs in the real-world. Performance on cognitively-based IADLs in the real world are measured pre-treatment, post, and 6-month follow-up. Measures of real-world ability are the: Canadian Occupational Performance Measure (COPM), Cognitive Task Activity Log (CTAL) and Inventory of Improved and New Abilities (INCA). In-laboratory measures included the D-KEFS and Timed IADL assessments. Results The real-world outcome measures used in this study were the COPM and two measures developed for this study, the CTAL and INCA. The mean change from pre to post on the COPM Performance Scale was 2.18 (SD = 1.33) and the mean change on the COPM Satisfaction Scale was 2.70 (SD = 1.27). The mean change on the CTAL was 1.96 (SD = 0.93). On the INCA, the mean number of improved real-world cognitive activities was 11.8 (SD = 4.9) and the mean number of new cognitive activities was 7.6 (SD = 3.9). Follow-up reported near-perfect retention on CTAL and continued improvement on the INCA. There were minimal changes on in-laboratory measures. Conclusions This case series provides a framework for achieving the transfer of cognitive training treatment effects in the real-world life situation by overcoming behavioral barriers to functioning.

scholarly journals Characterizing the Feasibility and Performance of Real-World Tumor Progression End Points and Their Association With Overall Survival in a Large Advanced Non–Small-Cell Lung Cancer Data Set

2019 ◽  
pp. 1-13 ◽  
Author(s):  
Sandra D. Griffith ◽  
Rebecca A. Miksad ◽  
Geoff Calkins ◽  
Paul You ◽  
Nicole G. Lipitz ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Large Scale ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Data Set ◽  
End Points

PURPOSE Large, generalizable real-world data can enhance traditional clinical trial results. The current study evaluates reliability, clinical relevance, and large-scale feasibility for a previously documented method with which to characterize cancer progression outcomes in advanced non–small-cell lung cancer from electronic health record (EHR) data. METHODS Patients who were diagnosed with advanced non–small-cell lung cancer between January 1, 2011, and February 28, 2018, with two or more EHR-documented visits and one or more systemic therapy line initiated were identified in Flatiron Health’s longitudinal EHR-derived database. After institutional review board approval, we retrospectively characterized real-world progression (rwP) dates, with a random duplicate sample to ascertain interabstractor agreement. We calculated real-world progression-free survival, real-world time to progression, real-world time to next treatment, and overall survival (OS) using the Kaplan-Meier method (index date was the date of first-line therapy initiation), and correlations between OS and other end points were assessed at the patient level (Spearman’s ρ). RESULTS Of 30,276 eligible patients,16,606 (55%) had one or more rwP event. Of these patients, 11,366 (68%) had subsequent death, treatment discontinuation, or new treatment initiation. Correlation of real-world progression-free survival with OS was moderate to high (Spearman’s ρ, 0.76; 95% CI, 0.75 to 0.77; evaluable patients, n = 20,020), and for real-world time to progression correlation with OS was lower (Spearman’s ρ, 0.69; 95% CI, 0.68 to 0.70; evaluable patients, n = 11,902). Interabstractor agreement on rwP occurrence was 0.94 (duplicate sample, n = 1,065) and on rwP date 0.85 (95% CI, 0.81 to 0.89; evaluable patients n = 358 [patients with two independent event captures within 30 days]). Median rwP abstraction time from individual EHRs was 18.0 minutes (interquartile range, 9.7 to 34.4 minutes). CONCLUSION We demonstrated that rwP-based end points correlate with OS, and that rwP curation from a large, contemporary EHR data set can be reliable, clinically relevant, and feasible on a large scale.

scholarly journals Real-World Results of Aflibercept versus Ranibizumab for the Treatment of Exudative AMD Using a Fixed Regimen

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Joana Providência ◽  
Tiago M. Rodrigues ◽  
Mariana Oliveira ◽  
João Bernardes ◽  
João Pedro Marques ◽  
...  
Keyword(s):  
Real World ◽  
Age Related Macular Degeneration ◽  
Treatment Protocols ◽  
Corrected Visual Acuity ◽  
Age Related ◽  
Significant Difference ◽  
Clinical Practice Setting ◽  
The Mean ◽  
Endothelial Growth Factors

Intravitreal injections of antivascular endothelial growth factors have been considered a milestone in the treatment of neovascular age-related macular degeneration (nAMD). However, the increasing incidence of AMD and the burden of visits and injections overcharge both the patient and the healthcare systems. Real-world solutions depend on treatment protocols aimed at optimizing the number of clinical visits while guaranteeing good functional outcomes. We performed a retrospective analysis of 72 eyes from 63 naïve patients diagnosed with nAMD that underwent a fixed intravitreal protocol consisting of bimonthly injections after a three-month loading dose, with either Aflibercept or Ranibizumab (no predefined criteria for treatment selection). Best corrected visual acuity (BCVA) and optical coherence tomography were analyzed at baseline and during follow-up clinical visits (months 3, 6, 12, and 18). From the included participants, 42 followed a fixed regimen with Aflibercept and 30 with Ranibizumab. At the 12-month visit, there was not a statistically significant difference in the mean change of BCVA between the two groups (p=0.121); however, the mean difference in the central retinal thickness was significantly superior in the Aflibercept group (-142.2 versus -51.5, p=0.011). The described fixed regimen seems to be efficient in the treatment of nAMD in a clinical practice setting.

Hysterectomy utilization among newly diagnosed endometrial cancer patients by body mass index category: A real-world analysis using a claims and electronic health record database.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17112-e17112
Author(s):  
Debra E. Irwin ◽  
Ellen Thiel
Keyword(s):  
Endometrial Cancer ◽  
Electronic Health Record ◽  
Real World ◽  
Patient Population ◽  
Morbidly Obese ◽  
Health Record ◽  
Newly Diagnosed ◽  
Data Set ◽  
Electronic Health

e17112 Background: For endometrial cancer (EC), laparoscopic hysterectomy (LH) is an effective, minimally invasive surgical treatment; however, this approach may not be recommended for obese patients due to increased risk for complications. Methods: This retrospective study utilized insurance claims linked to electronic health record (EHR) data contained in the IBM MarketScan Explorys Claims-EHR Data Set. Newly diagnosed EC patients (1/1/2007 - 6/30/2017) with continuous enrollment during a 12-month baseline and 6-month follow-up period were selected. Patients were stratified into four BMI subgroups based on baseline BMI on the EHR: normal or underweight (BMI < 25), overweight (BMI 25- < 30), obese (BMI 30- < 40), morbidly obese (BMI > 40), and were required to have had a hysterectomy within the follow-up period. Emergency room visits and rehospitalization within 30 days of hysterectomy were measured. Results: A total of 1,090 newly-diagnosed EC patients met the selection criteria, of whom, 16% were normal/underweight, 19% were overweight, 39% were obese, and 26% were morbidly obese. The proportion of patients receiving LH increased as BMI category increased (Table 1). Among those with LH between 6% and 15% had an ER visit or rehospitalization in 30 days, and rates were higher among other hysterectomy modalities. Conclusions: This real-world analysis shows that LH is utilized in a high proportion of morbidly obese EC patients, despite that it is frequently deemed infeasible in this patient population. Although the rate of ER visits and rehospitalization is lower among LH patients than those undergoing traditional hysterectomy across all BMI strata, further research is needed to determine the optimal patient population to receive LH.[Table: see text]

3rd-line anaplastic lymphoma kinase (ALK) inhibitors (ALKi) in advanced non-small cell lung cancer (aNSCLC): Real-world comparison to non-ALKi therapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21685-e21685
Author(s):  
Natalie Maimon ◽  
Elizabeth Dudnik ◽  
Yakir Rottenberg ◽  
Noa Popovits-Hadari ◽  
Noam Asna ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Real World ◽  
Small Cell ◽  
Line Treatment ◽  
Small Cell Lung ◽  
Alk Inhibitors ◽  
Anaplastic Lymphoma ◽  
Line Setting

e21685 Background: ALKi represent the standard 1st- and 2nd -line treatment (Tx) for ALK+ aNSCLC patients (pts). The value of ALKi in the 3rd-line setting is unclear. We retrospectively assessed the real-world impact of a 3rd -line ALKi vs. non-ALKi Tx in ALK+ aNSCLC pts. Methods: Consecutive ALK+ aNSCLC pts were identified in the working databases of 7 Israeli oncology centers; pts receiving any systemic Tx beyond 2 different ALKi were selected for the comparative analysis. Pts whose immediate next Tx line (post-2nd-ALKi) was a 3rdALKi (Group (Gr) A) were compared to pts whose immediate next Tx line (post-2nd-ALKi) was non-ALKi Tx (Gr B), in terms of overall survival (OS) and time to next Tx line (TNT). Results: 158 consecutive ALK+ aNSCLC pts diagnosed in January 2011 - March 2019 were included, median follow up from diagnosis of aNSCLC was 41 months (mo) (IQR 8-45). Median OS from aNSCLC diagnosis was 56 mo (95% CI 36-66). Post-2nd-ALKi line was a 3rd ALKi for 23 pts (Gr A) and a non-ALKi Tx for 10 pts (Gr B). 7 of Gr B (70%) received ALKi as a later line Tx. Median OS after initiation of post-2nd-ALKi Tx was 27 mo (95% CI, 7-NA) for Gr A vs. 16 mo (95% CI, 7-NA) for Gr B; p-non-significant (NS) with or without adjustment for sex, age, brain metastases. TNT on post-2nd-ALKi Tx was 6 mo (95% CI, 2-27) for Gr A vs. 2.5 mo (95% CI, 0-NA) for Gr B; p-NS. Conclusions: Following progression on a 2ndALKi, OS and TNT were numerically higher for pts receiving a 3rd ALKi, but statistically NS. Extensive exposure of pts in the non-ALKi Tx Gr to an ALKi at a later stage might have impacted these results. Further studies are required to identify patients likely to benefit from ALKi after progressing on 2 or more ALKi Tx lines. [Table: see text]

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