EP1.09-17 Spanish Lung Cancer Biomarker Testing Registry (Lungpath): Descriptive Analysis Focus in ALK Traslocation Results

López, José María Rodríguez; Alexandre, Leo; Caldero, Sonia Gatius; Gonzales, Atilio Navarro; Lopez, P. Saiz; Bellvert, Cristina Gómez; García, C. Camacho; Melgar, L.; Navarro, Estela Costa; Abdulkader-Nallib, Ihab; Dongo, C.A. Vasquez; Camín, Mónica Saiz; Hernando, Alberto; Cuevas, Lidia Atienza; Pijuán, Lara; Iglesias, Thomas; Martinez, Antonio; Antón, Clara Salas

doi:10.1016/j.jtho.2019.08.2213

Cited by 2 publications

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“…Biomarkers are becoming an essential requirement to properly treat patients with NSCLC. 22 This, coupled with recent advances in genomic and proteomic technologies plus bioinformatic tools that have allowed the discovery of several new biomarkers, has led to the fast and substantial accumulation of new biomarker-related data. 1 23 Nevertheless, while the research of new biomarkers is ongoing, the number of biomarkers for which a recommendation for testing is included in clinical guidelines is limited, as many of these promising biomarkers reported require reliable determination processes, validation and correlation to clinical outcomes.…”

Section: Discussionmentioning

confidence: 99%

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)

et al. 2021

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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.

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Section: Discussionmentioning

confidence: 99%

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)

et al. 2021

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“…Following the current clinical guidelines for molecular diagnosis in lung cancer [ 14 ], both patients with non-squamous histology and those with squamous NSCLC who were never smokers were considered . Table 1 shows the estimation of the target population based on the literature [ 3 , 18 – 22 ].…”

Section: Methodsmentioning

confidence: 99%

“…Current distribution in Spain of the four ALK determination strategies included in the model (Fig. 1 ) was obtained from the analysis of the LungPath database, as was the prevalence of positive results for the biomarkers of interest (positivity rate) [ 22 ].…”

Section: Methodsmentioning

confidence: 99%

“…TP was differentiated from FP, as treatments targeting ALK (alectinib/crizotinib) are not effective in patients without ALK rearrangement, and therefore these treatments in patients who are FP for ALK provides almost no benefit. In the case of negative tests, it was assumed that in FN patients (who were ALK+ actually), the determination of EGFR and ROS1 would be negative, assuming that the concurrency of more than one mutation in ALK and EGFR or ROS1 is very infrequent [ 22 ].…”

Section: Methodsmentioning

confidence: 99%

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Clinical and economic impact of current ALK rearrangement testing in Spain compared with a hypothetical no-testing scenario

et al. 2021

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Background Currently biomarkers play an essential role in diagnosis, treatment, and management of cancer. In non-small cell lung cancer (NSCLC) determination of biomarkers such as ALK, EGFR, ROS1 or PD-L1 is mandatory for an adequate treatment decision. The aim of this study is to determine the clinical and economic impact of current anaplastic lymphoma kinase testing scenario in Spain. Methods A joint model, composed by decision-tree and Markov models, was developed to estimate the long-term health outcomes and costs of NSCLC patients, by comparing the current testing scenario for ALK in Spain vs a hypothetical no-testing. The current distribution of testing strategies for ALK determination and their sensitivity and specificity data were obtained from the literature. Treatment allocation based on the molecular testing result were defined by a panel of Spanish experts. To assess long-term effects of each treatment, 3-states Markov models were developed, where progression-free survival and overall survival curves were extrapolated using exponential models. Medical direct costs (expressed in €, 2019) were included. A lifetime horizon was used and a discount rate of 3% was applied for both costs and health effects. Several sensitivity analyses, both deterministic and probabilistic, were performed in order test the robustness of the analysis. Results We estimated a target population of 7628 NSCLC patients, including those with non-squamous histology and those with squamous carcinomas who were never smokers. Over the lifetime horizon, the current ALK testing scenario produced additional 5060 and 3906 life-years and quality-adjusted life-years (QALY), respectively, compared with the no-testing scenario. Total direct costs were increased up to € 51,319,053 for testing scenario. The incremental cost-effectiveness ratio was 10,142 €/QALY. The sensitivity analyses carried out confirmed the robustness of the base-case results, being the treatment allocation and the test accuracy (sensitivity and specificity data) the key drivers of the model. Conclusions ALK testing in advanced NSCLC patients, non-squamous and never-smoker squamous, provides more than 3000 QALYs in Spain over a lifetime horizon. Comparing this gain in health outcomes with the incremental costs, the resulting incremental cost-effectiveness ratio reinforces that testing non-squamous and never-smoker squamous NSCLC is a cost-effective strategy in Spain.

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EP1.09-17 Spanish Lung Cancer Biomarker Testing Registry (Lungpath): Descriptive Analysis Focus in ALK Traslocation Results

Cited by 2 publications

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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)

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)

Clinical and economic impact of current ALK rearrangement testing in Spain compared with a hypothetical no-testing scenario

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