Abstract 1364P
Background
DigiONE integrated core variables into local Observational Medical Outcomes Partnership (OMOP) databases to create the first European pan-cancer hospital network using OMOP. With maintained databases and reproducible analytical approaches, centres aim to generate faster precision oncology Real World Evidence (RWE). These preliminary results of OS by sites of mets in mNSCLC is a first step to studying routine treatment received and additional outcomes.
Methods
Retrospective routine care data from OMOP databases at three centers (Leeds, Maastricht, Oslo) were collected for pts diagnosed with relapsed or de novo mNSCLC between 01/11/2018 - 30/09/2022. Demographic and clinical characteristics were described at index (mNSCLC diagnosis). Kaplan-Meier curves for OS from index were plotted. Log-rank tests compared OS across subgroups. A federated learning approach with Vantage6 was used, operating on Gaussian-noised individual survival time to further reduce risk of pt reidentification.
Results
The analysis included 1277 mNSCLC pts. Median age at index was 70 years, 52.8% were male, and 74.4% pts had mets at primary NSCLC diagnosis. Median OS (mOS) for the overall cohort was 8.7 months (mts) [Interquartile range (Q1-Q3): 2.6-29.4] and 15.4 mts [Q1-Q3: 6.9-38.9] for pts treated with systemic anti-cancer therapy (SACT). Pts with contralateral lung or pleura only mets had the longest mOS of 18.7 mts [Q1-Q3: 4.3-38.3] compared to pts with liver only mets (mOS 4.4 mts [Q1-Q3: 1.9-15.7]) p=0.001. Table: 1364P
Location of mets (5 of 7 subgroups presented) | Brain or leptomeninges only | Liver only | Bone only | Contralateral lung or pleura only | Multiple sites including brain | |
Total | Number pts | 172 | 93 | 126 | 76 | 114 |
Number deaths | 129 | 80 | 107 | 50 | 92 | |
Number censored pts | 43 | 13 | 19 | 26 | 22 | |
Median mts | 10.6 | 4.4 | 7.6 | 18.7 | 6.1 | |
Q1-Q3 | 2.6 - 26.1 | 1.9 - 15.7 | 2.3 - 17.8 | 4.3 - 38.3 | 1.8 - 16.2 | |
12 Mts | Number pts | 75 | 30 | 49 | 45 | 33 |
Survival probability (95% Confidence Interval) | 45.0 (38.1, 53.2) | 32.6 (24.3, 43.8) | 38.9 (31.2, 48.4) | 60.4 (50.4, 72.5) | 29.8 (22.4, 39.7) |
Conclusions
Curation, standardization, and harmonization across centres of routine care data is an extensive task due to its often unstructured, incomplete, and dissimilar nature. However, it can facilitate faster collaborations aiming at reliable RWE research. The survival differences in pts receiving SACT and OS by sites of mets are as expected compared to trials, reflecting the accuracy of this method.
Clinical trial identification
Editorial acknowledgement
Medical Writing support was provided by Junaid A Khan, who is a Senior Medical Writer at the Medical and Scientific Writing Department for Real World Solutions at IQVIA. There were no generative Artificial Intelligence (AI) or AI-assisted technologies involved in the writing process.
Legal entity responsible for the study
Digital Institute for Cancer Outcomes Research (DIGICORE), a European Economic Interest Grouping (EEIG). Address: C/o Fondation Universitaire Rue d'Egmont 1000, Brussels - Belgium.
Funding
1. IQVIA Ltd., 2. Illumina Netherlands, B.V.
Disclosure
P. Jain: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Gilead, Takeda, Roche; Non-Financial Interests, Personal, Sponsor/Funding: Roche, Takeda. L.E. Hendriks: Financial Interests, Institutional, Advisory Board: Amgen, Boehringer Ingelheim, Lilly, Novartis, Pfizer, Takeda, Merck, Janssen, MSD, AnHeart; Financial Interests, Institutional, Invited Speaker, for educational webinar: AstraZeneca, Lilly; Financial Interests, Institutional, Invited Speaker, educational webinar/interview: Bayer; Financial Interests, Institutional, Invited Speaker, Educationals: MSD; Financial Interests, Personal, Invited Speaker, for webinars: Medtalks; Financial Interests, Personal, Invited Speaker, payment for post ASCO round table discussion: VJOncology; Financial Interests, Personal, Invited Speaker, payment for post ASCO/ESMO/WCLC presentations, educational committee member: Benecke; Financial Interests, Institutional, Invited Speaker, payment for post ESMO/ASCO discussion: high5oncology; Financial Interests, Institutional, Other, podcast on brain metastases: Takeda; Financial Interests, Institutional, Other, educational webinar: Janssen; Financial Interests, Institutional, Invited Speaker, satellite symposium at conference: GSK, Sanofi; Financial Interests, Personal, Invited Speaker, presentation guideline: Medimix; Financial Interests, Institutional, Invited Speaker, podcast and educational: Pfizer; Financial Interests, Personal, Other, member of the committee that revised these guidelines: Dutch guidelines NSCLC, brain metastases and leptomeningeal metastases; Financial Interests, Institutional, Research Grant, for IIS: Roche, Boehringer Ingelheim, AstraZeneca, Takeda, Novartis; Financial Interests, Institutional, Research Grant, donation for health care improvement project: Merck; Financial Interests, Institutional, Research Grant, funding for healthcare improvement project: Pfizer; Financial Interests, Institutional, Research Grant, for IIS, under negotiation: Gilead; Financial Interests, Institutional, Local PI: AstraZeneca, GSK, Novartis, Merck Serono, Roche, Takeda, Blueprint Medicines, Mirati, AbbVie, MSD, Gilead; Non-Financial Interests, Other, Chair metastatic NSCLC for lung cancer group: EORTC; Non-Financial Interests, Other, secretary NVALT studies foundation: NVALT; Non-Financial Interests, Other, vice chair scientific committee: Dutch Thoracic Group. F.R. Ogliari: Non-Financial Interests, Institutional, Coordinating PI: MSD, Roche, BMS, Daiichi Sankyo, BeiGene; Financial Interests, Personal, Invited Speaker: Roche, Sanofi. F. Acker: Other, Personal, Invited Speaker: AstraZeneca; Other, Personal, Speaker, Consultant, Advisor: IQVIA. J. Brash, H.M. Fenton, R. McDonald: Financial Interests, Institutional, Full or part-time Employment, Full time employee of CRO that conducts research on behalf of life science clients and health systems: IQVIA Ltd. S. Cheeseman: Financial Interests, Institutional, Funding, Part of Dr Cheeseman's salary from LTHT is reimbursed by IQVIA. IQVIA conducts research on behalf of life science clients and health systems: IQVIA Ltd. T. Goering: Financial Interests, Institutional, Full or part-time Employment, Full time employee of CRO that conducts research on behalf of life science clients and health systems: IQVIA Commercial GmbH & Co. OHG. A. Helland: Non-Financial Interests, Institutional, Advisory Board: AbbVie, Takeda, AstraZeneca, Roche, Pfizer, Janssen, Eli Lilly, BMS, Pierre Fabre, Bayer, MSD, Novartis, Merck, Sanofi, Medicover; Non-Financial Interests, Institutional, Research Grant: Roche, AstraZeneca, Novartis, Incyte, Eli Lilly, BMS, Ultimovacs, Merck, GSK. All other authors have declared no conflicts of interest.
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