Abstract 4442
Background
Real-world (rw) evidence derived from electronic health records (EHRs) is being explored for use as a comparator to single arm clinical trials in oncology. While RECIST is a standard for assessing tumor response in trials, alternative approaches are needed in rw cohorts. Our objective was to examine whether rwRR derived from abstracted “real-world tumor response” (rwTR) might perform similarly to RECIST-based response rates in a variety of settings to support assessments of drug efficacy.
Methods
We focused on randomized clinical trials supporting FDA approvals in aNSCLC between 2015-2017 (4 trials, 5 arms). We selected rw cohorts of aNSCLC patients from de-identified Flatiron Health EHR-derived database by applying the eligibility criteria of each trial as feasible, following an established internal process; trials were considered infeasible for comparison and not reported when fewer than 30 eligible rw patients were identified at the time of analyses. rwTR was abstracted from unstructured clinical notes and was based on the treating oncologist’s assessment of disease change (e.g., partial response) indicated by imaging at each point of radiographic disease evaluation. We compared the rwRRs observed in rw cohorts to objective response rates (ORRs) from trials.
Results
rw cohorts included 862 patients, and clinical trial cohorts (2 control arms and 3 experimental arms) included 701 patients, see response rates in the table (all except ALEX were confirmed RRs).Table:
1581P
Trial | Trial arm | ORR | rwRR |
---|---|---|---|
CheckMate-017 | E: Nivolumab / 2L+ squamous | 20% (27/135) | 25% (17/68) |
CheckMate-057 | E: Nivolumab / 2L+ nonsquamous | 19% (56/292) | 17% (51/294) |
KEYNOTE-021 | E: Carboplatin, Pembrolizumab, Pemetrexed/ 1L nonsquamous | 55% (33/60) | 42% (37/88) |
KEYNOTE-021 | C: Carboplatin and Pemetrexed/ 1L nonsquamous | 29% (18/63) | 34% (101/294) |
ALEX | C: Crizotinib/ 1L | 75% (114/151) | 68% (80/118) |
Conclusions
Data curated from EHRs of rw patients with aNSCLC can provide estimates of response rates that are comparable to RECIST-based response rates observed in similar patient populations studied in clinical trial settings. These findings demonstrate the potential of leveraging rw cohorts as a comparator to single arm clinical trials in oncology.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Flatiron Health, Inc.
Funding
Flatiron Health Inc., independent subsidiary of the Roche group.
Disclosure
X. Ma: Full / Part-time employment, Flatiron Health, Inc. is an independent subsidiary of the Roche Group.: Flatiron Health, Inc.; Shareholder / Stockholder / Stock options: Roche. N.C. Nussbaum: Shareholder / Stockholder / Stock options, Full / Part-time employment, Flatiron Health, Inc. is an independent subsidiary of the Roche Group.: Flatiron Health, Inc.; Shareholder / Stockholder / Stock options: Roche. K. Magee: Full / Part-time employment, Flatiron Health, Inc. is an independent subsidiary of the Roche Group: Flatiron Health, Inc.; Shareholder / Stockholder / Stock options: Roche. A.B. Bourla: Shareholder / Stockholder / Stock options, Full / Part-time employment, Flatiron Health, Inc. is an independent subsidiary of the Roche Group: Flatiron Health, Inc.; Shareholder / Stockholder / Stock options: Roche. M. Tucker: Shareholder / Stockholder / Stock options, Full / Part-time employment, Flatiron Health, Inc. is an independent subsidiary of the Roche Group.: Flatiron Health, Inc.; Shareholder / Stockholder / Stock options: Roche. L. Bellomo: Shareholder / Stockholder / Stock options, Full / Part-time employment, Flatiron Health, Inc. is an independent subsidiary of the Roche Group: Flatiron Health, Inc.; Shareholder / Stockholder / Stock options: Roche. C. Bennette: Shareholder / Stockholder / Stock options, Full / Part-time employment, Flatiron Health, Inc. is an independent subsidiary of the Roche Group.: Flatiron Health, Inc.; Shareholder / Stockholder / Stock options: Roche.
Resources from the same session
5011 - LCSCAF1 maintains cancer stem-like traits by stabilizing c-Myc protein and promotes metastasis and recurrence in lung cancer
Presenter: Tao Guo
Session: Poster Display session 1
Resources:
Abstract
4955 - XAF1 Enhances Temozolomide Induced Autophagic Cell Death through AMPK signaling pathway
Presenter: Mingoo Lee
Session: Poster Display session 1
Resources:
Abstract
5616 - The effect of cortisol on methylation patterns in breast cancer cell lines
Presenter: Haya Intabli
Session: Poster Display session 1
Resources:
Abstract
4649 - Global and sex-specific epigenome-wide association studies for the identification of the main methylated loci related to smoking in a Mediterranean population
Presenter: Judith Begona Ramirez Sabio
Session: Poster Display session 1
Resources:
Abstract
4984 - Whole transcriptomics analyses of mimicking Circulating Tumor Cells (CTCs) by single-cell RNA sequencing (scRNAseq)
Presenter: Jessica Garcia
Session: Poster Display session 1
Resources:
Abstract
5926 - Comparison of enzymatic- and bisulfite conversion to map the plasma cell-free methylome in cancer
Presenter: Nicole Lambert
Session: Poster Display session 1
Resources:
Abstract
5454 - Detection of low mutations in hepatocellular carcinoma by using circulating tumor DNA
Presenter: Esl Kim
Session: Poster Display session 1
Resources:
Abstract
4428 - Variants in the JAK1 and JAK2 genes in the risk and prognosis of patients with cutaneous melanoma
Presenter: Bruna Carvalho
Session: Poster Display session 1
Resources:
Abstract
4409 - P-Rex1 expression in breast cancer patients.
Presenter: Angela Lara Montero
Session: Poster Display session 1
Resources:
Abstract
4185 - Modulation of Risk of Cutaneous Melanoma Patients by Variants in STAT3 Gene and Functional Analysis
Presenter: Gabriela Gomez
Session: Poster Display session 1
Resources:
Abstract