Dataset Information

Concordance of Clinician-Documented and Imaging Response in Patients With Stage IV Non-Small Cell Lung Cancer Treated With First-Line Therapy.

ABSTRACT:

Importance

In observational oncology studies of solid tumors, response to treatment can be evaluated based on electronic health record (EHR) documentation (clinician-assessed response [CAR]), an approach different from standardized radiologist-measured response (Response Evaluation Criteria in Solid Tumours [RECIST] 1.1).

Objective

To evaluate the feasibility of an imaging response based on RECIST (IRb-RECIST) and the concordance between CAR and imaging response based on RECIST assessments, and investigate discordance causes.

Design, setting, and participants

This cohort study used an EHR-derived, deidentified database that included patients with stage IV non-small cell lung cancer (NSCLC) diagnosed between January 1, 2011, to June 30, 2019, selected from 3 study sites. Data analysis was conducted in August, 2020.

Exposures

Undergoing first-line therapy and imaging assessments of response to treatment.

Main outcomes and measures

In this study, CAR assessments (referred to in prior publications as "real-world response" [rwR]) were defined as clinician-documented changes in disease burden at radiologic evaluation time points; they were abstracted manually and assigned to response categories. The RECIST-based assessments accommodated routine practice patterns by using a modified version of RECIST 1.1 (IRb-RECIST), with independent radiology reads. Concordance was calculated as the percent agreement across all response categories and across a dichotomous stratification (response [complete or partial] vs no response), unconfirmed or confirmed.

Results

This study found that, in 100 patients evaluated for concordance, agreement between CAR and IRb-RECIST was 71% (95% CI, 61%-80%), and 74% (95% CI, 64%-82%) for confirmed and unconfirmed response, respectively. There were more responders using CAR than IRb-RECIST (40 vs 29 with confirmation; 64 vs 43 without confirmation). The main sources of discordance were the different use of thresholds for tumor size changes by RECIST vs routine care, and unavailable baseline or follow-up scans resulting in inconsistent anatomic coverage over time.

Conclusions and relevance

In this cohort study of patients with stage IV NSCLC, we collected routine-care imaging, showing the feasibility of response evaluation using IRb-RECIST criteria with independent centralized review. Concordance between CAR and centralized IRb-RECIST was moderate. Future work is needed to evaluate the generalizability of these results to broader populations, and investigate concordance in other clinical settings.

SUBMITTER: Ma X

PROVIDER: S-EPMC9099424 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Concordance of Clinician-Documented and Imaging Response in Patients With Stage IV Non-Small Cell Lung Cancer Treated With First-Line Therapy.

Ma Xinran X Bellomo Lawrence L Hooley Ian I Williams Tori T Samant Meghna M Tan Katherine K Segal Brian B Bourla Ariel Bulua AB

JAMA network open 20220502 5

<h4>Importance</h4>In observational oncology studies of solid tumors, response to treatment can be evaluated based on electronic health record (EHR) documentation (clinician-assessed response [CAR]), an approach different from standardized radiologist-measured response (Response Evaluation Criteria in Solid Tumours [RECIST] 1.1).<h4>Objective</h4>To evaluate the feasibility of an imaging response based on RECIST (IRb-RECIST) and the concordance between CAR and imaging response based on RECIST as ...[more]

PMID: 35552726

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Dataset Information

Concordance of Clinician-Documented and Imaging Response in Patients With Stage IV Non-Small Cell Lung Cancer Treated With First-Line Therapy.

Importance

Objective

Design, setting, and participants

Exposures

Main outcomes and measures

Results

Conclusions and relevance

Publications

Concordance of Clinician-Documented and Imaging Response in Patients With Stage IV Non-Small Cell Lung Cancer Treated With First-Line Therapy.

Similar Datasets

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