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Related Experiment Video

Updated: Sep 30, 2025

Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
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Implementing Real-World RECIST-based Tumor Response Assessment in Patients With Metastatic Non-small Cell Lung

Monika A Izano1, Nguyet Tran2, Alan Fu2

  • 1Syapse, San Francisco, CA.

Clinical Lung Cancer
|March 14, 2022
PubMed
Summary

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Real-world data (RWD) can accurately assess cancer treatment response, similar to standard RECIST criteria. This study shows high concordance between oncologist narratives and radiologist assessments in electronic health records for lung cancer patients.

Area of Science:

  • Oncology
  • Radiology
  • Health Informatics

Background:

  • The US FDA now accepts real-world data (RWD) for drug approvals.
  • Deriving RECIST (Response Evaluation Criteria in Solid Tumors) from RWD is challenging.
  • This study explores using RWD for RECIST-based cancer response assessment.

Purpose of the Study:

  • To investigate the feasibility of applying RECIST criteria to RWD.
  • To compare lung cancer treatment response assessments from RWD with established methods.
  • To evaluate the concordance between medical oncologist narratives and radiologist assessments in EHRs.

Main Methods:

  • Compared treatment response in 30 metastatic non-small cell lung cancer (mNSCLC) patients.
  • Assessed responses using medical oncologist narratives versus radiologist re-assessments of archived images with RECIST v1.1.
Keywords:
Electronic health recordNSCLCReal-world RECISTReal-world treatment response dataReal-world tumor response assessment

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  • Classified best overall response as CR/PR, SD, PD, or NE.

    • Main Results:

    • Observed similar distributions of best overall response between methods.
    • Found substantial concordance (77%) between oncologist-reported and radiologist re-assessed responses.
    • No instances of CR/PR to PD or PD to CR/PR discordance were noted.

    Conclusions:

    • Accurate treatment responses, comparable to RECIST, can potentially be derived from RWD.
    • Further validation is needed for a scalable real-world response assessment approach.
    • RWD holds promise for supporting drug approvals and clinical trial evaluations.