Your browser doesn't support javascript.
loading
Implementing Real-World RECIST-based Tumor Response Assessment in Patients With Metastatic Non-small Cell Lung Cancer.
Izano, Monika A; Tran, Nguyet; Fu, Alan; Toland, Liz; Idryo, Danny; Hilbelink, Ryan; Tu, Huakang; Hsu, Hil; Sommers, Chris; Rioth, Matthew; Brown, Thomas.
Afiliación
  • Izano MA; Syapse, San Francisco, CA. Electronic address: monika.izano@syapse.com.
  • Tran N; Amgen, Thousand Oaks, CA.
  • Fu A; Amgen, Thousand Oaks, CA.
  • Toland L; Syapse, San Francisco, CA.
  • Idryo D; Syapse, San Francisco, CA.
  • Hilbelink R; Aurora Health Care, Milwaukee, WI.
  • Tu H; Amgen, Thousand Oaks, CA.
  • Hsu H; Amgen, Thousand Oaks, CA.
  • Sommers C; Syapse, San Francisco, CA.
  • Rioth M; Syapse, San Francisco, CA.
  • Brown T; Syapse, San Francisco, CA.
Clin Lung Cancer ; 23(3): 191-194, 2022 05.
Article en En | MEDLINE | ID: mdl-35283071
BACKGROUND: To accelerate drug approvals while maintaining scientific rigor in the evaluation of a therapeutic's efficacy and safety, the United States Food and Drug Administration now considers real-world data (RWD) to support New Drug Applications and expanded indications. Response Evaluation Criteria in Solid Tumors (RECIST) are the gold standard in clinical trials, but the derivation of RECIST-based treatment response from RWD is unproven. This study investigated the feasibility of implementing RECIST criteria in RWD by comparing lung cancer response assessments from RECIST-based measurement of lesions on archived radiologic films with results from medical oncologist and radiologist narratives recorded in electronic health records (EHR). MATERIALS AND METHODS: Response to index treatment via different assessment approaches was compared among 30 metastatic non-small cell lung cancer (mNSCLC) patients receiving systemic treatment (index) after progression on a platinum or anti-PD(L)-1-containing regimen. Specifically, responses based on assessments documented in the medical oncologists' narratives were compared to a radiologist's assessments of archived images using RECIST v1.1 criteria. Each patient's best overall response was characterized as complete or partial (CR/PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). RESULTS: Similar distributions of best overall response and substantial concordance (77%) between medical oncologist-reported and radiologist re-assessed responses were observed. There were no instances of CR/PR to PD or PD to CR/PR discordance. CONCLUSIONS: Results suggest that accurate treatment responses, similar to RECIST, may be derived using RWD. Further validation and improvement of real-world response assessment are needed to develop a scalable real-world approach for response assessment.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Límite: Humans Idioma: En Revista: Clin Lung Cancer Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Límite: Humans Idioma: En Revista: Clin Lung Cancer Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos