Real-world data (RWD) on tumor response (rwTR) in advanced non-small cell lung cancer (aNSCLC) patients receiving cancer immunotherapy and targeted therapies.
2018; Lippincott Williams & Wilkins; Volume: 36; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2018.36.15_suppl.6578
ISSN1527-7755
AutoresMichael W. Lu, Natalia Sadetsky, Peter Lambert, Sam Whipple, Michael D. Taylor, Todd Riehl, Gregory J. Riely,
Tópico(s)Cancer Genomics and Diagnostics
Resumo6578 Background: Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) is an established early efficacy endpoint used in clinical trials. Comparison of real world tumor response (rwTR) and ORR can provide important insights for health professionals, regulators, and researchers. Methods: We retrospectively analyzed electronic health records (EHRs) of patients with metastatic or recurrent NSCLC treated with epidermal growth factor receptor (EGFR)-targeted therapy (afatinib or erlotinib) and a programmed cell death 1 (PD-1) inhibitor (nivolumab), as well as a subset of BRAF mutation (BRAFmut)–positive patients in the Flatiron (FIH) EHR and FIH-Foundation Medicine (FMI) Clinico-Genomics database (CGDB) from 2011 to 2017. Structured and unstructured data elements from FIH EHRs were processed via technology-enabled abstraction. RwTR was based on abstraction of clinician’s assessment of radiographic evidence. Results: All patients with rwTR (CGDB, n=595; BRAFmut, n=30) were evaluated. Observed rwTR rates for the relevant patient populations are described in the Table. Conclusions: This analysis demonstrates the potential of leveraging routinely captured EHRs to provide RWD on treatment effectiveness in patients with NSCLC. These results show that rwTR for targeted and immunotherapies appear to correlate well with RECIST ORR rates in pivotal clinical studies matched by EGFR mutation status, treatment, and line of treatment. Future work includes expanding similar rwTR evaluation to more treatment contexts. ORR by line of therapy. rwTR Reference clinical study/ population/ RECIST response EGFR mut EGFR wt Afatinib 1L, n = 29 56% (14/25) 25% (1/4) LUX-Lung 3/ EGFR mut/ 56% 2L, n = 23 30% (6/20) NA Erlotinib 1L, n = 106 69% (60/86) 35% (7/20) EURTAC/ EGFR mut/ 65% ENSURE / EGFR mut/ 63% 2L, n = 34 53% (8/15) 15% (3/19) BR21/ EGFR (any)/ 9% Nivolumab All comers 1L, n = 63 33% (21/63) - Checkmate 026/ 1L/ 26% 2L, n = 131 28% (37/131) - Checkmate- 017/ 2L+ squamous/ 20% Checkmate- 057/ 2L+ nonsquamous/ 19% 3L, n = 55 15% (8/55) - Checkmate- 017/ 2L+ squamous/ 20% Checkmate- 057/ 2L+ nonsquamous/ 19%
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