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Illustration of the Preliminary Attainability Assessment of Real-World Data (PAR) framework and study design. CQ: clinical question.
Source publication
Background:
In recent decades, real-world evidence (RWE) in oncology has rapidly gained traction for its potential to answer clinical questions that cannot be directly addressed by randomized clinical trials. Integrating real-world data (RWD) into clinical research promises to contribute to more sustainable research designs, including extension, a...
Citations
... The CDW's functional user interface provides clinicians with access to nonidentified and anonymous high-quality data sets. 14 The present study was approved by the Institutional Review Board of Samsung Medical Centre (IRB no. 2021-07-070) and the need for informed consent was waived as de-identified data were used in the study analysis. ...
Background
Lung cancer diagnostic guidelines advocate for invasive mediastinal nodal staging (IMNS), but the survival benefits of this approach in patients with non-small cell lung cancer (NSCLC) without radiologic evidence of lymph node metastasis (rN0) remain uncertain. We aimed to investigate the impact of IMNS in patients with rN0 NSCLC by comparing the long-term survival between patients who underwent IMNS and those who did not (non-IMNS).
Methods
In this retrospective cohort study, we included patients with NSCLC but without radiologic evidence of lymph node metastasis from the Registry for Thoracic Cancer Surgery and the clinical data warehouse at the Samsung Medical Centre, Republic of Korea between January 2, 2008 and December 31, 2016. We compared the 5-year overall survival (OS) rate as the primary outcome after propensity score matching between the IMNS and non-IMNS groups. The age, sex, performance statue, tumor size, centrality, solidity, lung function, FDG uptake in PET-CT, and histological examination of the tumor before surgery were matched.
Findings
A total of 4545 patients (887 in the IMNS group and 3658 in the non-IMNS group) who received curative treatment for NSCLC were included in this study. By the mediastinal node dissection, the overall incidence of unforeseen mediastinal node metastasis (N2) was 7.2% (317/4378 patients). Despite the IMNS, 67% of pathological N2 was missed (61/91 patients with unforeseen N2). Based on propensity score matching, 866 patients each for the IMNS and non-IMNS groups were assigned. There was no significant difference in 5-year OS and recurrence-free survival (RFS) between two groups: 5-year OS was 73.9% (95% confidence interval, CI: 71%–77%) for IMNS and 71.7% (95% CI: 68.6%–74.9%; p = 0.23), for non-IMNS (hazard ratio, HR 0.90, 95% CI: 0.77–1.07), while 5-year RFS was 64.7% (95% CI: 61.5%–68.2%) and 67.5% (95% CI: 64.3%–70.9%; p = 0.35 (HR 1.08, 95% CI: 0.92–1.27), respectively. Moreover, the timing and locations of recurrence were similar in both groups.
Interpretation
IMNS might not be required before surgery for patients with NSCLC without LN suspicious of metastasis. Further randomised trials are required to validate the findings of the present study.
Funding
None.
