Abstract
Objective
To emulate two target clinical trials of radical nephrectomy (RN) with lymph node
dissection (LND) vs radical nephrectomy alone.
Methods
Using the National Cancer Database, we separately emulated an index trial of patients
with cT1-3cN0cM0 renal cell carcinoma (RCC), designed to resemble EORTC 30881 (“index
trial emulation”), and a hypothetical trial of patients at increased risk for lymph
node metastases with cT1-4cN0-1cM0 RCC (“high-risk trial emulation”). A propensity
score for LND was estimated using preoperative features (Model 1) or preoperative
and pathologic features (Model 2). The associations of LND with overall survival (OS)
were estimated using Cox regression with stabilized inverse probability weights.
Results
A total of 67,388 patients were included in the index trial emulation. Median follow-up
was 49.2 (interquartile range 27.2-74.3) months. LND was not associated with improved
OS when adjusting using either Model 1 (hazard ratio [HR] 1.26; 95% confidence interval
[CI] 1.20-1.33; P <.0001) or Model 2 (HR 1.13; 95% CI 1.07-1.20; P <.0001). A total of 69,477 patients were included in the high-risk trial emulation.
Median follow-up was 48.6 (interquartile range 26.6-73.8) months. LND was not associated
with improved OS when adjusting using either Model 1 (HR 1.24; 95% CI 1.18-1.30; P <.0001) or Model 2 (HR 1.09; 95% CI 1.04-1.16; P = .001). In sensitivity analyses, LND was not associated with improved OS across
cN stage, pT stage, tumor grade, histologic subtype, or probability of pN1 disease.
Conclusion
In observational analyses, that emulate target trials representing EORTC 30881 and
a trial of LND in high-risk RCC, LND was not associated with improved OS.
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Article info
Publication history
Published online: March 03, 2020
Accepted:
January 7,
2020
Received:
July 22,
2019
Footnotes
Funding support: The project described was supported by Institutional Development Award Number U54GM115677 from the National Institute of General Medical Sciences of theNational Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Conflict of Interest: The authors have no conflicts of interest to disclose.
The National Cancer Data Base (NCDB) is a joint project of the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society. The CoC's NCDB and the hospitals participating in the CoC NCDB are the source of the de-identified data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.
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© 2020 Elsevier Inc. All rights reserved.
