Predicting the Pathologic Complete Response After Neoadjuvant Pembrolizumab in Muscle-Invasive Bladder Cancer.

Journal of the National Cancer Institute
Marco BandiniAndrea Necchi

Abstract

In the PURE-01 study (NCT02736266), we aimed to evaluate the ability to predict the pathologic complete response (pT0N0) after pembrolizumab by using clinical and tumor biomarkers. In an open-label, single-arm, phase 2 study, 3 courses of 200 mg pembrolizumab preceding radical cystectomy were administered in patients with T2-4aN0M0 muscle-invasive bladder cancer. The analyses included a comprehensive genomic profiling and programmed cell-death-ligand-1 (PD-L1)-combined positive score assessment (CPS; Dako 22C3 antibody) of pre- and posttherapy samples. Multivariable logistic regression analyses evaluated baseline clinical T stage and tumor biomarkers in association with pT0N0 response. Corresponding coefficients were used to develop a calculator of pT0N0 response based on the tumor mutational burden (TMB), CPS, and the clinical T stage. Decision-curve analysis was also performed. All statistical tests were 2-sided. From February 2017 to June 2019, 112 patients with biomarker data were enrolled (105 with complete TMB and CPS data). Increasing TMB and CPS values featured a linear association with logistic pT0N0 probabilities (P = .02 and P = .004, respectively). For low TMB values (≤11 mut/Mb, median value, n = 53), pT0N0 probabi...Continue Reading

References

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Oct 18, 2016·Oncotarget·Joshua J MeeksFrancis J Giles
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Sep 17, 2019·The American Journal of Surgical Pathology·Charlotte S VoskuilenRoland Seiler

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Citations

Oct 14, 2020·Nature Reviews. Urology·Filippo PederzoliAndrea Necchi
Aug 8, 2020·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Umang SwamiNeeraj Agarwal
Jun 10, 2020·Journal of the National Cancer Institute·Leonard J Appleman
May 11, 2021·European Urology Oncology·M Carmen MirUNKNOWN EAU Section of Oncological Urology (ESOU) Board

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