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- Title
Tumor downstaging as an intermediate endpoint to assess the activity of neoadjuvant systemic therapy in patients with muscle-invasive bladder cancer.
- Authors
Martini, Alberto; Jia, Rachel; Ferket, Bart S.; Waingankar, Nikhil; Plimack, Elizabeth R.; Crabb, Simon J.; Harshman, Lauren C.; Yu, Evan Y.; Powles, Thomas; Rosenberg, Jonathan E.; Pal, Sumanta K.; Vaishampayan, Ulka N.; Necchi, Andrea; Wiklund, N. Peter; Mehrazin, Reza; Mazumdar, Madhu; Sfakianos, John P.; Galsky, Matthew D.
- Abstract
<bold>Background: </bold>Achieving a pathologic complete response (pCR) with neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC) has been associated with improved overall survival (OS). This study was aimed at evaluating the impact of pathologic downstaging (pDS; ie, a pT stage at least 1 stage lower than the pre-NAC cT stage) on the OS of patients with MIBC treated with NAC.<bold>Methods: </bold>The Retrospective International Study of Cancers of the Urothelial Tract (RISC) and the National Cancer Database (NCDB) were queried for cT2-4N0M0 patients treated with NAC. A multivariable Cox model including either pDS or pCR was generated. A nested model was built to evaluate the added value of pDS (excluding patients achieving a pCR) to a model including pCR alone. C indices were computed to assess discrimination. NCDB was used for validation. The treatment effect of NAC versus cystectomy alone in achieving pDS was estimated through an inverse probability-weighted regression adjustment.<bold>Results: </bold>Overall, 189 and 2010 patients from the RISC and NCDB cohorts, respectively, were included; pDS and pCR were achieved by 33% and 35% and by 20% and 15% in RISC and NCDB, respectively. In both data sets, pDS and pCR were associated with better OS and C indices. Adding pDS excluding pCR to the model with pCR fit the data better (likelihood ratio, P = .019 for RISC and P < .001 for NCDB), and it yielded better discrimination (incremental C index, 4.2 for RISC and 1.6 for NCDB). The treatment effect of NAC in achieving pDS was 2.07-fold (P < .001) in comparison with cystectomy alone.<bold>Conclusions: </bold>A decrease of at least 1 stage from the cT stage to the pT stage is associated with improved OS in patients with MIBC treated with NAC.
- Subjects
BLADDER cancer; REDUCED instruction set computers; TUMORS
- Publication
Cancer (0008543X), 2019, Vol 125, Issue 18, p3155
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/cncr.32169