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Circulating tumour cells to drive the use of neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer
- Source :
- Beije , N , de Kruijff , I E , de Jong , J J , Klaver , S O , de Vries , P , Jacobs , R A L , Somford , D M , te Slaa , E , van der Heijden , A G , Alfred Witjes , J , Fossion , L M C L , Boevé , E R , van der Hoeven , J , van Melick , H H E , Wijburg , C J , Bickerstaffe , H , Martens , J W M , de Wit , R , Kraan , J , Sleijfer , S & Boormans , J L 2022 , ' Circulating tumour cells to drive the use of neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer ' , ESMO Open , vol. 7 , no. 2 , 100416 .
- Publication Year :
- 2022
-
Abstract
- Background: Guidelines recommend neoadjuvant chemotherapy (NAC) for the treatment of nonmetastatic muscle-invasive bladder cancer (MIBC). NAC is, however, underutilized in practice because of its associated limited overall survival (OS) benefit and significant treatment-related toxicity. We hypothesized that the absence of circulating tumour cells (CTCs) identifies MIBC patients with such a favourable prognosis that NAC may be withheld. Patients and methods: The CirGuidance study was an open-label, multicentre trial that included patients with clinical stage T2-T4aN0-N1M0 MIBC, scheduled for radical cystectomy. CTC-negative patients (no CTCs detectable using the CELLSEARCH system) underwent radical surgery without NAC; CTC-positive patients (≥1 detectable CTCs) were advised to receive NAC, followed by radical surgery. The primary endpoint was the 2-year OS in the CTC-negative group with a prespecified criterion for trial success of ≥75% (95% confidence interval (CI) ±5%). Results: A total of 273 patients were enrolled. Median age was 69 years; median follow-up was 36 months. The primary endpoint of 2-year OS in the CTC-negative group was 69.5% (N = 203; 95% CI 62.6%-75.5%). Two-year OS was 58.2% in the CTC-positive group (N = 70; 95% CI 45.5%-68.9%). CTC-positive patients had a higher rate of cancer-related mortality [hazard ratio (HR) 1.61, 95% CI 1.05-2.45, P = 0.03] and disease relapse (HR 1.87, 95% CI 1.28-2.73, P = 0.001) than CTC-negative patients. Explorative analyses suggested that CTC-positive patients who had received NAC (n = 22) survived longer than CTC-positive patients who had not (n = 48). Conclusion: The absence of CTCs in MIBC patients was associated with improved cancer-related mortality and a lower risk of disease relapse after cystectomy; however, their absence alone does not justify to withhold NAC. Exploratory analyses suggested that CTC-positive MIBC patients might derive more benefit from NAC. Trial registration: Netherlands Trial Register
Details
- Database :
- OAIster
- Journal :
- Beije , N , de Kruijff , I E , de Jong , J J , Klaver , S O , de Vries , P , Jacobs , R A L , Somford , D M , te Slaa , E , van der Heijden , A G , Alfred Witjes , J , Fossion , L M C L , Boevé , E R , van der Hoeven , J , van Melick , H H E , Wijburg , C J , Bickerstaffe , H , Martens , J W M , de Wit , R , Kraan , J , Sleijfer , S & Boormans , J L 2022 , ' Circulating tumour cells to drive the use of neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer ' , ESMO Open , vol. 7 , no. 2 , 100416 .
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1356653161
- Document Type :
- Electronic Resource