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The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy

A

Ankara Etlik City Hospital

Status

Completed

Conditions

Bladder Cancer
Bladder Cancer Stage I
Bladder Cancer Stage II

Treatments

Drug: Cisplatin

Study type

Observational

Funder types

Other

Identifiers

NCT06358599
TUO-UR-21-01

Details and patient eligibility

About

The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen.

Enrollment

221 patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with squamous cell, micropapillary, nested variant, sarcomatoid, neuroendocrine, or plasmacytoid variant histology
  • Patients who were non-metastatic at diagnosis
  • Patients who completed staging and demographic data,
  • Patients with pathological stage (p)T2 or high grade pT1, clinical stage (c)N0 or cN1, and underwent radical cystectomy

Exclusion criteria

  • Although RC histopathology was variant histology, patients in whom variant histology was not detected in previously transurethral resection bladder pathology
  • Patients who received therapies other than radical cystectomy (intravesical bacillus-calmette-guerin or chemotherapy) were excluded from the study.
  • Patients with a concomitant diagnosis of upper urinary tract urothelial carcinoma
  • Patients with histopathologically pure urothelial carcinoma

Trial design

221 participants in 2 patient groups

Neoadjuvant chemotherapy prior to radical cystectomy
Treatment:
Drug: Cisplatin
radical cystectomy directly

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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