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

NCT ID: NCT06358599

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 221 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2024-01-15

Brief Summary

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.

Conditions

Bladder Cancer; Bladder Cancer Stage I; Bladder Cancer Stage II

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Neoadjuvant chemotherapy prior to radical cystectomy

Cisplatin

Intervention Type: DRUG

Neoadjuvant cisplatin-containing combination chemotherapy was defined as the receipt of multiagent systemic chemotherapy initiated within 6 months prior to the date of radical cystectomy

radical cystectomy directly

No interventions assigned to this group

Interventions

Cisplatin

Neoadjuvant cisplatin-containing combination chemotherapy was defined as the receipt of multiagent systemic chemotherapy initiated within 6 months prior to the date of radical cystectomy

Intervention Type: DRUG

Other Intervention Names

neoadjuvant cisplatin containing combination chemotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Cagri Akpinar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TUO-UR-21-01

Identifier Type: -

Identifier Source: org_study_id