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

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.

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Key information

Conditions

Bladder Cancer Bladder Cancer Stage I Bladder Cancer Stage II Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

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

Other names: neoadjuvant cisplatin containing combination chemotherapy

Primary outcomes

Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy.

Time frame: 2 years from radical cystectomy surgery

Secondary outcomes

Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy.

Time frame: 2 years from radical cystectomy surgery

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Who Underwent Radical Cystectomy: A Multicenter Study of the Turkish Urooncology Association

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2024
First posted: Apr 10, 2024
Registry last updated: Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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