Bladder Cancer
Conditions
Brief summary
The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline NLR is correlated with overall survival after curative treatment for BC and 2) that baseline NLR is correlated with the survival benefit of NAC. The study will look at the data from participants of the SWOG 8710 study.
Interventions
None listed
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. SWOG 8710 original trial inclusion criteria included: * Node-negative, muscle-invasive transitional cell carcinoma of the bladder, T2-T4aN0M0 per the AJCC 4th edition staging manual. * SWOG performance status of 0 or 1 * Adequate organ function by lab criteria (WBC \> 4,000 cells/mm3, platelets \>150,000 cells/mm3, creatinine \<1.5 md/dL (men) or \<1.3 md/dL (women), baseline liver tests \< 2 times normal limits) 2. Inclusion criteria for this secondary analysis are: * Eligible for original SWOG 8710 trial * Had complete blood count with differential prior to first treatment (radical cystectomy or NAC).
Exclusion criteria
1. SWOG 8710 original trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 26 years | Number of participants who survived at 26 years are reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prognostic Cohort Patients with NLR who completed curative therapy (surgery with or without chemo) | 230 |
| Predictive Cohort Patients with NLR who were assigned to a trial arm (chemo or no chemo) | 263 |
| Total | 493 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete curative therapy | 33 | 0 |
| Overall Study | No available NLR value | 44 | 44 |
| Overall Study | Not eligible for initial SWOG study | 10 | 10 |
Baseline characteristics
| Characteristic | Prognostic Cohort | Predictive Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 101 Participants | 115 Participants | 216 Participants |
| Age, Categorical Between 18 and 65 years | 129 Participants | 148 Participants | 277 Participants |
| Region of Enrollment United States | 230 Participants | 263 Participants | 493 Participants |
| Sex: Female, Male Female | 45 Participants | 50 Participants | 95 Participants |
| Sex: Female, Male Male | 185 Participants | 213 Participants | 398 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 230 | 0 / 263 |
| serious Total, serious adverse events | 0 / 230 | 0 / 263 |
Outcome results
Primary
Overall Survival
Number of participants who survived at 26 years are reported.
Time frame: 26 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prognostic Cohort | Overall Survival | 58 participants |
| Predictive Cohort | Overall Survival | 58 participants |
Comparison: The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.95% CI: [0.98, 1.11]
Comparison: The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.95% CI: [0.9, 1.14]