Trial Outcomes & Findings for Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710 (NCT NCT02756637)
NCT ID: NCT02756637
Last Updated: 2023-08-07
Results Overview
Number of participants who survived at 26 years are reported.
Recruitment status
COMPLETED
Target enrollment
634 participants
Primary outcome timeframe
26 years
Results posted on
2023-08-07
Participant Flow
Participant milestones
| Measure |
Prognostic Cohort
Patients with NLR who completed curative therapy (surgery with or without chemo)
|
Predictive Cohort
Patients with NLR who were assigned to a trial arm (chemo or no chemo)
|
|---|---|---|
|
Overall Study
STARTED
|
317
|
317
|
|
Overall Study
Eligible for SWOG 8710
|
307
|
307
|
|
Overall Study
Had NLR Value
|
263
|
263
|
|
Overall Study
Completed Curative Treatment
|
230
|
0
|
|
Overall Study
COMPLETED
|
230
|
263
|
|
Overall Study
NOT COMPLETED
|
87
|
54
|
Reasons for withdrawal
| Measure |
Prognostic Cohort
Patients with NLR who completed curative therapy (surgery with or without chemo)
|
Predictive Cohort
Patients with NLR who were assigned to a trial arm (chemo or no chemo)
|
|---|---|---|
|
Overall Study
Not eligible for initial SWOG study
|
10
|
10
|
|
Overall Study
No available NLR value
|
44
|
44
|
|
Overall Study
Did not complete curative therapy
|
33
|
0
|
Baseline Characteristics
Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710
Baseline characteristics by cohort
| Measure |
Prognostic Cohort
n=230 Participants
Patients with NLR who completed curative therapy (surgery with or without chemo)
|
Predictive Cohort
n=263 Participants
Patients with NLR who were assigned to a trial arm (chemo or no chemo)
|
Total
n=493 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
230 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
493 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 yearsNumber of participants who survived at 26 years are reported.
Outcome measures
| Measure |
Prognostic Cohort
n=230 Participants
Patients with NLR who completed curative therapy (surgery with or without chemo)
|
Predictive Cohort
n=263 Participants
Patients with NLR who were assigned to a trial arm (chemo or no chemo)
|
|---|---|---|
|
Overall Survival
|
58 participants
|
58 participants
|
Adverse Events
Prognostic Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Predictive Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Christodouleus
Abramson Cancer Center of the University of Pennsylvania
Phone: 215-662-2428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place