Muscle Invasive Bladder Cancer
Conditions
Keywords
Bladder cancer, PET CT, CT scan, Lymph node staging, TNM staging
Brief summary
Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years. Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC). Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.
Detailed description
Background: Bladder cancer is the second most frequent genito-urinary cancer, and the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years. Curative treatment of muscle invasive urothelial carcinoma localized to the bladder includes cisplatin-based neoadjuvant chemotherapy, followed by radical cystectomy with lymph nodes dissection. Nonetheless, surgery indications depend on pre-operative staging regarding nodes and metastatic involvement. Computed Tomography (CT) scan is the reference imaging study for loco-regional and metastatic staging. Lymph node involvement evaluation is based on morphologic criteria only. Its sensitivity lies between 30 and 53% and its specificity between 67 and 91%. Yet, optimal node staging is crucial for therapeutic decision. FDG-Positron Emission Tomography (PET) CT, using both morphologic and functional criteria, could help for node staging in muscle invasive bladder cancer assessment, especially by detecting infracentimetric involved lymph nodes. Moreover, it could be useful for detecting distant metastasis. Objective: To evaluate the accuracy of the PET CT for lymph node staging and to determine the rate of treatment modification according to PET CT results Methods: Retrospective study based on the medical records of every patient undergoing a PET CT at the time of diagnosis of MIBC from 01/2005 to 12/2017 in Bordeaux (Bergonie Institute and University Hospital). PET CT could have been done before any treatment (PET 1) and/or after neo-adjuvant chemotherapy and before surgery (PET 2).
Interventions
DEVICEPET CT
Every patient undergoing a PET CT at the time of diagnosis of muscle invasive bladder cancer from January 2005 to December 2017 in Bordeaux (Institut Bergonié and University Hospital).
Sponsors
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Muscle Invasive Urothelial Carcinoma of the bladder (classified at least pT2 on TURB) * Diagnosis between January 2005 and December 2017 * PET CT done during initial assessment before surgery (at the time of diagnosis and/or after neoadjuvant chemotherapy) * Management of cancer at Institut Bergonié or at Bordeaux University Hospital * Previous treatment for Non Muscle Invasive Bladder Cancer allowed
Exclusion criteria
* Management of cancer outside of Institut Bergonié or Bordeaux University Hospital * No PET CT done during initial assessment (before surgery) * Rare pathological type of bladder cancer without urothelial carcinoma (epidermoid carcinoma, neuro-endocrine carcinoma, …) * Extra-vesical urothelial carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate | 16 weeks after inclusion | Performance sensitivity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection). Gold standard : pathological results (complete response vs no complete response). Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response. Sensitivity rate : count of participants with complete response as per FDG-PET divided by count of participants with pathoplogical complete response |
| Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate | Date of pathological results, up to 20 weeks after inclusion | Performance specificity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection). Gold standard : pathological results (complete response vs no complete response). Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response Specificiity rate : count of participants with NO complete response as per FDG-PET divided by count of participants with NO pathoplogical complete response |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MIBC Patients with muscle invasive bladder cancer (MIBC)
PET CT: Every patient undergoing a PET CT at the time of diagnosis of muscle invasive bladder cancer from January 2005 to December 2017 in Bordeaux (Institut Bergonié and University Hospital). | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | MIBC | — |
|---|---|---|
| Age, Continuous | 66 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 130 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 113 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate
Performance sensitivity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection). Gold standard : pathological results (complete response vs no complete response). Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response. Sensitivity rate : count of participants with complete response as per FDG-PET divided by count of participants with pathoplogical complete response
Time frame: 16 weeks after inclusion
Population: Patients with complete pathological response
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible MIBC Patients | Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate | 21 Participants |
Primary
Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate
Performance specificity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection). Gold standard : pathological results (complete response vs no complete response). Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response Specificiity rate : count of participants with NO complete response as per FDG-PET divided by count of participants with NO pathoplogical complete response
Time frame: Date of pathological results, up to 20 weeks after inclusion
Population: Participants with NO pathoplogical complete response
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible MIBC Patients | Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate | 32 participants |