Trial Outcomes & Findings for Bristol Bladder Trial (NCT NCT01616875)
NCT ID: NCT01616875
Last Updated: 2026-03-06
Results Overview
Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues.
COMPLETED
PHASE2
28 participants
Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.
2026-03-06
Participant Flow
Recruitment took place at a single site, Bristol Haematology and Oncology Centre, Bristol, UK.. First patient was enrolled in July 2012 and the last in August 2017.
None. Screening as per the eligibility criteria. All eligible patients were registered into the trial and received the same treatment.
Participant milestones
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=28 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Age, Continuous
|
66 years
n=28 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=28 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG ≤1
|
28 participants
n=28 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG ≥2
|
0 participants
n=28 Participants
|
|
eGFR
|
73.7 ml/min/1.73m^2
n=28 Participants
|
|
Pathological T stage
T2
|
27 Participants
n=28 Participants
|
|
Pathological T stage
T3
|
1 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.Population: 28 patients were recruited. All completed trial treatment. 26 were analysed for the primary endpoint. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 1 patient did not have surgery after trial treatment and was excluded from the primary endpoint analysis but included in toxicity analysis.
Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=26 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Overall Pathological Response Rate
|
57.7 % of participants
Interval 36.9 to 76.6
|
SECONDARY outcome
Timeframe: From registration up to 5 years after surgeryPopulation: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 1 patient did not have surgery after trial treatment and was excluded from the PFS analysis but included in toxicity analysis.
From registration until progression or death from any cause up to 5 years after surgery. Outcome is the percentage of patients who are progression free. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=26 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Progression Free Survival at 5 Years After Cystectomy
|
61.5 % of participants
Interval 3.0 to 60.0
|
SECONDARY outcome
Timeframe: From registration up to 5 years after surgeryPopulation: Patients who did not show pathological downstaging after treatment are being analysed here - 11 in total.
From registration until progression or death from any cause up to 5 years after surgery. Outcome is the median number of months it takes 50% of patients to show progression. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=11 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Progression Free Survival of Patients Who Did Not Show Pathological Downstaging
|
7.2 months
Interval 0.1 to 40.5
|
SECONDARY outcome
Timeframe: From registration up to 5 years after cystectomyPopulation: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 1 patient did not have surgery after trial treatment and was excluded from the OS analysis but included in toxicity analysis.
From registration until death from any cause up to 5 years after surgery. Outcome is the percentage of patients alive at 5 years after cystectomy.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=26 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Overall Survival at 5 Years After Cystectomy
|
65.4 % of participants
Interval 6.0 to 60.0
|
SECONDARY outcome
Timeframe: From registration up to 5 years after cystectomyPopulation: Patients who did not show pathological downstaging after treatment are being analysed here - 11 in total.
From registration until death from any cause up to 5 years after surgery. Outcome is the median number of months it takes for 50% of patients to die.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=11 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Overall Survival of Patients Who Did Not Show Pathological Downstaging
|
20.5 months
Interval 0.1 to 40.5
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for the quality of life. However, not all patients answered all questionnaires at all time points.
EQ-5D-5L will be assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. The patients answer 5 questions which have 5 possible answers from no issue to extreme issue. The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point. Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health. This is what is presented here, the lower the score the worse the quality of life.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of EQ-5D-5L Quality of Life
Baseline
|
0.781 EQ-5D index value
Standard Deviation 0.095
|
|
Assessment of EQ-5D-5L Quality of Life
Pre Cycle 2
|
0.829 EQ-5D index value
Standard Deviation 0.164
|
|
Assessment of EQ-5D-5L Quality of Life
Pre Cycle 3
|
0.767 EQ-5D index value
Standard Deviation 0.165
|
|
Assessment of EQ-5D-5L Quality of Life
Pre Cycle 4
|
0.784 EQ-5D index value
Standard Deviation 0.130
|
|
Assessment of EQ-5D-5L Quality of Life
End of treatment
|
0.781 EQ-5D index value
Standard Deviation 0.095
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for the quality of life. However, not all patients answered all questionnaires at all time points.
EQ-5D-5L VAS score was assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of EQ-5D-5L VAS Score
Pre-cycle 2
|
79.042 EQ-5D VAS score
Standard Deviation 15.061
|
|
Assessment of EQ-5D-5L VAS Score
Pre-cycle 4
|
76.739 EQ-5D VAS score
Standard Deviation 16.139
|
|
Assessment of EQ-5D-5L VAS Score
Baseline
|
87.87 EQ-5D VAS score
Standard Deviation 9.883
|
|
Assessment of EQ-5D-5L VAS Score
Pre-cycle 3
|
77.524 EQ-5D VAS score
Standard Deviation 13.537
|
|
Assessment of EQ-5D-5L VAS Score
End of treatment
|
82.684 EQ-5D VAS score
Standard Deviation 9.481
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points.
EORTC QLQ-C30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete 30 questions and a combined summary score between 0-100 is derived from their answers. The higher the score the better their quality of life.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of EORTC QLQ-C30 Score
Baseline
|
88.96 summary score
Standard Deviation 12.844
|
|
Assessment of EORTC QLQ-C30 Score
Pre-cycle 2
|
76.62 summary score
Standard Deviation 13.62
|
|
Assessment of EORTC QLQ-C30 Score
Pre-cycle 3
|
73.57 summary score
Standard Deviation 17.554
|
|
Assessment of EORTC QLQ-C30 Score
Pre-cycle 4
|
72.94 summary score
Standard Deviation 14.426
|
|
Assessment of EORTC QLQ-C30 Score
End of treatment
|
77.61 summary score
Standard Deviation 14.854
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points.
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined urinary questions is shown.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of BLM30 Urinary Score
Baseline
|
29.87 summary score
Standard Deviation 27.30
|
|
Assessment of BLM30 Urinary Score
Pre-cycle 2
|
27.71 summary score
Standard Deviation 21.73
|
|
Assessment of BLM30 Urinary Score
Pre-cycle 3
|
27.08 summary score
Standard Deviation 23.57
|
|
Assessment of BLM30 Urinary Score
Pre-cycle 4
|
32.08 summary score
Standard Deviation 30.94
|
|
Assessment of BLM30 Urinary Score
End of treatment
|
31.37 summary score
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points.
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined future perspectives questions is shown.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of BLM30 Future Perspectives Score
Baseline
|
35.35 summary score
Standard Deviation 18.98
|
|
Assessment of BLM30 Future Perspectives Score
Pre-cycle 2
|
32.22 summary score
Standard Deviation 25.97
|
|
Assessment of BLM30 Future Perspectives Score
Pre-cycle 3
|
32.68 summary score
Standard Deviation 26.49
|
|
Assessment of BLM30 Future Perspectives Score
Pre-cycle 4
|
44.97 summary score
Standard Deviation 29.08
|
|
Assessment of BLM30 Future Perspectives Score
End of treatment
|
17.51 summary score
Standard Deviation 41.67
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points.
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined bloating/flatulence questions is shown.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of BLM30 Bloating/Flatulence Score
Baseline
|
15.15 summary score
Standard Deviation 16.99
|
|
Assessment of BLM30 Bloating/Flatulence Score
Pre-cycle 2
|
30.83 summary score
Standard Deviation 24.35
|
|
Assessment of BLM30 Bloating/Flatulence Score
Pre-cycle 3
|
26.47 summary score
Standard Deviation 23.61
|
|
Assessment of BLM30 Bloating/Flatulence Score
Pre-cycle 4
|
27.78 summary score
Standard Deviation 28.55
|
|
Assessment of BLM30 Bloating/Flatulence Score
End of treatment
|
26.04 summary score
Standard Deviation 25.07
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points.
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined Body Image questions is shown.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of BLM30 Body Image Score
Baseline
|
6.06 summary score
Standard Deviation 11.74
|
|
Assessment of BLM30 Body Image Score
Pre-cycle 2
|
12.87 summary score
Standard Deviation 16.26
|
|
Assessment of BLM30 Body Image Score
Pre-cycle 3
|
16.34 summary score
Standard Deviation 24.87
|
|
Assessment of BLM30 Body Image Score
Pre-cycle 4
|
24.87 summary score
Standard Deviation 29.59
|
|
Assessment of BLM30 Body Image Score
End of treatment
|
18.06 summary score
Standard Deviation 22.18
|
SECONDARY outcome
Timeframe: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)Population: 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points.
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined sexual functioning questions is shown.
Outcome measures
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 Participants
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Assessment of BLM30 Sexual Function Score
Baseline
|
18.51 summary score
Standard Deviation 13.45
|
|
Assessment of BLM30 Sexual Function Score
Pre-cycle 2
|
19.32 summary score
Standard Deviation 18.71
|
|
Assessment of BLM30 Sexual Function Score
Pre-cycle 3
|
15.62 summary score
Standard Deviation 15.71
|
|
Assessment of BLM30 Sexual Function Score
Pre-cycle 4
|
15.93 summary score
Standard Deviation 18.86
|
|
Assessment of BLM30 Sexual Function Score
End of treatment
|
19.27 summary score
Standard Deviation 21.62
|
Adverse Events
Cabazitaxel + Cisplatin Chemotherapy
Serious adverse events
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 participants at risk
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • Number of events 1 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Gastrointestinal disorders
Enterovesicular fistula
|
3.7%
1/27 • Number of events 1 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Infections and infestations
Post-surgical infection
|
3.7%
1/27 • Number of events 1 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Renal and urinary disorders
Urinary tract infection
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
General disorders
Fever
|
3.7%
1/27 • Number of events 1 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration leading to low eGFR
|
3.7%
1/27 • Number of events 1 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.7%
1/27 • Number of events 1 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Infections and infestations
Sepsis - urinary
|
3.7%
1/27 • Number of events 1 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
Other adverse events
| Measure |
Cabazitaxel + Cisplatin Chemotherapy
n=27 participants at risk
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
|
|---|---|
|
General disorders
Fatigue
|
74.1%
20/27 • Number of events 29 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
14.8%
4/27 • Number of events 4 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
3/27 • Number of events 3 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Investigations
Hypomagnesemia
|
11.1%
3/27 • Number of events 3 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Investigations
Low creatinine clearance
|
18.5%
5/27 • Number of events 5 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
25.9%
7/27 • Number of events 7 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
9/27 • Number of events 12 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
3/27 • Number of events 4 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
55.6%
15/27 • Number of events 22 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Ear and labyrinth disorders
Tinnitis
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Gastrointestinal disorders
Vomitting
|
33.3%
9/27 • Number of events 9 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
3/27 • Number of events 3 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
44.4%
12/27 • Number of events 21 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
40.7%
11/27 • Number of events 12 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Number of events 4 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Nervous system disorders
Lethargy
|
14.8%
4/27 • Number of events 4 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
3/27 • Number of events 5 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
14.8%
4/27 • Number of events 4 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.5%
5/27 • Number of events 5 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
6/27 • Number of events 7 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
14.8%
4/27 • Number of events 4 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
3/27 • Number of events 3 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
|
Renal and urinary disorders
Urinary tract pain
|
7.4%
2/27 • Number of events 2 • Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
|
Additional Information
Prof Amit Bahl
University Hospitals Bristol and Weston NHS Foundation Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place