Trial Outcomes & Findings for Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors (NCT NCT01177007)
NCT ID: NCT01177007
Last Updated: 2017-08-28
Results Overview
This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.
Results posted on
2017-08-28
Participant Flow
This study enrolled patients diagnosed with unresectable hepatic metastases who have failed or were intolerant to at least one line of systemic chemotherapy or liver-directed therapy. Participants were enrolled at Johns Hopkins Hospital with the last patient completed in April 2015.
Participant milestones
| Measure |
TheraSphere
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Completed First Y90 Treatment
|
50
|
|
Overall Study
Completed First Clinical and Imaging
|
43
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
TheraSphere
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
4
|
|
Overall Study
Entered hospice care
|
5
|
|
Overall Study
Required additional Y90 treatment
|
6
|
|
Overall Study
Change in treatment modality
|
21
|
Baseline Characteristics
Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors
Baseline characteristics by cohort
| Measure |
TheraSphere
n=50 Participants
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
|
|---|---|
|
Age, Continuous
|
59.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.Population: These data were not collected. See outcome measure #2.
This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 yearsPopulation: Median PFS for all subjects and stratified based on disease type.
Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9.
Outcome measures
| Measure |
TheraSphere
n=50 Participants
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
|
|---|---|
|
Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria
Median PFS for all disease types
|
10.3 months
Interval 7.6 to 13.0
|
|
Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria
Median PFS for CRC
|
22.0 months
Interval 0.0 to 45.6
|
|
Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria
Median PFS for NE
|
9.5 months
Interval 2.4 to 16.6
|
|
Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria
Median PFS for non-CRC/non-NE
|
15.8 months
Interval 2.8 to 28.7
|
SECONDARY outcome
Timeframe: Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.Population: Analysis for TTP was not performed. In lieu of TTP, the PFS based on RECIST and EASL criteria was analyzed.
This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12).
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, at 4 weeks post treatment, and subsequent 3 month intervals. Complete Response (CR): Disappearance of all lesions targeted by Y90 Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by Y90 Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by Y90 Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Outcome measures
| Measure |
TheraSphere
n=43 Participants
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
|
|---|---|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
All disease types · Complete Response (CR)
|
11 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
All disease types · Partial Response (PR)
|
9 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Colorectal cancer only · Partial Response (PR)
|
3 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Colorectal cancer only · Stable Disease (SD)
|
2 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Colorectal cancer only · Progressive Disease (PD)
|
3 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Neuroendocrine only · Complete Response (CR)
|
7 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Neuroendocrine only · Stable Disease (SD)
|
6 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Neuroendocrine only · Progressive Disease (PD)
|
5 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Non-CRC/Non-NE · Complete Response (CR)
|
3 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Non-CRC/Non-NE · Partial Response (PR)
|
2 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
All disease types · Stable Disease (SD)
|
11 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
All disease types · Progressive Disease (PD)
|
12 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Colorectal cancer only · Complete Response (CR)
|
1 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Neuroendocrine only · Partial Response (PR)
|
4 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Non-CRC/Non-NE · Stable Disease (SD)
|
3 Participants
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
Non-CRC/Non-NE · Progressive Disease (PD)
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12). 7 out of the 50 patients were not analyzed due to lack of follow-up imaging.
Efficacy as assessed by radiographic tumor response using EASL criteria at baseline up to 12 months post treatment. Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.
Outcome measures
| Measure |
TheraSphere
n=43 Participants
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
|
|---|---|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
All disease types · Stable Disease (SD)
|
10 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
All disease types · Progressive Disease (PD)
|
13 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Colorectal cancer only · Complete Response (CR)
|
1 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Colorectal cancer only · Partial Response (PR)
|
2 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Colorectal cancer only · Stable Disease (SD)
|
3 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Colorectal cancer only · Progressive Disease (PD)
|
3 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Neuroendocrine only · Complete Response (CR)
|
7 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Neuroendocrine only · Partial Response (PR)
|
5 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Neuroendocrine only · Stable Disease (SD)
|
4 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Neuroendocrine only · Progressive Disease (PD)
|
6 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Non-CRC/Non-NE · Complete Response (CR)
|
3 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Non-CRC/Non-NE · Partial Response (PR)
|
2 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Non-CRC/Non-NE · Stable Disease (SD)
|
3 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
All disease types · Complete Response (CR)
|
11 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
All disease types · Partial Response (PR)
|
9 Participants
|
|
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Non-CRC/Non-NE · Progressive Disease (PD)
|
4 Participants
|
SECONDARY outcome
Timeframe: Median follow-up time was 11.41 months (CI: 1.5-33.7)Population: Median OS for all patients (n=50) were analyzed and also stratified based on disease type: CRC (n=12); NE (n=26); and non-CRC/non-NE (n=12).
Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type.
Outcome measures
| Measure |
TheraSphere
n=50 Participants
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
|
|---|---|
|
Overall Survival (OS)
Median OS for all disease types
|
11.7 months
Interval 10.6 to 12.8
|
|
Overall Survival (OS)
Median OS for CRC
|
11.9 months
Interval 10.9 to 12.8
|
|
Overall Survival (OS)
Median OS for NE
|
7.6 months
Interval 0.0 to 15.9
|
|
Overall Survival (OS)
Median OS for non-CRC/non-NE
|
15.8 months
Interval 10.9 to 20.9
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 2-year OS rate for all patients (n=50) were analyzed and also stratified based on tumor burden: Patients with tumor burden of 25% or less (n=34) and patients with tumor burden greater than 25% (n=16).
Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". At the time of results reporting, this outcome was presented as "Up to 2 years". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. 2-year OS rates were also stratified based on tumor burden.
Outcome measures
| Measure |
TheraSphere
n=50 Participants
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
|
|---|---|
|
Overall Survival (OS) Rate at 2 Years
OS rate for tumor burden 25% or less
|
36 percentage of participants
|
|
Overall Survival (OS) Rate at 2 Years
OS rate for all patients
|
22 percentage of participants
|
|
Overall Survival (OS) Rate at 2 Years
OS rate for tumor burden greater than 25%
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 50 participants were assessed for adverse events, with a total of 207 adverse events reported. Two patients had grade 5 toxicities (grade 5 cholecystitis and death), which were attributed to disease progression and were not device-related.
Clinical and biochemical toxicity that were assessed as at least possibly related to treatment were recorded from the day of treatment until protocol exit or death. Toxicities were graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Outcome measures
| Measure |
TheraSphere
n=207 Adverse Events
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
|
|---|---|
|
Safety as Graded by CTCAE Version 3.0
Elevated alkaline phosphatase
|
21 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Elevated ALT
|
13 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Elevated AST
|
11 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Lymphocyte depression (asymptomatic)
|
23 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Fatigue
|
33 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Fever
|
8 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Nausea
|
19 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Heartburn
|
6 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Vomiting
|
6 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Pain
|
23 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Decreased albumin
|
4 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Elevated bilirubin
|
3 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Anorexia
|
11 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Weight loss
|
13 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Constipation
|
7 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Muscle pain
|
1 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Cholecystitis
|
1 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Death (disease progression)
|
1 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Allergic reaction (contrast media)
|
1 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Thrombosis/embolism (vascular access)
|
1 adverse events
|
|
Safety as Graded by CTCAE Version 3.0
Liver failure
|
1 adverse events
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Mean radiation doses were calculated for the total cohort of participants and also stratified according to disease type - colorectal cancer, neuroendocrine, and non-CRC/non-NE.
Therasphere dose calculation was performed using positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography (SPECT) imaging post-procedure to estimate the actual delivered dose of Theraspheres to the liver.
Outcome measures
| Measure |
TheraSphere
n=50 Participants
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
|
|---|---|
|
Mean Radiation Dose Delivered to Total Liver
Mean radiation dose for all patients
|
112.13 Gray
Standard Deviation 13.56
|
|
Mean Radiation Dose Delivered to Total Liver
Mean dosing for CRC
|
115.57 Gray
Standard Deviation 10.97
|
|
Mean Radiation Dose Delivered to Total Liver
Mean dosing for NE
|
109.41 Gray
Standard Deviation 13.08
|
|
Mean Radiation Dose Delivered to Total Liver
Mean dosing for non-CRC/non-NE
|
115.18 Gray
Standard Deviation 16.37
|
Adverse Events
TheraSphere
Serious events: 14 serious events
Other events: 48 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
TheraSphere
n=50 participants at risk
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
|
|---|---|
|
General disorders
Death (disease progression)
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Brain surgery for metastatic disease
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Investigations
Failure to thrive
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Hematemesis
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac infarction
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Investigations
Acetaminophen overdose
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Liver failure
|
2.0%
1/50 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
TheraSphere
n=50 participants at risk
TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
|
|---|---|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
12.0%
6/50 • Number of events 6 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
38.0%
19/50 • Number of events 21 • 12 months
|
|
General disorders
Edema: trunk
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Investigations
Lymphopenia
|
70.0%
35/50 • Number of events 54 • 12 months
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Investigations
Neutropenia
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Investigations
Elevated AST
|
50.0%
25/50 • Number of events 31 • 12 months
|
|
Investigations
Elevated ALT
|
30.0%
15/50 • Number of events 16 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
22.0%
11/50 • Number of events 12 • 12 months
|
|
Gastrointestinal disorders
Acid reflux
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Edema limbs
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
42.0%
21/50 • Number of events 23 • 12 months
|
|
Gastrointestinal disorders
Anal fissure
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.0%
11/50 • Number of events 13 • 12 months
|
|
Investigations
Elevated alkaline phosphatase
|
58.0%
29/50 • Number of events 32 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Nervous system disorders
Aphasia
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
5/50 • Number of events 6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Gingivitis
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Hematochezia
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Eye disorders
Blurred vision
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
10/50 • Number of events 17 • 12 months
|
|
Nervous system disorders
Confusion
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
9/50 • Number of events 10 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
12/50 • Number of events 15 • 12 months
|
|
Nervous system disorders
Depression
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.0%
8/50 • Number of events 10 • 12 months
|
|
General disorders
Fatigue
|
70.0%
35/50 • Number of events 49 • 12 months
|
|
General disorders
Fever
|
24.0%
12/50 • Number of events 14 • 12 months
|
|
Investigations
Hyperbilirubinemia
|
20.0%
10/50 • Number of events 11 • 12 months
|
|
Investigations
Elevated INR
|
10.0%
5/50 • Number of events 5 • 12 months
|
|
Nervous system disorders
Concentration impairment
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
52.0%
26/50 • Number of events 37 • 12 months
|
|
Nervous system disorders
Neuropathy
|
12.0%
6/50 • Number of events 7 • 12 months
|
|
Nervous system disorders
Headache
|
16.0%
8/50 • Number of events 11 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.0%
7/50 • Number of events 7 • 12 months
|
|
Investigations
Leukopenia
|
28.0%
14/50 • Number of events 17 • 12 months
|
|
Vascular disorders
Night sweat
|
16.0%
8/50 • Number of events 12 • 12 months
|
|
Investigations
Thrombocytopenia
|
18.0%
9/50 • Number of events 10 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
11/50 • Number of events 11 • 12 months
|
|
Investigations
Elevated creatinine
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Investigations
Weight gain
|
14.0%
7/50 • Number of events 9 • 12 months
|
|
Investigations
Weight loss
|
28.0%
14/50 • Number of events 18 • 12 months
|
|
General disorders
Chills
|
16.0%
8/50 • Number of events 8 • 12 months
|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Flushing
|
10.0%
5/50 • Number of events 5 • 12 months
|
|
Renal and urinary disorders
Urinary frequency
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Investigations
Hypercalcemia
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Investigations
Hyperglycemia
|
34.0%
17/50 • Number of events 23 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.0%
7/50 • Number of events 7 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Insomnia
|
22.0%
11/50 • Number of events 11 • 12 months
|
|
General disorders
Pain - general
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
General disorders
Pain - site of incision
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
General disorders
Chest pain - non-cardiac
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.0%
4/50 • Number of events 6 • 12 months
|
|
Gastrointestinal disorders
Pain - stomach
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
Nervous system disorders
Somnolence
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
General disorders
Edema face
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Lower extremity edema
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Nervous system disorders
Presyncope
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Eye disorders
Visual changes
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Vascular disorders
Hot flash
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Dysgeusia
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Number of events 2 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place