Gastrointestinal Stromal Tumors
Conditions
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.
Interventions
DRUGSUNITINIB MALATE
SUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated. The dosage may be decreased according to the patient's clinical condition.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.
Exclusion criteria
Patients not administered SUNITINIB MALATE(Sutent).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | MAX 2 Years | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI). |
| Number of Participants With Treatment-Related Adverse Events | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rates by c-Kit Mutation Status | MAX 2 Years | Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs. |
| Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | MAX 2 Years | Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs. |
| Number of Participants With Treatment-Related Adverse Events in Elderly Population | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older. |
| Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up. |
| Objective Response Rates by KIT Expression Status | MAX 2 Years | Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs. |
| Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors. |
| Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks. |
| Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | MAX 2 Years | The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). |
| Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Serious Adverse Events | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). |
| Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE) | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event. |
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Malate Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert. | 472 |
| Total | 472 |
Baseline characteristics
| Characteristic | Sunitinib Malate |
|---|---|
| Age, Customized >=15 and <65 years | 238 Participants |
| Age, Customized <15 years | 0 Participants |
| Age, Customized ˃=65 years | 227 Participants |
| Age, Customized Unknown | 7 Participants |
| Sex: Female, Male Female | 175 Participants |
| Sex: Female, Male Male | 297 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 429 / 472 |
| serious Total, serious adverse events | 259 / 472 |
Outcome results
Primary
Number of Participants With Treatment-Related Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events | 450 Participants |
Primary
Objective Response Rate
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Time frame: MAX 2 Years
Population: Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Objective Response Rate | 20.1 Percentage of participants |
Secondary
Number of Participants With Treatment-Related Adverse Events in Elderly Population
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events in Elderly Population | 220 Participants |
| KIT Negative | Number of Participants With Treatment-Related Adverse Events in Elderly Population | 226 Participants |
| Unknown | Number of Participants With Treatment-Related Adverse Events in Elderly Population | 4 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment | 52 Participants |
| KIT Negative | Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment | 394 Participants |
| Unknown | Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment | 4 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment | 47 Participants |
| KIT Negative | Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment | 400 Participants |
| Unknown | Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment | 3 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors | 12 Participants |
| KIT Negative | Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors | 12 Participants |
| Unknown | Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors | 426 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment | 3 Participants |
Secondary
Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation
The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Lung disorder | 1 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Bone marrow depression | 386 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Haemorrhage | 106 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Cardiac function disturbance | 29 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Dysfunction adrenal | 1 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Pancreatic dysfunction | 53 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Thyroid function decreased | 142 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Cutaneous symptoms (hand and foot syndrome) | 223 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Serious infections | 20 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | Rhabdomyolysis, myopathy | 17 Participants |
| Sunitinib Malate | Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation | RPLS | 4 Participants |
Secondary
Objective Response Rates by c-Kit Mutation Status
Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.
Time frame: MAX 2 Years
Population: Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Objective Response Rates by c-Kit Mutation Status | 22.1 Percentage of participants |
| KIT Negative | Objective Response Rates by c-Kit Mutation Status | 20.0 Percentage of participants |
| Unknown | Objective Response Rates by c-Kit Mutation Status | 19.5 Percentage of participants |
Secondary
Objective Response Rates by KIT Expression Status
Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.
Time frame: MAX 2 Years
Population: Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Objective Response Rates by KIT Expression Status | 21.2 Percentage of participants |
| KIT Negative | Objective Response Rates by KIT Expression Status | 12.5 Percentage of participants |
| Unknown | Objective Response Rates by KIT Expression Status | 11.9 Percentage of participants |
Secondary
Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status
Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.
Time frame: MAX 2 Years
Population: Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | 20.0 Percentage of participants |
| KIT Negative | Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | 27.8 Percentage of participants |
| Unknown | Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | 19.3 Percentage of participants |
Other Pre-specified
Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE) | 334 Participants |
Other Pre-specified
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 98 Participants |
Other Pre-specified
Number of Participants With Treatment-Related Serious Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time frame: MAX 2 Years
Population: Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Participants With Treatment-Related Serious Adverse Events | 201 Participants |