Advanced or Recurrent Colorectal Cancer
Conditions
Brief summary
The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied. Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.
Detailed description
The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied. Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients. The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient's condition.
Interventions
DRUGPanitumumab
Panitumumab for intravenous infusion
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Exclusion criteria
* Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | Baseline through Week 42 | The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Up to Week 42 or death (whichever occurred first) | Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. |
| Overall Survival | Up to Week 42 or death (whichever occurred first) | Overall survival was defined as the time to death from the start of panitumumab administration was tabulated. |
Participant flow
Recruitment details
Participants enrolled during the period from June 1, 2010 to November 14, 2010 were surveyed.
Pre-assignment details
Surveyed participants had a clinical diagnosis of wild-type KRAS unresectable advanced/recurrent colorectal cancer.
Participants by arm
| Arm | Count |
|---|---|
| Panitumumab Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks | 3,085 |
| Total | 3,085 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not treated | 1 |
| Overall Study | Survey form not completed | 5 |
Baseline characteristics
| Characteristic | Panitumumab |
|---|---|
| Age, Customized < 75 years | 2582 Participants |
| Age, Customized >= 75 years | 503 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:0 | 1877 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:1 | 942 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:2 | 241 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:3 | 22 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:4 | 3 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline Unknown | 0 Participants |
| KRAS genotype Mutant | 3 Participants |
| KRAS genotype Non-measurable/non-assessable | 78 Participants |
| KRAS genotype Not determined | 1 Participants |
| KRAS genotype Unknown | 0 Participants |
| KRAS genotype Wild type | 3003 Participants |
| Metastatic lesions/sites of relapse No | 38 Participants |
| Metastatic lesions/sites of relapse Unknown | 1 Participants |
| Metastatic lesions/sites of relapse Yes | 3046 Participants |
| Race/Ethnicity, Customized Asian | 3085 Participants |
| Region of Enrollment Japan | 3085 Participants |
| Sex: Female, Male Female | 1120 Participants |
| Sex: Female, Male Male | 1965 Participants |
| Treatment stage (excluding posteroperative adjuvant chemotherapy) First-line | 310 Participants |
| Treatment stage (excluding posteroperative adjuvant chemotherapy) Second-line | 543 Participants |
| Treatment stage (excluding posteroperative adjuvant chemotherapy) Third-line or later | 2232 Participants |
| Treatment stage (excluding posteroperative adjuvant chemotherapy) Unknown | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 640 / 1,254 | 1,084 / 1,831 |
| serious Total, serious adverse events | 614 / 1,254 | 747 / 1,831 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions
The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
Time frame: Baseline through Week 42
Population: Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panitumumab | Number of Participants With Adverse Drug Reactions | MedDRA SOC: Cardiac disorders | 7 Participants |
| Panitumumab | Number of Participants With Adverse Drug Reactions | Frequency of adverse drug reactions | 2595 Participants |
| Panitumumab | Number of Participants With Adverse Drug Reactions | MedDRA SOC: Skin and subcutaneous tissue disorders | 2364 Participants |
| Panitumumab | Number of Participants With Adverse Drug Reactions | MedDRA SOC: Infections and infestations | 771 Participants |
| Panitumumab | Number of Participants With Adverse Drug Reactions | MedDRA SOC: Gastrointestinal disorders | 642 Participants |
| Panitumumab | Number of Participants With Adverse Drug Reactions | MedDRA SOC: Metabolism and nutrition disorders | 552 Participants |
Secondary
Overall Survival
Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.
Time frame: Up to Week 42 or death (whichever occurred first)
Population: All participants that received panitumumab monotherapy as a third-line or later therapy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panitumumab | Overall Survival | 41 weeks |
Secondary
Progression-free Survival
Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Time frame: Up to Week 42 or death (whichever occurred first)
Population: Participants who were included in the efficacy analysis set and received panitumumab monotherapy as a third-line or later therapy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panitumumab | Progression-free Survival | 3.5 Months |