Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene (All-patient Surveillance)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vectibix for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene (All-patient Surveillance)

Conditions
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Advanced or Recurrent Colorectal Cancer

Intervention / Treatment
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* Drug: Panitumumab


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Panitumumab 6 mg/kg<br>Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks | Drug: Panitumumab<br>* Panitumumab for intravenous infusion<br>* Other names: Vectibix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Week 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Week 42 or death (whichever occurred first) | 
| Overall Survival | Overall survival was defined as the time to death from the start of panitumumab administration was tabulated. | Up to Week 42 or death (whichever occurred first) |