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.
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.
Study Type
OBSERVATIONAL
Enrollment
3,091
Panitumumab for intravenous infusion
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
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)
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)
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