39559
document
FDA review of a panitumumab ( Vectibix ) clinical trial for first-line treatment of metastatic colorectal cancer . On September 27 , 2006 , the U.S. Food and Drug Administration granted accelerated approval to panitumumab ( Vectibix ; Amgen , Inc. , Thousand Oaks , CA ) for the treatment of patients with epidermal growth factor receptor-expressing , metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine- , oxaliplatin- , and irinotecan-containing chemotherapy regimens . Accelerated approval was based on demonstration of a beneficial effect on progression-free survival ( PFS ) . The present submission summarizes a second clinical trial , to be included in the panitumumab package insert in June 2008 , of chemotherapy and bevacizumab with and without panitumumab in the first-line treatment of patients with metastatic colorectal cancer . The study was closed when inferior PFS and greater toxicity were demonstrated at the time of the planned interim efficacy analysis . Patients receiving panitumumab in combination with bevacizumab and chemotherapy experienced a higher incidence of death ( 9 % versus 4 % ) and a higher risk for grade 3 and 4 toxicities than patients receiving bevacizumab and chemotherapy alone . The incidences of any Common Terminology Criteria for Adverse Events grade 3 and 4 adverse events ( AEs ) were 87 % and 72 % in the panitumumab and control groups , respectively . Grade 3 and 4 AEs occurring more commonly in panitumumab-treated patients included rash/acneiform dermatitis , diarrhea , dehydration , primarily resulting from diarrhea , hypokalemia , stomatitis/mucositis , and pulmonary embolism . The addition of panitumumab to bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer was harmful when compared with bevacizumab and chemotherapy alone . The use of panitumumab in this setting can not be recommended .
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Intervention_Pharmacological
panitumumab ( Vectibix )
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Intervention_Pharmacological
panitumumab ( Vectibix ;
39562
Intervention_Pharmacological
fluoropyrimidine-
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Intervention_Pharmacological
irinotecan-containing chemotherapy regimens
39564
Intervention_Pharmacological
panitumumab
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Intervention_Pharmacological
chemotherapy
39566
Intervention_Pharmacological
bevacizumab with and without panitumumab
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Intervention_Pharmacological
panitumumab
39568
Intervention_Pharmacological
bevacizumab and chemotherapy
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Intervention_Pharmacological
bevacizumab
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Intervention_Pharmacological
chemotherapy
39571
Intervention_Pharmacological
panitumumab
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Intervention_Pharmacological
panitumumab-treated
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Intervention_Pharmacological
panitumumab to bevacizumab and chemotherapy
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Intervention_Pharmacological
bevacizumab and chemotherapy alone
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Intervention_Pharmacological
panitumumab
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Outcome_Mortality
death
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Outcome_Other
grade 3 and 4 toxicities
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Outcome_Adverse-effects
Common Terminology Criteria for Adverse Events grade 3 and 4 adverse events ( AEs )
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Outcome_Adverse-effects
Grade 3 and 4 AEs
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Outcome_Adverse-effects
rash/acneiform dermatitis
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Outcome_Adverse-effects
diarrhea
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Outcome_Adverse-effects
dehydration
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Outcome_Adverse-effects
diarrhea
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Outcome_Adverse-effects
hypokalemia
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Outcome_Adverse-effects
stomatitis/mucositis
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Outcome_Adverse-effects
pulmonary embolism
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Participant_Condition
colorectal cancer
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Participant_Condition
patients with epidermal growth factor receptor-expressing , metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine- , oxaliplatin- , and irinotecan-containing chemotherapy regimens
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Participant_Condition
metastatic colorectal cancer
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Participant_Condition
colorectal cancer