Linked Life Data

19282350

Source:http://linkedlifedata.com/resource/pubmed/id/19282350

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2009-3-27
pubmed:abstractText
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 cannot be recommended.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
1549-490X
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
14
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
284-90
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:19282350-Antibodies, Monoclonal, pubmed-meshheading:19282350-Antibodies, Monoclonal, Humanized, pubmed-meshheading:19282350-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:19282350-Camptothecin, pubmed-meshheading:19282350-Colorectal Neoplasms, pubmed-meshheading:19282350-Disease-Free Survival, pubmed-meshheading:19282350-Drug Approval, pubmed-meshheading:19282350-Female, pubmed-meshheading:19282350-Fluorouracil, pubmed-meshheading:19282350-Humans, pubmed-meshheading:19282350-Male, pubmed-meshheading:19282350-Middle Aged, pubmed-meshheading:19282350-Neoplasm Metastasis, pubmed-meshheading:19282350-Organoplatinum Compounds, pubmed-meshheading:19282350-Treatment Outcome, pubmed-meshheading:19282350-United States, pubmed-meshheading:19282350-United States Food and Drug Administration
pubmed:year
2009
pubmed:articleTitle
FDA review of a panitumumab (Vectibix) clinical trial for first-line treatment of metastatic colorectal cancer.
pubmed:affiliation
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA. ruthann.giusti@fda.hhs.gov
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Multicenter Study