WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS
Dermatologic Toxicity: Dermatologic toxicities occurred in 89% of patients and were severe (NCI-CTC grade 3 and higher) in 12% of patients receiving Vectibix monotherapy. [see Dosage and Administration, Warnings and Precautions , and Adverse Reactions].
Infusion Reactions: Severe infusion reactions occurred in approximately 1% of patients. [see Warnings and Precautions and Adverse Reactions ]. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. [see Dosage and Administration].
Vectibix (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR).
Vectibix is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival [see Clinical Studies]. Currently, no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Media Articles Related to Vectibix (Panitumumab)
Panitumumab With FOLFOX4 for Treatment of Metastatic CRC
Source: Medscape Headlines [2014.08.22]
It's 'prime time' for optimizing treatment for colorectal cancers. Find out why.
Annals of Oncology
FDA approves first non-invasive DNA screening test for colorectal cancer
Source: Colorectal Cancer News From Medical News Today [2014.08.13]
The U.S. Food and Drug Administration has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the...
New Colorectal Cancer Screening Test Approved
Source: MedicineNet Cancer Specialty [2014.08.13]
Title: New Colorectal Cancer Screening Test Approved
Category: Health News
Created: 8/12/2014 12:35:00 PM
Last Editorial Review: 8/13/2014 12:00:00 AM
Flexible sigmoidoscopy screening reduces colorectal cancer incidence and rate of death
Source: Colorectal Cancer News From Medical News Today [2014.08.12]
Among about 100,000 study participants, screening with flexible sigmoidoscopy resulted in a reduced incidence and rate of death of colorectal cancer, compared to no screening, according to a study...
Low uptake of colorectal cancer screening by African Americans revealed in a Veterans Affairs healthcare network
Source: Colorectal Cancer News From Medical News Today [2014.08.08]
According to researchers in California, African Americans' participation in colorectal cancer screening is low and the use of colonoscopy infrequent despite similar access to care across races in a...
Published Studies Related to Vectibix (Panitumumab)
Health-related quality of life and colorectal cancer-specific symptoms in patients with chemotherapy-refractory metastatic disease treated with panitumumab. [2011.02]
PURPOSE: Panitumumab monotherapy is approved for chemotherapy-refractory wild-type KRAS metastatic colorectal cancer (mCRC). Patient-reported outcomes-although important in the palliative setting-have not been reported in this patient population... CONCLUSIONS: Panitumumab-treated patients with wild-type KRAS mCRC maintained better control of CRC symptoms and quality of life compared with BSC alone, extending our understanding of the benefits of panitumumab treatment beyond improvements in progression-free survival.
Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. [2010.11.01]
PURPOSE: Panitumumab, a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS), is approved as monotherapy for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The Panitumumab Randomized Trial in Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy (PRIME) was designed to evaluate the efficacy and safety of panitumumab plus infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as initial treatment for mCRC... CONCLUSION: This study demonstrated that panitumumab-FOLFOX4 was well tolerated and significantly improved PFS in patients with WT KRAS tumors and underscores the importance of KRAS testing for patients with mCRC.
Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. [2010.11.01]
PURPOSE: Panitumumab is a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS) in chemotherapy-refractory metastatic colorectal cancer (mCRC). This trial evaluated the efficacy and safety of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone after failure of initial treatment for mCRC by tumor KRAS status... CONCLUSION: Panitumumab plus FOLFIRI significantly improved PFS and is well-tolerated as second-line treatment in patients with WT KRAS mCRC.
Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. [2010.03.10]
PURPOSE: Panitumumab, a fully human monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is approved in the United States and Europe for the treatment of refractory metastatic colorectal cancer (mCRC). Skin toxicities are the most common adverse events with EGFR inhibitors. This is the first study designed to examine differences between pre-emptive and reactive skin treatment for specific skin toxicities in patients with mCRC for any EGFR inhibitor... CONCLUSION: The pre-emptive skin treatment regimen was well tolerated. The incidence of specific >or= grade 2 skin toxicities during the 6-week skin treatment period was reduced by more than 50% in the pre-emptive group compared with the reactive group. Patients in the pre-emptive group reported less QOL impairment than patients in the reactive group.
Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. [2009.04.01]
BACKGROUND: The authors explored the association of skin toxicity (ST) severity as measured by patient-reported ST and Common Terminology Criteria for Adverse Events (CTCAE) grading with efficacy of panitumumab, a fully human antiepidermal growth factor receptor antibody, from a phase 3 metastatic colorectal cancer (CRC) trial... CONCLUSIONS: More severe ST, by both clinical grading and PRO, is associated with better CRC symptoms and HRQOL and with longer OS and PFS among panitumumab-treated patients. The associations for PFS were more pronounced in patients with WT KRAS tumors. (c) 2009 American Cancer Society
Clinical Trials Related to Vectibix (Panitumumab)
New Individualized Therapy Trial for Metastatic Colorectal Cancer [Recruiting]
The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in
combination with panitumumab for the treatment of stage IV colorectal cancer that has spread
to the liver. It will also assess the whether imatinib mesylate, either alone or in
combination with panitumumab, is effective in treating this type of cancer. In addition,
the study will evaluate the feasibility of a predefined lab score and whether it can predict
which patients will respond to treatment with imatinib mesylate.
Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer [Recruiting]
The purpose of this study is to investigate whether the addition of panitumumab to
radiotherapy plus gemcitabine will increase the number of patients who are alive and
progression free at 7 months.
Radio-chemotherapy With or Without Panitumumab (Vectibix�) in Irresectable Squamous Cell Carcinoma or Adenocarcinoma of the Oesophagus [Recruiting]
For esophageal cancer that can not be removed by surgery, the choice of treatment is a
combination of chemotherapy and radiotherapy. We call this combination- (or concurrent)
chemoradiotherapy. Chemotherapy is treatment with drugs that kill cancer cells. Both
chemotherapy and radiotherapy make the tumour smaller and enhance each other's effect. The
goal of treatment with chemotherapy and radiation therapy is to cure the cancer.
Unfortunately only a small proportion of patients are cured with this treatment.
Improvements in the outcome of treatment may be expected by using the so-called "targeted"
treatments. With esophageal cancer, a protein (the epidermal growth factor receptor (this is
a kind of trap), the EGFR), is present in many tumours. This protein causes the tumor to
grow. Panitumumab is a drug that blocks the functioning of this receptor (catcher), so that
possibly the growth and spread of esophageal cancer is prevented.
The main objective of this trial is to see if survival of patients with inoperable
esophageal cancer improves as panitumumab is added to standard treatment with
It will also investigate whether patients tolerate the addition of panitumumab to the
standard treatment. Also, the biological characteristics of the tumor will be examined. In a
proportion of patients it will be determined how the enhancement of the cancer is visible on
an FDG-PET scan before the start of treatment and how this changes during the treatment. It
will be also be evaluated how this treatment affects the survival.
Panitumumab and Irinotecan for Malignant Gliomas [Recruiting]
This is a phase II study of the combination of panitumumab with irinotecan in malignant
glioma patients. The primary objective of the study is to determine the activity of the
combination of panitumumab with irinotecan as measured by 6-month progression-free survival.
Secondary objectives include the following- to determine the safety of panitumumab in
combination with irinotecan in patients with malignant glioma; to determine the effect of
panitumumab in combination with irinotecan on corticosteroid dose for each patient; to
explore any relationship between epidermal growth factor receptor (EGF-R) mutational
analysis and efficacy or toxicity; and, to determine the response rate and overall survival
of recurrent glioblastoma (GBM) patients treated with panitumumab in combination with
The patients will have histologically documented grade 4 malignant gliomas (glioblastoma
multiforme or gliosarcoma) that have failed at least one prior chemotherapy regimen and all
patients will have received radiation therapy. This study will investigate second or greater
line of therapy for recurrent grade 4 malignant glioma. The patient population will include
The patients will undergo a baseline magnetic resonance imaging (MRI) as well as a MRI after
every six-week cycle to determine response and progression. After 16 patients with recurrent
GBM are treated, an interim analysis will be conducted. The most common side effects
associated with panitumumab have been dermatological (skin) problems such as erythema
(redness of the skin), acneiform rash (skin eruptions of the face), skin exfoliation,
pruritus (itching), skin fissures (skin tears), xerosis (dryness of the eye, skin, or
mouth), and rash. The most common side effects associated with irinotecan have been
decreased blood counts of platelets (increased risk of bleeding), white blood cells
(increased risk of infection), red blood cells (anemia); diarrhea, constipation, nausea,
vomiting, tiredness, fever, mouth sores, dehydration (excessive loss of body fluids), rash,
itching, changes in skin color, swelling, numbness, tingling, dizziness, confusion, low
blood pressure, sweating, hot flashes, hair loss, inflammation of the liver, flu-like
symptoms, decreased urine output, shortness of breath, and pneumonia (inflammatory disease
of the lungs).
Panitumumab (Vectibix�) in Cutaneous Squamous Cell Carcinoma (SCC) [Recruiting]
Squamous Cell Carcinoma (SCC) is one of the most common malignancies in caucasian
population. The effect of the immune system on the development of skin tumors has been
demonstrated in transplant patients taking immunosuppressive agents (65 fold risk increase).
It has been reported that activation of EGFR and RAS signaling pathways play an important
role in disease progression maybe through downregulation of the immune system.
The investigators want to treat unresectable SCC patients with an antibody against EGFR
(Vectibix®, panitumumab). This antibody induces tumor regression in metastatic colorectal
cancer and has been approved as single agent for this indication.
The investigators want to measure the response rate but also analyze the modification of
expression profile of some key proteins involved or supposed to be involved in the signaling
pathways of EGFR and in the regulation of the immune system. Chemokines such as CCL27 have
been shown to play a critical role in the skin-associated immune response by regulating T
cell homing. Pivarcsi et al have reported that downregulation of CCL27 is mediated by
activation of EGFR/RAS/MAPK signaling pathways.
Reports of Suspected Vectibix (Panitumumab) Side Effects
Disease Progression (12),
Skin Toxicity (10),
Skin Reaction (8),
DRY Skin (8),
Pulmonary Embolism (7),
Eczema (7), more >>
Page last updated: 2014-08-22