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Association details:
| Biomarker: | EGFR expression |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Erbitux (cetuximab) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
11/10/2020
Excerpt:
ERBITUX® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of:...Colorectal Cancer: K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test...in combination with FOLFIRI for first-line treatment…in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy… as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
Secondary therapy:
irinotecan
Test:
Source:
Published date:
11/10/2020
Excerpt:
ERBITUX® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of:...Colorectal Cancer: K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test...in combination with FOLFIRI for first-line treatment…in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy… as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
Secondary therapy:
FOLFIRI
Test:
Source:
Excerpt:
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:..in combination with irinotecan-based chemotherapy…in first-line in combination with FOLFOX…as a single agent in patients who have failed oxaliplatin- and irinotecan-basirinotecaned therapy and who are intolerant to irinotecan.
Secondary therapy:
irinotecan
Source:
Excerpt:
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:..in combination with irinotecan-based chemotherapy…in first-line in combination with FOLFOX…as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
Secondary therapy:
FOLFOX
Source:
Title:
Cetuximab for the treatment of colorectal cancer
Excerpt:
...572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR ...cetuximab treatment was associated with a significant improvement in overall survival (hazard ratio for death, 0.77; 95% confidence interval [CI], 0.64 to 0.92; P=0.005) and in progression-free survival (hazard ratio for disease progression or death, 0.68; 95% CI, 0.57 to 0.80; P<0.001)...The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone. Partial responses occurred in 23 patients (8.0%) in the cetuximab group but in none in the group assigned to supportive care alone (P<0.001); the disease was stable in an additional 31.4% of patients assigned to cetuximab and in 10.9% of patients assigned to supportive care alone (P<0.001).
DOI:
10.1056/NEJMoa071834
Trial ID:
Source:
Title:
FOLFOX 4 + CETUXIMAB IN UNTREATED PATIENTS WITH ADVANCED COLO-RECTAL TUMOUR. A PHASE II MULTICENTER STUDY OF THE GRUPPO ONCOLOGICO DELL'ITALIA MERIDIONALE
Excerpt:
...IMMUNOHISTOCHEMICAL EVIDENCE OF EGFR EXPRESSION IN THE PRIMITIVE TUMOUR AND/OR IN A METASTASIS AT LEAST 3. ...
Trial ID:
Source:
Title:
Biomarks of Resistance to Cetuximab in Colorectal Cancer
Excerpt:
...KRAS gene sequence - KRAS gene sequence; NRAS gene sequence - NRAS gene sequence; BRAF gene sequence - BRAF gene sequence; PIK3CA gene sequence - PIK3CA gene sequence; EGFR gene sequence - EGFR gene sequence; EGFR gene copy numbers - EGFR gene copy numbers; EGFR expression - EGFR expression; Her2 expression - Her2 expression; c-Met expression - c-Met expression; PTEN expression - PTEN expression; Progression-free survival - Progression-free survival; Overall survival - Overall survival; Rash - Rash; Diarrhea - Diarrhea; vomiting - vomiting; White blood cell count - White blood cell count; Platelet count - Platelet count; Hemoglobin - Hemoglobin; Red blood cell count - Red blood cell count...
Trial ID:
More C2 evidence
Source:
Title:
A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment
Excerpt:
...- EGFR expressing, KRAS wild-type subjects with metastatic colorectal cancer, who are indicated for Erbitux treatment according to the nationally authorized label (in combination with irinotecan, metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy)...
Trial ID:
Source:
Title:
An Observational Study of Erbitux® in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment
Excerpt:
...- Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux (i.e. in EGFR expressing, KRAS wild-type metastatic colorectal adenocarcinoma)....
Trial ID:
Source:
Title:
The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.
Excerpt:
...Confirmation of EGFR-Expression in the tumor4. ...
Trial ID:
Source:
Title:
A randomized, controlled, multicenter, phase I/II study of cetuximab plus irinotecan investigating the pharmacodynamics, genomics and -genetics as well as the safety and efficacy of a dose escalation schedule of cetuximab compared with the standard fixed dosing regimen in patients with irinotecan-resistant EGFR expressing metastatic colorectal cancer.
Excerpt:
...Immunohistochemical evidence of EGFR expression prior to study entry in primary tumor and/or at least one metastasis. ...
Trial ID:
Source:
Title:
Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
Excerpt:
...- Subjects for whom tumor tissue is available for IHC ( Immunohistochemistry) testing for EGFR expression....
Trial ID:
Source:
Title:
First Line UFT, OXALIPLATIN and ERBITUX combination (TEGAFOX-E) in Elderly (≥ 70 years) metastatic colorectal patients: a Phase II ITMO study.
Excerpt:
...Immunohistochemistry expression of EGFR on the primary tumor cells is not mandatory for patients` enrollement. ...
Trial ID:
Source:
Title:
Open-label, phase II, multicentre study on cetuximab treatment asfirst-line monotherapy in elderly patients with metastatic colorectalcancer expressing EGFR
Excerpt:
...·Non-resectable and/or non-operable metastatic colorectal carcinoma.·Presence of at least one lesion by two-dimensional measurement; index lesions should not be in a region with previous irradiation.·EGFR expression in the primary tumour and/or at least one of the metastases demonstrated by immunohistochemical analysis prior to study.·Karnofsky functional status > 70% at the time of enrollment in the study.·Life expectancy greater than 3 months.·Patients will not have received chemotherapy for advanced/metastatic disease. ...
Trial ID:
Source:
Title:
Open, randomized, controlled, multicenter phase II study comparing 5-FU/FA plus oxaliplatin (FOLFOX 4) plus cetuximab versus 5-FU/FA plus oxaliplatin as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer
Excerpt:
...· Signed written informed consents (first and second)· Inpatient or outpatient ≥18 years of age· Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum· 1st occurrence of metastatic disease (not curatively resectable)· Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue· Life expectancy of at least 12 weeks· Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)· ECOG performance status of ≤ 2 at study entry· Effective contraception for both male and female subjects if the risk of conception exists· White blood cell count (WBC) ≥ 3x109/L with neutrophils ≥1.5x109/L, platelet count > 100x109/L, hemoglobin ≥ 6.21 mmol/L (10 g/dL)· ASAT and ALAT ≤ 2.5 x upper reference range, or ≤ 5 x upper reference range in case of liver metastasis· Serum creatinine ≤ 1.5 x upper reference range· Recovery from relevant toxicity to previous treatment before study entry`...
Trial ID:
Source:
Title:
Open, randomized, controlled, multicenter study comparing 5-FU/FA plus irinotecan plus cetuximab versus 5-FU/FA plus irinotecan in metastaic colorectal cancer as first-line treatment.
Excerpt:
...Inpatient or outpatient ≥18 years of ageDiagnosis of histologically confirmed adenocarcinoma of the colon or rectum1st occurrence of metastatic disease (not curatively resectable)Immunohistochemical evidence of epidermal growth factor receptor Expression in tumor tissueLife expectancy of at least 12 weeksPresence of at least 1 bi-dimensionally measurable index lesion (not lie in an irradiated area)ECOG performance status of ≤2 at study entry Effective contraception for both male and female patients if the risk of conception existsWhite blood cell count ≥3 x 10E9/L with neutrophils ≥1.5 x 10E9/L, platelet count ≥100 x 10E9/L, hemoglobin ≥5.6 mmol/L (9 g/dL)Total bilirubin ≤1.5 x upper reference range· AST ≤2.5 x upper reference range, or ≤5 x upper reference range in case of liver metastasis· Serum creatinine ≤1.5 x upper reference range· Recovery from relevant toxicity to previous treatment before study entry.`...
Trial ID:
Source:
Title:
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
Excerpt:
...- Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit...
Trial ID:
Source:
Title:
A Phase 1b Study of WU-NK-101 in Combination With Cetuximab
Excerpt:
...Patients may be included in this study regardless of mutation status (e.g., RAS-mutant, wild-type, or unknown status, BRAF V600E, etc.) and EGFR expression....
Trial ID:
Source:
Title:
Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4
Excerpt:
...Stage IV (AJCC 7th Edition, TMN Staging, Appendix C) NSCLC expressing EGFR (IHC tested) 3....
Trial ID:
Source:
Title:
BAY 43-9006 Plus Cetuximab to Treat Colorectal Cancer
Excerpt:
...- Tumor should express epidermal growth factor receptor (EGFR), defined as any membrane staining for EGFR in tumor cells by immunohistochemistry (IHC) done on archival tumor blocks or slides....
Trial ID:
Source:
Title:
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Excerpt:
...- Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue...
Trial ID:
Source:
Title:
Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favorable FcγRIIa (CD32) Genotype
Excerpt:
...- Epidermal growth factor receptor (EGFR) expression in his/her tumor sample...
Trial ID:
Source:
Title:
A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment
Excerpt:
...- Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux ( i.e. in EGFR expressing, KRAS wild-type mCRC subjects in combination with chemotherapy, or as a single agent in subjects who failed oxaliplatin and irinotecan based therapy and who are intolerant to irinotecan)...
Trial ID:
Source:
Title:
FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema
Excerpt:
...- Confirmation of EGFR-Expression in the tumor...
Trial ID:
Source:
Title:
Cetuximab Plus Combination Chemotherapy in Treating Patients With Stage IV Colorectal Cancer
Excerpt:
...Histologically confirmed stage IV colorectal cancer Any T, any N, M1 Immunohistochemical evidence of epidermal growth factor receptor expression (at least 1+) Bidimensionally measurable metastatic disease Meningeal or CNS involvement by tumor allowed...
Trial ID:
Source:
Title:
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
Excerpt:
...With evidence of tumor EGFR expression and KRAS gene wild-type status; 5....
Trial ID:
Source:
Title:
Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy
Excerpt:
...- Immunohistochemical evidence of an absence of EGFR expression, (ie, EGFR-negative)....
Trial ID:
Source:
Title:
Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma
Excerpt:
...- Immunohistochemical evidence of EGFr expression....
Trial ID:
Source:
Title:
Cetuximab in Treating Patients With Stage IV Colorectal Cancer
Excerpt:
...Histologically confirmed recurrent stage IV colorectal cancer Any T, any N, M1 Documented progressive disease within 6 months of completing an irinotecan- containing regimen Bidimensionally measurable metastatic disease Meningeal or CNS involvement allowed Immunohistochemical evidence of EGFR expression (at least 1+)...
Trial ID:
Source:
Title:
Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib
Excerpt:
...EGFR expressing tumours of the following types:...
Trial ID:
Source:
Title:
XELOX Plus Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer
Excerpt:
......
Trial ID:
Source:
Title:
PREDICTIVE MARKERS OF THE EFFICACY IN METASTATIC COLORECTAL TUMOR TREATED WITH CETUXIMAB - PHASE 2 STUDY
Excerpt:
...Assessing in patients with metastatic colorectal cancer refractory to treatment with chemotherapy and Irinotecan 5FU the correlation between the response to treatment with Cetuximab in combination with chemotherapy based Irinotecan;search for mutations of K-RAS and odetermination of PTEN by immunohistochemistry;Gene amplification dell'EGFR determined by FISH;the intensity of expression dell'EGFR determined by immunohistochemistry test with DAKO and Zymed (monoclonal antibody clone 31G7)...
Trial ID:
Less C2 evidence
Source:
Title:
Phase II Trial of Cetuximab in Patients With Refractory Colorectal Cancer That Expresses the Epidermal Growth Factor Receptor
Excerpt:
Patients were required to have EGFr expression demonstrated on formalin-fixed paraffin-embedded tumor tissue by immunohistochemical staining before study participation...Patients were required to have received irinotecan...Cetuximab was administered weekly by intravenous infusion...Five patients (9%; 95% CI, 3% to 19%) achieved a partial response. Twenty-one additional patients had stable disease or minor responses.
DOI:
10.1200/JCO.2004.10.182
Test:
