^
    Back
    Association details:
    Biomarker:KRAS wild-type
    Cancer:Colorectal Cancer
    Drug:Erbitux (cetuximab) (EGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Nat Commun
    Title:

    The Oncology Biomarker Discovery framework reveals cetuximab and bevacizumab response patterns in metastatic colorectal cancer

    Published date:
    09/04/2023
    Excerpt:
    Here, we utilise the open-label, randomised phase III trial (FIRE-3, AIO KRK-0306) in metastatic colorectal carcinoma patients, who received either cetuximab or bevacizumab in combination with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI)....KRAS mutated tumours classified as CMS1 tended to show a longer OS compared to wild-type tumours when treated with bevacizumab...In particular, treatment response differed for tumours classified as CMS4 by KRAS status, showing better response for cetuximab in KRAS wild-type and for bevacizumab in KRAS mutated tumours, respectively.
    Secondary therapy:
    FOLFIRI
    DOI:
    https://doi.org/10.1038/s41467-023-41011-4
    Trial ID:
    FIRE-3
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer

    Excerpt:
    ...The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). ...
    Trial ID:
    NCCTG N0147
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer

    Excerpt:
    ...- Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum, with KRAS wild type on mutational analysis....
    Trial ID:
    NCT00444678
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer

    Excerpt:
    ...- The colorectal primary tumor or metastatic tumor must be determined to be KRAS and NRAS wild-type....
    Trial ID:
    FOCULM
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer

    Excerpt:
    ...eligible malignancies include: colorectal cancer KRAS wild-type and squamous cell head and neck cancer...
    Trial ID:
    NCT01254617
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer

    Excerpt:
    ...KRAS/BRAF mutant disease or KRAS wild type w/previous anti-EGFR treatment 5....
    Trial ID:
    NCT01741038
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors

    Excerpt:
    ...Recurrent and/or metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck 2....
    Trial ID:
    NCT01871311
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A randomized phase II study of FOLFORI plus or not CETUXIMAB in elderly advanced colorectal cancer patients. Studio randomizatto di fase II con FOLFIRI piu' CETUXIMAB o FOLFIRI da solo in pazienti anziani affetti da tumore colo-rettale avanzato.

    Excerpt:
    ...Wild-type KRAS tumors. ...
    Trial ID:
    2012-000477-23
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Biomarks of Resistance to Cetuximab in Colorectal Cancer

    Excerpt:
    ...KRAS wild-type status; 6. ...
    Trial ID:
    ChiCTR-ROB-15006385
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A study on NKTR-255 in combination with Cetuximab as salvage treatment for Solid Tumors Estudio sobre NKTR-255 en combinación con Cetuximab como tratamiento de rescate para tumores sólidos.

    Excerpt:
    ...Patients must have a histologically or cytologically confirmed diagnosis of advanced CRC; patients in Phase 2 must have confirmed KRAS wild type EGFR-expressing advanced CRC. ...
    Trial ID:
    2021-002177-25
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic colorectal cancer (CRC) with either KRAS WT or G13D mutation.

    Excerpt:
    ...To determine the 6 month PFS benefit of cetuximab alone or in combination with irinotecan in patients with KRAS WT or KRAS G13D mutated mCRC (PFS defined from time of randomisation to disease progression as defined by RECIST criteria version 1.1)....
    Trial ID:
    ACTRN12612000901808
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A study to explore the effects of cetuximab alone or in combination with irinotecan in patients with an abnormal gene (KRAS) in their colon cancer cells.

    Excerpt:
    ...Prior confirmation of tumour KRAS status as either KRAS WT (with no mutations or changes in BRAF, NRAS, PIK3CA exon20) OR KRAS G13D mutation,6. ...
    Trial ID:
    2012-003638-18
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Alternating chemotherapy plus cetuximab to allow resection of metastases from a colorectal cancer that is wild-type KRAS and BRAF - a randomised phase II trial - Nordic 7.6

    Excerpt:
    ...KRAS and BRAF status - Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF General conditions - age > 18 years - WHO performance status ≤ 1; - expected survival > 3 months - sufficient bone-marrow function (Hb ≥ 6.2 µmol/l/Hb > 10 g/dl ANC ≥ 1.5 x 109/l, thrombocytes ≥ 100 x 109/l) - sufficient kidney and liver function: total bilirubin ≤ 1.5 x upper normal limit, serum creatinine ≤ 1.25 x upper normal limit, ALAT ≤ 3 x upper normal limit and ≤ 5 x upper normal limit with liver metastases - the patient must have signed an informed declaration of consent before being registered; this must be documentable according to national guidelines...
    Trial ID:
    2011-004188-65
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A randomised phase II study evaluating Dual inhibition of epidermal growth factor receptor (EGFR) signalling using CetUXimab and Erlotinib or dose escalated Cetuximab in patients with chemotherapy refractory KRAS wild-type metastatic colorectal cancer

    Excerpt:
    ...KRAS wild type tumour status, confirmed by means of mutation analysis performed on representative samples of diagnostic tumour tissue....
    Trial ID:
    ACTRN12611001142921
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer

    Excerpt:
    ...- Have KRAS WT or KRAS mut tumor...
    Trial ID:
    SWOG-150506-80405-BRAF
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

    Excerpt:
    ...Must be KRAS WT; 4....
    Trial ID:
    PRIMUS
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer

    Excerpt:
    ...- Subjects with KRAS wild-type status of tumour tissue...
    Trial ID:
    NCT01134666
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

    Excerpt:
    ...- Histology or cytology proven KRAS-WT mCRC....
    Trial ID:
    NCT01382407
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response

    Excerpt:
    ...- Patient with histologically proven metastatic colorectal cancer with KRAS wild-type...
    Trial ID:
    NCT01292356
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cetuximab for Elderly Patients With mCRC

    Excerpt:
    ...- Tumour with wild-type KRAS and wild-type BRAF gene...
    Trial ID:
    SAKK 41/10
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    FOLFOX Chemotherapy Regimen (5-FU, Leucovorin, Oxaliplatin) in Metastatic Colorectal Cancer

    Excerpt:
    ...Phase IB: Patient must have wild type KRAS....
    Trial ID:
    NCT00501410
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Randomized, Placebo-controlled, Double-blind Phase II Study Evaluating if Glucophage Can Avoid Liver Injury Due to Chemotherapy Associated Steatosis

    Excerpt:
    ...- Diagnosis of histologically confirmed, KRAS "wild-type" adenocarcinoma of the colon or rectum...
    Trial ID:
    NCT01523639
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Randomized, open-label phase II study evaluating the safety and efficacy of Cetuximab plus modified FOLFOX - 6 versus modified FOLFOX - 6 alone as 2nd line therapy after progression on the 1st line treatment with Cetuximab + FOLFIRI in patients with metastatic colorectal cancer KRAS wild-type – TAGUS Study

    Excerpt:
    ...- Signed written informed consent- Male or Female with, at least, 18 years old- Histologically or cytologically-proven metastatic adenocarcinoma of the colon or rectum with wild-type KRAS status- Patients treated in 1st line treatment with cetuximab + FOLFIRI- Metastatic disease (M1) not amenable to potentially curative treatment- Presence of at least one unidimensionally measurable lesion with a diameter ≥ 20 mm by conventional CT or magnetic resonance imaging (MRI) or ≥ 10 mm by spiral CT (Target lesion(s) must not lie within an irradiated area)- Life expectancy of at least 3 months- ECOG performance status of 0 or 1 at study entry- Effective contraception for both male and female with reproductive potential while on treatment and for 6 months after study treatment...
    Trial ID:
    2008-008282-36
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Multicenter prospective single-arm study investigating the efficacy and safety of second-line cetuximab plus chemotherapy treatment in initially RAS-mt mCRC patients who converted to RAS-wt at the time of first progression Studio di fase II a singolo braccio di terapia di II linea con cetuximab e chemioterapia in pazienti con carcinoma colorettale metastatico KRAS e NRAS mutato alla diagnosi con assenza di mutazioni di KRAS/NRAS su plasma alla progressione da prima linea

    Excerpt:
    ...• Consenso informato scritto nella fase di screening e nella fase di arruolamento• KRAS/NRAS wild-type su plasma (DNA tumorale circolante) al momento della progressione da prima linea di trattamento• Aspettativa di vita di almeno 3 mesi...
    Trial ID:
    2019-001328-36
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)

    Excerpt:
    ...Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments`Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments...
    Trial ID:
    CRYSTAL
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    EMR 62202-509
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)

    Excerpt:
    ...Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)`Best Overall Response Rate (KRAS Mutant Population)`Progression-free Survival Time`Progression-free Survival Time (KRAS Wild-Type Population)`Progression-free Survival Time (KRAS Mutant Population)`Overall Survival Time`Overall Survival Time (KRAS Wild-Type Population)`Overall Survival Time (KRAS Mutant Population)`Participants With No Residual Tumor After Metastatic Surgery`Disease Control Rate (Cut Off Date 4 August 2006)`Duration of Response`Safety - Number of Patients Experiencing Any Adverse Event...
    Trial ID:
    OPUS
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT01074333
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Safety and Efficacy Study of mFOLFOX-6 Plus Cetuximab for 8 Cycles Followed by mFOLFOX-6 Plus Cetuximab or Single Agent Cetuximab as Maintenance Therapy in Patients With Metastatic Colorectal Cancer and WT KRAS Tumours

    Excerpt:
    ......
    Trial ID:
    MACRO-2
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)

    Excerpt:
    ......
    Trial ID:
    APEC-Study
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    RAS Switch in Patients With Metastatic RAS Native Colorectal Tumors Treated With 1st Line FOLFIRI-Cetuximab

    Excerpt:
    ...- Wild-type KRAS...
    Trial ID:
    NCT01943786
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery

    Excerpt:
    ...- Although KRAS status will be evaluated in the tumor, wild type KRAS status is...
    Trial ID:
    NCT00835679
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.

    Excerpt:
    ...- Signed written informed consent for enrolment (pts with KRAS wild type)...
    Trial ID:
    NCT01068132
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT01134640
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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 KRAS wildtype status...
    Trial ID:
    DERMATUX
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Optimal Control of Liver Metastases From Colorectal Cancer With Cetuximab and Hepatic Artery Infusion of Chemotherapy

    Excerpt:
    ...- Patient with wild type (WT) KRAS tumor status...
    Trial ID:
    OPTILIV
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT01564810
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients

    Excerpt:
    ...- KRAS, NRAS, BRAF wild-type;...
    Trial ID:
    CIFRA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab

    Excerpt:
    ...- RAS wild-type tumour status (KRAS and NRAS exon 2-4) (proven in the primary tumour or metastasis) at any timepoint of randomisation...
    Trial ID:
    FIRE-4
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Cetuximab in Combination With mFOLFOX-6 (Oxaliplatin, Leucovorin, 5-FU) to Treat Colorectal Liver Metastatic Cancer Patients

    Excerpt:
    ...- Tumor tissue (primary or metastasis) genotypologically classified as KRAS wild-type in codon 12 and codon 13 of the KRAS gene exon 2...
    Trial ID:
    CLIME
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer

    Excerpt:
    ...Patients with wild type KRAS, APC or TP53 are ineligible.....
    Trial ID:
    NCT04853043
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4

    Excerpt:
    ...Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC with wild-type KRAS and...
    Trial ID:
    NCT01726309
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer

    Excerpt:
    ...- Tumor classified WT KRAS...
    Trial ID:
    NCT00954876
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM

    Excerpt:
    ...- RAS wild-type tested in KRAS exon 2 (codons 12/13) KRAS exon 3 (codons 59/61) KRAS exon 4 (codons 117/146) NRAS exon 2 (codons 12/13) NRAS exon 3 (codons 59/61) NRAS exon 4 (codons 117/146)...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)

    Excerpt:
    ...KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis 3....
    Trial ID:
    TIME-PRODIGE 28 UNICANCER
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating Biomarkers in Patients With Colorectal Cancer and Native KRAS Treated With Chemotherapy + Cetuximab

    Excerpt:
    ...- Colorectal cancer with KRAS wild type genotype...
    Trial ID:
    POSIBA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer

    Excerpt:
    ...Patients with wild-type KRAS,NRAS and BRAF V600E metastatic colorectal adenocarcinoma confirmed by histology and genetic testing....
    Trial ID:
    NCT04718038
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Biomarker Directed Treatment in Metastatic Colorectal Cancer

    Excerpt:
    ...- Untreated wild-type KRAS metastatic colorectal cancer...
    Trial ID:
    NCT01703390
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery

    Excerpt:
    ...DFS time in the ITT KRAS wild-type population`Disease-free survival...
    Trial ID:
    PETACC-8
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Nordic 8 - A Phase II Trial

    Excerpt:
    ...- Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF...
    Trial ID:
    NCT01867697
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A case records based retrospectively study for the clinical efficacy of cetuximab maintenance therapy in KRAS wild metastatic colorectal carcinoma

    Excerpt:
    ...inoperable metastatic colorectal cancer with wild type KRAS which was confirmed by PCR/NGS; 3. ...
    Trial ID:
    ChiCTR1900026312
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Monitoring RAS Phenotypic Changes Based on ctDNA to Predict the Efficacy of Cetuximab in Metastatic Colorectal Cancer

    Excerpt:
    ...Histological RAS gene detection KRAS, NRAS is wild type; 7. ...
    Trial ID:
    ChiCTR1900026962
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Colorectal Cancer
    Title:

    Plasma Cetuximab Concentrations Correlate With Survival in Patients With Advanced KRAS Wild Type Colorectal Cancer

    Published date:
    08/23/2023
    Excerpt:
    The CO. 20 study randomized patients with RAS WT advanced colorectal cancer in a 1:1 ratio to cetuximab...The median overall survival (OS) was 11.4 months and 7.8 months for patients in the highest (T3) and lowest tertiles (T1) respectively. On multivariable analysis, plasma cetuximab concentration was associated with OS (HR 0.66, 95% confidence interval [CI]: 0.53-0.83, P < .001, T3 vs. T1), and a trend towards progression-free survival (HR 0.82, 95% CI: 0.66-1.02, P = .07, T3 vs. T1).
    DOI:
    https://doi.org/10.1016/j.clcc.2023.08.006
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO-GI 2023
    Title:

    SOX plus bevacizumab versus SOX plus cetuximab as initial treatment of recurrent advanced colorectal cancer with wild-type KRAS (MCSGO-1107 study): A phase II randomized study.

    Published date:
    01/17/2023
    Excerpt:
    The safety and efficacy of SOX+B-mab and SOX+C-mab as initial treatment for unresectable CRC with wild-type KRAS were almost the same. ETS was more correlated with PFS in the SOX+C-mab group than in the SOX+B-mab group, suggesting consideration of treatment strategy based on ETS may improve patient prognosis, especially in patients receiving the SOX+C-mab regimen.
    Secondary therapy:
    SOX
    DOI:
    10.1200/JCO.2023.41.3_suppl.136
    Trial ID:
    NCT01442649
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Expert Rev Anticancer Ther
    Title:

    Chemotherapy plus panitumumab/cetuximab versus chemotherapy plus bevacizumab in wild-type KRAS/RAS metastatic colorectal cancer: a meta-analysis

    Published date:
    11/14/2022
    Excerpt:
    Meta-analysis showed that EGFR inhibitors significantly prolonged the overall survival (OS) [HR = 0.83, 95%CI (0.73, 0.94), P = 0.003] and overall response rate (ORR) [RR = 1.11, 95%CI (1.05, 1.18), P = 0.0003] compared to VEGF inhibitors in wild-type KRAS/RAS mCRC patients... ​Our study showed that EGFR inhibitors were superior to VEGF inhibitors in wild-type KRAS/RAS mCRC patients, especially in patients with first-line treatment.
    Secondary therapy:
    Chemotherapy
    DOI:
    10.1080/14737140.2022.2147512
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Ann Oncol
    Title:

    Right vs left-sided RAS wild-type metastatic colorectal cancer treated with EGFR inhibitors: prognostic differences

    Published date:
    07/01/2019
    Excerpt:
    CONTRADICTING EVIDENCE: A retrospective study of a total of 44 patients with metastatic and KRAS/NRAS wt status CRC, treated with cetuximab or panitumumab was performed...In patients with mCRC RAS wt treated with EGFR inhibitors, regardless of the line of treatment, the right-side location was associated with poor survival.
    DOI:
    https://doi.org/10.1093/annonc/mdz155.193
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Ann Oncol
    Title:

    Survival analysis of KRAS, NRAS, BRAF, PIK3CA wild type (wt) metastatic colorectal cancer (mCRC) patients (pts) treated with FOLFIRI plus cetuximab in the CAPRI- GOIM trial

    Published date:
    10/01/2017
    Excerpt:
    Long-term follow-up analysis of pts enrolled in the CAPRI-GOIM trial showed a median OS of approximately 36 m in KRAS, NRAS, BRAF and PIK3CA wt pts. A better prognostic outcome in terms of OS and PFS was observed in left-sided as compared to right-sided tumors.
    Secondary therapy:
    FOLFIRI
    DOI:
    https://doi.org/10.1093/annonc/mdx422.006
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    ESMO Open
    Title:

    Tumour location and efficacy of first-line EGFR inhibitors in KRAS/RAS wild-type metastatic colorectal cancer: retrospective analyses of two phase II randomised Spanish TTD trials

    Excerpt:
    Patients with KRAS/RAS-wild type (wt) mCRC treated in first line with epidermal growth factor receptor inhibitors (EGFR-Is) (cetuximab or panitumumab) plus oxaliplatin or irinotecan...Patients with KRAS-wt right-sided tumours (n=52) had significantly lower efficacy as compared with patients with KRAS-wt left-sided tumours (n=209); confirmed ORR (25% vs 47%, respectively; OR 0.4, 95% CI 0.2 to 0.8, p=0.004); and shorter median PFS (7.2 vs 9.9 months; HR 0.6, 95% CI 0.4 to 0.9, p=0.0157) and OS (13.6 vs 27.7 months; HR 0.5, 95% CI 0.3 to 0.7, p<0.0001).... We observed significantly improved efficacy outcomes in patients with KRAS/RAS-wt mCRC treated with first-line EGFR-I plus chemotherapy in left-sided primary tumours as compared with right-sided primary tumours.
    Secondary therapy:
    oxaliplatin; irinotecan
    DOI:
    10.1136/esmoopen-2019-000599
    Trial ID:
    PLANET; MACRO-2
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    Br J Cancer
    Title:

    Phase 2 study of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type metastatic colorectal cancer: JACCRO CC-08

    Excerpt:
    Among 34 eligible patients who received treatment at least once, 3-month PFS rate was 44.1% (95% confidence interval, 27.4–60.8%). The median PFS and overall survival (OS) were 2.4 and 8.2 months, respectively. The response and disease control rates were 2.9 and 55.9%, respectively....Irinotecan plus cetuximab rechallenge as third-line treatment for KRAS wild-type mCRC was safe and had promising activity...
    Secondary therapy:
    irinotecan
    DOI:
    https://doi.org/10.1038/s41416-020-01042-w