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Association details:
| Biomarker: | RAS mutation |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Erbitux (cetuximab) (EGFR inhibitor) |
| Direction: | Resistant |
Evidence:
Source:
Title:
Cetuximab as salvage therapy in patients with neo wild-type RAS/RAF metastatic colorectal cancer. A Proof-of-concept study
Excerpt:
...Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation) colorectal cancer, 5. ...
Trial ID:
Source:
Title:
A study evaluating the efficacy of cetuximab in combination with FOLFIRI in patients with metastatic colorectal cancer after positive genetic testing of cancer cells Eine Studie zur Überprüfung der Wirksamkeit von Cetuximab in Kombination mit FOLFIRI bei Patienten mit metastasiertem Darmkrebs nach erfolgter positiver genetischer Untersuchung der Krebszellen
Excerpt:
...• Histologically confirmed, UICC stage IV adenocarcinoma of the left-sided colon or rectum with metastases (metastatic colorectal cancer), primarily non-resectable, confirmed RAS mutations proven in the primary tumor or metastasis (KRAS and NRAS exon 2, 3, 4)• Age ≥ 18 years on day of signing informed consent• No previous chemotherapy for metastatic disease (1- 2 cycles FOLFIRI or mFOLFIRI are permitted before enrolment until RAS status is determined)• Patients suitable for chemotherapy administration• ECOG performance status 0-1• Consent to liquid biopsy and mutation analysis• Estimated life expectancy > 3 months• Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria (chest CT and abdominal CT 4 weeks or less before enrollment)• Adequate bone marrow function defined as:o Leukocytes 3.0 x 109/L with neutrophils 1.5 x 109/Lo Thrombocytes 100 x 109/Lo Hemoglobin 9 g/dL• Adequate hepatic function defined as:o Serum bilirubin 1.5 x ULNo ALAT and ASAT 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT 5 x ULN)• Adequate renal function: Creatinine clearance 50 mL/min• Adequate cardiac function defined aso Normal ECG and echocardiogram with a left ventricular ejection fraction (LVEF) of 55%• INR < 1.5 and aPTT < 1.5 x ULN (patients without anticoagulation). ...
Trial ID:
More C2 evidence
Source:
Title:
A study to evaluate the efficacy and safety of SOT101 in combination with cetuximab in patients with a specific subtype of colon and/or rectum cancer Estudio para evaluar la eficacia y seguridad de SOT101 en combinación con cetuximab en pacientes con un subtipo específico de cáncer de colon y/o recto
Excerpt:
...For the assessment of the RAS mutational status, a US Food and Drug Administration (FDA)-approved test or an experienced local laboratory using validated test methods for the detection of K-RAS and N-RAS (exons 2, 3, and 4) mutations must be used.6. ...
Trial ID:
Source:
Title:
Evaluation of RAS mutations in cell free deoxyribonucleic acid (cfDNA) in response to cetuximab anti-epidermal growth factor receptor (EGFR) therapy in patients with metastatic colorectal cancer.
Excerpt:
...To explore the emergence of Ras mutations in cfDNA as an escape mechanism for first-line cetuximab anti-EGFR therapy....
Trial ID:
Source:
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:
...Verificare il tasso di risposta secondo criteri RECIST v1.1 alla chemioterapia di II linea in combinazione con cetuximab in pazienti con tumori del colon-retto metastatici RAS mutati su biopsia tissutale alla diagnosi, con assenza di mutazioni di RAS su plasma alla progressione da prima linea, misurata con il tasso di risposta al trattamento...
Trial ID:
Source:
Title:
Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer
Excerpt:
...All RAS mutations are allowed (KRAS, NRAS, HRAS)....
Trial ID:
Source:
Title:
MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab
Excerpt:
...- Histologically confirmed, UICC stage IV adenocarcinoma of the left-sided colon or rectum with metastases (metastatic colorectal cancer), primarily non-resectable, confirmed RAS mutations proven in the primary tumor or metastasis (KRAS ans NRAS exon 2, 3, 4)...
Trial ID:
Source:
Title:
CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen
Excerpt:
...These include mutation in RAS, BRAF, PI3KCA; amplification of HER2, MET and loss of PTEN expression, all of which are implicated in resistance to anti-EGFR treatment....
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:
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
Excerpt:
...Patients with initial RAS mutant, BRAF wild-type left-sided mCRC....
Trial ID:
Source:
Title:
Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases.
Excerpt:
...Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation) colorectal cancer, 5....
Trial ID:
Source:
Title:
The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment
Excerpt:
...Percentage of detected RAS mutations during cetuximab treatment.`...
Trial ID:
Source:
Title:
Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favorable FcγRIIa (CD32) Genotype
Excerpt:
...- Histological confirmed colorectal cancer (CRC) with mutated K-RAS and favorable genotypes (any H in FcγRIIa-131)....
Trial ID:
Source:
Title:
Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Excerpt:
...- Failed prior oxaliplatin-, fluorouracil (5-FU)-, and irinotecan-containing regimens AND have the presence of a k-ras mutation within codon 12, 13, or 61...
Trial ID:
Source:
Title:
A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
Excerpt:
...Confirmed K-RAS mutant tumor 3....
Trial ID:
Source:
Title:
Lenalidomide and Cetuximab in Treating Patients With Metastatic Colorectal Cancer
Excerpt:
...Time to progression of disease`Tumor response according to RECIST`Lab correlatives (FCGRIIa and FCGRIIIa polymorphisms, K-Ras and B-Raf mutations)...
Trial ID:
Source:
Title:
Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab and Erlotinib
Excerpt:
...Responses will be evaluated for the whole patient group and separately for k-ras wild-type and k-ras mutant tumours...
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:
The emergence of RAS mutations in patients with RAS wild-type mCRC receiving cetuximab as first-line treatment: a noninterventional, uncontrolled multicenter study
Published date:
07/24/2023
Excerpt:
The subgroup of patients with RAS mutations exhibited significantly inferior progression-free survival and overall survival (P = 0.002 and 0.027, respectively)...We demonstrated that RAS ctDNA status might be a valuable biomarker for detecting early tumour response and predicting benefit to anti-EGFR therapy.
DOI:
10.1038/s41416-023-02366-z
Source:
Title:
Chemotherapy (doublet or triplet) plus targeted therapy by RAS status as conversion therapy in colorectal cancer patients with initially unresectable liver-only metastases. The UNICANCER PRODIGE-14 randomised clinical trial
Published date:
01/06/2022
Excerpt:
PRODIGE 14 was an open-label, multicenter, randomised Phase 2 trial. CRC patients with initially defined unresectable liver-only metastases received either, 2-CTx (FOLFOX or FOLFIRI) or 3-CTx (FOLFIRINOX), plus bevacizumab/cetuximab by RAS status. We failed to increase from 50 to 70% the R0/R1 liver-resection rate with the use of 3-CTx combined with bevacizumab or cetuximab by RAS status in CRC patients with initially unresectable liver metastases.
Secondary therapy:
FOLFIRINOX
DOI:
10.1038/s41416-021-01644-y
