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Association details:
| Biomarker: | RAS wild-type |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Erbitux (cetuximab) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
Published date:
10/25/2022
Excerpt:
In RAS-wt patients not previously treated with an anti-EGFR mAb, treatment with ChT (FOLFIRI or irinotecan) and cetuximab or panitumumab could be considered for left-sided colon tumours [II, C].
Secondary therapy:
irinotecan; FOLFIRI
Source:
Title:
Randomized study to investigate a switch maintenance concept with 5-FU plus bevacizumab after FOLFIRI plus cetuximab induction treatment versus continued treatment with FOLFIRI plus cetuximab: Report of a secondary endpoint of the phase-III FIRE-4 study (AIO KRK-0114)
Published date:
05/26/2022
Excerpt:
FIRE-4 confirms the efficacy of FOLFIRI plus cetuximab as first-line treatment of patients with RAS wild-type mCRC.
Secondary therapy:
FOLFIRI
DOI:
10.1200/JCO.2022.40.16_suppl.3519
Trial ID:
Source:
Title:
Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial
Excerpt:
In the modified intent-to-treat population of 393 patients with RAS wt mCRC, adding cetuximab to FOLFOX-4 significantly improved the primary end point of progression-free survival time compared with FOLFOX-4 alone (hazard ratio, 0.69; 95% CI, 0.54 to 0.89; P = .004; median, 9.2 v 7.4 months, respectively), as well as the secondary end points of overall survival time (current assessment after 300 events: hazard ratio, 0.76; 95% CI, 0.61 to 0.96; P = .02; median, 20.7 v 17.8 months, respectively) and overall response rate (odds ratio, 2.41; 95% CI, 1.61 to 3.61; P < .001; 61.1% v 39.5%, respectively)....The TAILOR study met all of its objectives and relevant clinical end points, confirming cetuximab in combination with FOLFOX as an effective standard-of-care first-line treatment regimen for patients with RAS wt mCRC.
Secondary therapy:
FOLFOX
DOI:
10.1200/JCO.2018.78.3183
Trial ID:
Source:
Title:
Extended RAS Analysis of the Phase III EPIC Trial: Irinotecan + Cetuximab Versus Irinotecan as Second-Line Treatment for Patients with Metastatic Colorectal Cancer
Excerpt:
In the cetuximab plus irinotecan versus irinotecan arms, median overall survival was 12.3 versus 12.0 months, median progression-free survival (PFS) was 5.4 versus 2.6 months, and objective response rate (ORR) was 29.4% versus 5.0%, respectively….PFS, ORR, and QoL were improved with cetuximab plus irinotecan as a second-line treatment in patients with RAS-wt mCRC, confirming that cetuximab-based therapy is suitable in this population.
Secondary therapy:
irinotecan
DOI:
10.1002/onco.13591
Source:
Title:
Perioperative chemotherapy with FOLFOX plus Cetuximab versus adjuvant FOLFOX plus Cetuximab for patients with resectable liver metastases of colorectal carcinoma
Excerpt:
...Proven K-RAS wildtype in primary tumour or metastasis tissue4. ...
Trial ID:
Source:
Title:
Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy
Excerpt:
...- c-MET positive (defined by c-MET IHC intensity score +2 in ≥ 50% of tumor cells and MET gene copy number ≥ 5 by FISH or IHC intensity score +3 in ≥ 50% of tumor cells) and K/NRAS WT status for mCRC patients only...
Trial ID:
More C2 evidence
Source:
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:
Source:
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:
Source:
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:
...- Confirmed histological diagnosis of colorectal carcinoma with metastatic disease and wild-type KRAS....
Trial ID:
Source:
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:
Source:
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:
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:
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:
...The plasma will then be tested for Ras mutant status using BEAMing., To determine if treatment responses can be seen in patients with tissue Ras wild-type status but with cfDNA Ras mutation at initial testing....
Trial ID:
Source:
Title:
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer
Excerpt:
...RAS wild type as confirmed by:...
Source:
Title:
FLOX + Erbitux. 1. line treatment to patients with metastatic colorectal cancer and wild type K-RAS tumor. A phase II study.
Excerpt:
...Histology and staging disease:• Histological proven adenocarcinoma of the colon or rectum• At least one measurable metastatic lesion according to RECIST criteria• If only one metastatic lesion, histology is mandatoryMutation level:• Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCRGeneral conditions: • Age >18 and < 75 years • WHO performance status ≤ 2; life expectancy of more than 3 months• Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)• Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases• Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirementsOther:• Fertile patients must use adequate contraceptives`Histology and staging disease:• Histologically proven adenocarcinoma of the colon or rectum• At least one measurable metastatic lesion according to RECIST criteria• If only one metastatic lesion, histology is mandatoryMutation level:• Tumor tissue (primary or metastasis) typologically classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCRGeneral conditions: • Age >18 and < 75 years • WHO performance status ≤ 2; life expectancy of more than 3 months• Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)• Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases• Written informed consent prior to inclusion must be obtained and documented according to the local regulatory requirementsOther:• Fertile patients must use adequate contraceptives...
Trial ID:
Source:
Title:
Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
Excerpt:
...- Tumor is K-ras wildtype by method of choice at respective institution (testing codons 12 and 13) -...
Trial ID:
Source:
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:
Source:
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)...
Source:
Title:
The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment
Excerpt:
...Patients who are molecularly diagnosed as having RAS wild-type mCRC....
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Cetuximab for Elderly Patients With mCRC
Excerpt:
...- Tumour with wild-type KRAS and wild-type BRAF gene...
Trial ID:
Source:
Title:
Irinotecan Hydrochloride With FOLFIRI and Cetuximab as First-Line Therapy in Treating Patients With RAS Wild-Type Colorectal Cancer
Excerpt:
...- RAS wild-type status (by a Clinical Laboratory Improvement Amendments [CLIA] certified assay that includes all known mutations in Kirsten rat sarcoma viral oncogene homolog [KRAS], Harvey rat sarcoma viral oncogene homolog [HRAS], and neuroblastoma RAS viral (v-ras) oncogene homolog [NRAS])...
Trial ID:
Source:
Title:
Treatment Regimens for Patients With Resectable Liver Metastases (PANTER Study)
Excerpt:
...- Proven K-RAS wildtype in primary tumour or metastasis tissue...
Trial ID:
Source:
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:
...- KRAS wild-type status of tumor tissue...
Trial ID:
Source:
Title:
Observational Study on Second Line Treatment of Liver Metastases With DEBIRI and Cetuximab
Excerpt:
...Patients K-RAS wild type...
Trial ID:
Source:
Title:
RAS Switch in Patients With Metastatic RAS Native Colorectal Tumors Treated With 1st Line FOLFIRI-Cetuximab
Excerpt:
...- Wild-type KRAS...
Trial ID:
Source:
Title:
Pharmacokinetics and Metabolic Activation of Capecitabine
Excerpt:
...- K-ras wild type adenocarcinoma of the colon or rectum...
Trial ID:
Source:
Title:
FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor
Excerpt:
...- Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR...
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:
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:
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
Excerpt:
...To explore whether cetuximab in combination with chemotherapy as treatment could improve the resection rate in patients with KRAS wild-type, unresectable colorectal liver-limited metastases compared with chemotherapy alone.`...
Trial ID:
Source:
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:
Source:
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:
Source:
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:
...“All RAS WT”, - that is no mutation or changes in either KRAS NRAS...
Trial ID:
Source:
Title:
TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer
Excerpt:
...Patients with confirmed diagnosis of stage IV (UICC) colorectal cancer with unresectable liver metastases (primary tumour may be present) and k-ras wild-type tumours 2....
Trial ID:
Source:
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:
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 KRAS wildtype status...
Trial ID:
Source:
Title:
Response monitoring with special chemotherapie (monoclonal antibody) in metastatic colorectal cancer
Excerpt:
...• Histologically confirmed metastatic colorectal cancer• RAS-wildtype status of the tumor• No history of therapy with an EGFR targeting agent• No history of previous chemotherapy for advanced disease• Measurable tumor lesion with a diameter no smaller than 1.0 cm detected by CT, MRIor ultrasound• For contrast-enhanced ultrasound: metastases no smaller than 2.0 cm• ECOG-performance status 0 or 1 or Karnofsky performance scale min. ...
Source:
Title:
Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project
Excerpt:
...- K-Ras wild type tumour...
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:
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:
...Histologically or cytologically confirmed advanced and/or metastatic RAS wild-type colorectal cancer as confirmed by the investigational site within 3 months prior to the first administration of study treatment. ...
Trial ID:
Source:
Title:
First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes
Excerpt:
...- Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes;...
Trial ID:
Source:
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:
Source:
Title:
Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer
Excerpt:
...In RAS wt population`Median Progression free survival (PFS)...
Trial ID:
Source:
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:
Source:
Title:
Cetuximab+mFOLFOX6 VS. mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable CRLM
Excerpt:
...RAS wild type； 4....
Trial ID:
Source:
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:
Source:
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:
Source:
Title:
A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver
Excerpt:
......
Trial ID:
Source:
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:
Source:
Title:
Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream
Excerpt:
...- Patients eligible for Erbitux and FOLFIRI treatment K-Ras wild type tumour...
Trial ID:
Source:
Title:
Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis
Excerpt:
...- Rat sarcoma viral oncogene homolog(RAS) wild-type...
Trial ID:
Source:
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:
Source:
Title:
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
Excerpt:
...- Colorectal adenocarcinoma, Wild KRAS, 18-75 yr...
Trial ID:
Source:
Title:
Biomarker Directed Treatment in Metastatic Colorectal Cancer
Excerpt:
...- Untreated wild-type KRAS metastatic colorectal cancer...
Trial ID:
Source:
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:
Source:
Title:
Nordic 8 - A Phase II Trial
Excerpt:
...- Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF...
Trial ID:
Source:
Title:
Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
Excerpt:
...- Have KRAS WT or KRAS mut tumor...
Trial ID:
Source:
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:
Source:
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:
Source:
Title:
Pre-emptive Cycline Treatment on Cetuximab Induced Skin Toxicity in Colorectal Cancer
Excerpt:
...- K-RAS wild-type...
Trial ID:
Source:
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:
Source:
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:
Source:
Title:
Cetuximab Standard or Dose Escalation in First Line Colorectal Cancer
Excerpt:
...K-Ras wild type tumour eligible for treatment with cetuximab....
Trial ID:
Source:
Title:
FOLFOX Chemotherapy Regimen (5-FU, Leucovorin, Oxaliplatin) in Metastatic Colorectal Cancer
Excerpt:
...Phase IB: Patient must have wild type KRAS....
Trial ID:
Source:
Title:
Tumour markers response to chemotherapy in patients with colorectal liver metastases Marcatori di risposta alla chemioterapia in pazienti con metastasi epatiche colorettali
Excerpt:
...Adenocarcinoma del colon-retto istologicamente accertato, k-ras wild type. ...
Trial ID:
Source:
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:
Source:
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:
Source:
Title:
First-line treatment of mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS/BRAF genes: a multicenter, randomised, phase 2 study
Excerpt:
...Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes; 4. ...
Trial ID:
Source:
Title:
Efficacy of cetuximab combined with thalidomide in the treatment of advanced colorectal cancer: a multicenter prospective randomized controlled clinical study
Excerpt:
...Patients with newly histologically confirmed advanced colorectal cancer,RAS wild type; 2. ...
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:
...• 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:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V Studio di fase II sull'utilizzo dell'associazione FOLFIRI+Cetuximab nel trattamento di prima linea dei pazienti affetti da carcinoma del colon-retto avanzato con RAS wild type e FcYRIIIA-V/V
Excerpt:
...• Cytological or histological diagnosis of colorectal adenocarcinoma• wild-type RAS• FcγRIIIa-158V / V genotype• Stage IV• Negative pregnancy test where applicable• Age <75 years• At least 1 lesion measurable according to the RECIST criteria v1.1• ECOG Performance Status 0 or 1• Life expectancy> 3 months• Written informed consent • Diagnosi citologica o istologica di adenocarcinoma del colon-retto • RAS wild-type• Genotipo FcγRIIIa-158V/V • Stadio IV• Test di gravidanza negativo ove applicabile• Età < 75 anni• Almeno 1 lesione misurabile secondo i criteri RECIST v1.1• Performance Status ECOG 0 o 1 • Aspettativa di vita >3 mesi • Consenso informato scritto...
Trial ID:
Source:
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:
Source:
Title:
Biomarks of Resistance to Cetuximab in Colorectal Cancer
Excerpt:
...KRAS wild-type status; 6. ...
Trial ID:
Source:
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:
Less C2 evidence
Source:
Title:
120P - Improved clinical outcomes with cetuximab maintenance therapy in left-sided RAS/BRAF wild-type metastatic colorectal cancer: A real-world study of Hunan cancer hospital
Published date:
11/27/2023
Excerpt:
We performed a retrospective review of pts with LS RAS/BRAF wt mCRC who had disease controlled (CR, PR or SD) after 6 cycles of Cet based induction therapy from JAN 2018 to JUN 2022 at HuNan Cancer Hospital. The 1L regimen consists of Cet plus mFOLFOX6 or FOLFIRI, based on pts selection, followed by maintenance therapy with Cetuximab with or without chemotherapy (cohort A) or chemotherapy alone (cohort B)....cohort A (14.2 m, 95% CI 12.4-17.0) had a significantly longer median PFS than cohort B (11.0 m, 95% CI 9.6-11.7; p=0.021).
Secondary therapy:
FOLFIRI + mFOLFOX6
Source:
Title:
555MO - Modified (m)-FOLFOXIRI plus cetuximab treatment and predictive clinical factors for RAS/BRAF wild-type and left-sided metastatic colorectal cancer (mCRC): The DEEPER trial (JACCRO CC-13)
Published date:
10/16/2023
Excerpt:
178 pts with RAS/BRAF wild-type and left-sided tumors, DpR and PFS both were significantly better in the cet compared to the bev arm (DpR, median 59.2% vs. 47.5%, P=0.0017; PFS, median 14.5 vs. 11.9 months, HR 0.71, P=0.032). A sub-group analysis by clinical factors showed that PFS was better in the cet arm among pts without surgical resection of R0/1 (HR 0.66, P=0.029)...m-FOLFOXIRI plus cet regimen could be a good option for upfront chemotherapy with high DpR and longer PFS in mCRC pts with RAS/BRAF wild-type and left-sided tumors.
Secondary therapy:
FOLFOXIRI
Trial ID:
Source:
Title:
Efficacy and tolerability of cetuximab 750 mg/m2 every three weeks in metastatic colorectal cancer
Published date:
06/27/2023
Excerpt:
Cetuximab at a dose of 750 mg/m2 q3w in combination with chemotherapy had manageable toxicity and encouraging efficacy in patients with RAS-wt mCRC.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.annonc.2023.04.268
Source:
Title:
Optimal maintenance strategy following FOLFOX plus anti-EGFR induction therapy in patients with RAS wild type metastatic colorectal cancer: an individual patient data pooled analysis of randomized clinical trials
Published date:
06/19/2023
Excerpt:
We performed an individual patient data pooled analysis of Valentino, Panama, MACRO-2, COIN-B trials including RAS wild-type mCRC patients who received first-line therapy with FOLFOX plus panitumumab or cetuximab...Overall, 123, 185, 210 patients received maintenance with 5-FU/LV, anti-EGFR, 5-FU/LV+anti-EGFR, respectively. Median PFS was 5.6, 6.0 and 9.0 (P=0.009) and OS was 25.7, 24.0 and 28.0 months (P=0.134) in 5-FU/LV, anti-EGFR and 5-FU/LV+anti-EGFR arms, respectively....This pooled analysis including four randomized phase II supports the use of 5-FU/LV plus anti-EGFR as preferred maintenance regimen.
Secondary therapy:
5-fluorouracil + leucovorin calcium
DOI:
https://doi.org/10.1016/j.ejca.2023.112945
Source:
Title:
Cetuximab as third-line rechallenge plus either irinotecan or avelumab is an effective treatment in metastatic colorectal cancer patients with baseline plasma RAS/BRAF wild-type circulating tumor DNA: Individual patient data pooled analysis of CRICKET and CAVE trials
Published date:
03/07/2023
Excerpt:
For the whole 46 patient population, median PFS (mPFS) was 3.9 months (95% Confidence Interval, CI 3.0–4.9) with median OS (mOS) of 16.9 months (95% CI 11.7–22.1). For CRICKET patients, mPFS was 3.9 months (95% CI 1.7–6.2); mOS was 13.1 months (95% CI 7.3–18.9) with OS rates at 12, 18, and 24 months of 62%, 23%, and 0%, respectively. For CAVE patients, mPFS was 4.1 months (95% CI 3.0–5.2); mOS was 18.6 months (95% CI 11.7–25.4) with OS rates at 12, 18, 24 months of 61%, 52%, 21%, respectively....Third-line cetuximab rechallenge in combination with either irinotecan or avelumab in RAS/BRAF WT ctDNA mCRC patients represents a promising therapy.
Secondary therapy:
irinotecan
DOI:
https://doi.org/10.1002/cam4.5699
Source:
Title:
Biweekly cetuximab in combination with capecitabine and oxaliplatin (XELOX) or irinotecan (XELIRI) in the first-line and second-line treatment of patients with RAS wild-type metastatic colorectal cancer
Published date:
12/15/2022
Excerpt:
Here, we report the tolerability and efficacy of biweekly cetuximab in combination with biweekly XELOX or XELIRI in patients with RAS wild-type metastatic colorectal cancer (RAS-WT mCRC)....For all patients in the second-line setting, the ORR, PFS and OS were 50%, 7 months and 20 months, respectively….Biweekly cetuximab in combination with XELOX or XELIRI is tolerable and effective. The addition of cetuximab to capecitabine and oxaliplatin is associated with favourable outcome.
Secondary therapy:
capecitabine + oxaliplatin; capecitabine + irinotecan
DOI:
10.3332/ecancer.2022.1490
Source:
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
Source:
Title:
406P - Real-world evidence of efficacy and safety in first-line cetuximab treatment of RAS wild-type metastatic colorectal cancer: A multicenter retrospective study in Taiwan
Published date:
09/05/2022
Excerpt:
Further stratified analysis by tumor location demonstrated that left-sided mCRC patients had significantly longer OS than right-sided in RAS WT population (36.3 vs. 19.9 months, p<0.001). On the other hands, left-sided and right-sided mCRC showed comparable ORR (62.8% vs. 54.8%), CR rate (9.4% vs. 12.9%)...1L cetuximab therapy shows promising efficacy and safety in Taiwanese mCRC patients in real-world setting.
Source:
Title:
Comparison of UGT1A1 polymorphism as guidance of irinotecan dose escalation in RAS wild type metastatic colorectal cancer patients treated with cetuximab or bevacizumab plus FOLFIRI as the first-line therapy
Published date:
02/17/2022
Excerpt:
This retrospective, observational study compared the clinical outcomes and adverse events (AEs) in RAS wild-type metastatic colorectal cancer (mCRC) patients treated with cetuximab or bevacizumab plus FOLFIRI with UGT1A1 genotyping and irinotecan dose escalation as the first-line therapy. In total, 173 patients with mCRC with RAS wild type were enrolled. Among them, 98 patients were treated with cetuximab, whereas 75 patients were treated with bevacizumab. All patients received irinotecan dose escalation based on UGT1A1 genotyping. Over a median follow-up of 23.0 months [interquartile range (IQR), 15.0-32.5 months), no significant differences were observed between the cetuximab and bevacizumab groups in PFS [18.0 months versus 14.0 months; 95% confidence interval (CI), 0.517- 1.027; hazard ratio (HR), 0.729; P = 0.071], OS (40.0 months versus 30.0 months; 95% CI, 0.410-1.008; HR, 0.643; P = 0.054), ORR (65.3% versus 62.7%; P = 0.720), DCR (92.8% versus 86.7%; P = 0.175)...Our results revealed that patients with wild-type RAS mCRC, regardless of biologics, with UGT1A1 genotyping can tolerate escalated doses of irinotecan and potentially achieve a more favorable clinical outcome without significantly increased toxicity.
Secondary therapy:
FOLFIRI + irinotecan
DOI:
10.3727/096504022X16451187313084
Source:
Title:
Feasibility and Efficacy of Neoadjuvant Chemotherapy without Radiotherapy for Locally Advanced Rectal Cancer
Published date:
01/28/2022
Excerpt:
The study enrolled 30 patients. mFOLFOX6 or SOX plus cetuximab was administered to 12 patients with the wild-type RAS gene and FOLFOXIRI or SOXIRI to 18 patients with mutant-type RAS. NAC was considered to be a safe, feasible treatment option for LARC. The NAC regimen, effect of NAC, and relative dose intensity of each agent are summarized in Table 2. Doublet chemotherapy (dCT) plus Cmab was administered to all patients with wild-type RAS and triplet chemotherapy (tCT) to all patients with mutant-type RAS. The tumor sizes after the administration of dCT plus Cmab and tCT were 67.1% and 70.6%, respectively, and the response rates of dCT plus Cmab vs. tCT were 66.7% vs. 50.0%, respectively. The proportions of patients with HATE ≥ grade 2 after the administration of dCT plus Cmab and tCT were 50% and 44.4%, respectively.
Secondary therapy:
SOX; mFOLFOX6
DOI:
10.23922/jarc.2021-033
Title:
[Efficacy and Prognostic Factors of Cetuximab Therapy in Treating KRAS or All RAS Wild-type Metastatic Colorectal Cancer]
Excerpt:
For the 34 patients receiving cetuximab as first-line treatment, the objective response rate (ORR) was 55.9%,and the progression-free survival and overall survival (OS) was 10 and 24 months, respectively. All-RAS-WT mCRC had significantly lower risk of progression than those with KRAS-only-WT (P=0.012), and left-sided colorectal cancer had higher ORR than right-sided colon cancer (62.1% vs. 0,P=0.033) during the first-line treatment....The efficacy of cetuximab for left-sided colorectal cancer was better than for right-sided colon cancer, and patients with all-RAS-WT have lower risk of progression than those with KRAS-only-WT.
DOI:
10.3881/j.issn.1000-503X.10125
