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Association details:
| Biomarker: | BRAF 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 and BRAF-wt patients not previously treated with EGFR antibodies, cetuximab and panitumumab are recommended as single agents...
Source:
Title:
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Excerpt:
...Difference in Disease Free Survival (DFS) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only .`...
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:
More C2 evidence
Source:
Title:
study to investigate cetuximab plus irinotecan as rechallenge 3rd-line treatment of kras, nras and braf wild-type irinotecan-pretreated metastatic colorectal cancer patients progressing after an initial response to a 1st-line cetuximab-containing therapy and a standard 2nd-line. studio per valutare un ritrattamento con cetuximab e irinotecano in pazienti con tumore del colon-retto metastatico KRAS, NRAS e BRAF wild-type, irinotecano resistenti, progrediti ad una prima linea a base di irinotecano (FOLFIRI o FOLFOXIRI) contenente cetuximab dalla quale abbiano ricevuto un iniziale beneficio
Excerpt:
...Histologically proven diagnosis of colorectal adenocarcinoma; RAS and BRAF wild-type status of primary colorectal cancer and/or related metastasis; First-line irinotecan-based (FOLFIRI or FOLFOXIRI) cetuximab-containing therapy producing at least a partial response; First-line progression-free survival in response to cetuximab-containing therapy ≥6 months; Documentation of progression to first-line cetuximab within 4 weeks after last cetuximab administration; Time between the end of first-line therapy and the start of third-line treatment with cetuximab plus irinotecan ≥4 months; Second-line oxaliplatin-based (FOLFOXIRI, FOLFOX or XELOX) bevacizumab-containing therapy; Documentation of progression to second-line treatment; Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1); Have tumor tissue (of primary tumor and metastases or at least one of the two) available for biomarker analysis; Male or female, aged > 18 years of age; ECOG Performance Status ≤ 2; Life expectancy of at least 3 months; Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment; Signed informed consent obtained before any study specific procedures....
Trial ID:
Source:
Title:
Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).
Excerpt:
...- RAS and BRAF wild-type status;...
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:
Evaluation of CTCs Combined With Tumor Marker Detection of Efficacy of Chemotherapy in mCRC
Excerpt:
...- RAS and B-raf wild type...
Trial ID:
Source:
Title:
Efficacy and Safety of Triweekly Cetuximab in Combination With Capecitabine as First-line Maintenance Treatment for KRAS/BRAF Wild-type Metastatic Colorectal Cancer
Excerpt:
...- Patients have histologically or cytologically confirmed RAS and BRAF wild-type metastatic colorectal adenocarcinoma (mCRC), excluding appendiceal and anal cancers....
Trial ID:
Source:
Title:
Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy
Excerpt:
...An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type; 3....
Trial ID:
Source:
Title:
CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen
Excerpt:
...RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis 4....
Trial ID:
Source:
Title:
The Efficacy and Safety of Modified XELOX(mXELOX) Plus Cetuximab vs FOLFOX Plus Cetuximab in RAS and BRAF WT mCRC Pts
Excerpt:
...- Patients who had histologically or cytologically confirmed RAS and BRAF wild-type, initially unresectable metastatic adenocarcinoma of the left-sided colon or rectum, excluding appendiceal or anal cancer....
Trial ID:
Source:
Title:
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
Excerpt:
...- KRAS, NRAS, BRAF wild-type;...
Trial ID:
Source:
Title:
c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI
Excerpt:
...RAS, B-RAF gene wild type...
Trial ID:
Source:
Title:
Decision-making of ctDNA in Patients With mCRC After Failure of First-line Treatment Containing Cetuximab - a Single-center, Phase II Clinical Study
Excerpt:
...Patients with RAS and BRAF wild-type tissue genetic testing, receiving first-line treatment containing cetuximab, and radiographic evaluation of disease progression; 4....
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:
Erbitux MEtastatic Colorectal Cancer Strategy Study
Excerpt:
...- RAS and BRAF wildtype...
Trial ID:
Source:
Title:
Cetuximab Plus Capecitabine as Maintenance Treatment in RAS and BRAF wt Metastatic Colorectal Cancer
Excerpt:
...Patients who have histologically or cytologically confirmed adenocarcinoma of the colon or rectum, excluding appendix carcinoma or anal canal carcinoma, with RAS and BRAF wild-type mutation status....
Trial ID:
Less C2 evidence
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:
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
