^
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:
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:
CAPRI 2 GOIM study: investigate the efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line. Studio CAPRI 2 GOIM: studio sull’efficacia e la sicurezza del regime di trattamento basato su cetuximab e guidato da biomarcatori su 3 linee di trattamento in pazienti affetti da carcinoma del colonretto metastatico che presentano uno stato Wild Type di RAS e BRAF prima dell’inizio del trattamento di prima linea
Excerpt:
...RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis4. ...
Trial ID:
More C2 evidence
Source:
Title:
Efficacy and safety of cetuximab plus FOLFIRI/FOLFOX combined with thalidomide in first-line treatment of RAS and BRAF wild-type stage IV left colorectal cancer
Excerpt:
...Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing; 2. ...
Trial ID:
Source:
Title:
FOLFIRI plus cetuximab as first-line therapy followed by cetuximab maintenance therapy in patients with RAS and BRAF wild-type unresectable metastatic colorectal cancer: a single institute study
Excerpt:
...RAS and BRAF wild type; 5. ...
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:
Medical Records Based Real-World Study of Cetuximab in Combination with FOLFIRI Regimen as First-Line Chemotherapy and Subsequent Cetuximab-based Maintenance Therapy for the Maintenance Treatment of Patients with RAS and BRAF Wild-Type Unresectable Metastatic Colorectal Cancer
Excerpt:
...Subjects must meet all of the following criteria to be included in this retrospective study: A. Aged 18 to 75 years, male or female; B. histologically diagnosed adenocarcinoma of the colon or rectum; C. metastatic disease (not amenable to curative resection); D. RAS and BRAF wild-type; E. complete imaging assessment data: including baseline and PD data confirmed by CT or MRI; F. treated with the study's specified treatment regimen....
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:
Biomarcer-2 :Biomarker informed optimal management of advanced RAS wild type colorectal cancer
Excerpt:
...RAS/BRAF wild type...
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:
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:
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 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:
Source:
Title:
Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
Excerpt:
...RAS and BRAF V600E wild-type; 7....
Trial ID:
Source:
Title:
c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI
Excerpt:
...RAS, B-RAF gene wild type...
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 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:
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:
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:
Peripheral blood ctDNA second-generation sequencing to guide RAS/BRAF wild type: A clinical study of cetuximab re-challenge in patients with metastatic colorectal cancer
Excerpt:
...Patients with pathologically confirmed advanced adenocarcinoma of the colon or rectum; initial tissue RAS/BRAF wild type; 2. ...
Trial ID:
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:
Zuojinwan Combined With Chemotherapy and Cetuximab for Advanced Colorectal Cancer: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Excerpt:
...RAS, BRAF wild-type, advanced unresectable colorectal cancer patients receiving chemotherapy combined with cetuximab; 4. ...
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:
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
