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Association details:
Biomarker:BRAF wild-type
Cancer:Colon Cancer
Drug:Vectibix (panitumumab) (EGFR inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Colon Cancer...SYSTEMIC THERAPY FOR ADVANCED OR METASTATIC DISEASE - CHEMOTHERAPY REGIMENS...FOLFIRI + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)...Irinotecan + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)...FOLFOX + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)...FOLFIRINOX or mFOLFIRINOX + panitumumab (KRAS/NRAS/BRAF WT and left-sided tumors only)
Secondary therapy:
FOLFIRINOX; irinotecan; FOLFIRI; FOLFOX
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Excerpt:
...Overall Survival`Percentage of Participants With an Objective Response`Duration of Response`Time to Disease Progression`Time to Initial Objective Response`Resection Rate`Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)`Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)`Overall Survival in Participants With Wild-type RAS`Overall Survival in Participants With Wild-type RAS / BRAF`Percentage of Participants With an Objective Response for Participants With Wild-type RAS`Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF`Number of Participants With Adverse Events (AEs)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

The purpose of this clinical research is to compare two different treatments to assess whether the use of a single chemotherapy (5-FU) in combination with panitumumab may provide better results in terms of safety and efficacy compared to treatment with two chemotherapy drugs (5 -fluorouracile and oxaliplatin) in combination with panitumumab as first-line therapy in elderly patients (aged =70 years) with cancer without mutations of RAS and BRAF. Lo scopo di questa ricerca clinica è confrontare due diversi trattamenti per valutare se l’utilizzo di un solo chemioterapico (5-fluorouracile) in associazione a panitumumab possa fornire risultati migliori in termini di tollerabilità ed efficacia rispetto ad un trattamento con due farmaci chemioterapici (5-fluorouracile e oxaliplatino) in associazione a panitumumab come terapia di prima linea nei pazienti anziani (età =70 anni) con neoplasia senza mutazioni dei geni RAS e BRAF.

Excerpt:
...ECOG PS 1 or 2 for patients aged 70 to 75 years; ECOG PS 0 or 1 for patients aged > 75 years.Life expectancy of at least 12 weeks.Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse.RAS and BRAF status wild-type of primary colorectal cancer or related metastasis, centrally assessed.Neutrophils =1.5 x 109/L, Platelets =100 x 109/L, Hgb =9 g/dl.Total bilirubin =1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) =2.5 x UNL (or confermata istologicamente di adenocarcinoma del colon-rettaleMalattia metastatica inizialmente non resecabile e non precedentemente trattata con chemioterapia;Almeno una lesione misurabile secondo i criteri RECIST 1.1;Disponibilità di campione tissutale di tumore primitivo e/o metastasi;Età =70 anni;ECOG PS 1 o 2 se età compresa tra 70 e 75 anni, ECOG PS 0 o 1 se >75 anni;Aspettativa di vita di almeno 12 settimaneUna precedente chemioterapia adiuvante con fluoropirimidine in monoterapia è permessa se sono trascorsi almeno 6 mesi tra la fine dell’adiuvante e la prima recidiva;Stato mutazionale wild-type di RAS e BRAF sul tumore primitivo o sulla metastasi valutato centralmente;Neutrofili >1.5 x 109/L, Piastrine >100 x 109/L, Emoglobina >9 g/dl;Bilirubina totale 50 mL/min o creatinina sierica 1.5 x UNL;I soggetti maschili con partner fertili devono accettare l’uso di un adeguato metodo contraccettivo approvato dallo sperimentatore (es. ...
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

MONARCC: A randomised phase II study of Panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer.

Excerpt:
...BRAF wild type as assessed by the investigator’s choice of testing laboratory. ...