Evidence Level:Resistant: B - Late Trials
Title:
Codon-specific KRAS mutations predict survival benefit of trifluridine/tipiracil in metastatic colorectal cancer
Excerpt:...double-blind, placebo-controlled, phase 3 RECOURSE trial (n = 800 patients) and found that KRASG12 mutations (n = 279) were predictive biomarkers for reduced overall survival (OS) benefit of FTD/TPI versus placebo (unadjusted interaction P = 0.0031, adjusted interaction P = 0.015)....In conclusion, these data show that KRASG12 mutations are biomarkers for reduced OS benefit of FTD/TPI treatment, with potential implications for approximately 28% of patients with mCRC under consideration for treatment with FTD/TPI.
DOI:https://doi.org/10.1038/s41591-023-02240-8
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutation Μια Πολυκεντρική, Τυχαιοποιημένη, Ανοιχτού Σχεδιασμού, Ελεγχόμενη με Δραστικό Φάρμακο Δοκιμή Φάσης 3 του Συνδυασμού Σοτορασίμπης και Πανιτουμουμάμπης Έναντι της Θεραπείας Επιλογής του Ερευνητή (Τριφλουριδίνη και Τιπιρακίλη, ή Ρεγοραφενίμπη) για την Αντιμετώπιση Ασθενών που Φέρουν τη Μετάλλαξη KRAS p.G12C και Είχαν Λάβει Προηγούμενη Θεραπεία για Μεταστατικό Ορθοκολικό Καρκίνο
Excerpt:...101Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.102Age ≥ 18 years103Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation as determined by central testing104Subjects will have received at least 1 prior line of therapy for metastatic disease. ...