5-fluorouracil (5-FU) is a standard of care in frail/elderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. In this study, We assess the safety and efficacy of 5FU combination with Panitumumab and Sotorasib as first-line treatment in frail/elderly patients with unresectable KRAS G12C mutated CRC
Age ≥ 18 years.
Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma.
Proven KRAS G12C mutation as locally assessed by means of an IVDR-compliant test
Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency.
Patients with high microsatellite instability (MSI-H) or a tumour with mismatched repair (dMMR).
Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments).
Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL).
Single group
Administration of experimental treatment association (sotorasib, panitumumab 5FU)
DrugPanitumumab is administered at a dose of 6 mg/kg via intravenous infusion over one hour during the first cycle, and over 30 minutes from the second cycle onward. The LV5FU2 regimen includes folinic acid (400 mg/m², or 200 mg/m² if levo-leucovorin is used) as a two-hour IV infusion, followed by a 5-FU bolus (400 mg/m² over 10 minutes), and a continuous 5-FU infusion (2400 mg/m² over 46 hours). Sotorasib is given orally at a dose of 960 mg once daily on a continuous basis.
Percentage of patient alive or without progression 8 months after inclusion.
Progression will be assessed by the investigator according to recist 1.1 based on images performed every 8 weeks even in case of deferred treatments. Clinical progression will not be considered as an event.
Overall survival (OS)
Overall survival was defined as the time from the date of inclusion to the patient's death (all causes). For alive patients, the date of the latest news was taken into account.
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Federation Francophone de Cancerologie Digestive
Lead sponsor
Northwest Oncology Cooperative Group(GONO)
Collaborator
Arbeitsgemeinschaft fur Internistische Onkologie
Collaborator
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborator
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