Patients
hepatic, cardiac and bone marrow function, ascites, pulmonary fibrosis, toxicity, active malignancies, infection, diabetes
BRAIN METASTASIS, ASCITES, PULMONARY FIBROSIS, TUMOURS, POLAND, INFECTION, ONCOLOGY, DIABETES
Patients were enrolled in 16 countries (Australia, Belgium, Brazil, Bulgaria, Croatia, France, Ireland, Italy, Panama, Poland, Portugal, Romania, Slovakia, Slovenia, Turkey, and Ukraine) and treated between October 2016 and November 2020. Eligible patients with mCRC were refractory to, or not candidates for, standard chemotherapies and had received ≥2 previous regimens of standard chemotherapies for mCRC (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-vascular endothelial growth factor monoclonal antibody and ≥ 1 epidermal growth factor receptor monoclonal antibodies for RAS wild-type tumours), an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 during the screening period, and adequate renal (creatinine clearance ≥60 ml/min assessed with the Cockcroft-Gault formula), hepatic, cardiac and bone marrow function.Exclusion criteria were: pregnancy, breast feeding or likely to become pregnant during the study; participation in another interventional study within 4 weeks of entering PRECONNECT; previously receiving or hypersensitive to FTD/TPI or excipients; had other active malignancies, brain metastasis, active infection, ascites, pulmonary fibrosis or uncontrolled diabetes; had major surgery within 4 weeks, and anticancer therapy within 3 weeks or bevacizumab treatment within 4 weeks, radiation therapy within 4 weeks; or any unresolved grade 2 or higher toxicity attributed to previous therapy.