6533b834fe1ef96bd129cb39

RESEARCH PRODUCT

Dermatux: Phase IV trial of C-FOLFIRI in 1st-line metastatic colorectal cancer receiving a pre-defined skin care.

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e15048Background: Dose- and treatment limiting cetuximab-induced skin rash ≥ 3° occur in 18% of colorectal cancer (CRC) patients. Survival, response and toxicity parameters were re-evaluated under a pre-defined skin prophylaxis consistent of vitamin K1 ointment and oral doxycycline. Methods: This is a national, phase IV, multicenter, 1st-line CRC trial (N = 165, KRAS wt, EGFR +, ECOG 0/1) in UICC stage 4 patients. Patients received irinotecan 180 mg/m² (d1) , folinic acid 400 mg/m² (d1), and 5-FU 400 mg/m² (d1, d2) and cetuximab ( 400 mg² (d1), then 250 mg/m² qw). Concurrently, patients received 0.1% vitamin K1 ointment qd and oral doxycycline 100 mg bid. Upon occurrence of rash ≥ 3°, an additional topical corticoid ointment bid and cetuximab dose-reduction according the license were applied. If rash 4° occurred, cetuximab was stopped. Primary objective: 1-year PFS rate; secondary objectives: rash ≥ 2°, time to occurrence of rash ≥ 2°, paronychia and skin fissures, response rate (RR), progression free sur...