SAFETY REPORT OF A PHASE II TRIAL OF IRINOTECAN PLUS S-1 (IRIS) WITH CETUXIMAB IN PRE-TREATED PATIENTS WITH KRAS WILD TYPE OF METASTATIC COLORECTAL CANCER: HGCSG0902

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Abstract

Background

IRIS is one of the standard regimens as second line treatment in metastatic colorectal cancer since IRIS demonstrated the non-inferiority to FOLFIRI (FIRIS study) in Japan. We previously presented IRIS plus bevacizumab (ESMO 2010), however; there is still lack of combination data of IRIS plus molecular target drugs. Thus we conduct the study of IRIS plus cetuximab (HGCSG0902) and this is the planned safety analysis for first 20 patients.

Methods

HGSCG0902 is a multicenter phase ll study. Eligibility includes histologically confirmed colorectal cancer, previously received oxaliplatin-contained chemotherapy, PS: 0-1, EGFR positive and KRAS wild type. Patients received S-1 80-120 mg/m2/day p.o. on days 1–14 and irinotecan 100 mg/m2 on days 1 and 15 repeated 28 days. Cetuximab administrated 400 mg/m2 loading dose and continued 250 mg/m2 every week or 500 mg/m2 bi-weekly. The primary end point was response rate and the secondary end points were disease control rate, PFS, OS and safety.

Results

Demographics of the 20 enrolled patients were male/female: 13/7, median age: 64.5, colon/rectal: 13/7, PS0/1: 12/8, prior bevacizumab ±: 15/4 patients. Cetixumab were administrated weelkly/bi-weekly: 9/11 patients. 70% of patients had adverse events (AE). The most common non-hematological AE were diarrhea (85%), acne-like rash (80%), fatigue (75%) and anorexia (60%) and hematological AE were anemia (90%), AST increase (75%) and ALT increase (70%). The main grade 3-4 AE were diarrhea (45%), acne-like rash (20%), anorexia (20%) and stomatitis (20%). These AE were as expected. Nineteen patients stopped the treatment due to progression (52.6%) and AE (36.8%).

Conclusions

This safety analysis suggests that IRIS plus cetuximab is well-tolerated and easy to administer.

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