J Korean Med Sci.  2007 Sep;22(Suppl):S98-S103. 10.3346/jkms.2007.22.S.S98.

A Phase II Study of Cetuximab (Erbitux(R)) plus FOLFIRI for Irinotecan and Oxaliplatin-refractory Metastatic Colorectal Cancer

• Koo DH
• Lee JL
• Kim TW
• Chang HM
• Ryu MH
• Lee SS
• Kim MK
• Sym SJ
• Lee JS
• Kang YK

• KMID: 1785796
• DOI: http://doi.org/10.3346/jkms.2007.22.S.S98

Abstract

We have evaluated the efficacy and safety of cetuximab plus FOLFIRI for irinotecan and oxaliplatin-refractory colorectal cancers. From September 2004 to February 2006, 31 patients with metastatic colorectal cancer were treated with cetuximab (400 mg/m2 intravenously [IV] over 2 hr on day 1 followed by weekly 1-hr infusions of 250 mg/m2) plus bi-weekly FOLFIRI (irinotecan 150 mg/m2 IV over 90 min, and leucovorin 100 mg/m2 IV over 2 hr, followed by 5-FU 400 mg/m2 IV bolus on day 1, and followed by 5-FU 2,400 mg/m2 by continuous IV over 46 hrs). Patients received a median of four cycles (range: 1-23). Eight (25.8%) patients had confirmed partial responses and 10 (32.2%) had stable disease. After a median follow-up of 13.2 months for surviving patients, the median time to progression was 2.9 months, the median duration of response was 5.4 months, and the median overall survival was 10.9 months. Skin toxicity was observed in 25 patients (80.4%) including grade 3 in 6 patients (19.4%). Other common non-hematologic toxicities of all grades were mucositis (32.3%), asthenia (22.6%), diarrhea (12.9%), and paronychial cracking (12.9%). The combination of cetuximab with FOLFIRI was effective and tolerable in colorectal cancer patients heavily pretreated with a number of chemotherapy regimens.

Keyword

Cetuximab; Irinotecan; Oxaliplatin; Chemotherapy; Colorectal Neoplasms

MeSH Terms

Adult
Aged
Antibodies, Monoclonal/*administration & dosage/adverse effects
Antineoplastic Agents/*administration & dosage/adverse effects
Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse
Camptothecin/administration & dosage/adverse effects/analogs & derivatives
Colorectal Neoplasms/*drug therapy/secondary
Drug Resistance, Neoplasm
Female
Fluorouracil/administration & dosage/adverse effects
Humans
Leucovorin/administration & dosage/adverse effects
Male
Middle Aged
Organoplatinum Compounds/pharmacology
Prognosis
Receptor, Epidermal Growth Factor/antagonists & inhibitors
Safety

Figure

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  Fig. 1 Survival curves; (A) Time to progression and (B) Overall survival.

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