Adverse Drug Reaction

Study results from Oita University provide new insights into solid cancer

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"Thirty patients were enrolled in the study; 29 with colorectal adenocarcinomas and one with an adenocarcinoma of the lung. received an initial/weekly infusion of cetuximab at dose levels of 100/100 (dose level 1), 250/250 (dose level 2), 400/250 (dose level 3), 500/250 (dose level 4) or 400/250 (dose level 5) mg/m(2), for 7 or more weeks, with an interval between the initial and second infusion of 1 (dose level 5 representing the standard regimen) or 2 weeks (dose levels 1-4 of the non-standard regimens). No dose-limiting toxicities (DLTs) were observed during the evaluation period. All patients had at least one adverse event (AE). The most common cetuximab-related AEs were skin toxicity (93% of patients), including acneiform dermatitis (83% of patients). Two patients experienced cetuximab-related grade 3 AEs of skin toxicity and diarrhea after DLT evaluation. C (max) and AUC(0-a) after the initial infusion showed dose-proportional increases. Mean total body clearance (CL) values decreased with dose at the lower dose levels. At doses of a parts per thousand yen400 mg/m(2), CL values appeared to level off. Mean trough concentrations for dose level 5 were constant from week 4 (day 29) onward. Two patients (8%) achieved partial response (at 100/100 mg/m(2)). The overall disease control rate (partial response + stable disease) was 58%. The current study demonstrated that cetuximab PK and safety profiles are similar between Japanese and non-Japanese patient populations," wrote K. Shirao and colleagues, Oita University.

The researchers concluded: "It would appear that the standard dose of an initial 2-h infusion of 400 mg/m(2) followed thereafter by weekly 1-h infusions of 250 mg/m(2) for non-Japanese patients is feasible for future clinical studies in Japanese patients."

Shirao and colleagues published their study in Cancer Chemotherapy and Pharmacology (A phase I escalating single-dose and weekly fixed-dose study of cetuximab pharmacokinetics in Japanese patients with solid tumors. Cancer Chemotherapy and Pharmacology, 2009;64(3):557-564).

For additional information, contact K. Shirao, Oita University, Dept. of Med Oncology, Faculty Medical, 1-1 Idaigaoka, Oita 8795593, Japan.

The publisher's contact information for the journal Cancer Chemotherapy and Pharmacology is: Springer, 233 Spring St., New York, NY 10013, USA.

Keywords: Japan, Oita, Adenocarcinoma, Adverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Biotechnology, Cetuximab, Chemotherapy, Clinical Trial Research, Colorectal, Drug Therapy, Drugs, Gastroenterology, Infectious Disease, Medical Device, Monoclonal Antibodies, Monoclonal Antibody, Oncology, Pharmaceuticals, Pharmacokinetics, Pharmacology, Pulmonology, Respiratory Infection, Solid Cancers, Solid Carcinomas, Therapies, Therapy, Treatment, Oita University.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.