| Background and Objective:Cetuximab (cetuximab, C225) is a receptor for epidermal growth factor(EGFR) targeted drugs, a number of clinical studies in foreign countries has shown its efficacy in head and neck squamous cell cancer, and was approvalled the joint with radiation therapy for locally advanced head and neck squamous cell carcinoma by EMEA in April 2006. This paper aims to observe the short term efficiency and safety of Cetuximab combined with radiotherapy of head and neck squamous Cell carcinoma in Chinese patients.Methods:The implementation of the trial is in accordance with EMR 62241-054 study, EMR 62241-054 study is an open-lable, Single-arm, multi-center, phaseâ…¢clinical trial to assess the antitumor activity and safety profile of Cetuximab when given in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck in Chinese subjects, and a total of eight centers all over the country carry out this program. This article selected eight patients with locally advanced head and neck squamous cell carcinoma in oncology department of Xiangya Hospital, Central South University between Apr 2009 to Apr2010. The patients received radiotherapy plus weekly doses of cetuximab:400 mg/m2 initial dose, followed by six weekly doses at 250 mg/m2. The radiotherapy program a total dose of 72.0 Gy, which is divided into 42 times for 6 weeks. At the first period patients received 1.8Gy per day for conventional radiotherapy,5 times per week, and the total dose is 32.4 Gy. At the second period, patients received 2 fractions per day since the beginning of the post-course accelerated hyperfractionation treatment, the morning dose was 1.8 Gy per time,5 times per week, a total of 2.4 weeks and total dose is 21.6 Gy; afternoon on the primary tumor and positive lymph node using conformal radiotherapy up amount of radiation 1.5 Gy per fraction,5 times per week, a total of 2.4 weeks, a total of irradiation 18 Gy. Following completion of treatment, patients underwent physical examination and radiographic imaging at the end of the treatment, also at the 2months and 3months thereafter. We observed the acute toxicity, monitored the blood and urine routine, blood biochemical indicators, analysis the recent efficacy and safety of cetuximab plus radiotherapy for the Chinese patients with locally advanced head and neck squamous cell carcinoma.Results:7 patients have completed the treatment,1 patient is still hospitalized. Objective response, spiral CT evaluation of the 7 patients at the end of the treatment shows that 4 cases effective PR,3 patients SD, including one patient with Cetuximab allergies, who only received hyperfractionated radiotherapy.7 patients were reviewed in two months after treatment and all reached PR.3 months after completion of therapy review, except one patient received radiotherapy only was SD, the other 6 cases were PR, 100% efficient. Mucositis was the most common toxic effect, and encountered in 8 patients, including 1 case of 3 degrees,2 degrees in 7 cases.8 patients had 3 cases of acne-like rash, including 1 case of 1 degree,2 degrees in 2 cases. One patients with 3 degrees cetuximab allergic reaction occurred during first infusion, after the relevant treatment of symptoms without sequelae. Furthermore,1 patient 2 degrees weight loss. Hematological toxicity, one case of 3 degrees white blood cells dropped,2 degrees in 1 case,1 degree in 1 case,1 case of 2 degrees hemoglobin decrease,2 degrees of platelet decline in 1 case.Conclusion:1 Cetuximab plus radiotherapy is effective for patients with locally advanced head and neck squamous cell carcinoma;2 Cetuximab is security and reliable;3. In this trail, a few of patients had heavier mucositis which affected the treatment, the radiotherapy may be adjusted.
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