Prospective, Post Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck in Korea

• Frequency of Adverse Events [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  The frequency and severity of all adverse events, regardless of the causal relationship to Erbitux, will be measured within 6 years of the observational period from the approval date of the new indication
  
  

• Clinical efficacy [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  The duration of control of locoregional disease, 1-year/2-year/3-year locoregional control rate, best tumor response will be measured within the observational period from the approval date of the new indication
  
  

Drug: Cetuximab
Subjects will be treated according to the national label of cetuximab in combination with radiation therapy.
Other Name: Erbitux

This is a prospective, Post Marketing Surveillance (PMS) study on Erbitux® (Cetuximab) in patients with locally advanced or recurrent and/or metastatic squamous cell cancer of the head and neck in Korea

This prospective study will collect safety information from more than 300 subjects treated with Erbitux as final evaluable cases. During the PMS period, subject background, subject's medical (surgery, anti-cancer treatment) history, Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all adverse events (AEs; regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected for the study purpose.

The PMS is based on all cases treated with Erbitux at least once. The PMS will be done within 6 years from the approval date of the new indication. This PMS is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, it is further required to investigate more than 300 subjects during 6 years according to local regulations to continue monitoring and provide further information about safety and toxicity in clinical practice.

OBJECTIVES Analysis on safety and efficacy information on the use of Erbitux in the market and factors affecting its safety and efficacy.

Primary objective:

• To obtain safety information on the use of Erbitux in subjects with locally advanced SCCHN or recurrent and/or metastatic in terms of frequency and severity of AEs

Secondary objectives:

• To gather clinical efficacy information of the treatment