Trial Information

Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

The medical record review will be conducted for 3 rounds in months 0, 12, and 24 after the
first medical record abstraction. Before the beginning of the study, a sampling list will
be created by Amgen by merging lists of oncologists (and their contact information) to be
collected from Cegedim, the ESMO, from major cancer centers and oncology clinics in 5
countries of Europe, including France, Germany, Italy, Spain and the Czech Republic. In each
round of medical record review, potential participating oncologists will be randomly sampled
from all identified oncologists. Potential oncologists will be contacted by letter,
telephone or email. The oncologists will be introduced to the study, and their eligibility
to participate in the study will be assessed using a standardized questionnaire. The number
of oncologists sampled per country will be proportional to the number of oncology centers
per country. The minimum and maximum for the number of oncologists in each country for each
round of medical record review are proposed to be: 10-20 for France and Germany; 5-10 for
Italy, Spain and Czech Republic, such that 50 oncologists participate in each round of the
study. We will attempt to sample the numbers of oncologists in each country according to
these ranges. From each eligible participating oncologist, study staff will then obtain 3 or
more medical records for patients who have received Vectibix for the treatment of mCRC
during the 6-month period prior to the time of contact with the relevant oncologist and are
not involved in an experimental clinical trial when treated with Vectibix. A written
consent may be obtained from participating patients to access their medical records,
depending on local laws. Medical information will be abstracted from the medical records
using standardized forms. Such medical information will include the occurrence and timing of
treatment with Vectibix and oxaliplatin-containing chemotherapy, diagnosis of mCRC and the
occurrence, timing and results of KRAS testing. The oncologist will also be asked to collect
information from the pathology laboratory that performed the KRAS mutation test on the
patient, using a standardized pathology data extraction form.