Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients

This is a multi-center retrospective matched cohort study of early and late stage CRC
patients who received 5-FU doses determined using body surface area (BSA) and in patients
who underwent pharmacokinetically (PK)-guided 5-FU dose monitoring and adjustment. A
retrospective chart / electronic medical record review of colorectal cancer patients treated
with infusional 5-FU regimens between May 1, 2009 and December 31, 2013, satisfying the
inclusion/exclusion criteria, will be performed. In this multi-center study, patients who
underwent PK-testing during at least two different 5-FU administrations will be matched to
patients who received doses based on their BSA, treated at the same institution. Matching
for selection of the BSA cohort at each site will be done using the following criteria
(based on factors that may influence 5-FU metabolism): age, gender, disease stage, prior
chemotherapy treatment, and 5-FU containing treatment regimen being used. Each patient will
be assigned a random five-digit Study ID number to protect patient confidentiality. Minimal
medical history/demographics data will be collected from the patient's medical records /
clinic chart using paper case report forms (CRFs). The data to be collected from each
patient's records will include: patient demographics (i.e. gender, age, height, and race),
colorectal cancer diagnosis (i.e. date of primary diagnosis, tumor stage, grade, histology
and phenotype, and date of metastatic diagnosis and sites of metastases if applicable), use
of prior therapies for treatment of CRC, 5-FU containing regimen details throughout the 5-FU
treatment (i.e. weight, BSA, ECOG status, doses of each drug used in the regimen, and 5-FU
infusion start/stop dates and times), 5-FU PK testing results (if applicable), concomitant
procedures and medications, CBC and chemistry testing results, adverse events experienced
during 5-FU therapy regimen, and tumor response and follow-up information. Patients will not
be contacted for the purposes of this study and a waiver of HIPAA authorization will be
requested from the appropriate IRB. Once data has been collected and monitored, all records
tying the random Study ID number to a specific patient at the sites will be destroyed,
rendering all information de-identified.

Inclusion Criteria:

- Male or female patients 18 years of age or older.

- Patients with histologically confirmed colorectal cancer who were treated with an
infusional 5-FU regimen between May 1, 2009 and December 31, 2013.

- PK-Guided Cohort: Patients monitored with 5-FU PK-testing at a minimum of two
administrations of 5-FU throughout the course of a single infusional 5-FU containing
treatment regimen.

- BSA Cohort: Patients who received infusional 5-FU doses calculated based on their
BSA.

Exclusion Criteria:

- Patients less than 18 years of age.

- Patients with concurrent treatment of other active malignancies.

- Patients that underwent radiation therapy concurrently with chemotherapy.