An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame: From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)

Population: The efficacy population (EFF) included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in study was collected for overall participants and not as per dose administered.

The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people.

Time frame: Baseline, Month 6, 12, 24

Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.

Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death.

Time frame: From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)

Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.

The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent.

Time frame: Baseline, Month 6, 12, 24

Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.

An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Time frame: Up to 53 months

Population: Safety population included all participants who had at least one infusion of bevacizumab. Data in the study was collected for overall participants and not as per dose administered to participants.

Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes.

Time frame: Baseline, Month 6, 12, 24

Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.

Time frame: Up to 36 months

Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation.