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

Study Overview
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Brief Summary
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This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.

Official Title
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Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 75 years of age Metastatic colorectal cancer Initiating Avastin first-line therapy in combination with chemotherapy Exclusion Criteria: Previous Avastin therapy Patient participating in a clinical study evaluating a cytotoxic anti-cancer therapy and/or an investigational new drug

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | 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. | From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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. | From the time of first dose of study treatment to the time of death from any cause (Up to 53 months) | 
| Percentage of Participants With Bevacizumab Administration |  | Up to 36 months | 
| Percentage of Participants With Adverse Events (AEs) | 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. | Up to 53 months | 
| Percentage of Participants With Activities of Daily Living (ADL) | 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. | Baseline, Month 6, 12, 24 | 
| Lawton Instrumental Activities of Daily Living Score (IADL) | 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. | Baseline, Month 6, 12, 24 | 
| Percentage of Participants With Balducci Score | 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. | Baseline, Month 6, 12, 24 |