An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases

Study Overview
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Brief Summary
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This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.

Official Title
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A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases First-line treatment with bevacizumab for potentially resectable metastatic disease Exclusion Criteria: Outright resectable disease Clearly inoperable disease Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Bevacizumab<br>Participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases will be observed. | Drug: Bevacizumab<br>* Participants with mCRC and having exclusively liver or liver and lung metastases who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion will be observed. All concomitant medications as used in routine clinical practice are allowed.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery | Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place [missing metastases]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI). | Baseline up to 36 months | 
| Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery | The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported. | Baseline up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Disease and Comorbidity at Day 0 | Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category. | Day 0 | 
| Percentage of Participants With Different Previous Therapies at Day 0 | Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX [folinic acid+5-fluorouracil+oxaliplatin], LV5FU2 [leucovorin+5-Fluorouracil], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported. | Day 0 | 
| Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period |  | Baseline up to 36 months | 
| Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period |  | Baseline up to 36 months | 
| Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment | Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category. | Baseline up to 36 months | 
| Percentage of Participants With Disease Progression or Death | Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions. | Baseline until disease progression or death, whichever occurred first, assessed up to 36 months | 
| Progression-free Survival (PFS) | Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions. | Baseline until disease progression or death, whichever occurred first, assessed up to 36 months | 
| Percentage of Participants With Disease Relapse | Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion [participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions. | Baseline until disease progression or death, whichever occurred first, assessed up to 36 months | 
| Relapse-free Survival (RFS) | RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion [participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions. | Baseline until disease progression or death, whichever occurred first, assessed up to 36 months | 
| Percentage of Participants Who Died |  | Baseline until death; assessed up to 36 months | 
| Overall Survival (OS) | OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation. | Baseline until death, assessed up to 36 months | 
| Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery | For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%). | Baseline up to 36 months | 
| Number of Cumulated Cycles of First Line Bevacizumab at Day 0 |  | Day 0 | 
| Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0 |  | Day 0 | 
| Total Duration of First Line Bevacizumab Treatment at Day 0 |  | Day 0 | 
| Percentage of Participants With Unresectability Criteria |  | Day 0 |