This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.
Study Type
OBSERVATIONAL
Enrollment
609
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Changzhou, China
Percentage of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
Time frame: 36 months
Percentage of Participants With Serious Adverse Events
A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
Time frame: 36 months
Percentage of Participants With Adverse Events of Special Interest
Time frame: 36 months
Percentage of Participants With Bevacizumab-Related Adverse Events
Time frame: 36 months
Percentage of Participants With Bevacizumab-related Serious Adverse Events
Time frame: 36 months
Percentage of Participants Achieving an Overall Response
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.
Time frame: 36 months
Progression-free Survival
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Unnamed facility
Chengdu, China
Unnamed facility
Fuzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Hangzhou, China
...and 14 more locations
Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.
Time frame: 36 months
One-year Progression-free Survival Rate
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.
Time frame: 1 year
One-year Survival Rate
Time frame: 1 year
Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
Time frame: 36 months
One-year Progression-free Survival Rate Per KRAS Subgroup
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
Time frame: 1 year
One-year Survival Rate by the KRAS Subgroup
Time frame: 1 year
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.
Time frame: Up to 36 Months
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.
Time frame: 1 year
One-year Survival Rate by the Chemotherapy Regimen Subgroup
Time frame: 1 year
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.
Time frame: Up to 36 Months