A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.

Time frame: Baseline to the end of the study (up to 5 years 8 months)

Population: Intent-to-treat population: All participants randomized into the study.

Time frame: Throughout study

BOR was defined as the best response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\], not evaluable \[NE\], or not assessed \[NA\]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.

Time frame: Baseline to the end of the study (up to 5 years 8 months)

Population: Intent-to-treat population: All participants randomized into the study. Only participants with a response were included in the analysis.

Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.

Time frame: Baseline to the end of the study (up to 5 years 8 months)

Population: Intent-to-treat population: All participants randomized into the study.

Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.

Time frame: Baseline to the end of the study (up to 5 years 8 months)

Population: Intent-to-treat population: All participants randomized into the study. Only participants with a complete response or partial response were included in the analysis.

The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, \< 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, \> 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.

Time frame: Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).

Population: Intent-to-treat population: All participants randomized into the study.

Overall survival was defined as the time in months from randomization to death from any cause.

Time frame: Baseline to the end of the study (up to 5 years 8 months)

Population: Intent-to-treat population: All participants randomized into the study.

Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.

Time frame: Baseline to the end of the study (up to 5 years 8 months)

Population: Intent-to-treat population: All participants randomized into the study.

Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.

Time frame: Baseline to the end of the study (up to 5 years 8 months)

Population: Intent-to-treat population: All participants randomized into the study.