A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

Экспериментальный: Bevacizumab + Chemotherapy

Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Лекарство: 5-Fluorouracil

Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.

Лекарство: Bevacizumab

Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.

Другие имена:

• Авастин

Лекарство: Irinotecan

Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Лекарство: Oxaliplatin

Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Percentage of Participants With Adverse Events

An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.

Percentage of Participants Who Died

Duration of Survival

Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.

Percentage of Participants With Disease Progression or Death

Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).

Progression-Free Survival Time

Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.

Number of Participants With Best Overall Response

The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.

Mean Direct Medical Cost for Cancer Related Medical Care Utilization

Direct medical cost included cost of out-patient consultation and cost of hospitalization.