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NCT00738530 · OUTCOME

Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy · Source last updated 2016-06-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)

What was measured

Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to mRECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: \>=30% decrease under baseline of the sum of the LD of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.

Analysis population: ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.

Groups in this outcome

Bevacizumab + IFN-Alfa-2A

Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

Placebo + IFN-Alfa-2A

Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bevacizumab + IFN-Alfa-2A306
Placebo + IFN-Alfa-2A289

Reported measurements

Complete Response (CR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A1.6Not reportedNot reportedNot reportedNot reported
Placebo + IFN-Alfa-2A2.4Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A30.7Not reportedNot reportedNot reportedNot reported
Placebo + IFN-Alfa-2A10.0Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A44.4Not reportedNot reportedNot reportedNot reported
Placebo + IFN-Alfa-2A50.5Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A20.6Not reportedNot reportedNot reportedNot reported
Placebo + IFN-Alfa-2A33.2Not reportedNot reportedNot reportedNot reported
Missing (no response assessment)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A2.6Not reportedNot reportedNot reportedNot reported
Placebo + IFN-Alfa-2A3.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
      2. group Id
        OG001
        value
        2.4
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30.7
      2. group Id
        OG001
        value
        10.0
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        44.4
      2. group Id
        OG001
        value
        50.5
    title
    Stable Disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        20.6
      2. group Id
        OG001
        value
        33.2
    title
    Progressive Disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2.6
      2. group Id
        OG001
        value
        3.8
    title
    Missing (no response assessment)
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      289
    units
    Participants
description
Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to mRECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: \>=30% decrease under baseline of the sum of the LD of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.
groups
  1. description
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    id
    OG000
    title
    Bevacizumab + IFN-Alfa-2A
  2. description
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    id
    OG001
    title
    Placebo + IFN-Alfa-2A
param Type
NUMBER
population Description
ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.
reporting Status
POSTED
time Frame
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
title
Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice