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NCT00844649 · OUTCOME

Overall Survival (OS)

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas · Source last updated 2019-11-25

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.

What was measured

Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.

Analysis population: Intent to Treat population (ITT population) consisted of all randomized participants.

Groups in this outcome

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine

Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest

Gemcitabine

Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

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

Analysis denominator · Participants

GroupSource count
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine431
Gemcitabine430

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine8.5Not reported7.899.53Not reported
Gemcitabine6.7Not reported6.017.23Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.617
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.835
    estimate Comment
    Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis
    param Type
    Hazard Ratio (HR)
    param Value
    0.72
    statistical Method
    Stratified Log-rank Test
Complete source fields
analyses
  1. ci Lower Limit
    0.617
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.835
    estimate Comment
    Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis
    param Type
    Hazard Ratio (HR)
    param Value
    0.72
    statistical Method
    Stratified Log-rank Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.89
        upper Limit
        9.53
        value
        8.5
      2. group Id
        OG001
        lower Limit
        6.01
        upper Limit
        7.23
        value
        6.7
denoms
  1. counts
    1. group Id
      OG000
      value
      431
    2. group Id
      OG001
      value
      430
    units
    Participants
description
Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
dispersion Type
95% Confidence Interval
groups
  1. description
    Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
    id
    OG000
    title
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
  2. description
    Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
    id
    OG001
    title
    Gemcitabine
param Type
MEDIAN
population Description
Intent to Treat population (ITT population) consisted of all randomized participants.
reporting Status
POSTED
time Frame
From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice