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NCT01532687 · OUTCOME

Overall Survival

Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma · Source last updated 2021-09-27

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 due to any cause, or until last patient contact if the patient did not die, assessed up to 3 years

What was measured

Two treatment arms will be compared using a one-sided log-rank test stratified by sarcoma subtype and study site. Kaplan-Meier estimates and the survival curves for each treatment arm will be presented with the estimated hazard ratios and their associated confidence interval.

Analysis population: All randomized participants

Groups in this outcome

Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO

Gemcitabine Hydrochloride Plus Placebo

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO Placebo Administration: Given PO

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

Analysis denominator · Participants

GroupSource count
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride29
Gemcitabine Hydrochloride Plus Placebo25

Reported measurements

All Randomized

Analysis denominator · Participants

GroupSource count
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride29
Gemcitabine Hydrochloride Plus Placebo25
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride11.0Not reported9.620.7Not reported
Gemcitabine Hydrochloride Plus Placebo15.6Not reported6.127.0Not reported
Liposarcoma participants

Analysis denominator · Participants

GroupSource count
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride9
Gemcitabine Hydrochloride Plus Placebo7
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride20.5Not reported11.0NAUpper limit was not estimable because there was no observed death time greater than the median survival that touched or crossed -1,96 using the log-transformation of the survival function (ref: Formula 4.5.5, Klein JP and Moeschberger ML, Survival Analysis: Techniques for censored and truncated data). This is likely due to small sample size (n = 9).
Gemcitabine Hydrochloride Plus Placebo5.7Not reported3.5NAUpper limit was not estimable due to small sample size (n = 7) and failure to cross the 25% line.
Other Sarcoma participants

Analysis denominator · Participants

GroupSource count
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride20
Gemcitabine Hydrochloride Plus Placebo18
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride10.2Not reported7.620.7Not reported
Gemcitabine Hydrochloride Plus Placebo17.7Not reported7.630.7Not reported

Source statistical analyses

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

  1. group Description
    Overall survival estimated among all randomized participants (n = 54)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.
    non Inferiority Type
    OTHER
    p Value
    0.481
    statistical Method
    Gehan-Wilcoxon
  2. group Description
    Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.
    non Inferiority Type
    OTHER
    p Value
    0.353
    statistical Method
    Gehan-Wilcoxon
  3. group Description
    Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.
    non Inferiority Type
    OTHER
    p Value
    0.408
    statistical Method
    Gehan-Wilcoxon
Complete source fields
analyses
  1. group Description
    Overall survival estimated among all randomized participants (n = 54)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.
    non Inferiority Type
    OTHER
    p Value
    0.481
    statistical Method
    Gehan-Wilcoxon
  2. group Description
    Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.
    non Inferiority Type
    OTHER
    p Value
    0.353
    statistical Method
    Gehan-Wilcoxon
  3. group Description
    Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.
    non Inferiority Type
    OTHER
    p Value
    0.408
    statistical Method
    Gehan-Wilcoxon
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.6
        upper Limit
        20.7
        value
        11.0
      2. group Id
        OG001
        lower Limit
        6.1
        upper Limit
        27.0
        value
        15.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    All Randomized
  2. categories
    1. measurements
      1. comment
        Upper limit was not estimable because there was no observed death time greater than the median survival that touched or crossed -1,96 using the log-transformation of the survival function (ref: Formula 4.5.5, Klein JP and Moeschberger ML, Survival Analysis: Techniques for censored and truncated data). This is likely due to small sample size (n = 9).
        group Id
        OG000
        lower Limit
        11.0
        upper Limit
        NA
        value
        20.5
      2. comment
        Upper limit was not estimable due to small sample size (n = 7) and failure to cross the 25% line.
        group Id
        OG001
        lower Limit
        3.5
        upper Limit
        NA
        value
        5.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    Liposarcoma participants
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.6
        upper Limit
        20.7
        value
        10.2
      2. group Id
        OG001
        lower Limit
        7.6
        upper Limit
        30.7
        value
        17.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Other Sarcoma participants
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Two treatment arms will be compared using a one-sided log-rank test stratified by sarcoma subtype and study site. Kaplan-Meier estimates and the survival curves for each treatment arm will be presented with the estimated hazard ratios and their associated confidence interval.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO
    id
    OG000
    title
    Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride
  2. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO Placebo Administration: Given PO
    id
    OG001
    title
    Gemcitabine Hydrochloride Plus Placebo
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to death due to any cause, or until last patient contact if the patient did not die, assessed up to 3 years
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice