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NCT01532687 · OUTCOME

Progression-free Survival (PFS)

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
Calculated as the time from randomization to the first documented progression or death, whichever occurs first, or until time of last contact if no progression or death occurred, assessed up to 3 years

What was measured

Compared using a one-sided Gehan-Wilcoxon test stratified by sarcoma subtype. Kaplan-Meier estimates for each treatment arm will be presented with the estimated hazard ratios and their associated confidence intervals. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions.

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 Hydrochloride4.5Not reported3.08.5Not reported
Gemcitabine Hydrochloride Plus Placebo1.6Not reported1.44.3Not reported
Liposarcoma

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 Hydrochloride8.9Not reported4.3NAThere were not sufficient events to define the upper limit of the confidence interval (two out of nine participants progressed)
Gemcitabine Hydrochloride Plus Placebo1.5Not reported1.0NADue to the small sample size (n = 7) the upper confidence limit was not estimable (did not cross the 50% line)
Other Sarcoma

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 Hydrochloride4.4Not reported3.08.8Not reported
Gemcitabine Hydrochloride Plus Placebo2.2Not reported1.44.6Not reported

Source statistical analyses

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

  1. group Description
    Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.
    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
    SUPERIORITY
    p Value
    0.017
    statistical Method
    Gehan-Wilcoxon
  2. group Description
    Comparison between the two arms for the liposarcoma subgroup
    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
    0.195
    statistical Method
    Gehan-Wilcoxon
  3. group Description
    Statistical results are for the 'other' sarcoma subgroup (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
    0.079
    statistical Method
    Gehan-Wilcoxon
Complete source fields
analyses
  1. group Description
    Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.
    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
    SUPERIORITY
    p Value
    0.017
    statistical Method
    Gehan-Wilcoxon
  2. group Description
    Comparison between the two arms for the liposarcoma subgroup
    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
    0.195
    statistical Method
    Gehan-Wilcoxon
  3. group Description
    Statistical results are for the 'other' sarcoma subgroup (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
    0.079
    statistical Method
    Gehan-Wilcoxon
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        8.5
        value
        4.5
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        4.3
        value
        1.6
    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
        There were not sufficient events to define the upper limit of the confidence interval (two out of nine participants progressed)
        group Id
        OG000
        lower Limit
        4.3
        upper Limit
        NA
        value
        8.9
      2. comment
        Due to the small sample size (n = 7) the upper confidence limit was not estimable (did not cross the 50% line)
        group Id
        OG001
        lower Limit
        1.0
        upper Limit
        NA
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    Liposarcoma
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        8.8
        value
        4.4
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        4.6
        value
        2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Other Sarcoma
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Compared using a one-sided Gehan-Wilcoxon test stratified by sarcoma subtype. Kaplan-Meier estimates for each treatment arm will be presented with the estimated hazard ratios and their associated confidence intervals. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions.
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
Calculated as the time from randomization to the first documented progression or death, whichever occurs first, or until time of last contact if no progression or death occurred, assessed up to 3 years
title
Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice