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NCT01964300 · OUTCOME

Progression-free Survival (PFS)

Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery · Source last updated 2020-02-24

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
95% Confidence Interval
Time frame
2 years after treatment start

What was measured

PFS estimates for each stratum were estimated using the method of Kaplan and Meier. PFS was defined as the time interval from date on treatment to the earliest date of disease progression, second malignancy, or death; or to date of last contact for patients without events. One- and two-year PFS estimates are reported by stratum. Only eligible patients were included in this analysis (7 stratum 1 patients and 11 stratum 2 patients).

Analysis population: The one ineligible stratum 2 patient enrolled on the study was excluded from this analysis, leaving 7 stratum 1 patients and 11 stratum 2 patients.

Groups in this outcome

Stratum 1

Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Stratum 2

Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable 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
Stratum 17
Stratum 211

Reported measurements

PFS at 1 year
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 183.3Not reported50.0100.0Not reported
Stratum 268.2Not reported39.896.6Not reported
PFS at 2 years
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 127.8Not reported0.060.5Not reported
Stratum 234.1Not reported0.072.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.0
        upper Limit
        100.0
        value
        83.3
      2. group Id
        OG001
        lower Limit
        39.8
        upper Limit
        96.6
        value
        68.2
    title
    PFS at 1 year
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        60.5
        value
        27.8
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        72.5
        value
        34.1
    title
    PFS at 2 years
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      11
    units
    Participants
description
PFS estimates for each stratum were estimated using the method of Kaplan and Meier. PFS was defined as the time interval from date on treatment to the earliest date of disease progression, second malignancy, or death; or to date of last contact for patients without events. One- and two-year PFS estimates are reported by stratum. Only eligible patients were included in this analysis (7 stratum 1 patients and 11 stratum 2 patients).
dispersion Type
95% Confidence Interval
groups
  1. description
    Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Stratum 1
  2. description
    Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Stratum 2
param Type
NUMBER
population Description
The one ineligible stratum 2 patient enrolled on the study was excluded from this analysis, leaving 7 stratum 1 patients and 11 stratum 2 patients.
reporting Status
POSTED
time Frame
2 years after treatment start
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice