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NCT01399372 · OUTCOME

Progression-free Survival

Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma · Source last updated 2023-07-20

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.

What was measured

Progression is defined as any of the following: more than 25% increase in the contrast-enhancing lesion seen on magnetic resonance imaging (MRI) compared with baseline or best response; new site of disease (central nervous system or systemic); recurrent or new ocular disease; recurrent or positive cerebrospinal fluid (CSF) cytology. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.

Analysis population: Eligible participants

Groups in this outcome

Chemotherapy

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.

Chemotherapy + Low-Dose WBRT

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.

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

Analysis denominator · Participants

GroupSource count
Chemotherapy44
Chemotherapy + Low-Dose WBRT43

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy2.1Not reported1.0NAThere were not enough events to estimate the upper confidence boundary.
Chemotherapy + Low-Dose WBRTNANot reported3.3NAThe median has not yet been reached. Additionally there were not enough events to estimate the upper confidence boundary.

Source statistical analyses

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

  1. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Reference arm = Chemotherapy
    group Description
    Sample size of 89 provided 80% power to detect a hazard ratio of 0.63 at a one-sided alpha level of 0.15.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.015
    p Value Comment
    One-sided significance level = 0.15
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Reference arm = Chemotherapy
    group Description
    Sample size of 89 provided 80% power to detect a hazard ratio of 0.63 at a one-sided alpha level of 0.15.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.015
    p Value Comment
    One-sided significance level = 0.15
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        There were not enough events to estimate the upper confidence boundary.
        group Id
        OG000
        lower Limit
        1.0
        upper Limit
        NA
        value
        2.1
      2. comment
        The median has not yet been reached. Additionally there were not enough events to estimate the upper confidence boundary.
        group Id
        OG001
        lower Limit
        3.3
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Progression is defined as any of the following: more than 25% increase in the contrast-enhancing lesion seen on magnetic resonance imaging (MRI) compared with baseline or best response; new site of disease (central nervous system or systemic); recurrent or new ocular disease; recurrent or positive cerebrospinal fluid (CSF) cytology. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
    id
    OG000
    title
    Chemotherapy
  2. description
    Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
    id
    OG001
    title
    Chemotherapy + Low-Dose WBRT
param Type
MEDIAN
population Description
Eligible participants
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.
title
Progression-free Survival
type
PRIMARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice