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NCT00436618 · OUTCOME

Progression-free Survival

Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment · Source last updated 2019-10-22

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
5 years

What was measured

Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes.

Analysis population: 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.

Groups in this outcome

Relapsed Aggressive Non-Hodgkin Lymphoma

Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Relapsed Indolent Non-Hodgkin Lymphoma

Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Uncommon Lymphomas

Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

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

Analysis denominator · Participants

GroupSource count
Relapsed Aggressive Non-Hodgkin Lymphoma114
Relapsed Indolent Non-Hodgkin Lymphoma55
Uncommon Lymphomas107

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Relapsed Aggressive Non-Hodgkin Lymphoma0.18Not reported0.160.27Not reported
Relapsed Indolent Non-Hodgkin Lymphoma0.60Not reported0.411.03Not reported
Uncommon Lymphomas0.79Not reported0.521.09Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.16
        upper Limit
        0.27
        value
        0.18
      2. group Id
        OG001
        lower Limit
        0.41
        upper Limit
        1.03
        value
        0.60
      3. group Id
        OG002
        lower Limit
        0.52
        upper Limit
        1.09
        value
        0.79
denoms
  1. counts
    1. group Id
      OG000
      value
      114
    2. group Id
      OG001
      value
      55
    3. group Id
      OG002
      value
      107
    units
    Participants
description
Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes.
dispersion Type
95% Confidence Interval
groups
  1. description
    Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
    id
    OG000
    title
    Relapsed Aggressive Non-Hodgkin Lymphoma
  2. description
    Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
    id
    OG001
    title
    Relapsed Indolent Non-Hodgkin Lymphoma
  3. description
    Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
    id
    OG002
    title
    Uncommon Lymphomas
param Type
MEDIAN
population Description
276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
reporting Status
POSTED
time Frame
5 years
title
Progression-free Survival
type
SECONDARY
unit Of Measure
years

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Preserved source evidence · Not medical advice