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NCT00103259 · OUTCOME

Overall Survival on Step 1

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2014-05-23

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
Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years

What was measured

Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.

Analysis population: 61 eligible and treated patients were included in the analysis

Groups in this outcome

Arm I (Bortezomib+Irinotecan)

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II (Bortezomib)

Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).

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

Analysis denominator · Participants

GroupSource count
Arm I (Bortezomib+Irinotecan)23
Arm II (Bortezomib)38

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Bortezomib+Irinotecan)9.1Not reported2.312.5Not reported
Arm II (Bortezomib)7.3Not reported5.19.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.3
        upper Limit
        12.5
        value
        9.1
      2. group Id
        OG001
        lower Limit
        5.1
        upper Limit
        9.4
        value
        7.3
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      38
    units
    Participants
description
Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I (Bortezomib+Irinotecan)
  2. description
    Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
    id
    OG001
    title
    Arm II (Bortezomib)
param Type
MEDIAN
population Description
61 eligible and treated patients were included in the analysis
reporting Status
POSTED
time Frame
Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years
title
Overall Survival on Step 1
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice