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NCT00822120 · OUTCOME

Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma · Source last updated 2022-08-18

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

What was measured

Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Analysis population: Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.

Groups in this outcome

HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP

HIV-negative patients who are PET-positive are treated with 2 cycles of ABVD followed by escalated BEACOPP. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.

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

Analysis denominator · Participants

GroupSource count
HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP60

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP64Not reported5075Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50
        upper Limit
        75
        value
        64
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    units
    Participants
description
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    HIV-negative patients who are PET-positive are treated with 2 cycles of ABVD followed by escalated BEACOPP. Initial ABVD: Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
    id
    OG000
    title
    HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP
param Type
NUMBER
population Description
Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.
reporting Status
POSTED
time Frame
2 years
title
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice