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NCT01891344 · OUTCOME

Duration of Response Per RECIST v1.1

A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) · Source last updated 2023-06-12

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.

What was measured

Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of progressive disease (PD) per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Analysis population: Efficacy population by HRD subgroups. The overall number of patients analyzed includes only patients with confirmed RECIST CR or PR.

Groups in this outcome

Part 1: tBRCA

Patients with a deleterious BRCA mutation detected in their tumor.

Part 1: Non-tBRCA LOH+

Patients without a BRCA mutation in their tumor, but have high LOH.

Part 1: Non-tBRCA LOH-

Patients without a BRCA mutation in their tumor, but have low LOH.

Part 1: Non-tBRCA LOH Unknown

Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).

Part 2: tBRCA

Patients with a deleterious BRCA mutation detected in their tumor.

Part 2: Non-tBRCA LOH+

Patients without a BRCA mutation in their tumor, but have high LOH.

Part 2: Non-tBRCA LOH-

Patients without a BRCA mutation in their tumor, but have low LOH.

Part 2: Non-tBRCA LOH Unknown

Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).

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

Analysis denominator · Participants

GroupSource count
Part 1: tBRCA32
Part 1: Non-tBRCA LOH+23
Part 1: Non-tBRCA LOH-7
Part 1: Non-tBRCA LOH Unknown4
Part 2: tBRCA26
Part 2: Non-tBRCA LOH+5
Part 2: Non-tBRCA LOH-6
Part 2: Non-tBRCA LOH Unknown3

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: tBRCA281Not reported194393Not reported
Part 1: Non-tBRCA LOH+329Not reported174451Not reported
Part 1: Non-tBRCA LOH-169Not reported141260Not reported
Part 1: Non-tBRCA LOH Unknown225Not reported1001454Not reported
Part 2: tBRCA176Not reported169312Not reported
Part 2: Non-tBRCA LOH+282Not reported111NAThe upper limit of the confidence interval is not estimated due to insufficient number of participants with events.
Part 2: Non-tBRCA LOH-314Not reported169NAThe upper limit of the confidence interval is not estimated due to insufficient number of participants with events.
Part 2: Non-tBRCA LOH Unknown181Not reported169224Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        194
        upper Limit
        393
        value
        281
      2. group Id
        OG001
        lower Limit
        174
        upper Limit
        451
        value
        329
      3. group Id
        OG002
        lower Limit
        141
        upper Limit
        260
        value
        169
      4. group Id
        OG003
        lower Limit
        100
        upper Limit
        1454
        value
        225
      5. group Id
        OG004
        lower Limit
        169
        upper Limit
        312
        value
        176
      6. comment
        The upper limit of the confidence interval is not estimated due to insufficient number of participants with events.
        group Id
        OG005
        lower Limit
        111
        upper Limit
        NA
        value
        282
      7. comment
        The upper limit of the confidence interval is not estimated due to insufficient number of participants with events.
        group Id
        OG006
        lower Limit
        169
        upper Limit
        NA
        value
        314
      8. group Id
        OG007
        lower Limit
        169
        upper Limit
        224
        value
        181
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      23
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      26
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      3
    units
    Participants
description
Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of progressive disease (PD) per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with a deleterious BRCA mutation detected in their tumor.
    id
    OG000
    title
    Part 1: tBRCA
  2. description
    Patients without a BRCA mutation in their tumor, but have high LOH.
    id
    OG001
    title
    Part 1: Non-tBRCA LOH+
  3. description
    Patients without a BRCA mutation in their tumor, but have low LOH.
    id
    OG002
    title
    Part 1: Non-tBRCA LOH-
  4. description
    Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
    id
    OG003
    title
    Part 1: Non-tBRCA LOH Unknown
  5. description
    Patients with a deleterious BRCA mutation detected in their tumor.
    id
    OG004
    title
    Part 2: tBRCA
  6. description
    Patients without a BRCA mutation in their tumor, but have high LOH.
    id
    OG005
    title
    Part 2: Non-tBRCA LOH+
  7. description
    Patients without a BRCA mutation in their tumor, but have low LOH.
    id
    OG006
    title
    Part 2: Non-tBRCA LOH-
  8. description
    Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
    id
    OG007
    title
    Part 2: Non-tBRCA LOH Unknown
param Type
MEDIAN
population Description
Efficacy population by HRD subgroups. The overall number of patients analyzed includes only patients with confirmed RECIST CR or PR.
reporting Status
POSTED
time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
title
Duration of Response Per RECIST v1.1
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice