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NCT01891344 · OUTCOME

Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria

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
NUMBER
Unit
percentage of patients
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

The endpoint of ORR defined as the percentage of patients with a best response of CR or PR using RECIST v 1.1 or a response per Gynecologic Cancer InterGroup cancer antigen 125 (GCIG CA-125) criteria. 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. A response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response.

Analysis population: Safety population by HRD subgroups: Consist of all Part 1 and Part 2 patients who received at least one dose of rucaparib.

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: tBRCA40
Part 1: Non-tBRCA LOH+82
Part 1: Non-tBRCA LOH-70
Part 1: Non-tBRCA LOH Unknown12
Part 2: tBRCA84
Part 2: Non-tBRCA LOH+73
Part 2: Non-tBRCA LOH-107
Part 2: Non-tBRCA LOH Unknown23

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: tBRCA87.5Not reported73.295.8Not reported
Part 1: Non-tBRCA LOH+46.3Not reported35.357.7Not reported
Part 1: Non-tBRCA LOH-21.4Not reported12.532.9Not reported
Part 1: Non-tBRCA LOH Unknown50.0Not reported21.178.9Not reported
Part 2: tBRCA54.8Not reported43.565.7Not reported
Part 2: Non-tBRCA LOH+12.3Not reported5.822.1Not reported
Part 2: Non-tBRCA LOH-13.1Not reported7.321.0Not reported
Part 2: Non-tBRCA LOH Unknown30.4Not reported13.252.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.2
        upper Limit
        95.8
        value
        87.5
      2. group Id
        OG001
        lower Limit
        35.3
        upper Limit
        57.7
        value
        46.3
      3. group Id
        OG002
        lower Limit
        12.5
        upper Limit
        32.9
        value
        21.4
      4. group Id
        OG003
        lower Limit
        21.1
        upper Limit
        78.9
        value
        50.0
      5. group Id
        OG004
        lower Limit
        43.5
        upper Limit
        65.7
        value
        54.8
      6. group Id
        OG005
        lower Limit
        5.8
        upper Limit
        22.1
        value
        12.3
      7. group Id
        OG006
        lower Limit
        7.3
        upper Limit
        21.0
        value
        13.1
      8. group Id
        OG007
        lower Limit
        13.2
        upper Limit
        52.9
        value
        30.4
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      82
    3. group Id
      OG002
      value
      70
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      84
    6. group Id
      OG005
      value
      73
    7. group Id
      OG006
      value
      107
    8. group Id
      OG007
      value
      23
    units
    Participants
description
The endpoint of ORR defined as the percentage of patients with a best response of CR or PR using RECIST v 1.1 or a response per Gynecologic Cancer InterGroup cancer antigen 125 (GCIG CA-125) criteria. 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. A response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response.
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
NUMBER
population Description
Safety population by HRD subgroups: Consist of all Part 1 and Part 2 patients who received at least one dose of rucaparib.
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
Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria
type
SECONDARY
unit Of Measure
percentage of patients

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Preserved source evidence · Not medical advice