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NCT02454972 · OUTCOME

Clinical Benefit

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors · Source last updated 2023-03-02

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
From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

What was measured

Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months)

Analysis population: Treated patients with disease measurement

Groups in this outcome

Biliary Tract Carcinoma Cohort

Patients with Pathologically proven diagnosis of biliary tract carcinoma

Carcinoma of Unknown Primary Site Cohort

Patients with pathologically proven diagnosis of carcinoma of unknown primary site

Endometrial Carcinoma Cohort

Patients with pathologically proven diagnosis of endometrial carcinoma

Ewing's Family of Tumors Cohort

Patients with pathologically proven diagnosis of Ewing's Family of Tumors

Germ Cell Tumors Cohort

Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.

Head and Neck Carcinoma Cohort

Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.

BRCA1/2-associated Metastatic Breast Carcinoma Cohort

Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma

Neuroendocrine Tumors Cohort

Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.

Small Cell Lung Cancer Cohort

Patients with pathologically proven diagnosis of small cell lung cancer

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

Analysis denominator · Participants

GroupSource count
Biliary Tract Carcinoma Cohort18
Carcinoma of Unknown Primary Site Cohort19
Endometrial Carcinoma Cohort71
Ewing's Family of Tumors Cohort28
Germ Cell Tumors Cohort23
Head and Neck Carcinoma Cohort13
BRCA1/2-associated Metastatic Breast Carcinoma Cohort21
Neuroendocrine Tumors Cohort31
Small Cell Lung Cancer Cohort105

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Biliary Tract Carcinoma Cohort11.1Not reported1.434.7Not reported
Carcinoma of Unknown Primary Site Cohort36.8Not reported16.361.6Not reported
Endometrial Carcinoma Cohort35.2Not reported24.247.5Not reported
Ewing's Family of Tumors Cohort39.3Not reported21.559.4Not reported
Germ Cell Tumors Cohort26.1Not reported10.248.4Not reported
Head and Neck Carcinoma Cohort15.4Not reported1.945.4Not reported
BRCA1/2-associated Metastatic Breast Carcinoma Cohort57.1Not reported34.078.2Not reported
Neuroendocrine Tumors Cohort29.0Not reported14.248.0Not reported
Small Cell Lung Cancer Cohort45.7Not reported36.055.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        34.7
        value
        11.1
      2. group Id
        OG001
        lower Limit
        16.3
        upper Limit
        61.6
        value
        36.8
      3. group Id
        OG002
        lower Limit
        24.2
        upper Limit
        47.5
        value
        35.2
      4. group Id
        OG003
        lower Limit
        21.5
        upper Limit
        59.4
        value
        39.3
      5. group Id
        OG004
        lower Limit
        10.2
        upper Limit
        48.4
        value
        26.1
      6. group Id
        OG005
        lower Limit
        1.9
        upper Limit
        45.4
        value
        15.4
      7. group Id
        OG006
        lower Limit
        34.0
        upper Limit
        78.2
        value
        57.1
      8. group Id
        OG007
        lower Limit
        14.2
        upper Limit
        48.0
        value
        29.0
      9. group Id
        OG008
        lower Limit
        36.0
        upper Limit
        55.7
        value
        45.7
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      71
    4. group Id
      OG003
      value
      28
    5. group Id
      OG004
      value
      23
    6. group Id
      OG005
      value
      13
    7. group Id
      OG006
      value
      21
    8. group Id
      OG007
      value
      31
    9. group Id
      OG008
      value
      105
    units
    Participants
description
Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months)
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with Pathologically proven diagnosis of biliary tract carcinoma
    id
    OG000
    title
    Biliary Tract Carcinoma Cohort
  2. description
    Patients with pathologically proven diagnosis of carcinoma of unknown primary site
    id
    OG001
    title
    Carcinoma of Unknown Primary Site Cohort
  3. description
    Patients with pathologically proven diagnosis of endometrial carcinoma
    id
    OG002
    title
    Endometrial Carcinoma Cohort
  4. description
    Patients with pathologically proven diagnosis of Ewing's Family of Tumors
    id
    OG003
    title
    Ewing's Family of Tumors Cohort
  5. description
    Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
    id
    OG004
    title
    Germ Cell Tumors Cohort
  6. description
    Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
    id
    OG005
    title
    Head and Neck Carcinoma Cohort
  7. description
    Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
    id
    OG006
    title
    BRCA1/2-associated Metastatic Breast Carcinoma Cohort
  8. description
    Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
    id
    OG007
    title
    Neuroendocrine Tumors Cohort
  9. description
    Patients with pathologically proven diagnosis of small cell lung cancer
    id
    OG008
    title
    Small Cell Lung Cancer Cohort
param Type
NUMBER
population Description
Treated patients with disease measurement
reporting Status
POSTED
time Frame
From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
title
Clinical Benefit
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice