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NCT02454972 · OUTCOME

Progression Free Survival (PFS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years

What was measured

Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Biliary Tract Carcinoma Cohort1.3Not reported1.12.5Not reported
Carcinoma of Unknown Primary Site Cohort2.7Not reported1.34.4Not reported
Endometrial Carcinoma Cohort2.6Not reported1.44.0Not reported
Ewing's Family of Tumors Cohort2.7Not reported1.44.3Not reported
Germ Cell Tumors Cohort1.5Not reported0.98.9Not reported
Head and Neck Carcinoma Cohort1.3Not reported1.22.1Not reported
BRCA1/2-associated Metastatic Breast Carcinoma Cohort4.1Not reported2.36.5Not reported
Neuroendocrine Tumors Cohort1.4Not reported1.23.0Not reported
Small Cell Lung Cancer Cohort3.7Not reported2.64.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        2.5
        value
        1.3
      2. group Id
        OG001
        lower Limit
        1.3
        upper Limit
        4.4
        value
        2.7
      3. group Id
        OG002
        lower Limit
        1.4
        upper Limit
        4.0
        value
        2.6
      4. group Id
        OG003
        lower Limit
        1.4
        upper Limit
        4.3
        value
        2.7
      5. group Id
        OG004
        lower Limit
        0.9
        upper Limit
        8.9
        value
        1.5
      6. group Id
        OG005
        lower Limit
        1.2
        upper Limit
        2.1
        value
        1.3
      7. group Id
        OG006
        lower Limit
        2.3
        upper Limit
        6.5
        value
        4.1
      8. group Id
        OG007
        lower Limit
        1.2
        upper Limit
        3.0
        value
        1.4
      9. group Id
        OG008
        lower Limit
        2.6
        upper Limit
        4.3
        value
        3.7
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
Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest
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
MEDIAN
population Description
Treated patients with disease measurement
reporting Status
POSTED
time Frame
From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice