NCT02454972 · OUTCOME

Duration of Response

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 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

Duration of Response by Investigator's Assessment, defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented.

Analysis population: Patients with response to treatment

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

Group	Source count
Biliary Tract Carcinoma Cohort	1
Carcinoma of Unknown Primary Site Cohort	0
Endometrial Carcinoma Cohort	8
Ewing's Family of Tumors Cohort	4
Germ Cell Tumors Cohort	1
Head and Neck Carcinoma Cohort	0
BRCA1/2-associated Metastatic Breast Carcinoma Cohort	6
Neuroendocrine Tumors Cohort	2
Small Cell Lung Cancer Cohort	38

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Biliary Tract Carcinoma Cohort	3.4	Not reported	NA	NA	Only 1 patient
Endometrial Carcinoma Cohort	9.2	Not reported	3.4	18.0	Not reported
Ewing's Family of Tumors Cohort	4.2	Not reported	2.9	5.5	Not reported
Germ Cell Tumors Cohort	10.6	Not reported	NA	NA	Only 1 patient
BRCA1/2-associated Metastatic Breast Carcinoma Cohort	8.6	Not reported	2.9	NA	Not reached
Neuroendocrine Tumors Cohort	4.7	Not reported	4.0	5.4	Not reported
Small Cell Lung Cancer Cohort	5.3	Not reported	4.1	6.2	Not reported

Complete source fields

classes

categories
measurements
comment
Only 1 patient
group Id
OG000
lower Limit
NA
upper Limit
NA
value
3.4
group Id
OG002
lower Limit
3.4
upper Limit
18.0
value
9.2
group Id
OG003
lower Limit
2.9
upper Limit
5.5
value
4.2
comment
Only 1 patient
group Id
OG004
lower Limit
NA
upper Limit
NA
value
10.6
comment
Not reached
group Id
OG006
lower Limit
2.9
upper Limit
NA
value
8.6
group Id
OG007
lower Limit
4.0
upper Limit
5.4
value
4.7
group Id
OG008
lower Limit
4.1
upper Limit
6.2
value
5.3

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
8
group Id
OG003
value
4
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
6
group Id
OG007
value
2
group Id
OG008
value
38
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Patients with Pathologically proven diagnosis of biliary tract carcinoma
id
OG000
title
Biliary Tract Carcinoma Cohort
description
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
id
OG001
title
Carcinoma of Unknown Primary Site Cohort
description
Patients with pathologically proven diagnosis of endometrial carcinoma
id
OG002
title
Endometrial Carcinoma Cohort
description
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
id
OG003
title
Ewing's Family of Tumors Cohort
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
description
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
id
OG005
title
Head and Neck Carcinoma Cohort
description
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
id
OG006
title
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
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
description
Patients with pathologically proven diagnosis of small cell lung cancer
id
OG008
title
Small Cell Lung Cancer Cohort

param Type

MEDIAN

population Description

Patients with response to treatment

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

Duration of Response

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice