NCT00932893 · OUTCOME

Progression-Free Survival (PFS)

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

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: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

What was measured

PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Analysis population: Full analysis set (FAS) included all participants who were randomized to study treatment.

Groups in this outcome

Crizotinib

Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

Chemotherapy

Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

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
Crizotinib	173
Chemotherapy	174

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	7.7	Not reported	6.0	8.8	Not reported
Chemotherapy	3.0	Not reported	2.6	4.3	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.371
ci Pct Value
95
ci Upper Limit
0.638
group Description
P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
p Value Comment
To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.
param Type
Hazard Ratio (HR)
param Value
0.487
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.371
ci Pct Value
95
ci Upper Limit
0.638
group Description
P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
p Value Comment
To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.
param Type
Hazard Ratio (HR)
param Value
0.487
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
6.0
upper Limit
8.8
value
7.7
group Id
OG001
lower Limit
2.6
upper Limit
4.3
value
3.0

denoms

counts
group Id
OG000
value
173
group Id
OG001
value
174
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
id
OG000
title
Crizotinib
description
Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
id
OG001
title
Chemotherapy

param Type

MEDIAN

population Description

Full analysis set (FAS) included all participants who were randomized to study treatment.

reporting Status

POSTED

time Frame

Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

title

Progression-Free Survival (PFS)

type

PRIMARY

unit Of Measure

months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice