BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) · Source last updated 2018-12-14
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
Not reported
Time frame
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
What was measured
OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.
For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.
Outcome data are the percentage of patients with OR by each scheduled tumour assessment.
Analysis population: The RS included all patients randomised to receive treatment, whether treated or not.
Groups in this outcome
Afatinib 40 Milligram (mg)
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
Gemcitabine / Cisplatin Chemotherapy
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
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
Afatinib 40 Milligram (mg)
242
Gemcitabine / Cisplatin Chemotherapy
122
Reported measurements
By Week 6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
49.2
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
13.1
Not reported
Not reported
Not reported
Not reported
By Week 12
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
59.9
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
19.7
Not reported
Not reported
Not reported
Not reported
By Week 18
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
64.0
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 24
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
64.9
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 30
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
65.7
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 36
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
66.1
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 42
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
66.5
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 48
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
66.5
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 60
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
66.9
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 72
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
66.9
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 84
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
66.9
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 96
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
67.4
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 108
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
67.4
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
By Week 120
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Afatinib 40 Milligram (mg)
67.8
Not reported
Not reported
Not reported
Not reported
Gemcitabine / Cisplatin Chemotherapy
23.0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
49.2
group Id
OG001
value
13.1
title
By Week 6
categories
measurements
group Id
OG000
value
59.9
group Id
OG001
value
19.7
title
By Week 12
categories
measurements
group Id
OG000
value
64.0
group Id
OG001
value
23.0
title
By Week 18
categories
measurements
group Id
OG000
value
64.9
group Id
OG001
value
23.0
title
By Week 24
categories
measurements
group Id
OG000
value
65.7
group Id
OG001
value
23.0
title
By Week 30
categories
measurements
group Id
OG000
value
66.1
group Id
OG001
value
23.0
title
By Week 36
categories
measurements
group Id
OG000
value
66.5
group Id
OG001
value
23.0
title
By Week 42
categories
measurements
group Id
OG000
value
66.5
group Id
OG001
value
23.0
title
By Week 48
categories
measurements
group Id
OG000
value
66.9
group Id
OG001
value
23.0
title
By Week 60
categories
measurements
group Id
OG000
value
66.9
group Id
OG001
value
23.0
title
By Week 72
categories
measurements
group Id
OG000
value
66.9
group Id
OG001
value
23.0
title
By Week 84
categories
measurements
group Id
OG000
value
67.4
group Id
OG001
value
23.0
title
By Week 96
denoms
counts
group Id
OG000
value
242
group Id
OG001
value
122
units
Participants
description
OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.
For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.
Outcome data are the percentage of patients with OR by each scheduled tumour assessment.
groups
description
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
id
OG000
title
Afatinib 40 Milligram (mg)
description
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
id
OG001
title
Gemcitabine / Cisplatin Chemotherapy
param Type
NUMBER
population Description
The RS included all patients randomised to receive treatment, whether treated or not.
reporting Status
POSTED
time Frame
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
Triangle