Trial Outcomes & Findings for Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma (NCT NCT04795245)
NCT ID: NCT04795245
Last Updated: 2024-12-27
Results Overview
Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.
COMPLETED
805 participants
From start of afatinib as first line treatment up to 18 months and up to 36 months.
2024-12-27
Participant Flow
Non-interventional, multi-center study from existing data of patients treated with afatinib as the first-line treatment. 40 study sites in Japan were planned for participating. Recruitment of patients was stopped at all sites when it was determined that a sufficient number of patients have been enrolled. A maximum of 50 patients were limited for enrolment per site to avoid differential study site influence on study results. Data extraction started on 01 April 2021 and ended on 07 November 2022.
Only subjects that met all inclusion and none of the exclusion criteria were included.
Participant milestones
| Measure |
Patients Treated With Afatinib
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
|
|---|---|
|
Overall Study
STARTED
|
805
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
720
|
Reasons for withdrawal
| Measure |
Patients Treated With Afatinib
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
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|---|---|
|
Overall Study
Unkown reason
|
7
|
|
Overall Study
Death
|
17
|
|
Overall Study
Other than listed
|
19
|
|
Overall Study
Adverse Event
|
143
|
|
Overall Study
Progressive disease
|
512
|
|
Overall Study
Unknown if patients were still on treatment at end of observation period
|
22
|
Baseline Characteristics
Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Patients Treated With Afatinib
n=805 Participants
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
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|---|---|
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Age, Continuous
|
65.8 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
440 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
365 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
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799 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Asian
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of afatinib as first line treatment up to 18 months and up to 36 months.Population: Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.
Outcome measures
| Measure |
Patients Treated With Afatinib
n=805 Participants
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
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|---|---|
|
Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)
At 18 months
|
0.39 Proportion of participants
Interval 0.35 to 0.42
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|
Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)
At 36 months
|
0.15 Proportion of participants
Interval 0.12 to 0.17
|
SECONDARY outcome
Timeframe: From start of afatinib up to 18 months and up to 36 months.Population: Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
Time on treatment from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause (TOT). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. If patients were on first-line treatment and did not move to second-line treatment at the data extraction, ToT is same as first-line TOT (ToT1) for these patients. The survival probability rate (95% confidence interval) against time to treatment failure at 18 months and at 36 months is reported.
Outcome measures
| Measure |
Patients Treated With Afatinib
n=805 Participants
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
|
|---|---|
|
Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)
At 18 months
|
0.58 Proportion of participants
Interval 0.54 to 0.61
|
|
Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)
At 36 months
|
0.30 Proportion of participants
Interval 0.27 to 0.34
|
SECONDARY outcome
Timeframe: From start of afatinib as second line treatment up to 18 months and up to 36 months.Population: Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
Time on treatment from start of the second-line treatment until end of the second-line treatment or death by any cause (TOT2). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. The survival probability rate (95% confidence interval) against time to second-line treatment failure at 18 months and at 36 months is reported.
Outcome measures
| Measure |
Patients Treated With Afatinib
n=805 Participants
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
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|---|---|
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Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2)
At 18 months
|
0.17 Proportion of participants
Interval 0.14 to 0.2
|
|
Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2)
At 36 months
|
0.09 Proportion of participants
Interval 0.07 to 0.12
|
SECONDARY outcome
Timeframe: From start of afatinib up to 18 months and up to 36 months.Population: Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
If patients did not die at the data extraction, they were censored on the date they are last verified to be alive. The survival probability rate (95% confidence interval) at 18 months and at 36 months is reported.
Outcome measures
| Measure |
Patients Treated With Afatinib
n=805 Participants
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
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|---|---|
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Overall Survival
At 18 months
|
0.80 Proportion of participants
Interval 0.78 to 0.83
|
|
Overall Survival
At 36 months
|
0.54 Proportion of participants
Interval 0.51 to 0.58
|
SECONDARY outcome
Timeframe: From start of afatinib up to 18 months and up to 36 months.Population: Participants included in the full analysis set and who had received afatinib at initial dose of 40 mg.
Time to initial dose reduction of afatinib. If patients did not reduce initial dose of afatinib at the data extraction, they were censored on the date they were last verified to have been on the initial dose of afatinib or increased dose of afatinib. The survival probability rate (95% confidence interval) against time to initial dose reduction of afatinib at 18 months and 36 months is reported.
Outcome measures
| Measure |
Patients Treated With Afatinib
n=594 Participants
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
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|---|---|
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Time to Initial Dose Reduction of Afatinib
At 18 months
|
0.22 Proportion of participants
Interval 0.19 to 0.26
|
|
Time to Initial Dose Reduction of Afatinib
At 36 months
|
0.20 Proportion of participants
Interval 0.16 to 0.24
|
SECONDARY outcome
Timeframe: From start of data extraction until end of data extraction, up to 586 days.Population: Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
Percentage of participants with dose modifications of afatinib.
Outcome measures
| Measure |
Patients Treated With Afatinib
n=805 Participants
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
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|---|---|
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Percentage of Participants With Dose Modifications of Afatinib
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73.7 Percentage of participants
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Adverse Events
Patients Treated With Afatinib
Serious adverse events
| Measure |
Patients Treated With Afatinib
n=805 participants at risk
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
|
|---|---|
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Cardiac disorders
Acute myocardial infarction
|
0.12%
1/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
2/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
|
Immune system disorders
Anaphylactic reaction
|
0.12%
1/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
|
Injury, poisoning and procedural complications
Fall
|
0.12%
1/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
|
Metabolism and nutrition disorders
Decreased appetite
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0.12%
1/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
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0.12%
1/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.25%
2/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.12%
1/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
Other adverse events
| Measure |
Patients Treated With Afatinib
n=805 participants at risk
Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).
|
|---|---|
|
Gastrointestinal disorders
Nasopharyngitis
|
5.3%
43/805 • Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER