Non-Small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer
Brief summary
This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.
Interventions
DRUGErlotinib
Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
35 Years to 86 Years
Healthy volunteers
No
Inclusion criteria
* It is the physician's decision to prescribe erlotinib in participants and to document their treatment * Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label
Exclusion criteria
* Participants will be excluded if safety concerns occurred * If the participant was not compliant or if the participant would wish to stop erlotinib therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Time | Up to 6 years | Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS. |
| Percentage of Participants With Best Overall Response | Up to 6 years | Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimeter \[mm\]). No new lesions. PR was defined as greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) Time | Up to 6 years | Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS. |
Countries
Austria
Participant flow
Pre-assignment details
It was physician's decision to prescribe erlotinib in participants and to document their treatment cycles.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files. | 291 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrolled, but not treated | 8 |
| Overall Study | Unspecified (only completed 1 cycle) | 73 |
Baseline characteristics
| Characteristic | Erlotinib |
|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 119 Participants |
| Sex: Female, Male Male | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 134 / 291 |
| serious Total, serious adverse events | 14 / 291 |
Outcome results
Primary
Percentage of Participants With Best Overall Response
Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimeter \[mm\]). No new lesions. PR was defined as greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.
Time frame: Up to 6 years
Population: Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib | Percentage of Participants With Best Overall Response | CR | 0.92 percentage of participants |
| Erlotinib | Percentage of Participants With Best Overall Response | PR | 15.14 percentage of participants |
| Erlotinib | Percentage of Participants With Best Overall Response | SD | 63.76 percentage of participants |
| Erlotinib | Percentage of Participants With Best Overall Response | PD | 12.39 percentage of participants |
Primary
Progression-free Survival (PFS) Time
Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.
Time frame: Up to 6 years
Population: Analysis population included participants who received at least 2 documented treatment cycles.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Progression-free Survival (PFS) Time | 4.87 months |
Secondary
Overall Survival (OS) Time
Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.
Time frame: Up to 6 years
Population: As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival (OS) Time | NA months |