An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This prospective observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in routine clinical practice will be collected for 1 year.

Official Title
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Erlotinib (Tarceva®) in Routine Clinical Practice in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) After Failure of at Least One Prior Chemotherapy Regimen With Focus on the Elderly Patient.

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, > 65 years of age Locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV) Failure of at least one prior standard platinum-based chemotherapy Exclusion Criteria: Age < 65 years

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Were Alive 1 Year After Start of Treatment | Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported. | Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival: Age | Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported. | From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) | 
| Percentage of Participants With Fatigue |  | Months 3, 6, 9, 12 | 
| Percentage of Participants With Rash |  | Months 3, 6, 9, 12 | 
| Percentage of Participants With Diarrhea |  | Months 3, 6, 9, 12 | 
| Percentage of Participants With Rash Based on Severity During the Course of Time | Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported. | Months 3, 6, 9, 12 | 
| Percentage of Participants With Diarrhea Based on Severity During the Course of Time | Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported. | Months 3, 6, 9, 12 | 
| Percentage of Participants With Fatigue Based on Severity During the Course of Time | Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported. | Months 3, 6, 9, 12 | 
| Percentage of Participants With Dose Modifications by Reason | Dose modification included increase or decreased in the dose of the drug and interrupted dose. Reasons for dose modification included progression, participants' wish, intolerance and others. Only participants that were included in any of the specified categories were reported. | Months 3, 6, 9, 12 | 
| Percentage of Participants With Dose Withdrawals by Reason | Reasons for dose withdrawals included progression, participants' wish, intolerance, others and not known. Only participants that were included in any of the specified categories were reported. | Months 3, 6, 9, 12 | 
| Percentage of Participants With Cough by Severity | Severity of cough was categorized as mild, moderate, severe and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no cough were not included. | Baseline, Months 3, 6, 9, 12 | 
| Percentage of Participants With Dyspnea by Severity | Severity of dyspnea was categorized as mild, moderate, severe, life-threatening and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no dyspnea were not included. | Baseline, Months 3, 6, 9, 12 | 
| Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD) | Response rate was observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST). It consisted of CR, PR, SD and progressive disease (PD). Participants with CR, PR and SD were reported. CR: disappearance of all target lesions (TLs) and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. | Months 3, 6, 9, 12 | 
| Time to Start of Erlotinib Therapy After End of First Line Therapy |  | Baseline | 
| Percentage of Participants With Remission of CR and PR | Remission was defined as participants with CR or PR. CR: disappearance of all TLs and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. | Months 3, 6, 9, 12 | 
| Median Progression Free Survival: Overall | Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression no death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. | From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40) | 
| Median Progression Free Survival: Age | Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported. | From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40) | 
| Median Progression Free Survival: Gender | Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of gender (male and female) were reported. | From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40) | 
| Median Progression Free Survival: Smoking Status | Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported. | From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40) | 
| Median Progression Free Survival: Best Response to Prior Chemotherapy | Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. | From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40) | 
| Median Overall Survival: Overall | Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. | From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) | 
| Median Overall Survival: Gender | Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of gender (male and female) were reported. | From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) | 
| Median Overall Survival: Smoking Status | Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported. | From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) | 
| Median Overall Survival: Best Response to Prior Chemotherapy | Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. | From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) |