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

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.

Time frame: Year 1

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)

Population: Data for best response to prior chemotherapy could not be collected, as it was not recorded in the CRF, hence, the analysis could not be performed.

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.

Time frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)

Population: Data for best response to prior chemotherapy could not be collected, as it was not recorded in the Case Report Form (CRF), hence, the analysis could not be performed.

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.

Time frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)

Population: SAF

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.

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Baseline, Months 3, 6, 9, 12

Population: SAF

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Baseline, Months 3, 6, 9, 12

Population: SAF

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Months 3, 6, 9, 12

Population: SAF

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Months 3, 6, 9, 12

Population: SAF

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.

Time frame: Months 3, 6, 9, 12

Population: SAF

Time frame: Baseline

Population: SAF with number of participants evaluable for this outcome measure.