An observational study in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-10-29.
Sponsored by Hoffmann-La Roche · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 465 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Elderly patients with advanced non-small cell lung cancer after first-line platinum-based chemotherapy
Exclusion Criteria:
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.
Time frame: Year 1
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.
Time frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
Percentage of Participants With Fatigue
Time frame: Months 3, 6, 9, 12
Percentage of Participants With Rash
Time frame: Months 3, 6, 9, 12
Percentage of Participants With Diarrhea
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Months 3, 6, 9, 12
Time to Start of Erlotinib Therapy After End of First Line Therapy
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
| Milestone | Non-small Cell Lung Cancer (NSCLC) Elderly Participants |
|---|---|
| Started | 465 |
| Treated | 385 |
| Completed | 49 |
| Not completed | 416 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Disease progression | 230 |
| Withdrew: Discontinued treatment | 25 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Death | 52 |
| Withdrew: Other | 19 |
| Withdrew: Did not sign informed consent | 1 |
| Withdrew: No previous chemotherapy | 33 |
| Withdrew: Nsclc grade iv histology not confirmed | 20 |
| Withdrew: Protocol violation | 11 |
| Withdrew: Screening failure | 1 |
| Withdrew: Not treated | 9 |
| Withdrew: No participant record available | 5 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Overall | 30.6 (25.2 to 36.0) |
| 65-69 years | 26.6 (16.8 to 36.3) |
| 70-74 years | 29.8 (20.6 to 39.0) |
| 75-79 years | 37.2 (26.3 to 48.2) |
| ≥ 80 years | 25.6 (9.0 to 42.3) |
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.
| months | NSCLC Elderly Participants |
|---|---|
| 65-69 years | 7.039 (5.033 to 8.717) |
| 70-74 years | 6.612 (5.164 to 8.125) |
| 75-79 years | 7.928 (6.118 to 11.349) |
| ≥ 80 years | 6.020 (4.507 to 10.954) |
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3 | 89.1 |
| Month 6 | 38.7 |
| Month 9 | 19.5 |
| Month 12 | 13.8 |
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3 | 90.6 |
| Month 6 | 37.9 |
| Month 9 | 19.5 |
| Month 12 | 13.8 |
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3 | 89.6 |
| Month 6 | 39.0 |
| Month 9 | 19.5 |
| Month 12 | 13.8 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3: Grade 1 | 19.2 |
| Month 3: Grade 2 | 23.1 |
| Month 3: Grade 3 | 4.4 |
| Month 6: Grade 1 | 8.1 |
| Month 6: Grade 2 | 5.7 |
| Month 6: Grade 3 | 1.0 |
| Month 9: Grade 1 | 3.6 |
| Month 9: Grade 2 | 2.3 |
| Month 12: Grade 1 | 1.8 |
| Month 12: Grade 2 | 1.6 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3: Grade 1 | 11.9 |
| Month 3: Grade 2 | 7.3 |
| Month 3: Grade 3 | 0.3 |
| Month 3: Grade 4 | 0.3 |
| Month 6: Grade 1 | 2.3 |
| Month 6: Grade 2 | 0.8 |
| Month 6: Grade 3 | 0.3 |
| Month 9: Grade 1 | 1.0 |
| Month 9: Grade 2 | 0.3 |
| Month 9: Grade 3 | 0.3 |
| Month 12: Grade 1 | 0.3 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3: Grade 1 | 6.8 |
| Month 3: Grade 2 | 8.1 |
| Month 3: Grade 3 | 0.3 |
| Month 6: Grade 1 | 1.8 |
| Month 6: Grade 2 | 1.8 |
| Month 6: Grade 3 | 0.3 |
| Month 9: Grade 1 | 1.0 |
| Month 9: Grade 2 | 0.5 |
| Month 12: Grade 1 | 0.5 |
| Month 12: Grade 2 | 0.3 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3: Increased (other) | 1.0 |
| Month 6: Increased (other) | 0.8 |
| Month 9: Increased (other) | 0.3 |
| Month 12: Increased (participants' wish) | 0.3 |
| Month 12: Increased (other) | 0.3 |
| Month 3: Decreased (participants' wish) | 0.3 |
| Month 3: Decreased (intolerance) | 7.0 |
| Month 3: Decreased (other) | 0.8 |
| Month 6: Decreased (participants' wish) | 0.8 |
| Month 6: Decreased (intolerance) | 1.6 |
| Month 6: Decreased (other) | 0.3 |
| Month 9: Decreased (intolerance) | 0.8 |
| Month 9: Decreased (other) | 0.3 |
| Month 12: Decreased (intolerance) | 0.5 |
| Month 3: Interruption (progression) | 0.3 |
| Month 3: Interruption (intolerance) | 1.8 |
| Month 3: Interruption (other) | 2.9 |
| Month 6: Interruption (progression) | 1.0 |
| Month 6: Interruption (other) | 1.6 |
| Month 9: Interruption (progression) | 0.5 |
| Month 9: Interruption (other) | 0.3 |
| Month 12: Interruption (other) | 0.5 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3: Progression | 34.3 |
| Month 3: Participants' wish | 2.9 |
| Month 3: Intolerance | 3.4 |
| Month 3: Other | 8.3 |
| Month 3: Not known | 1.0 |
| Month 6: Progression | 12.7 |
| Month 6: Participants' wish | 0.5 |
| Month 6: Intolerance | 0.3 |
| Month 6: Other | 2.9 |
| Month 6: Not known | 0.3 |
| Month 9: Progression | 4.7 |
| Month 9: Participants' wish | 0.3 |
| Month 9: Intolerance | 0.3 |
| Month 9: Other | 1.0 |
| Month 12: Progression | 2.9 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Baseline: Mild | 13.8 |
| Baseline: Moderate | 24.9 |
| Baseline: Severe | 2.9 |
| Baseline: Unknown | 1.6 |
| Month 3: Mild | 15.1 |
| Month 3: Moderate | 14.5 |
| Month 3: Severe | 0.3 |
| Month 3: Unknown | 0.5 |
| Month 6: Mild | 4.4 |
| Month 6: Moderate | 3.6 |
| Month 6: Severe | 0.3 |
| Month 6: Unknown | 0.5 |
| Month 9: Mild | 4.7 |
| Month 9: Moderate | 0.5 |
| Month 9: Unknown | 0.3 |
| Month 12: Mild | 1.8 |
| Month 12: Moderate | 1.3 |
| Month 12: Severe | 0.3 |
| Month 12: Unknown | 0.3 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Baseline: Mild | 16.1 |
| Baseline: Moderate | 20.3 |
| Baseline: Severe | 8.1 |
| Baseline: Unknown | 1.3 |
| Month 3: Mild | 10.1 |
| Month 3: Moderate | 17.4 |
| Month 3: Severe | 4.4 |
| Month 3: Life-threatening | 0.3 |
| Month 3: Unknown | 0.8 |
| Month 6: Mild | 4.7 |
| Month 6: Moderate | 3.4 |
| Month 6: Severe | 2.1 |
| Month 6: Unknown | 0.3 |
| Month 9: Mild | 3.4 |
| Month 9: Moderate | 1.0 |
| Month 9: Severe | 0.5 |
| Month 9: Unknown | 0.3 |
| Month 12: Mild | 1.6 |
| Month 12: Moderate | 0.8 |
| Month 12: Severe | 0.5 |
| Month 12: Unknown | 0.3 |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3: CR | 0.8 |
| Month 3: PR | 4.9 |
| Month 3: SD | 25.2 |
| Month 6: CR | 0.5 |
| Month 6: PR | 3.1 |
| Month 6: SD | 14.3 |
| Month 9: CR | 0.3 |
| Month 9: PR | 1.6 |
| Month 9: PD | 10.6 |
| Month 12: CR | 0.5 |
| Month 12: PR | 1.6 |
| Month 12: SD | 8.1 |
| months | NSCLC Elderly Participants |
|---|---|
| Time to Start of Erlotinib Therapy After End of First Line Therapy | 2.30 (0.03 to 100.39) |
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.
| percentage of participants | NSCLC Elderly Participants |
|---|---|
| Month 3 | 5.7 |
| Month 6 | 3.6 |
| Month 9 | 1.8 |
| Month 12 | 2.1 |
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.
| months | NSCLC Elderly Participants |
|---|---|
| Median Progression Free Survival: Overall | 3.5 (3.2 to 3.9) |
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.
| months | NSCLC Elderly Participants |
|---|---|
| 65-69 years | 3.257 (2.632 to 3.914) |
| 70-74 years | 3.388 (2.763 to 4.079) |
| 75-79 years | 5.033 (3.717 to 6.382) |
| ≥ 80 years | 2.928 (2.039 to 3.750) |
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.
| months | NSCLC Elderly Participants |
|---|---|
| Male | 3.355 (2.993 to 3.750) |
| Female | 4.046 (3.257 to 5.888) |
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.
| months | NSCLC Elderly Participants |
|---|---|
| Smoker | 3.454 (2.928 to 4.572) |
| Non-smoker | 5.526 (3.849 to 10.855) |
| Ex-smoker | 2.993 (2.566 to 3.487) |
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.
No measurements were reported for this outcome.
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.
| months | NSCLC Elderly Participants |
|---|---|
| Median Overall Survival: Overall | 7.1 (6.0 to 7.9) |
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.
| months | NSCLC Elderly Participants |
|---|---|
| Male | 6.283 (5.526 to 7.467) |
| Female | 8.125 (6.349 to 12.237) |
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.
| months | NSCLC Elderly Participants |
|---|---|
| Smoker | 6.612 (5.329 to 8.388) |
| Non-smoker | 11.184 (7.928 to NA) |
| Ex-smoker | 5.855 (5.033 to 7.270) |
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.
No measurements were reported for this outcome.
Collected over Up to Month 40 (Maximum follow-up). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NSCLC Elderly Participants | — | 79/385 (20.5%) | 135/385 (35.1%) |
| Event | NSCLC Elderly Participants |
|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 16/385 |
| RashSkin and subcutaneous tissue disorders | 10/385 |
| PneumoniaInfections and infestations | 9/385 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 8/385 |
| General physical health deteriorationGeneral disorders | 6/385 |
| AnaemiaBlood and lymphatic system disorders | 4/385 |
| Rash pustularInfections and infestations | 4/385 |
| DehydrationMetabolism and nutrition disorders | 4/385 |
| NauseaGastrointestinal disorders | 3/385 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 3/385 |
| Event | NSCLC Elderly Participants |
|---|---|
| RashSkin and subcutaneous tissue disorders | 84/385 |
| DiarrhoeaGastrointestinal disorders | 52/385 |
| FatigueGeneral disorders | 41/385 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 36/385 |
| CoughRespiratory, thoracic and mediastinal disorders | 30/385 |
Safety Analysis Set (SAF), included participants who received at least one dose of Tarceva®.
| Age, Continuous(years) | NSCLC Elderly Participants |
|---|---|
| Mean | 72.66 ± 5.23 |
| Sex: Female, Male(Participants) | NSCLC Elderly Participants |
|---|---|
| Female | 127 |
| Male | 258 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche