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

実験的：1

薬：erlotinib [Tarceva]

150 mg, orally once a day for up to 6 cycles of 21 days each

アクティブコンパレータ：2

薬：vinorelbine

60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)

CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.

Percentage of Participants Achieving Disease Control

Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.

Duration of Response Among Participants Who Achieved Either a CR or PR

Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.

Percentage of Participants With Disease Progression

Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time to Disease Progression

Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.

Overall Survival: Percentage of Participants With an Progressive Disease or Death

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Overall Survival: Time to Event

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.

Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire

The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.

Changes in Quality of Life as Measured by the FACT Questionnaire

The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.

Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change

The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.

Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire

The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).

Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change

The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.