A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

OS was time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, overall survival time was censored at the last date the participant was known to be alive, or the study cutoff date, whichever was earlier. The cut-off date for the OS was date when 687 deaths were observed. OS was estimated from Kaplan-Meier Curves.

Time frame: Baseline to the date when 687 deaths occurred (26 January 2011)

Population: All randomized participants.

HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies, and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).

Time frame: Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.

Population: ITT population with questionnaires evaluable for ABSI.

HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).

Time frame: Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.

Population: ITT population with questionnaires evaluable for LCSS.

Participants with OR were those who had a confirmed complete response \[CR\] or a confirmed partial response \[PR\], based on RECIST criteria, in which * CR refected the disappearance of all tumor lesions (with no new tumors) * PR reflected a pre-defined decrease in tumor burden - a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD * OR was CR + PR The response rate was the percent of participants with a response. To determine a response, tumors were assessed by the investigators using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.

Time frame: Baseline to data cut-off (26 January 2011)

Population: Evaluable population: All ITT participants with measurable disease at study entry, and with at least one valid post baseline tumor evaluation, except if the participant died due to progressive disease or had documented (ie, radiological) progression before having any post-baseline tumor evaluation.

PFS was defined as the time interval between the date of randomization and the time of occurrence of the first radiological tumor progression detected by a computer tomography (CT) scan and /or by Magnetic Resonance Imaging (MRI); or death due to any cause; whichever was earlier. Participants without disease progression were censored at the earliest date between their last valid tumour assessment and the data cutoff date. PFS was estimated from Kaplan-Meier Curves.

Time frame: Baseline to data cut-off (26 January 2011)

Population: Intent to treat (ITT) population. The results are based on a total of 865 PFS events (434 in the placebo group and 431 in the aflibercept group) at the time of cutoff.