Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.

Time frame: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)

Population: Intent to treat population. Number of patients censored (up to 24 months): pemetrexed = 51, docetaxel = 55. Number of participants censored (up to 30 months): pemetrexed = 30, docetaxel = 32.

Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as Number of Patients with Disease Progression.

Time frame: time of response to progressive disease (up to 24 months)

Population: Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Results not presented because median was not calculable for the docetaxel arm.

Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.

Time frame: baseline to measured tumor response (up to 24 months after study enrollment)

Population: Patients who received at least one dose of study drug and qualified for tumor response analysis (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease).

Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.

Time frame: first dose of study drug up to 24 months

Population: Patients who received at least one dose of study drug.

Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.

Time frame: baseline to measured progressive disease (up to 24 months after study enrollment)

Population: Intent to treat population. Patient censored:~pemetrexed=25, docetaxel=39.

Number of patients who have died or have had progression of disease. This outcome substitutes for the outcome on Duration of Response.

Time frame: time of response to progressive disease (up to 12 months)

Population: Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Patients censored: pemetrexed=6, docetaxel=3.