An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer

The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR.

The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Overall survival was defined as the time from Baseline until or death from any cause

Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.

At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.