S342 Results: A total of 7 RCTs were identified (2,867 patients). IPD analyses are still pending for one trial. The pooled estimate for overall survival showed an improvement in favor of docetaxel whatever the source data used: Trial No. of pts Design Hazard ratio [95% CI] Published data Study report data IPD Fossella F et al. J Clin Oncol 2003 1218 DC vs VC 0.85 [0.70.1.01] 0.85 [0.72;0.99] 0.89 [0.76;1.04] DCb vs VC 0.95 [0.80;1.14] 0.95 [0.81;1.12] 1.02 [0.88;1.20] Douillard JY et al. Am

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... l 2005 233 DC vs VC 0.89 [0.68;1.16] 0.89 [0.66:1.19] 0.87 [0.66;1.13] Kubota K et al. J Clin Oncol 2004 311 DC vs VdC 0.73 [0.57;0.94] 0.75 [0.58;0.97] 0.71 [0.56.0.91] Georgoulias V et al. J Clin Oncol 2005 413 DG vs VC 1.00 [0.80;1.26] 1.00 [0.80;1.26] 1.02 [0.81;1.27] Pujol JL et al. Ann Oncol 2005 311 DG vs VC 0.90 [0.70;1.16] 0.90 [0.70;1.16] pending Kudoh S et al. J Clin Oncol 2006 180 D vs VC 0.78 [0.56;1.08] 0.78 [0.56;1.08] 0.78 [0.56;1.08] Monnier A et al. Proc ASCO 2003 201 D vs V NA (abstract) 0.95 [0.70;1.30] 0.96 [0.70;1.31] Overall HR 0.88 [0.81;0.96] 0.89 [0.82;0.96] 0.90 [0.82;0.98] Background: In the BR.21 phase III placebo-controlled study (Shepherd et al. NEJM 2005;353:123-132), erlotinib (Tarceva ® ) was well tolerated and significantly improved survival, delayed symptom progression and improved quality of life in patients with relapsed advanced NSCLC. The multicentre, open-label TRUST study was initiated to provide erlotinib access for patients with stage III/IV advanced NSCLC. Methods: Eligible patients had failed prior chemotherapy, or were unsuitable for chemotherapy. Erlotinib was administered orally 150mg/ day until disease progression or unacceptable toxicity. The NCI-CTC v3.0 was used to grade toxicities, including: incidence and grade of erlotinib-related rash; serious adverse events (SAEs) and treatment-related SAEs; and adverse events (AEs) leading to treatment withdrawal. Other treatment-related AEs were reported if they were not included on a list of 15 pre-specified AEs in the study protocol (rash; pruritis; dry skin; diarrhoea; nausea; vomiting; stomatitis; abdominal pain; fatigue; dyspnoea; cough; anorexia; infection; conjunctivitis; and keratoconjunctivitis sicca). Dose reductions (50mg increments) were allowed as required. Results: 5,015 patients from 51 countries were included in the analysis at the data cut-off (20/11/06). Median age was 63 years (range 19-95). Patient characteristics: male 62%, female 38%; stage IIIB 22%, stage IV 78%; ECOG PS 0 21%, PS 1 53%, PS 2 20%, PS 3 6%; Caucasian 76%, Oriental 19%, other 5%; non-smoker 28%, ever-smoker 71% (no data 1%); adenocarcinoma 53%, squamous-cell carcinoma 25%, other 21% (no data <1%); erlotinib 1st line 14%, 2nd line 48%, 3rd line 37%, other 1%. Data on the occurrence of rash were available for 4,965 patients, of whom 70% experienced rash, which was mainly mild or moderate (among those with rash, 84% of cases were grade 1/2 and 16% were grade 3/4). AE safety data were available for 4,423 patients, of whom, 55% experienced at least one AE. Erlotinib-related SAEs were experienced by 5% of patients, the most common of these being gastrointestinal (GI) disorders (2% all grades, 1% ≥ grade 3). Lung-related SAEs occurred in <1% of patients. 10% of patients had at least one treatment-related AE that was not pre-specified (3% had at least one grade 3/4 event), but no single such event occurred in more than 1% of patients. Treatment discontinuation due to erlotinib-related AEs occurred in 6% of patients, mainly due to GI disorders (2% all grades, 1% ≥ grade 3) and skin disorders (2% all grades, 1% ≥ grade 3). Lung-related AEs led to erlotinib withdrawal in <1% of patients. Among 4,405 patients with available data, 577 patients (13%) required dose reductions due to erlotinib-related events, most commonly related to rash (n=416) or diarrhoea (n=72). Safety results for the subgroup of patients who received erlotinib second-line were similar to the overall results. Efficacy data will be presented. Conclusions: The safety data obtained in the TRUST study of erlotinib in advanced NSCLC confirm in a wider clinical setting the favourable safety profile of erlotinib observed in previous clinical trials. Erlotinib was generally well tolerated, thus enabling the majority of patients to receive the full therapeutic dose.