Erlotinib In First-line Treatment Research Articles

PCN79 Cost Effectiveness of Erlotinib in First Line Treatment of Advanced Non Small Cell Lung Cancer (NSCLC) in Vulnerable Elderly Patients: An Economical Analysis of a prospective Phase 2 Study (GFPC 0505)

Weekly gemcitabin and erlotinib are both active in elderly patients treated for NSCLC. The aim of the GFPC0505 randomized phase II trial was to compare the efficacy and the cost of weekly gemcitabin (G) followed by erlotinib after progression (arm A) versus erlotinib followed by G after progression (arm B) in frail elderly patients with advanced non small-cell lung cancer (NSCLC), selected on the basis of a comprehensive geriatric assessment (CGA). Frail elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA. Main clinical outcome was time to second progression (TTP2). Costs were limited to direct medical costs and were prospectively collected until progression, from the third party payer perspective. Health utilities (based on disease states and grade 3-4 toxicities) and costs after progression were derived from the literature. Sensitivity analyses were performed. Median age of the 94 enrolled patients was 78.2 years, and 76 (80%) were male. There is no significantly difference between the 44 and 50 patients respectively randomized in arm A and B, in terms of efficacy (TTP2: 4.3 and 3.5 months: overall survival: 4.4 and 3.9 months, mean QALY:0.347 and 0.325) and in terms of mean direct costs (15,363 and 15,233€). In this population, the 2 strategies appeared equivalent in terms of efficacy and costs. Supported by an unrestricted educational grant from Roche

First-line erlotinib in advanced non-small cell lung cancer (NSCLC) carrying an activating EGFR mutation: A multicenter academic phase II study in Caucasian patients (pts) (NCT00339586)—FIELT study group.

7597 Background: Compared to chemotherapy, 1st line treatment with EGFR-TK inhibitors results in superior progression-free survival (PFS) in Asian patients with advanced NSCLC with activating EGFR TK domain mutations. We conducted a prospective study with 1st line erlotinib in Caucasian pts with EGFR TK domain mutations. Methods: Multicentre phase II study. EGFR mutation status was determined in a central lab on macro-dissected biopsies obtained from pts with advanced adenocarcinoma with a non- or past smoking history. Pts were given erlotinib, 150 mg daily till disease progression or prohibitive toxicity. The primary end point of the study was a 70% PFS at 3 months. Results: An EGFR mutation was found in 64 (28%) of 247 pts screened. Eighteen pts did not enter the study because of deterioration, withholding of consent after mutation analysis, or failing other clinical selection criteria. Forty six pts (8 male, 38 female) with median age of 72 years (35-83), median performance status of 1 (1-3) stage distribution Ib (1), IIIb (4) and IV (41) patients were included. EGFR mutations found: exon 18 (1), exon 19 (27), exon 20 (3) and exon 21 (15). Smoking history: 38 never smokers, 7 past smokers, 1 smoker. Median follow-up is 83 weeks. PFS was 83 % at 3 months and 74% at 6 months. Best response was: PR 26; SD 10, PD 10. The median time to progression and overall survival are not reached: 44+ and 56+ weeks respectively. One patient ended treatment prematurely because of skin toxicity while in PR for 83+ wks. Conclusions: In this the first formal prospective phase II genotype based study with erlotinib in first-line treatment of Caucasian pts with EGFR mutant advanced NSCLC, efficacy appears similar to the results obtained with gefitinib and erlotinib in randomized studies involving Asian patients and other first-line data with erlotinib. The study achieved its primary end point (PFS ≥ 70% at 3 months). A randomized study comparing first-line erlotinib versus chemotherapy is ongoing in Europe.

Response to Erlotinib in First-Line Treatment of Non–Small-Cell Lung Cancer in a White Male Smoker with Squamous-Cell Histology

Erlotinib, a potent inhibitor of the tyrosine-kinase (TK) activity of human epidermal growth factor receptor (HER1/EGFR), produces significant survival and quality of life benefits in patients with previously treated advanced-stage non-small-cell lung cancer. Although the survival benefit from erlotinib was observed in varied subgroups of patients, the radiographic responses were more common in certain patient subgroups, such as women, never-smokers, patients with adenocarcinoma histology, patients of Asian ethnicity, and patients with presence of HER1/EGFR TK domain mutations. Herein, we describe a white male former smoker with advancedstage squamous cell non–small-cell lung cancer, who responded to first-line erlotinib. A molecular analysis of the tumor did not reveal HER1/EGFR TK mutations. This case study, along with subgroup analyses of the BR.21 phase III study, suggests that patients should not be selected for erlotinib treatment based only on characteristics, such as smoking status, tumor histology, HER1/EGFR TK mutation status, sex, or ethnicity.