title: Activity and safety of erlotinib as second- and third-line treatment in elderly patients with advanced non-small cell lung cancer: a phase II trial.
abstract: Erlotinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Efficacy of this drug was documented in the BR.21 trial showing that adenocarcinoma, female gender, Asian ethnicity and never-smoker status are predictive of clinical response to erlotinib. Retrospective studies documented the same benefits for elderly patients as young patients in terms of response, progression-free survival, and overall survival. The primary aim of our trial was to confirm these findings in a prospective way; the secondary aim was to identify if the aforementioned clinical characteristics may be predictive of response even in elderly patients. The trial included 31 patients with pretreated stage IIIB (2) and IV (29) non-small cell lung cancer (NSCLC). Median age was 75 years (range: 65-85). Twenty-seven patients were current/former-smokers and four never-smokers. Twenty-three patients are evaluable for response. Objective response rates were reported in five patients (16%). Five patients had stable disease (16%) and 13 progressive disease (43%). Seven patients had a "clinical benefit" from erlotinib (22.5%; 95% C.I.: 7.9-37.2%). Grade 3 skin rash was recorded in three patients (10%). Median survival was 9 months (range 1-30). Median time to progression was 3 months (range: 1-24 months). Our study confirmed erlotinib activity and safety as second- and third-line treatment in elderly patients with advanced NSCLC, especially in terms of median survival. Even though this trial does not allow us to draw a definitive conclusion about the role of a particular clinical characteristic predictive of response, the "clinical benefit" was documented especially in females, in patients with adenocarcinoma histology and skin rash, confirming previous retrospective data.
authors.affiliation: Oncology Unit, San Salvatore Hospital, via Lombroso, 61100 Pesaro, Italy. d.rossi63@libero.it
authors.forename: David
authors.initials: D
authors.lastname: Rossi
authors.forename: Donatella
authors.initials: D
authors.lastname: Dennetta
authors.forename: Marcello
authors.initials: M
authors.lastname: Ugolini
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Catalano
authors.forename: Paolo
authors.initials: P
authors.lastname: Alessandroni
authors.forename: Paolo
authors.initials: P
authors.lastname: Giordani
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Baldelli
authors.forename: Virginia
authors.initials: V
authors.lastname: Casadei
authors.forename: Francesco
authors.initials: F
authors.lastname: Graziano
authors.forename: S
authors.initials: S
authors.lastname: Luzi Fedeli
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology; D000077192:Adenocarcinoma of Lung; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology; D008297:Male; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D012907:Smoking / Q000009:adverse effects; D014410:Tumor Stem Cell Assay
chemical_list: D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors