Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 7010
© 2004 American Society of Clinical Oncology

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Abstract

Results of a phase III trial of erlotinib (OSI-774) combined with cisplatin and gemcitabine (GC) chemotherapy in advanced non-small cell lung cancer (NSCLC)

Hospital Grosshansdorf, Hamburg, Germany; Regionalny Osrodek Onkologii, Klinika Chemioterapi, Lodz, Poland; Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlic, Otwock, Poland; Akademische Krankenhaus, Hamburg, Germany; Klinika Tuberkulozy a Respiracnich Onemocneni, Fakultni Nemocnice s poliklinikou Ostrava, Lublin, Poland; F. Hoffmann La Roche, Inc, Basel, Switzerland; Asklepios Fachkliniken Muenchen-Gauting, Onkologie, Gauting, Germany

7010

Background: Oral erlotinib is a potent HER1/EGFR tyrosine kinase-phosphorylation inhibitor with single-agent antitumor activity and has shown additive effects when added to chemotherapy in preclinical models. TALENT was a placebo-controlled study in patients (pts) with previously untreated advanced NSCLC to receive erlotinib at 150mg/d or placebo (PBO) with 6 cycles of gemcitabine and cisplatin (GC) followed by monotherapy. The primary endpoint was duration of survival with secondary efficacy endpoints of: time to progression, response rate, duration of response (using RECIST); pharmacokinetic and pharmacodynamic parameters; quality of life (using the Lung Cancer Symptom Scale). EGFR and HER2 expression rates were also assessed. A standard safety analysis was done. Methods: Chemotherapy was given for a maximum of 6 cycles after which patients continued on study drug until disease progression (PD). Treatment with study drug beyond PD was permitted. Eligibility criteria for both parts of the study included: chemo-naive patients with unresectable stage III or IV NSCLC; age 18 years and ECOG PS of 0–1. Results: A total of 1172 pts were enrolled from 164 sites worldwide. The demographic and disease characteristics were well balanced across the two treatment groups. There were no statistically significant differences in overall survival (OS), time to progression (TTP) as described in the table below and quality of life (time to symptomatic progression [TSP]).

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Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Lilly AstraZeneca Merck; Eli Lilly; AstraZeneca; Bristol-Myers Squibb

Abstract presentation from the 2004 ASCO Annual Meeting