Autori: J. Ayllon, V. Plazanet, E. Fabre Guillevin, E. Banu, B. Bonan, S. Oudard, F. Le Pimpec Barthes, N. Theou, H. Sors and J. M. Andrieu

Editorial: Abstract 7323. J Clin Oncol (supplement) 2005;23(16S):700s., 2005.

Rezumat:

Background: Gefitinib (IressaTM) is approved in for use as monotherapy for the treatment of patients (pts) with locally advanced or metastatic NSCLC after failure of both platinum-based and docetaxel chemotherapy (CT). CT that include a taxane, vinorelbine or gemcitabine remains the alternative for the second- and third-line CT. The modality of combining these CT in a sequential manner and the place of target therapies could have a major impact on survival. Methods: The present analysis evaluates the efficacy of Gefitinib for metastatic NSCLC pts. The primary outcome measure was the impact of the moment of gefitinib initiation on Time from Primary Diagnosis (TPD). TPD was calculated from primary diagnosis until death or last follow-up. Cox hazard regression analysis was performed, stratified according the initial stage of disease (AJCC 1997) and baseline ECOG performance status (PS). Progression-free survival (PFS), overall survival (OS) and TPD were estimated by Kaplan-Meier method. Gefitinib was given at a dose of 250 mg daily until disease progression in an expanded access program. Results: A retrospective analysis was performed on 71 pts, treated with gefitinib from August 2001 to October 2004 in a single institution. Median age was 59 year (range 44–85), sex M/F: 52/19 pts, ECOG PS: 0–1/2–3: 20/44 pts. Pts distribution according to treatment line was:17 pts (24%) receiving gefitinib as second-line, 16 pts (23%) as third-line, 23 pts (32%) as fourth-line CT. There were 4 pts (6%) with partial response, and 15 pts (21%) with stable disease. The median PFS and OS were 2.6 months (95% CI,1.8–3.4 months) and 5 months (95% CI,3–7 months), respectively, independently of CT line number. The median TPD for our cohort was 18.5 months (95% CI, 15.7–21.2 months). A negative and strong association (Cox coefficient = -0.6) between TPD and the moment of gefitinib initiation was observed (P=0.006, two-sided), demonstrating a major impact of precocity of treatment initiation. Conclusions: Our analysis demonstrates that the prognosis in these patients depends on the precocity of gefitinib initiation. These data may be useful in the design of clinical trials to earlier introduce target therapy, combined with chemotherapy.

Cuvinte cheie: cancer pulmonar, inhibitor de tirosine-kinaza, gefitinib, supravietuire // non small cell lung cancer, tyrosine-kinase inhibitor, survival, gefitinib

URL: http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7323