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Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03

D'Addario, G. ; Rauch, D. ; Stupp, R. ; Pless, M. ; Stahel, R. ; Mach, N. ; Jost, L. ; Widmer, L. ; Tapia, C. ; Bihl, M. ; Mayer, M. ; Ribi, K. ; Lerch, S. ; Bubendorf, L. ; Betticher, D. C.

In: Annals of Oncology, 2007, vol. 19, no. 4, p. 739-745

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    Titre
    • Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03
    Auteur
    • D'Addario, G.. Department of Oncology, Kantonsspital St.Gallen, St Gallen
    • Rauch, D.. Department of Oncology, Spital Thun, Thun
    • Stupp, R.. Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne
    • Pless, M.. Universitaetsspital Basel, Basel
    • Stahel, R.. Department of Oncology, Universitaetsspital Zuerich, Zuerich
    • Mach, N.. Deaprtment of Oncology, Hôpitaux Universitaires de Genève, Genève
    • Jost, L.. Department of Oncology, Kantonsspital Bruderholz, Bruderholz
    • Widmer, L.. Department of Oncology, Triemlispital Zuerich, Zuerich
    • Tapia, C.. Institut für Pathologie, Universitaetsspital Basel, Basel
    • Bihl, M.. Institut für Pathologie, Universitaetsspital Basel, Basel
    • Mayer, M.. SAKK Coordinating Center, Bern
    • Ribi, K.. SAKK Coordinating Center, Bern
    • Lerch, S.. SAKK Coordinating Center, Bern
    • Bubendorf, L.. Institut für Pathologie, Universitaetsspital Basel, Basel
    • Betticher, D. C.. Institute of Medical Oncology, Inselspital Bern, Bern, Switzerland
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Annals of Oncology, 2007, vol. 19, no. 4, p. 739-745. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:295520
    Summary
    Background: Gefitinib is active in patients with pretreated non-small-cell lung cancer (NSCLC). We evaluated the activity and toxicity of gefitinib first-line treatment in advanced NSCLC followed by chemotherapy at disease progression. Patients and methods: In all, 63 patients with chemotherapy-naive stage IIIB/IV NSCLC received gefitinib 250 mg/day. At disease progression, gefitinib was replaced by cisplatin 80 mg/m2 on day 1 and gemcitabine 1250 mg/m2 on days 1, 8 for up to six 3-week cycles. Primary end point was the disease stabilization rate (DSR) after 12 weeks of gefitinib. Results: After 12 weeks of gefitinib, the DSR was 24% and the response rate (RR) was 8%. Median time to progression (TtP) was 2.5 months and median overall survival (OS) 11.5 months. Never smokers (n = 9) had a DSR of 56% and a median OS of 20.2 months; patients with epidermal growth factor receptor (EGFR) mutation (n = 4) had a DSR of 75% and the median OS was not reached after the follow-up of 21.6 months. In all, 41 patients received chemotherapy with an overall RR of 34%, DSR of 71% and median TtP of 6.7 months. Conclusions: First-line gefitinib monotherapy led to a DSR of 24% at 12 weeks in an unselected patients population. Never smokers and patients with EGFR mutations tend to have a better outcome; hence, further trials in selected patients are warranted