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Annals of Oncology Advance Access published online on December 19, 2007
Annals of Oncology, doi:10.1093/annonc/mdm564
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© 2007 European Society for Medical Oncology

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

G. D'Addario1,*, D. Rauch2, R. Stupp3, M. Pless4,{dagger}, R. Stahel5, N. Mach6, L. Jost7, L. Widmer8, C. Tapia9, M. Bihl9, M. Mayer10, K. Ribi10, S. Lerch10, L. Bubendorf9 and D. C. Betticher11,{dagger}{dagger}

1 Department of Oncology, Kantonsspital St.Gallen, St Gallen
2 Department of Oncology, Spital Thun, Thun
3 Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne
4 Universitaetsspital Basel, Basel
5 Department of Oncology, Universitaetsspital Zuerich, Zuerich
6 Deaprtment of Oncology, Hôpitaux Universitaires de Genève, Genève
7 Department of Oncology, Kantonsspital Bruderholz, Bruderholz
8 Department of Oncology, Triemlispital Zuerich, Zuerich
9 Institut für Pathologie, Universitaetsspital Basel, Basel
10 SAKK Coordinating Center, Bern
11 Institute of Medical Oncology, Inselspital Bern, Bern, Switzerland

* Correspondence to: Dr G. D'Addario, Onkologie Schaffhausen, Rheinstrasse 17, 8200 Schaffhausen, Switzerland. Tel: +41-52-624-18-18; Fax: +41-52-624-55-36; E-mail: g.daddario{at}hin.ch

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.

advanced disease, chemotherapy, first-line therapy, gefitinib, non-small-cell lung cancer

{dagger} Present address: Kantonsspital Winterthur, Medizinische Onkologie, Kantonsspital Winterthur, Winterthur, Switzerland

{dagger}{dagger} Present address: Hôpital Cantonal Fribourg, Oncologie, Hôpital Cantonal Fribourg, Fribourg, Switzerland

Received for publication September 1, 2007. Revision received November 10, 2007. Accepted for publication November 13, 2007.


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