en
Scientific article
Open access
English

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

Published inAnnals of oncology, vol. 19, no. 4, p. 739-745
Publication date2008-04
Abstract

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/m(2) on day 1 and gemcitabine 1250 mg/m(2) 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.

eng
Keywords
  • Advanced disease
  • Chemotherapy
  • First-line therapy
  • Gefitinib
  • Non-small-cell lung cancer
Citation (ISO format)
D’ADDARIO, G. et al. Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03. In: Annals of oncology, 2008, vol. 19, n° 4, p. 739–745. doi: 10.1093/annonc/mdm564
Main files (1)
Article (Published version)
accessLevelPublic
Identifiers
ISSN of the journal0923-7534
94views
28downloads

Technical informations

Creation02/25/2022 9:53:00 AM
First validation02/25/2022 9:53:00 AM
Update time03/16/2023 6:44:02 AM
Status update03/16/2023 6:43:59 AM
Last indexation01/17/2024 8:40:47 PM
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack