Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03.
Ann Oncol
; 19(4): 739-45, 2008 Apr.
Article
in En
| MEDLINE
| ID: mdl-18096565
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 ANDMETHODS:
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.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Quinazolines
/
Antineoplastic Combined Chemotherapy Protocols
/
Carcinoma, Non-Small-Cell Lung
/
Lung Neoplasms
/
Antineoplastic Agents
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Guideline
/
Risk_factors_studies
Limits:
Aged80
Country/Region as subject:
Europa
Language:
En
Journal:
Ann Oncol
Journal subject:
NEOPLASIAS
Year:
2008
Type:
Article
Affiliation country:
Switzerland