Article

Sequential administration of docetaxel followed by maintenance gefitinib, as salvage treatment in patients with advanced NSCLC: a multicenter phase II trial.

Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece.
Lung Cancer (impact factor: 3.43). 02/2007; 55(1):101-7. DOI:10.1016/j.lungcan.2006.08.019 pp.101-7
Source: PubMed

ABSTRACT To evaluate the activity and toxicity of the sequential administration of docetaxel followed by gefitinib in patients with advanced non-small cell lung cancer (NSCLC).
Forty-one patients pre-treated with at least one prior chemotherapy regimen (platinum- or taxane-based) for advanced/metastatic NSCLC received three cycles of docetaxel 30 mg/m2, administered as a 1-h IV infusion, on days 1, 8 and 15 of each 4-week cycle followed by gefitinib 250 mg daily po. Gefitinib treatment was continued until disease progression, development of unacceptable toxicity, or withdrawal of patients consent.
Two (4.9%) patients achieved a partial response and 10 (24.4%) stable disease, for a disease control rate of 29.3% (95% CI: 15.3%-43.2%) while on weekly docetaxel treatment. Additionally, progressive disease (PD) was observed in 29 (70.7%). No objective responses were observed during the gefitinib maintenance therapy; however, 17 (41.5%) patients presented stable disease maintained for more than 2 months. Median time to progression was 3.0 months (range: 1-38.3 months; 95% CI: 2.4-3.6); median overall survival 6.9 months (range: 1.2-40.2 months; 95% CI: 5.34-8.52) while the 1-year survival was 28.8%. Therapy was generally well tolerated with diarrhea and rash being the most frequent toxicities.
The sequential administration of docetaxel and gefitinib was well tolerated and moderately active against advanced pre-treated NSCLC.

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Keywords

1-h IV infusion
 
1-year survival
 
2 months
 
advanced/metastatic NSCLC
 
disease control rate
 
docetaxel 30 mg/m2
 
frequent toxicities
 
gefitinib 250 mg
 
gefitinib maintenance therapy
 
non-small cell lung cancer
 
objective responses
 
one prior chemotherapy regimen
 
partial response
 
patients consent
 
patients pre-treated
 
pre-treated NSCLC
 
progressive disease
 
sequential administration
 
stable disease
 
unacceptable toxicity