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

Pallis, A.G.; Christofillakis, Ch.; Tselepatiotis, E.; Agelaki, S.; Vamvakas, L.; Souglakos, J.; Vardakis, N.; Kalykaki, A.; Kotsakis, A.; Argiraki, A.; Mavroudis, D.; Georgoulias, V.

doi:10.1016/j.lungcan.2006.08.019

« Previous Next »Lung Cancer
Volume 55, Issue 1 , Pages 101-107, January 2007

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

A.G. Pallis
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
Ch. Christofillakis
- Medical Oncology Unit, 401 Military Hospital of Athens, Greece
E. Tselepatiotis
- Department of Internal Medicine, “Patision” General Hospital of Athens, Greece
S. Agelaki
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
L. Vamvakas
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
J. Souglakos
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
N. Vardakis
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
A. Kalykaki
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
A. Kotsakis
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
A. Argiraki
- Department of Medical Oncology, “Iaso” General Hospital of Athens, Greece
D. Mavroudis
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
V. Georgoulias
- Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece
- Corresponding author. Tel.: +30 2810 392750; fax: +30 2810 392802.

Received 12 July 2006; received in revised form 30 August 2006; accepted 31 August 2006.

Summary

Purpose

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).

Patients and treatment

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 30mg/m², administered as a 1-h IV infusion, on days 1, 8 and 15 of each 4-week cycle followed by gefitinib 250mg daily po. Gefitinib treatment was continued until disease progression, development of unacceptable toxicity, or withdrawal of patients consent.

Results

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.