Front-line treatment of advanced non-small cell lung cancer with irinotecan and docetaxel: a multicentre phase II study.
OBJECTIVE
To evaluate the efficacy and tolerance of the irinotecan plus docetaxel combination in patients with advanced non-small cell lung cancer (NSCLC).


METHODS
Thirty-nine chemotherapy-naïve patients with advanced NSCLC were treated with irinotecan 200mg/m2 followed by docetaxel 80 mg/m2 intravenously on day 1 with granulocyte colony-stimulating factor (150 microg/m2) support from day 2 to 9. Treatment was repeated every 3 weeks.


RESULTS
A partial response was achieved in 9 (23%; 95% confidence interval 9.85-36.3%) patients; stable and progressive disease were observed in 10 (25.6%) and 20 (51.4%) patients, respectively. The median duration of response was 7.1 months and the median time to tumor progression 3 months. The median survival time was 10.8 months and the 1-year survival 42.2%. Four (10.3%) patients developed grade 4 neutropenia and all but one were complicated with fever; there was no treatment-related death. Nine (23.1%) patients developed grade 3 or 4 diarrhea while grade 2 or 3 fatigue occurred in nine (23.1%), and grade 3 mucositis in two (2.6%).


CONCLUSIONS
The combination of irinotecan/docetaxel is a relatively active non-platinum-based chemotherapy regimen with manageable toxicity, which could be given in an outpatient basis; this regimen merits to be further studied in order to improve its tolerance and evaluate its clinical relevance in patients who can not tolerate platinum-based doublets.
Ziotopoulos
Panagiotis
P
Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71100 Heraklion, Crete, Greece.
Androulakis
Nikolaos
N
Mylonaki
Efthimia
E
Chandrinos
Vassilios
V
Zachariadis
Emmanouel
E
Boukovinas
Ioannis
I
Agelidou
Athina
A
Kentepozidis
Nikolaos
N
Ignatiadis
Michail
M
Vossos
Andreas
A
Georgoulias
Vassilis
V
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin