Annals of Oncology Advance Access originally published online on December 21, 2005
Annals of Oncology 2006 17(3):467-472; doi:10.1093/annonc/mdj115
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© 2005 European Society for Medical Oncology
Randomized phase III study of 3-weekly versus weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial
1 Consorcio Hospital General Universitario de Valencia, Valencia, Spain; 2 Hospital General de Alicante, Alicante, Spain; 3 Hospital de Alcorcón, Alcorcón, Spain; 4 Hospital Virgen de los Lirios, Alcoy, Spain; 5 Hospital Gregorio Marañón, Madrid, Spain; 6 Hospital Clínico Lozano Blesa, Zaragoza, Spain; 7 Hospital Clínico San Carlos, Madrid, Spain; 8 Hospital Dr. Peset, Valencia, Spain; 9 Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Spain; 10 Hospital General de Elche, Elche, Spain; 11 Hospital Clínico de Barcelona, Barcelona, Spain; 12 Hospital Universitario de Canarias, Tenerife, Spain; 13 Hospital General Yagüe, Burgos, Spain; 14 Hospital de Sagunto, Sagunto, Spain; 15 Hospital Marqués de Valdecilla, Santander, Spain; 16 Consorcio Sanitario de Terrassa, Terrassa, Spain; 17 Clínica Puerta de Hierro, Madrid, Spain; 18 Hospital de León, León, Spain; 19 Hospital Valle de Hebrón, Barcelona, Spain
* Correspondence to: Dr R. Rosell, Medical Oncology Service, Scientific Director of Oncology Research, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Ctra Canyet, s/n 08916 Badalona, Barcelona, Spain. Tel: +34-93-497-89-25; Fax: +34-93-497-89-50; E-mail: rrosell{at}ico.scs.es
Background: Docetaxel is a widely accepted second-line treatment in advanced non-small-cell lung cancer (NSCLC) with a risk of myelotoxicity. This study evaluated the efficacy and toxicity profile of two docetaxel regimens in NSCLC patients who had failed first-line non-docetaxel-based chemotherapy.
Patients and methods: A total of 259 patients from 33 Spanish centers were randomized to receive either docetaxel 75 mg/m2 administered every 3 weeks (3W arm) or docetaxel 36 mg/m2 given weekly (1W arm) for 6 weeks followed by 2 weeks of rest. The primary end point was 1-year survival; secondary end points were median survival, time to progression, response and toxicity.
Results: One-year survival was 27% in the 3W and 22% in the 1W arm. Median time to progression was also similar in the two arms. Median survival was 6.6 months in the 3W arm versus 5.4 months in the 1W arm (P = 0.075). Response rates were 9.3% in the 3W arm and 4.8% in the 1W arm. More patients in the 1W arm experienced mucositis [1W, nine patients (7.2%); 3W, two patients (1.6%); P = 0.032], while febrile neutropenia was significantly higher in the 3W arm [3W, 10 patients (7.8%); 1W, one patient (0.8%); P = 0.010].
Conclusions: Both weekly and 3-weekly docetaxel were effective and well-tolerated, with different toxicity profiles. In general, there was no indication to recommend the weekly schedule. However, the significant lower rate of febrile neutropenia observed in the weekly schedule makes it a good alternative for patients at risk of severe neutropenia.
Key words: docetaxel, non-small-cell lung cancer, second-line chemotherapy
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