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Annals of Oncology Advance Access published online on December 21, 2005
Annals of Oncology, doi:10.1093/annonc/mdj115
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© 2005 European Society for Medical Oncology
Received June 16, 2005
Revised November 18, 2005
Accepted November 23, 2005

original article

Randomized phase III study of 3-weekly versus weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial

C. Camps 1, B. Massuti 2, A. Jiménez 3, I. Maestu 4, R. García Gómez 5, D. Isla 6, J. L. González 7, D. Almenar 8, A. Blasco 1, R. Rosell 9 *, A. Carrato 10, N. Viñolas 11, N. Batista 12, C. García Girón 13, A. Galán 14, M. López 15, R. Blanco 16, M. Provencio 17, P. Diz 18, E. Felip 19, and On behalf of the Spanish Lung Cancer Group

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

* To whom correspondence should be addressed.
R. Rosell, E-mail: rrosell{at}ico.scs.es


  Abstract

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.

Keywords: docetaxel; non-small-cell lung cancer; second-line chemotherapy.
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