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Annals of Oncology 15:38-44, 2004
© 2004 European Society for Medical Oncology

Original Paper

Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy for non-small-cell lung cancer

Received 30 June 2003; accepted 13 August 2003

Background:

The survival benefit associated with first-line chemotherapy in advanced lung cancer led to the need for second-line chemotherapy. Docetaxel (Taxotere®) has proven efficacy in both settings. This study evaluated the safety and efficacy of two doses of docetaxel in patients with non-small-cell lung cancer who had failed first-line platinum-based chemotherapy.

Patients and methods:

In total, 182 patients from 24 French centres were randomised and treated with either docetaxel 75 mg/m2 (arm A) or 100 mg/m2 (arm B) every 3 weeks. Baseline characteristics were well balanced, except more patients in arm A had metastatic disease (91.4% versus 78.7%) and therefore the median number of sites involved for arm A was three compared with two for arm B.

Results:

Median time to treatment failure was 1.34 months [95% confidence interval (CI) 1.28–1.64] for arm A and 1.64 months (95% CI 1.34–2.62) for arm B. Median overall survival was 4.7 months (95% CI 3.8–5.9) for arm A versus 6.7 months (95% CI 4.8–7.1) for arm B. According to a blinded expert panel, disease control was achieved in 35 (43.8%) patients in arm A and 39 (49.4%) patients in arm B. More patients in arm B experienced grade 3–4 neutropenia (B: 72.7% versus A: 44.0%), asthenia (B: 20.2% versus A: 10.8%) and infection (B: 6.7% versus A: 2.2%). Three treatment-related deaths were reported in each arm.

Conclusions:

The optimal docetaxel dosage in this second-line setting is 75 mg/m2, as it has a more favourable safety profile and on balance a similar efficacy to the 100 mg/m2 dose.

E. Quoix1,*, B. Lebeau2, A. Depierre3, A. Ducolone4, D. Moro-Sibilot5, B. Milleron6, J. L. Breton7, E. Lemarie8, J. L. Pujol9, J. M. Brechot10, G. Zalcman11, D. Debieuvre12, F. Vaylet13, A. Vergnenegre14 and P. Clouet15

1 Hôpital Lyautey, Strasbourg; 2 Hôpital Saint Antoine, Paris; 3 Hôpital Jean Minjoz, Besançon; 4 Hôpital Hautepierre, Strasbourg; 5 DMAS Thoracic Oncology, CHU Grenoble, Grenoble; 6 Hôpital Tenon, Paris; 7 Centre Hospitalier Général, Belfort; 8 Hôpital Bretonneau, Tours; 9 CHU-Hôpital A. de Villeneuve, Montpellier; 10 Hôtel-Dieu, Paris; 11 Institut Curie, Paris; 12 CHI de la Haute-Saône, Vesoul; 13 Hôpital d’Instruction des Armées de Percy, Clamart; 14 CHU-Hôpital du Cluzeau, Limoges; 15 Laboratoire Aventis, Paris, France

Key words: chemotherapy, docetaxel (Taxotere®), non-small-cell lung cancer, randomised


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