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Annals of Oncology 14:1640-1647, 2003
© 2003 European Society for Medical Oncology


Original Paper

Prospective randomised phase II study of docetaxel versus paclitaxel administered weekly in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy

E. Esteban+, L. González de Sande, Y. Fernández, N. Corral, J Fra, I. Muñiz, J. M. Vieitez, I. Palacio, J. L. Fernández, E. Estrada and A. J. Lacave

Servicio de Oncología Médica, Hospital Central de Asturias, Oviedo, Asturias, Spain

Received 9 February 2003; revised 19 June 2003; accepted 8 August 2003

Background:

Docetaxel and paclitaxel have activity in the second-line treatment of non-small-cell lung cancer (NSCLC), and can be administered as weekly schedules. This phase II randomised study was designed to test the efficacy and toxicity of both taxanes in patients with NSCLC previously treated with platinum-based chemotherapy.

Patients and methods:

Patients (n = 71) with documented NSCLC were randomised to receive docetaxel (n = 35 patients; 36 mg/m2) or paclitaxel (n = 36 patients; 80 mg/m2) as a 1 h weekly infusion for 6 weeks followed by a 2-week rest. The cycles were repeated until disease progression or non-acceptable toxicities occurred.

Results:

Treatment achieved partial response of one versus five patients, median time-to-progression of 74 versus 68 days, and overall survival of 184 versus 105 days, with docetaxel and paclitaxel, respectively. The most common non-haematological toxicities were (docetaxel versus paclitaxel): grade 3/4 pulmonary toxicity in seven versus one patient; grade 2/3 diarrhoea in nine versus five; and grade 3/4 haematological toxicities occurred in two versus four patients. There were no treatment-related deaths.

Conclusions:

Docetaxel and paclitaxel administered weekly have discrete efficacy in patients with NSCLC previously treated with platinum-based chemotherapy. The higher non-haematological toxicity of docetaxel, particularly pulmonary toxicity and diarrhoea, is of concern and warrants further investigation.

Key words: docetaxel, NSCLC, paclitaxel, second-line therapy, weekly administration


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