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Annals of Oncology 12:193-198, 2001
© 2001 European Society for Medical Oncology

research-article

Paclitaxel in combination with carboplatin as salvage treatment in refractory small-cell lung cancer (SCLC): A multicenter phase II study

A. Kakolyris1, D. Mavroudis1, N. Tsavaris2, J. Souglakos1, P. Tsiafaki3, K. Kalbakis1, S. Agelaki1, N. Androulakis1 and D. Georgoulias3,

1Department of Clinical Oncology, University General Hospital of Heraklion Heraklion, Crete
2Medical Oncology Unit, Department of Pathophysiology, University of Athens
3Department of Pulmonary Diseases, ‘Sismanoglion’ General Hospital of Athens
4Seventh Department of Pulmonary Diseases, 'Sotiria General Hospital of Athens Athens, Greece

Department of Medical Oncology University General Hospital of Heraklion Heraklion 71110, P.O. Box 1352 Crete Greecegeogoul{at}med.uch.gr

PURPOSE:: The activity and toxicity of paclitaxel plus carboplatin combination in patients with disease progression after initial chemotherapy for small-cell lung cancer (SCLC) was investigated in a multicenter phase II study.

PATIENTS AND METHODS:: Thirty-two patients (twenty-seven men) with extensive stage refractory SCLC after EP or CAV front-line chemotherapy were treated with paclitaxel 200 mg/m2 on day 1 and carboplatin 6 AUC on day 2 in a four-week schedule. The patients' median age was 60 years and the performance status (WHO) was 0 for 9, 1 for 20 and 2 for 3 patients. All patients were evaluable for toxicity and 29 for response.

RESULTS:: Complete response was observed in one (3%) and partial response in seven (22%) for an overall response rate of 25% (95% confidence interval (CI): 10%–40%). Seven (22%) patients had stable disease and seventeen (53%) progressive disease. All but one of the responders had been previously treated with EP combination and three of them had failed to respond. The median duration of response and the median TIP were 3 and 5.5 months, respectively. The median overall survival was seven months. Grade 3–4 neutropenia was ob served in 12 (37%) patients and in 2 of these it was associated with infection. There were no toxic deaths. Grade 4 anaemia was observed in one (3%) patient and grade 3 thrombocytopenia in three (9.4%). Non-hematologic toxicity was very mild with grade 2–3 asthenia occurring in 10 (25%) patients; asthenia was the reason for treatment discontinuation in 3 patients.

CONCLUSIONS:: The combination of paclitaxel and carboplatin is a relatively active and well-tolerated regimen as salvage treatment in patients with refractory SCLC.

carboplatin, paclitaxel, salvage treatment, SCLC


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