1. ¹Division of Medical Oncology, Civil Hospital, Livorno, Italy
2. ²Division of Medical Oncology, S Chiara Hospital, Pisa, Italy
3. ³Division of Medical Oncology, Civil Hospital, Carrara, Italy
4. ⁴Division of Pneumology, Civil Hospital, Pistoia, Italy
5. ⁵Department of Oncology, Transplants and Advanced Technologies, University of Pisa, Italy
6. ⁶Department of Oncology, University of Modena, Italy

Correspondence: Dr C Tibaldi, UO Oncologia Medica, Presidio Ospedaliero, Viale Alfieri, 36, Livorno 57100, Italy. E-mail: tiby@katamail.com

Received 14 December 2005; Revised 7 March 2006; Accepted 7 March 2006; Published online 4 April 2006.

Abstract

The aim of this study was to evaluate feasibility and toxicity of escalating doses of epirubicin and paclitaxel plus fixed dose of etoposide and to define the activity of the triplet in extensive disease small-cell lung cancer. Thirteen patients entered the phase I study: the maximum tolerated doses were epirubicin (EpiDX) 90 mg m^-2 and paclitaxel (P) 175 mg m^-2 with febrile neutropenia as dose-limiting toxicity. The recommended schedule for this regimen for the phase II study was EpiDX 75 mg m^-2, P 175 mg m^-2, etoposide (E) 100 mg m^-2 intravenous (fixed dose) days 1–3 with courses repeated every 21 days. The prophylactic use of colony-stimulating factors (CSFs) was not allowed. Twenty patients entered the phase II trial: median age was 61 years (range 50–70), median Eastern Cooperative Oncology Group performance status 0 (0–2); nine patients had visceral disease and 17 had more than two metastatic sites. A total of 100 courses were administered with a median of 5 (range 1–6) per patients. Main toxicity (NCI-CTC) was myelosuppression: neutropenia grades 3 and 4 in 16 and 35% of the courses, respectively. Seven episodes of febrile neutropenia were documented and one patient required hospital admission. Nonhaematological toxicity was moderate. Seven out of 19 evaluable patients achieved a complete response (37%), nine patients (47.3%) a partial response with an overall response rate of 84.2% ((95% confidence interval=60.4–96.6)). In this poor prognostic population of patients the triplet epirubicin/paclitaxel/etoposide showed high antitumour activity with mild nonhaematological side effects. The use of CSFs should be able to improve the haematological profile.