Phase II Study of the Activity and Tolerability of a Combined Regimen of High-Dose Epirubicin and Cisplatin in Stage IIIb and IV Non-Small Cell Lung Cancer

Autor: Clerici, Maurizia, De Marinis, Filippo, Piazza, Elena, Frontini, Luciano, Tucci, Enrico, Barni, Sandro, Bretti, Sergio, Luporini, Gino, Intini, Claudio
Zdroj: Tumori Journal; November 1998, Vol. 84 Issue: 6 p669-672, 4p
Abstrakt: Aim To explore the feasibility and activity of a combined regimen of high-dose epirubicin and cisplatin as an alternative to current treatments for non-small cell lung cancer (NSCLC).Method Forty-four patients with stage IIIb or IV NSCLC, median Karnofsky index 90, were enrolled. Epirubicin (60 mg/m2) was administered on days 1 and 2 and cisplatin (100 mg/m2) on day 1. Treatment was repeated every 21 days for a maximum of six cycles. A hematopoietic growth factor (G-CSF) was used only for patients reaching codified nadir count values.Results A total of 130 cycles were administered with a mean of 2.9 cycles per patient. Of 41 assessable patients one showed a complete response and 15 had partial responses (overall response rate, 39%). Grade 3 or 4 leukopenia and grade 3 hemoglobin toxicity were seen in 40% and 14%, respectively, of the administered cycles. The most common nonhematologic toxic events were nausea and vomiting, mucositis, anorexia, and asthenia.Conclusions This epirubicin-cisplatin regimen seemed effective and was generally well tolerated, and therefore suitable for use in an outpatient setting.
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