Carboplatin and Gemcitabine in the Palliative Treatment of Stage IV Non-Small Cell Lung Cancer: Definitive Results of a Phase II Trial

Autor: Tassinari, Davide, Fochessati, Francesca, Arcangeli, Valentina, Sartori, Sergio, Agostini, Vanessa, Fantini, Manuela, Genestreti, Giovenzio, Grassia, Sergio, Ioli, Giorgio, Imola, Manuela, Iorio, Domenico, Mianulli, Anna Maria, Monticelli, Giancarla, Oliverio, Giovanni, Panzini, Ilaria, Papi, Maximilian, Poggi, Barbara, Polselli, Antonio, Pulini, Stefano, Tamburini, Emiliano, Fattori, Pier Paolo, Ravaioli, Alberto
Zdroj: Tumori Journal; January 2004, Vol. 90 Issue: 1 p54-59, 6p
Abstrakt: Background Cisplatin-containing regimens represent the gold standard in the treatment of advanced non-small cell lung cancer, but carboplatin is often preferred for its better toxic profile when palliation is the aim of the treatment. The synergistic effect and tolerability of carboplatin-gemcitabine combination are well known. In this phase II trial, we evaluated the activity and safety of a schedule with carboplatin and gemcitabine, defined in our previous phase I trial.Methods Thirty-seven patients with measurable stage IV non-small cell lung cancer were treated with carboplatin, AUC 4.5 mg/ml/min on day 1, and gemcitabine, 800 mg/m2on days 1 and 8, every 21 days. All patients were treated until disease progression or intractable toxicity and were evaluated before each course of chemotherapy for toxicity and after every 3 courses for response.Results After a median follow-up of over 10 months, complete response, partial response, and stabilization of the disease were observed in 3 (8.1%), 9 (24.3%), and 15 patients (40.5%), respectively. Median time to progression was 7 months. At this writing, 27 patients have died, with a median survival of 10 months, and 29 (78.3%), 16 (43.2%), and 11 (29.7%) patients are alive after 6, 12, and 15 months of follow-up, respectively. Toxicity was mild, and mainly hematological, with a significant correlation with the number of courses of chemotherapy (P = 0.0003).Conclusions Our results are comparable with those reported in the literature and confirm the good activity and tolerability of the carboplatin-gemcitabine combination. Up to 4 courses of chemotherapy with carboplatin and gemcitabine may represent an interesting option in the palliative treatment of non-small cell lung cancer.
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