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

Autor: Alberto Ravaioli, Pier Paolo Fattori, Davide Tassinari, Giorgio Ioli, Francesca Fochessati, Emiliano Tamburini, Valentina Arcangeli, Ilaria Panzini, Maximilian Papi, Giovenzio Genestreti, Domenico Iorio, Manuela Fantini, Stefano Pulini, Anna Maria Mianulli, Sergio Sartori, G. Oliverio, Vanessa Agostini, Manuela Imola, A. Polselli, Barbara Poggi, Giancarla Monticelli, Sergio Grassia
Rok vydání: 2004
Předmět:
Zdroj: Tumori Journal. 90:54-59
ISSN: 2038-2529
0300-8916
DOI: 10.1177/030089160409000113
Popis: 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/m2 on 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.
Databáze: OpenAIRE