Phase I Trial of Weekly Gemcitabine and Concurrent Radiotherapy in Patients With Inoperable Non-Small-Cell Lung Cancer
2002; Lippincott Williams & Wilkins; Volume: 20; Issue: 3 Linguagem: Inglês
10.1200/jco.20.3.804
ISSN1527-7755
AutoresLucio Trodella, Pierluigi Granone, Salvatore Valente, Adriana Turriziani, Giuseppe Macis, Giuseppe Maria Corbo, Stefano Margaritora, Alfredo Cesario, Rolando Maria D’Angelillo, Gina Gualano, Sara Ramella, Domenico Galetta, Numa Cellini,
Tópico(s)Advanced Radiotherapy Techniques
ResumoPURPOSE: To report the evidence of a phase I trial planned to determine the maximum-tolerated dose (MTD) and related toxicity of weekly gemcitabine (GEM) and concurrent radiotherapy in patients with non–small-cell lung cancer (NSCLC). In addition, the response to treatment was evaluated and reported. PATIENTS AND METHODS: Thirty-six patients with histologically confirmed NSCLC deemed unresectable because of advanced stage were observed and treated according to a combined chemoradiation protocol with GEM as chemotherapeutic agent. GEM was given weekly for 5 consecutive weeks as a 30-minute intravenous infusion concurrent with radiotherapy (1.8 Gy/d; total dose, 50.4 Gy). The initial dose was 100 mg/m2. Pulmonary, esophageal, cardiac, hematologic, and skin toxicities were assessed. The dose of GEM was increased by 50 mg/m2 up to a dose of 250 mg/m2; an additional increase by 25 mg/m2 up to the MTD was planned and realized. Three patients were enrolled for each dose level. RESULTS: Dose-limiting toxicity was...
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