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Phase I Trial of Weekly Gemcitabine and Concurrent Radiotherapy in Patients With Inoperable Non–Small-Cell Lung Cancer

From the Departments of Radiation Oncology, Thoracic Surgery, Respiratory Physio-Pathology, and Radiology, Università Cattolica del Sacro Cuore, Rome, Italy.

Address reprint requests to Lucio Trodella, MD, Department of Radiation Oncology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168 Rome, Italy; email: ltrodella{at}rm.unicatt.it

PURPOSE: 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 identified for the 375-mg/m² level with two episodes of grade 2 esophagitis and two of grade 3 pulmonary actinic interstitial disease. The weekly dose of GEM 350 mg/m² was well tolerated.

CONCLUSION: A weekly GEM dose of 350 mg/m² concurrent with radiotherapy was well tolerated. Promising results regarding response to treatment were observed and reported.

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