TY - JOUR
T1 - Phase I trial of weekly gemcitabine and concurrent radiotherapy in patients with inoperable non-small-cell lung cancer
AU - Trodella, Lucio
AU - Granone, Pierluigi
AU - Valente, Salvatore
AU - Turriziani, Adriana
AU - Macis, Giuseppe
AU - Corbo, Giuseppe M.
AU - Margaritora, Stefano
AU - Cesario, Alfredo
AU - D'Angelillo, Rolando M.
AU - Gualano, Gina
AU - Ramella, Sara
AU - Galetta, Domenico
AU - Cellini, Numa
PY - 2002/2/1
Y1 - 2002/2/1
N2 - 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.
AB - 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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U2 - 10.1200/JCO.20.3.804
DO - 10.1200/JCO.20.3.804
M3 - Article
C2 - 11821464
AN - SCOPUS:0036467639
SN - 0732-183X
VL - 20
SP - 804
EP - 810
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 3
ER -