title: Phase I trial of weekly gemcitabine and concurrent radiotherapy in patients with inoperable non-small-cell lung cancer.
abstract: OBJECTIVE
  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.
  
  
  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/m(2). Pulmonary, esophageal, cardiac, hematologic, and skin toxicities were assessed. The dose of GEM was increased by 50 mg/m(2) up to a dose of 250 mg/m(2); an additional increase by 25 mg/m(2) 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/m(2) level with two episodes of grade 2 esophagitis and two of grade 3 pulmonary actinic interstitial disease. The weekly dose of GEM 350 mg/m(2) was well tolerated.
  
  
  CONCLUSIONS
  A weekly GEM dose of 350 mg/m(2) concurrent with radiotherapy was well tolerated. Promising results regarding response to treatment were observed and reported.
authors.affiliation: Department of Radiation Oncology, Università Cattolica del Sacro Cuore, Rome, Italy. ltrodella@rm.unicatt.it
authors.forename: Lucio
authors.initials: L
authors.lastname: Trodella
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Granone
authors.forename: Salvatore
authors.initials: S
authors.lastname: Valente
authors.forename: Adriana
authors.initials: A
authors.lastname: Turriziani
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Macis
authors.forename: Giuseppe M
authors.initials: GM
authors.lastname: Corbo
authors.forename: Stefano
authors.initials: S
authors.lastname: Margaritora
authors.forename: Alfredo
authors.initials: A
authors.lastname: Cesario
authors.forename: Rolando M
authors.initials: RM
authors.lastname: D'Angelillo
authors.forename: Gina
authors.initials: G
authors.lastname: Gualano
authors.forename: Sara
authors.initials: S
authors.lastname: Ramella
authors.forename: Domenico
authors.initials: D
authors.lastname: Galetta
authors.forename: Numa
authors.initials: N
authors.lastname: Cellini
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D003131:Combined Modality Therapy / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine