title: A phase I study of moderate-dose radiation therapy and weekly gemcitabine in patients with locally advanced non-small cell lung cancer not suitable for radical chemoradiation therapy.
abstract: OBJECTIVE
  To describe the toxicity and response seen in patients receiving moderate-dose radiation therapy with concurrent weekly low-dose gemcitabine in the management of locally advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eighteen patients with confirmed NSCLC were enrolled over a 17-month period from August 2000 until January 2002. All had localised disease but were considered unsuitable for curative therapy. Radiation therapy was given to a dose of 30 Gy in 15 fractions over 3 weeks. Gemcitabine was given weekly before and within 3 h of fractions 1, 6 and 11. The study was designed as a dose-escalation study, commencing at 100 mg/m2 and increasing at levels of 50 mg/m2, until the maximum tolerated dose (MTD) was reached.
  
  
  RESULTS
  The MTD was regarded as being 150 mg/m2. The major acute toxicity observed was oesophagitis. Skin reactions were also reported. The overall response rate in all patients was 88%, with 44% achieving a complete response.
  
  
  CONCLUSIONS
  The combination of gemcitabine and moderate-dose radiation therapy is feasible, and offers low toxicity and excellent response rates in patients with localised NSCLC not suitable for high-dose therapy.
authors.affiliation: University of Queensland, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia. bryan_burmeister@health.qld.gov.au
authors.forename: B H
authors.initials: BH
authors.lastname: Burmeister
authors.forename: D I
authors.initials: DI
authors.lastname: Fielding
authors.forename: J R
authors.initials: JR
authors.lastname: Ramsay
authors.forename: K C
authors.initials: KC
authors.lastname: Baumann
authors.forename: M
authors.initials: M
authors.lastname: Dauth
authors.forename: E T
authors.initials: ET
authors.lastname: Walpole
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000532:radiotherapy*; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D006801:Humans; D008175:Lung Neoplasms / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017564:Radiation Pneumonitis / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D013997:Time Factors; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000093542:Gemcitabine