title: Phase I/II study of gemcitabine and oxaliplatin chemotherapy in combination with concurrent 3-D conformal radiotherapy for locally advanced non-small cell lung cancer.
abstract: BACKGROUND
  Recent studies have showed that combination of chemotherapy and radiotherapy might result in better outcome for locally advanced non-small cell lung cancer (NSCLC). The aim of this study is to determine the maximal tolerance dose (MTD) and efficacy of full-dose gemcitabine and oxaliplatin when given concurrently with 3-dimentional radiation therapy (3D-RT) for locally advanced NSCLC.
  
  
  METHODS
  Oxaliplatin was administered at a fixed dose of 130mg/m², and gemcitabine was administered at a starting dose of 800mg/m² with an incremental dose gradient of 200mg/m² for 3 dose levels. MTD was defined as the immediate dose level lower than the dose at which dose-limiting toxicity (DLT) occurred in more than one-third of the patients. The chemotherapy was administered at 3-week cycle. The RT was given as 3-D conformal manner at a single daily dose of 2Gy for 5 days per week.
  
  
  RESULTS
  Twenty-two patients were evaluable and distributed to three different dose levels: 6 at level 1, 8 at level 2 and 8 at level 3. Pulmonary toxicity, esophageal and hematologic toxicity were the main DLT. Grade III acute pulmonary toxicity occurred in one patient each at level 2 and level 3, both with V20 > 20%, and grade III esophagitis in two patients at level 3. The MTD of gemcitabine in this study was 1000mg/m². The overall response rate was 75.0% (9/12). The 1- and 2-year survival rate was 70.0% and 30.5% respectively. The median time to progression was 8.7 months (range 5-11.8 months).
  
  
  CONCLUSIONS
  With reduced radiation volume, gemcitabine of 1000mg/m² in combination with oxaliplatin of 130mg/m² was effective and could be safely administered for NSCLC.
authors.affiliation: Department of Radiation Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P.R.China.
authors.forename: Feng
authors.initials: F
authors.lastname: Xu
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.forename: Yali
authors.initials: Y
authors.lastname: Shen
authors.forename: Hong
authors.initials: H
authors.lastname: Zhang
authors.forename: Qinghua
authors.initials: Q
authors.lastname: Zhou