title: Prospective phase II trial of a combination of gemcitabine and UFT as first-line treatment in elderly patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  The standard regimen in elderly patients with non-small-cell lung cancer (NSCLC) is still uncertain. Gemcitabine is one of the most widely used drugs for the treatment of NSCLC, and several phase II trials specifically designed for elderly patients with advanced NSCLC have confirmed the role of gemcitabine in this setting. In addition, oral uracil-tegafur (UFT) was associated with a survival advantage in the adjuvant setting. Therefore, we performed a phase II study using the combination of gemcitabine and UFT as first-line therapy in elderly patients with advanced NSCLC.
  
  
  METHODS
  Chemotherapy-naïve, elderly (≥ 70 years) patients who had histologically or cytologically confirmed with stage IIIB or IV NSCLC with a performance status of 1-2 were enrolled. Patients received gemcitabine (1250 mg/m(2) on days 1 and 8, respectively) and UFT (400mg/day on days 1-14) every 3 weeks for up to four cycles. Patients who had not progressed after four cycles continued UFT monotherapy until progression. Primary endpoint was overall response rate and secondary endpoints were overall survival, time to progression and safety profiles.
  
  
  RESULTS
  Between March 2008 and November 2010, 48 patients were enrolled. The median age was 74.5 years (range: 70-84 years), and there were 29 males. The performance status was 1 in 41 and 2 in 7 patients. Thirty-one (64.6%) patients were stage IV and seventeen (35.4%) patients were stage IIIB. Thirty patients (62.5%) completed four cycles of chemotherapy. Response was evaluated in 44 patients. Partial response was achieved in twelve (25.0%) patients and stable disease in 23 (47.9%) patients. Disease control rate was 72.9%. The median survival time was 6.1 months (95% confidence interval [CI]; 5.1-7.0 months), the 1-year survival rate was 29.1% and the median time to progression was 4.6 months (95% CI; 3.7-5.5 months). Toxicities were mild and mostly hematological adverse events. Grade 3/4 neutropenia occurred in 8.3% of patients and one patients experienced febrile neutropenia. Grade 3/4 anemia and thrombocytopenia occurred in 2.1% and 2.1% of patients, respectively. Non-hematological toxicities were tolerable.
  
  
  CONCLUSIONS
  The combination of gemcitabine and UFT was effective in disease control and well tolerated first-line regimen in elderly patients with advanced NSCLC.
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, 290-3 Jeonha-dong, Dong-gu, Ulsan 682-714, Republic of Korea.
authors.forename: Jin Ho
authors.initials: JH
authors.lastname: Baek
authors.forename: Hawk
authors.initials: H
authors.lastname: Kim
authors.forename: Jong-Joon
authors.initials: JJ
authors.lastname: Ahn
authors.forename: Yangjin
authors.initials: Y
authors.lastname: Jegal
authors.forename: Kwang Won
authors.initials: KW
authors.lastname: Seo
authors.forename: Seung Won
authors.initials: SW
authors.lastname: Ra
authors.forename: Chang Ryul
authors.initials: CR
authors.lastname: Park
authors.forename: Jong Pil
authors.initials: JP
authors.lastname: Jung
authors.forename: Jeong Won
authors.initials: JW
authors.lastname: Kim
authors.forename: Yong Jik
authors.initials: YJ
authors.lastname: Lee
authors.forename: Hee Jeong
authors.initials: HJ
authors.lastname: Cha
authors.forename: Woon Jung
authors.initials: WJ
authors.lastname: Kwon
authors.forename: Young Ju
authors.initials: YJ
authors.lastname: Noh
authors.forename: Sukjoong
authors.initials: S
authors.lastname: Oh
authors.forename: Jae-Hoo
authors.initials: JH
authors.lastname: Park
authors.forename: Young Joo
authors.initials: YJ
authors.lastname: Min
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D009367:Neoplasm Staging; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D005641:Tegafur; D014498:Uracil; D000093542:Gemcitabine