title: A pilot trial of gemcitabine and vinorelbine plus capecitabine in locally advanced or metastatic nonsmall cell lung cancer.
abstract: OBJECTIVE
  We conducted a pilot study of gemcitabine, vinorelbine and capecitabine combination to evaluate its toxicity and efficacy in chemo-naive patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) after a short phase IB trial.
  
  
  METHODS
  Eligible chemo-naive patients with stage IIIB or IV NSCLC received outpatient administration of gemcitabine 900 mg/m2 and vinorelbine 25 mg/m2 intravenously on days 1 and 8, every 3 weeks, concurrently with capecitabine 1000 mg/m2 given orally twice a day on days 1 to 5 and 8 to 12 (dose level I), or days 1 to 6 and 8 to 13 (dose level II).
  
  
  RESULTS
  Between November 2002 and December 2003, 19 patients participated in the study at either dose level I (7 patients) or dose level II (12 patients). The maximum tolerated dose, defined as the dose at which no more than 1 of 6 patients in a cohort experienced a dose-limiting toxicity (DLT) in the first cycle, was not established. However, 1 of 7 patients at dose level I, and 2 of 12 at dose level II experienced DLTs (ie, grade 3 hepatotoxicity in 2 patients, and grade 3 febrile neutropenia in 1 patient). In addition, 2 patients experienced treatment-related pneumonitis requiring mechanical ventilator support after the second course of therapy. Objective tumor response was observed in 5 (26.3%) of 19 patients. Further patient accrual was stopped according to the study design.
  
  
  CONCLUSIONS
  This 3-drug combination showed disappointing antitumor activity against NSCLC with unexpected life-threatening pulmonary toxicity. No further investigation of this regimen is recommended for patients with NSCLC.
authors.affiliation: Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, Korea.
authors.forename: Dae Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Han
authors.forename: Seong Min
authors.initials: SM
authors.lastname: Yoon
authors.forename: Jae Jin
authors.initials: JJ
authors.lastname: Lee
authors.forename: Hong Gi
authors.initials: HG
authors.lastname: Lee
authors.forename: Hyae Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Sung Jin
authors.initials: SJ
authors.lastname: Yoon
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Hong
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011014:Pneumonia / Q000139:chemically induced; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine; D005472:Fluorouracil; D000093542:Gemcitabine