title: Irinotecan and oxaliplatin combination as the first-line treatment for patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  We conducted a prospective phase II trial of IrOx in patients with advanced non-small cell lung cancer to evaluate the efficacy and toxicity.
  
  
  METHODS
  Patients with histologically or cytologically proven non-small cell lung cancer (NSCLC), aged > or =18 years, Eastern Cooperative Oncology Group performance status 0-1, at stage IIIB (pleural effusion)/IV or with recurrent disease not suitable for primary surgical treatment, with no palliative chemotherapy or radiotherapy to the chest or immunotherapy or biologic therapy, the presence of measurable disease by RECIST, and who had given signed written informed consent, were eligible. Treatment consisted of irinotecan 65 mg/m(2) on days 1 and 8 and oxaliplatin 130 mg/m(2) on day 1, repeated every 3 weeks.
  
  
  RESULTS
  A total of 18 patients were enrolled in June and August 2007, the median age was 59 years (47-73). In total, 71 cycles were administered with a median of 4 cycles per patient (range, 1-6 cycles) and 18 patients were evaluable for treatment response. An independent review of tumor responses gave an overall response rate of 27.7% (CR: 0, PR: 5/18; 95% CI, 7-48.4%) by intent-to-treat analysis. The median overall survival of all patients was 14 months and the median time-to-progression was 4.2 months (95% CI, 1.959-6.441). The most common grade 3/4 toxicities were diarrhea (7% of all cycles) and neutropenia (5.6% of all cycles). Grade 3 peripheral neuropathy occurred in one patient and one patient died due to sepsis.
  
  
  CONCLUSIONS
  This study suggests that IrOx combination therapy has moderate activity with a tolerable toxicity profile. However, it was not warranted to evaluate further this regimen as first-line treatment for patients with advanced or metastatic NSCLC using the current dosages and schedule.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Seoul, South Korea.
authors.forename: Myung Hee
authors.initials: MH
authors.lastname: Chang
authors.forename: Kyoung Ha
authors.initials: KH
authors.lastname: Kim
authors.forename: Hyun Jung
authors.initials: HJ
authors.lastname: Jun
authors.forename: Hyo Song
authors.initials: HS
authors.lastname: Kim
authors.forename: Seong Yoon
authors.initials: SY
authors.lastname: Yi
authors.forename: Ji Eun
authors.initials: JE
authors.lastname: Uhm
authors.forename: Min Jae
authors.initials: MJ
authors.lastname: Park
authors.forename: Do Hyoung
authors.initials: DH
authors.lastname: Lim
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ji
authors.forename: In Gyu
authors.initials: IG
authors.lastname: Hwang
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.forename: Yeon Hee
authors.initials: YH
authors.lastname: Park
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Ahn
authors.forename: Myung-Ju
authors.initials: MJ
authors.lastname: Ahn
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005838:Genotype; D014453:Glucuronosyltransferase / Q000235:genetics; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011110:Polymorphism, Genetic; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000077146:Irinotecan; D014453:Glucuronosyltransferase; D002166:Camptothecin