title: Cisplatin in combination with metronomic vinorelbine as front-line treatment in advanced non-small cell lung cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG).
abstract: OBJECTIVE
  To evaluate the safety and efficacy of metronomic vinorelbine in combination with cisplatin as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  A total of 41 patients with inoperable stage IIIb or stage IV NSCLC (14 with adenocarcinomas, 19 with squamous cell carcinoma and eight with other types), PS = 0-2, were treated with cisplatin (80 mg/m(2)) in combination with oral metronomic vinorelbine (60 mg total dose, every other day) in cycles of 21 days.
  
  
  RESULTS
  A total of 35 patients who received at least one cycle of chemotherapy were evaluable for toxicity and response. Partial response was achieved in 13 patients (ORR 37.1%; CI 21.1-53.1%) and stable disease in 10 (28.6%). After a median follow-up period of 26.2 months (range 0.5-33.4 months), the median progression-free survival was 4.2 months and the median overall survival 12.0 months. The 1-year survival rate was 52.6%. Myelosuppression was the main adverse event with grade 3 and 4 neutropenia occurring in five (14.3%) and six (17.1%) patients, respectively. Three of these patients presented with febrile neutropenia and there was one death due to sepsis. Non-hematologic toxicities were mild.
  
  
  CONCLUSIONS
  Cisplatin in combination with metronomic vinorelbine is an active, although myelotoxic, therapeutic option in the first-line setting for the treatment of patients with locally advanced and metastatic non-small cell lung cancer, which merits further evaluation in randomized trials.
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lombardou Str, 11470, Athens, Greece.
authors.forename: P
authors.initials: P
authors.lastname: Katsaounis
authors.forename: A
authors.initials: A
authors.lastname: Kotsakis
authors.forename: S
authors.initials: S
authors.lastname: Agelaki
authors.forename: E
authors.initials: E
authors.lastname: Kontopodis
authors.forename: A
authors.initials: A
authors.lastname: Agelidou
authors.forename: N
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: L
authors.initials: L
authors.lastname: Vamvakas
authors.forename: A
authors.initials: A
authors.lastname: Christopoulou
authors.forename: N
authors.initials: N
authors.lastname: Karachaliou
authors.forename: D
authors.initials: D
authors.lastname: Hatzidaki
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D059250:Administration, Metronomic; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine