title: A phase II study of induction chemotherapy with gemcitabine (G) and cisplatin (P) in locally advanced non-small cell lung cancer: interim analysis.
abstract: BACKGROUND
  Gemcitabine-cisplatin (GP) combination is one of the most active and well tolerated regimens in advanced non-small cell lung cancer (NSCLC). The aim of this study is to evaluate the activity and toxicity of the GP regimen as a 21-day schedule in patients (pts) with stage IIIAN2-IIIB NSCLC.
  
  
  METHODS
  From October 1997 to July 2000, 47 pts entered the study: 43 were eligible (40 men and three women); median age was 61 years (range 45-73); ECOG PS 0-1; histology was squamous (20 pts), adenocarcinoma (12 pts), large cell (five pts), and undifferentiated (six pts); stage was IIIAN2 (14 pts, 32.56%), and IIIB (29 pts, 67.44%). Malignant pleural effusion or superior vena cava syndrome was criteria of exclusion. Induction treatment consisted of three cycles of GP (G 1250 mg/m(2) i.v. on days 1 and 8, and P 100 mg/m(2) on day 8 every 3 weeks). Responding and stable pts underwent surgery (S) and/or radiotherapy (RT).
  
  
  RESULTS
  Following a minimum of two cycles, 39 pts were evaluable for response and 42 for toxicity. Two pts had complete responses (CR; 5.2%), 24 had partial response (PR; 61.5%), eight had stable disease (SD; 20.5%), and five had progressive disease (PRO; 12.8%). WHO grades 3 and 4 anaemia, neutropenia and thrombocytopenia were observed in two, four and two pts, respectively; non-haematological toxicity was moderate. After induction, stable and responding pts received either RT (18 pts) or S+RT (13 pts). Among the 16 resected pts, a radical complete resection was possible in 13 cases (81.3%), whereas tumour down-staging was observed in nine pts (56.2%).
  
  
  CONCLUSIONS
  GP, as a 3-week neoadjuvant schedule, appears a safe and active regimen.
authors.affiliation: Department of Medical Oncology, University of Verona, Verona, Italy. antonio.santo@univr.it
authors.forename: A
authors.initials: A
authors.lastname: Santo
authors.forename: R
authors.initials: R
authors.lastname: Pedersini
authors.forename: F
authors.initials: F
authors.lastname: Pasini
authors.forename: A
authors.initials: A
authors.lastname: Terzi
authors.forename: F
authors.initials: F
authors.lastname: Pari
authors.forename: G
authors.initials: G
authors.lastname: Cartei
authors.forename: A
authors.initials: A
authors.lastname: Sibau
authors.forename: A
authors.initials: A
authors.lastname: Molino
authors.forename: A
authors.initials: A
authors.lastname: Maiorino
authors.forename: N
authors.initials: N
authors.lastname: Panza
authors.forename: M V
authors.initials: MV
authors.lastname: Oletti
authors.forename: S
authors.initials: S
authors.lastname: Maluta
authors.forename: F
authors.initials: F
authors.lastname: Calabrò
authors.forename: G L
authors.initials: GL
authors.lastname: Cetto
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D008297:Male; D008875:Middle Aged; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine