title: Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study).
abstract: BACKGROUND
  Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles.
  
  
  METHODS
  Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m2 d1+2) and docetaxel (75 mg/m2 d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m2 d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST.
  
  
  RESULTS
  40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months.
  
  
  CONCLUSIONS
  Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected.
  
  
  BACKGROUND
  EU Clinical Trials Register; Eudract-Nr: 2006-004639-31.
authors.affiliation: Medical University Innsbruck, Department of Internal Medicine V (Haematology and Oncology), Innsbruck, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hilbe
authors.affiliation: Medical University Innsbruck, Department of Internal Medicine V (Haematology and Oncology), Innsbruck, Austria.
authors.forename: Georg
authors.initials: G
authors.lastname: Pall
authors.affiliation: Medical University Innsbruck, Department of Internal Medicine V (Haematology and Oncology), Innsbruck, Austria; Tyrolean Cancer Research Institute, Innsbruck, Austria.
authors.forename: Florian
authors.initials: F
authors.lastname: Kocher
authors.affiliation: Medical University Innsbruck, Department of Internal Medicine V (Haematology and Oncology), Innsbruck, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pircher
authors.affiliation: Department of Internal Medicine, County Hospital Kufstein, Kufstein, Austria.
authors.forename: August
authors.initials: A
authors.lastname: Zabernigg
authors.affiliation: Department of Surgery, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmid
authors.affiliation: Department of Pneumology, General Hospital, Elisabethinen Linz, Linz, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Schumacher
authors.affiliation: Department of Pneumology, County Hospital Natters, Natters, Austria.
authors.forename: Herbert
authors.initials: H
authors.lastname: Jamnig
authors.affiliation: Medical University Innsbruck, Department of Internal Medicine V (Haematology and Oncology), Innsbruck, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Fiegl
authors.affiliation: Medical University Innsbruck, Department of Internal Medicine V (Haematology and Oncology), Innsbruck, Austria.
authors.forename: Anne
authors.initials: A
authors.lastname: Gächter
authors.affiliation: Department of Radiology, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Freund
authors.affiliation: Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Dorota
authors.initials: D
authors.lastname: Kendler
authors.affiliation: Department of Pathology, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Claudia
authors.initials: C
authors.lastname: Manzl
authors.affiliation: Department of Pathology, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Bettina
authors.initials: B
authors.lastname: Zelger
authors.affiliation: Department of Pathology, Medical University Innsbruck, Innsbruck, Austria; Department of Pathology, Medical University Graz, Graz, Austria.
authors.forename: Helmut
authors.initials: H
authors.lastname: Popper
authors.affiliation: Department of Internal Medicine, Saint Vincent Hospital Zams, Zams, Austria.
authors.forename: Ewald
authors.initials: E
authors.lastname: Wöll
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D000068818:Cetuximab / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000068818:Cetuximab; D002945:Cisplatin