title: Multicenter phase II study evaluating docetaxel and cisplatin as neoadjuvant induction regimen prior to surgery or radiochemotherapy with docetaxel, followed by adjuvant docetaxel therapy in chemonaive patients with NSCLC stage II, IIIA and IIIB (TAX-AT 1.203 Trial).
abstract: OBJECTIVE
  Neoadjuvant therapy with a platinum based doublet is an option in NSCLC patients with upfront resectable disease. However, the role of neoadjuvant induction in stages IIIA and IIIB and in initially not resectable patients is unclear.
  
  
  METHODS
  In this phase II trial, 78 patients with locally advanced NSCLC, of whom 56 were considered not resectable at initial diagnosis, were treated with three neoadjuvant cycles of docetaxel and cisplatin and subjected to radical surgery if resectable. Definitive radiochemotherapy (RCT) using weekly docetaxel was the prespecified alternative if patients were not resectable at restaging. The primary objective was response to neoadjuvant induction.
  
  
  RESULTS
  After induction, 36 (46%) were radically operated and 24 (31%) were treated with RCT. Overall, 32 patients (41%) completed the entire study plan. Partial response to induction therapy was observed in 43 patients (55%); furthermore, 19 of 56 initially not resectable cases (34%) became resectable upon induction. Median progression-free (PFS) and overall survival (OS) were 8.5 and 16.4 months for the whole cohort. Encouragingly, conversion to resectability was predictive for favorable outcome. On the other hand, patients who were not resectable at restaging and received RCT were characterized by a rather unfavorable prognosis (5-year and 10-year OS, whole cohort: 20% and 12%; RCT: 8% and 0%; surgery: 37% and 24%, respectively).
  
  
  CONCLUSIONS
  Neoadjuvant induction with the doublet docetaxel/cisplatin and subsequent radical resection resulted in favorable survival. Of note, conversion to resectability was mandatory for the chance of cure in patients considered initially not resectable.
authors.affiliation: Department of Hematology and Oncology, Internal Medicine V, Innsbruck Medical University, Innsbruck, Austria. Electronic address: florian.kocher@i-med.ac.at.
authors.forename: F
authors.initials: F
authors.lastname: Kocher
authors.affiliation: Department of Hematology and Oncology, Internal Medicine V, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Pircher
authors.affiliation: Department of Pulmonary Medicine II, SMZ Otto Wagner Hospital, Vienna, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Mohn-Staudner
authors.affiliation: Department of Internal Medicine III, Paracelsus Medical University Hospital, Salzburg, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Romeder
authors.affiliation: Department of Pneumology, General Hospital of Linz, Linz, Austria.
authors.forename: W
authors.initials: W
authors.lastname: Duller
authors.affiliation: Department of Pneumology, General Hospital Wels, Wels, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Steinmaurer
authors.affiliation: Department of Pneumology, General Hospital Wels, Wels, Austria.
authors.forename: J
authors.initials: J
authors.lastname: Eckmayr
authors.affiliation: Department of Visceral and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: T
authors.initials: T
authors.lastname: Schmid
authors.affiliation: Department of Hematology and Oncology, Internal Medicine V, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: W
authors.initials: W
authors.lastname: Hilbe
authors.affiliation: Department of Hematology and Oncology, Internal Medicine V, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Fiegl
authors.affiliation: Department of Internal Medicine III, Paracelsus Medical University Hospital, Salzburg, Austria.
authors.forename: R
authors.initials: R
authors.lastname: Greil
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery; D059248:Chemoradiotherapy; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin
keywords: Cisplatin; Docetaxel; Induction; Neoadjuvant; Non-small cell lung cancer (NSCLC); Radiochemotherapy; Surgery