title: GILT--A randomised phase III study of oral vinorelbine and cisplatin with concomitant radiotherapy followed by either consolidation therapy with oral vinorelbine and cisplatin or best supportive care alone in stage III non-small cell lung cancer.
abstract: BACKGROUND
  Concurrent chemoradiotherapy (CRT) is considered standard for inoperable stage III non-small cell lung cancer (NSCLC). Consolidation chemotherapy (CC) following CRT is intended to further improve outcomes, yet studies have shown discordant results. This phase III study assessed CRT followed by best supportive care (BSC) or consolidation with oral vinorelbine and cisplatin.
  
  
  METHODS
  Patients received two cycles of oral vinorelbine (50 mg/m(2) days 1, 8 and 15) + cisplatin (20 mg/m(2) days 1-4) q4w + radiotherapy (RT; 66 Gy). Patients with at least stable disease (SD) were randomised to either two cycles oral vinorelbine (60-80 mg/m(2) days 1 and 8) + cisplatin (80 mg/m(2) day 1) q3w + BSC or BSC alone. Primary endpoint was progression-free survival (PFS).
  
  
  RESULTS
  A total of 279 patients were enrolled for CRT and 201 patients were randomised to CC or BSC. Both CRT and CC were well tolerated, with limited radiation-mediated grade 3/4 toxicities (CRT/CC/BSC: oesophagitis-related events 12.9 %/3.1 %/0 %; grade 3 pneumonitis 0 %/0 %/2 %) and chemotherapy-mediated grade 3/4 toxicities (CRT/CC: neutropenia 11.2 %/22.1 %; leukopenia 18.3 %/26.7 %; grade 3 nausea 5.0 %/2.3 %, grade 3 vomiting 3.2 %/3.5 %). Median PFS from randomisation was 6.4 (5.0-8.7) and 5.5 (3.8-7.4) months in the CC and BSC arms (hazard ratio, HR = 0.93 [0.69-1.26]; p = 0.63), respectively; median overall survival (OS) 20.8 (13.5-25.3) and 18.5 (13.6-24.7) months, respectively.
  
  
  CONCLUSIONS
  Consolidation chemotherapy after concurrent CRT did not prolong PFS or OS. Concurrent RT with oral vinorelbine and cisplatin demonstrated a favourable safety profile and represents a suitable treatment regimen for inoperable stage III NSCLC.
authors.affiliation: Dept. of Radiotherapy, University hospital Wuerzburg, Josef-Schneiderstr.11, 97084, Wuerzburg, Germany. flentje_m@ukw.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Flentje
authors.affiliation: Member of the German Center for Lung Research (DZL CPC-M), University hospital Munich, Munich, Germany.
authors.forename: Rudolf M
authors.initials: RM
authors.lastname: Huber
authors.affiliation: University Hospital Merheim, Dept.of Pneumonology, Cologne, Germany.
authors.forename: Walburga
authors.initials: W
authors.lastname: Engel-Riedel
authors.affiliation: Dept.of Pneumonology, Immenhausen, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Andreas
authors.affiliation: Helios Emil-von-Behring Hospital, Berlin, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Kollmeier
authors.affiliation: Municipal Hospital Bremen-Mitte, Bremen, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Staar
authors.affiliation: University hospital Hannover, Hannover, Germany.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Dickgreber
authors.affiliation: Institut de Recherche Pierre Fabre, Boulogne, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Vaissiere
authors.affiliation: Institut de Recherche Pierre Fabre, Boulogne, France.
authors.forename: Cecilia
authors.initials: C
authors.lastname: De Almeida
authors.affiliation: Pierre Fabre Pharma GmbH, Freiburg, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Edlich
authors.affiliation: University Hospital Erlangen, Erlangen, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Fietkau
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D060830:Consolidation Chemotherapy; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine
keywords: Chemoradiotherapy; Combined modality therapy; Consolidation chemotherapy; Survival; Toxicity
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