title: Oral vinorelbine and cisplatin with concomitant radiotherapy in stage III non-small cell lung cancer (NSCLC): a feasibility study.
abstract: BACKGROUND
  Concurrent chemoradiotherapy has improved survival in inoperable stage III non-small cell lung cancer (NSCLC). This phase I trial was performed in order to establish a dose recommendation for oral vinorelbine in combination with cisplatin and simultaneous radiotherapy.
  
  
  METHODS
  Previously untreated patients with stage IIIB NSCLC received concurrent chemoradiotherapy with 66 Gy and 2 cycles of cisplatin and oral vinorelbine which was administered at 3 different levels (40, 50 and 60 mg/m2). This was to be followed by 2 cycles of cisplatin/ vinorelbine oral consolidation chemotherapy. The study goal was to determine the maximal recommended dose of oral vinorelbine during concurrent treatment.
  
  
  RESULTS
  11 stage IIIB patients were entered into the study. The median radiotherapy dose was 66 Gy. Grade 3-4 toxicity included neutropenia, esophagitis, gastritis and febrile neutropenia. The dose-limiting toxicity for concurrent chemoradiotherapy was esophagitis. 9 patients received consolidation chemotherapy, with neutropenia and anemia/thrombocytopenia grade 3 being the only toxicities. The overall response was 73%.
  
  
  CONCLUSIONS
  Oral vinorelbine 50 mg/m2 (days 1, 8, 15 over 4 weeks) in combination with cisplatin 20 mg/m2 (days 1-4) is the recommended dose in combination with radiotherapy (66 Gy) and will be used for concurrent chemoradiotherapy in a forthcoming phase III trial testing the efficacy of consolidation chemotherapy in patients not progressing after chemoradiotherapy.
authors.affiliation: Klinik und Poliklinik für Strahlentherapie Universität Würzburg, Germany. beckmann_g@klink.uni-wuerzburg.de
authors.forename: Gabriele
authors.initials: G
authors.lastname: Beckmann
authors.forename: Rainer
authors.initials: R
authors.lastname: Fietkau
authors.forename: Rudolf M
authors.initials: RM
authors.lastname: Huber
authors.forename: Philip
authors.initials: P
authors.lastname: Kleine
authors.forename: Michael
authors.initials: M
authors.lastname: Schmidt
authors.forename: Sabine
authors.initials: S
authors.lastname: Semrau
authors.forename: Delphine
authors.initials: D
authors.lastname: Aubert
authors.forename: Alberto
authors.initials: A
authors.lastname: Fittipaldo
authors.forename: Michael
authors.initials: M
authors.lastname: Flentje
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005240:Feasibility Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine