title: Concurrent chemotherapy and short course radiotherapy in patients with stage IIIA to IIIB non-small cell lung cancer not eligible for radical treatment: results of a randomized phase II study.
abstract: BACKGROUND
  The optimal treatment for patients with stage IIIA to IIIB non-small cell lung cancer (NSCLC) not eligible for surgery and definitive chemoradiotherapy is unknown. The aim of this study was to evaluate concurrent chemotherapy and palliative radiotherapy.
  
  
  METHODS
  Patients with stage IIIA to IIIB NSCLC with tumor >8 cm and/or forced expiratory volume < or =40%, performance status 0 to 2, and tumor-related chest symptoms were randomly assigned to arm A: radiotherapy alone (30 Gy/10 fractions) or arm B: chemoradiotherapy (two cycles of cisplatin and vinorelbine followed by radiotherapy together with third cycle). Primary end point was response rate, the power of the study was 90%, and the significance level was p = 0.1.
  
  
  RESULTS
  A total of 99 patients were eligible for response, overall survival, and progression-free survival evaluation. Median age was 66 years (45-78 years). Response rate was 27% versus 53%, p = 0.08; median overall survival was 9.0 versus 12.9 months, p = 0.0342; and median progression-free survival was 4.7 versus 7.3 months, p = 0.046, in arm A versus arm B, respectively. There were no deaths during treatment in arm A and six deaths in arm B; no hematological G3 to G4 toxicities in arm A and 14 toxicities in arm B. Symptom control was high and similar in both arms.
  
  
  CONCLUSIONS
  Upfront chemotherapy combined with palliative radiotherapy (30 Gy) is a promising treatment option in the subpopulation of patients with stage IIIA to IIIB NSCLC not amenable for definitive chemoradiotherapy and deserves further investigation.
authors.affiliation: Radiation Oncology Unit, University of Warmia and Mazury, 10-228 Olsztyn, Al. Wojska Polskiego 37, Poland. sergiusz@cyberia.pl
authors.forename: Sergiusz
authors.initials: S
authors.lastname: Nawrocki
authors.forename: Maciej
authors.initials: M
authors.lastname: Krzakowski
authors.forename: Ewa
authors.initials: E
authors.lastname: Wasilewska-Tesluk
authors.forename: Dariusz
authors.initials: D
authors.lastname: Kowalski
authors.forename: Monika
authors.initials: M
authors.lastname: Rucinska
authors.forename: Rafal
authors.initials: R
authors.lastname: Dziadziuszko
authors.forename: Aleksander
authors.initials: A
authors.lastname: Sowa
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine