title: Results of a phase II study of high-dose thoracic radiation therapy with concurrent cisplatin and etoposide in limited-stage small-cell lung cancer (NCCTG 95-20-53).
abstract: OBJECTIVE
  To evaluate the outcome of patients with limited-stage small-cell lung cancer (L-SCLC) treated with cisplatin and etoposide (PE), early prophylactic cranial irradiation (PCI), and high-dose twice-daily thoracic radiotherapy (bid RT).
  
  
  METHODS
  A total of 76 assessable patients were treated on this phase II trial, which included six cycles of PE. PCI (25 Gy/10 fractions) was delivered during cycle 3 to responding patients. Cycles 4 and 5 included concurrent chemotherapy and thoracic RT (30 Gy/20 bid fractions, a 2-week break, and another 30 Gy/20 bid fractions).
  
  
  RESULTS
  Of the 76 assessable patients, 74 patients (97%) suffered grade 3 or greater (3+) toxicity and 61 patients (80%) had grade 4 or greater (4+) toxicity. Of these adverse events, grade 3+ hematologic toxicity occurred in 72 patients (95%), and grade 3+ nonhematologic toxicity occurred in 55 patients (72%). Only one (2%) of the 61 patients who received PCI experienced treatment failure in the brain. The 5-year survival rate of the 76 assessable patients was 24% (median, 20 months). The 5-year survival rate of the 64 patients who received thoracic RT was 29% (median, 22 months). The 5-year cumulative incidence of in-field treatment failure was 34%.
  
  
  CONCLUSIONS
  This regimen included a high total dose of bid TRT, which resulted in a favorable 5-year survival rate. Local failure remains a problem that will require additional investigation. Newer technology should allow the safe administration of greater doses of RT, which should improve patient outcome. Data from eight trials were combined to demonstrate a relationship between RT dose fractionation and 5-year survival.
authors.affiliation: Mayo Clinic Arizona, Department of Radiation Oncology, Scottsdale, AZ 85259, USA. sschild@mayo.edu
authors.forename: Steven E
authors.initials: SE
authors.lastname: Schild
authors.forename: James A
authors.initials: JA
authors.lastname: Bonner
authors.forename: Shauna
authors.initials: S
authors.lastname: Hillman
authors.forename: Timothy F
authors.initials: TF
authors.lastname: Kozelsky
authors.forename: Antonio P G
authors.initials: AP
authors.lastname: Vigliotti
authors.forename: Randolph S
authors.initials: RS
authors.lastname: Marks
authors.forename: David L
authors.initials: DL
authors.lastname: Graham
authors.forename: Gamini S
authors.initials: GS
authors.lastname: Soori
authors.forename: John W
authors.initials: JW
authors.lastname: Kugler
authors.forename: Richard C
authors.initials: RC
authors.lastname: Tenglin
authors.forename: Donald B
authors.initials: DB
authors.lastname: Wender
authors.forename: Alex
authors.initials: A
authors.lastname: Adjei
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D018288:Carcinoma, Small Cell / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D008175:Lung Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011882:Radiotherapy, High-Energy / Q000379:methods*; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D005047:Etoposide; D002945:Cisplatin