title: Adjuvant radiotherapy in non-small cell lung cancer with pathological stage I: definitive results of a phase III randomized trial.
abstract: OBJECTIVE
  To evaluate the benefits and the drawbacks of post-operative radiotherapy in completely resected Stage I (a and b) non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with pathological Stages Ia and Ib NSCLC have been randomized into two groups: Group 1 (G1) received adjuvant radiotherapy, Group 0 (G0) the control group did not receive any adjuvant therapy. Local control, toxicity and survival have been evaluated.
  
  
  RESULTS
  Between July 1989 and June 1997, 104 patients with pathological stage I NSCLC have been enrolled in this study. Fifty-one patients were randomized to G1 and 53 to G0. Six patients have been excluded from the study due to incomplete follow-up data. Regarding local control, one patient in the G1 group had a local recurrence (2.2%) while in the G0 12 local recurrences have been observed (23%). Seventy-one percent of patients are disease-free at 5 years in G1 and 60% in G0 (P=0.039). Overall 5-year survival (Kaplan-Meier) showed a positive trend in the treated group: 67 versus 58% (P=0.048). Regarding toxicity in G1, six patients experienced a grade 1 acute toxicity. Radiological evidence of long-term lung toxicity, with no significant impairment of the respiratory function, has been detected in 18 of the 19 patients who have been diagnosed as having a post-radiation lung fibrosis.
  
  
  CONCLUSIONS
  Adjuvant radiotherapy gave good results in terms of local control in patients with completely resected NSCLC with pathological Stage I. Overall 5-year survival and disease-free survival showed a promising trend. Treatment-related toxicity is acceptable.
authors.affiliation: Department of Radiation Oncology, 'Universita' Cattolica del S. Cuore', Largo A. Gemelli 8, 00168, Rome, Italy.
authors.forename: Lucio
authors.initials: L
authors.lastname: Trodella
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Granone
authors.forename: Salvatore
authors.initials: S
authors.lastname: Valente
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.forename: Mario
authors.initials: M
authors.lastname: Balducci
authors.forename: Giovanna
authors.initials: G
authors.lastname: Mantini
authors.forename: Adriana
authors.initials: A
authors.lastname: Turriziani
authors.forename: Stefano
authors.initials: S
authors.lastname: Margaritora
authors.forename: Alfredo
authors.initials: A
authors.lastname: Cesario
authors.forename: Sara
authors.initials: S
authors.lastname: Ramella
authors.forename: Giuseppe M
authors.initials: GM
authors.lastname: Corbo
authors.forename: Rolando M
authors.initials: RM
authors.lastname: D'Angelillo
authors.forename: Antonella
authors.initials: A
authors.lastname: Fontana
authors.forename: Domenico
authors.initials: D
authors.lastname: Galetta
authors.forename: Numa
authors.initials: N
authors.lastname: Cellini
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D002945:Cisplatin / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000532:radiotherapy; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin