Adjuvant radiotherapy in non small cell lung cancer with pathological stage I: definitive results of a phase III randomized trial.

Pierluigi Granone, Stefano Margaritora, Alfredo Cesario, Lucio Trodella, Salvatore Valente, Vincenzo Valentini, Mario Balducci, Giovanna Mantini, Adriana Turriziani, Giuseppe Maria Corbo, Numa Cellini, R. M. D'Angelillo, A. Fontana, D. Galetta, S. Ramella

Research output: Contribution to journalArticle


BACKGROUND AND PURPOSE: 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). MATERIALS AND 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.
Original languageEnglish
Pages (from-to)11-19
Number of pages9
JournalRadiotherapy and Oncology
Publication statusPublished - 2003


  • Non Small Cell Lung Cancer
  • Radiotherapy
  • Surgery


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