TY - JOUR
T1 - Adjuvant radiotherapy in non-small cell lung cancer with pathological stage I
T2 - Definitive results of a phase III randomized trial
AU - Trodella, Lucio
AU - Granone, Pierluigi
AU - Valente, Salvatore
AU - Valentini, Vincenzo
AU - Balducci, Mario
AU - Mantini, Giovanna
AU - Turriziani, Adriana
AU - Margaritora, Stefano
AU - Cesario, Alfredo
AU - Ramella, Sara
AU - Corbo, Giuseppe M.
AU - D'Angelillo, Rolando M.
AU - Fontana, Antonella
AU - Galetta, Domenico
AU - Cellini, Numa
PY - 2002
Y1 - 2002
N2 - 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.
AB - 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.
KW - Adjuvant radiotherapy
KW - Non-small cell lung cancer
KW - Phase III trial
KW - Post-operative radiotherapy
KW - Stage I
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U2 - 10.1016/S0167-8140(01)00478-9
DO - 10.1016/S0167-8140(01)00478-9
M3 - Article
C2 - 11830308
AN - SCOPUS:0036162282
VL - 62
SP - 11
EP - 19
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
SN - 0167-8140
IS - 1
ER -