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Eur J Cardiothorac Surg 2000;18:418-424
© 2000 Elsevier Science NL


Radiotherapy versus follow-up in the treatment of pathological stage Ia and Ib non-small cell lung cancer. Early stopped analysis of a randomized controlled study

Pierluigi Granonea, Lucio Trodellab, Stefano Margaritoraa, Alfredo Cesarioa, Giuseppe Maria Corboc, Giovanna Mantinib, Mario Balduccib, Giorgio Fumagallic

a General Thoracic Surgery, Department of General Surgery, Catholic University of Rome, 00168 Rome, Italy
b Department of Radiotherapy, Catholic University of Rome, 00168 Rome, Italy
c Department of Pneumology, Catholic University of Rome, 00168 Rome, Italy

Received 6 September 1999; received in revised form 17 July 2000; accepted 18 July 2000.

Corresponding author. Tel.: +39-335-836-6161; fax: +39-6-305-1162
e-mail: alfcesario{at}yahoo.com

Objective: This is an analysis of a randomized controlled clinical trial planned to evaluate the effects of adjuvant radiotherapy (AR) on the local recurrence rate in patients with non-small cell lung cancer (NSCLC) with pathological stage (pStage) Ia (pT1N0) and Ib (pT2N0). The effects of AR on the long-term survival have also been marginally evaluated. Materials and methods: This clinical trial was planned with the hypothesis that AR on pStage Ia and Ib, R0 NSCLCs was effective on local recurrence rate. From July 1989 through March 1997, 104 patients with NSCLC who presented with pStage Ia and Ib have been observed and treated and entered the study. Male/female ratio was 91:13; the mean age was 62 years (range 41–75 years). All patients underwent major pulmonary resection and homolateral standard hilar and mediastinal lymph node dissection. pStage was T1N0 in 29 and T2N0 in 75 cases. Patients have been randomized ‘by chance’ into two groups (G1 and G2). G1 received radiotherapy, G2 did not receive any adjuvant treatment. Fifty-two patients entered G1 and 52 entered G2. Results: Post-operative mortality was nil. Seven patients have been excluded from the study (four in G1 and three in G2), due to incomplete follow-up data. We do not report any radiotherapy-related complication or deterioration of lung function. The treatment effect on the local recurrence rate demonstrated a clearly significant protective effect of the AR. No statistically significant difference was found from the comparison of the 5-year survival rate of the treated (83%) versus untreated (70%) patients. No detrimental effect of the radiotherapy has been assessed. Conclusions: AR in the treatment of pStage Ia and Ib NSCLC has been well tolerated and had a significant relative effect on the local recurrence rate but did not significantly modify overall survival even if a positive trend in the group of treated patients is reported.

Key Words: Non-small cell lung cancer • Early stage • Surgery • Adjuvant radiotherapy • Randomized study




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