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

Objective: This is an analysis of a randomized controlled clinical trial pl anned to evaluate the effects of adjuvant radiotherapy (AR) on the local re currence rate in patients with non-small cell lung cancer (NSCLC) with path ological stage (pStag:) Ia (pT1N0) and Ib (pT2N0). The effects of AR on the long-term survival have also been marginally evaluated. Materials and meth ods: This clinical trial was planned with the hypothesis that AR on pStage Ia and Ib, RO NSCLCs was effective on local recurrence rate. From July 1989 through March 1997, 104 patients with NSCLC who presented with pStage Ia a nd Ib have been observed and treated and entered the study. Male/female rat io was 91:13; the mean age was 62 years (range 41-75 years). All patients u nderwent major pulmonary resection and homolateral standard hilar and media stinal lymph node dissection. pStage was T1N0 in 29 and T2N0 in 75 cases. P atients have been randomized 'by chance' into two groups (GI and G2). G1 re ceived radiotherapy, G2 did not receive any adjuvant treatment. Fifty-two p atients entered G1 and 52 entered G2. Results: Post-operative mortality was nil. Seven patients have been excluded from the study (four in G1;Ind thre e in G2), due to incomplete follow-up data. We do not report any radiothera py-related complication or deterioration of lung function. The treatment ef fect on the local recurrence rate demonstrated a clearly significant protec tive effect of the AR. No statistically significant difference was found fr om the comparison of the 5-year survival rate of the treated (83%) versus u ntreated (70%) patients. No detrimental effect of the radiotherapy has been assessed. Conclusions: AR in the treatment of pStage Ia and Ib NSCLC has b een well tolerated anti had a significant relative effect on the local recu rrence rate but did not significantly modify overall survival even if a pos itive trend in the Stoup of treated patients is reported. (C) 2000 Elsevier Science B.V. All rights reserved.