A randomised phase III trial comparing consolidation treatment with further chemotherapy to chest irradiation in patients with initially unresectablelocoregional non-small-cell lung cancer responding to induction chemotherapy

Purpose: A phase III randomised trial was conducted in patients with non-me tastatic unresectable non-small-cell lung cancer in order to compare, in re sponders to induction chemotherapy, consolidation treatment by further chem otherapy to chest irradiation. Patients and methods: A total of 462 untreated NSCLC patients were eligible for three courses of induction chemotherapy (MIP) consisting of cisplatin (50 mg/m(2)), ifosfamide (3 g/m(2)) and mitomycin C (6 mg/m(2)). It was pro posed that objective responders be randomised to either three further cours es of MIP or to chest irradiation (60 Gy; 2 Gy per fraction given over six weeks). Results: An objective response rate of 35% was achieved; 115 patients (incl uding 52% with initial stage IIIA and 44% with initial stage IIIB) were ran domised to consolidation treatment, 60 of them to further chemotherapy and 55 to chest radiotherapy. There was no significant difference in survival b etween the two arms, with a respective median and two-year survival of 42 w eeks (95% confidence intervals (95% CI): 35-51) and 18% (95% CI: 8-28) for chemotherapy and 54 weeks (95% CI: 43-73) and 22% (95% CI: 11-33) for irrad iation. There was also no statistical difference for response duration betw een the two arms but chest irradiation was associated with a significantly greater duration of local control than chemotherapy (median duration times: 158 vs. 31 weeks, P = 0.0007). Conclusions: For non-metastatic unresectable NSCLC treated by an induction chemotherapy regimen containing cisplatin and ifosfamide, if an objective r esponse is obtained, consolidation treatments by further chemotherapy or by chest irradiation result in non-statistically different survival distribut ions, although a better local control duration is observed with radiotherap y.