Preresectional chemotherapy in stage IIIA non-small-cell lung cancer: a 7-year assessment of a randomized controlled trial

In 1989, we began a multicenter study to evaluate the potential benefit of preoperative chemotherapy with cisplatin, ifosfamide and mitomycin over sur gery alone in CT-visible N2 non-small-cell lung cancer. We present here a 7 -year assessment of this randomized trial. Sixty patients were randomized t o receive either surgery alone or three cycles of mitomycin 6 mg/m(2), ifos famide 3 g/m(2) and cisplatin 50 mg/m(2), given intravenously on day 1 of e ach cycle at 3-week intervals and followed by surgery. All patients receive d thoracic irradiation after surgery. The resected tumors were evaluated fo r the presence of K-ras gene point mutations. Treatment arms were well-bala nced in characteristics such as gender, age, histology, and tumor size. Med iastinoscopy and/or mediastinotomy (Chamberlain procedure) with a biopsy wa s performed in all patients with N2 stage detected by CT scan of the chest (83% of the patients in the preresectional chemotherapy arm and 63% of thos e in the surgery arm). In eight of the 25 patients (32%) who had mediastino scopy in the preresectional chemotherapy arm, the initially positive medias tinal lymph nodes were downstaged. For the 30 patients who received prerese ctional chemotherapy, overall median survival was 22 months (95% Cl. 13.4-3 0.6). Of the 30 patients who received surgery alone, overall median surviva l was 10 months (95% CI, 7.4-12.6: P = 0.005 by the log rank test). Updated survival data reveals a plateau in the preresectional chemotherapy group, and this still significant long-term survival benefit prompts us to hypothe size that even with short-term preresectional chemotherapy, the natural his tory of still resectable CT-visible N2 non-small cell lune cancer is favora bly altered. The results of our study mirror the long-term survival recentl y reported in the MD Anderson randomized study. (C) 1999 Elsevier Science i reland Ltd. All rights reserved.