1053 Phase III study of neo-adjuvant chemotherapy in resectable non-small cell lung cancer (NSCLC)

Neo-adjuvant chemotherapy is a promising new concept in the treatment of resemble NSCLC. In 1991, a randomized study was initiated to compare two treatment strategies for patients (pts) with operable stages I (except T1N0), II or IIIa NSCLC. Pts are randomized into two arms. Surgery is performed first in group I. In group 2, pts start with two cycles of chemotherapy; following surgery, two more cycles are administered in responder pts. Chemotherapy is the MIP protocol: mitomycin 6 mg/m 2 day 1, ifosfamide 1.5 g/m 2 days 1 to 3, cisplatin 30 mg/m 2 days 1 to 3. In both groups, if the surgical staging is N2 or T3, a radiotherapy is performed. From June 1991 until Jan. 1995, 256 pts have been randomized; 35% are stage I, 16% are stage II. 205 pts have completed the treatment. In group 1, 105 out of 106 and in group 2, 91 out of 99 pts underwent thoracotomy. Surgery was complete in 85% of group 1, 83% of group 2, incomplete in 10% of group 1, 5% of group 2. The chemotherapy response rate assessed by surgical evaluation was as follow: complete and subcomplete response. 27%, 18%, partial response 31% (overall: 58%). The study is still ongoing as a total number of 350 patients should be included to reach the required power.