A randomized trial of postoperative CDDP-based chemotherapy/chemoradiotherapy vs short-term immunochemotherapy in lung cancer

Background. Although a few reports indicated some benefit to survival, the effect of adjuvant therapy for the patients with resected lung cancer was s till controversial. The aim of our study was to evaluate survival advantage of CDDP-based adjuvant therapy compared with short-term immunochemotherapy , Methods. Experimental design: prospective randomized trial. Patients: from 1990 through 1994, 94 patients were registered. Forty-seven patients were r andomly assigned to each group, i.e., CDDP-based therapy group (CB Group, C DDP+VDS+tegafur+OK-432 or CDDP+OK-432+mediastinal irradiation) or immunoche motherapy group (IC Group, tegafur+OK-432), Patients in both groups were fo llowed at 4-month intervals with the routine follow-up program of our depar tment. Results, No significant difference was observed between the patients' chara cteristics of two groups. Compliance of the regimen in each group was 79% i n CB Group and 85% in IC Group. No treatment-related death was observed. Fi ve-year survival rates of CB Group and IC Group were 49% and 51%, and 5-yea r disease-free survival rates were 46% and 44%, respectively. There were no statistical differences between the two groups. Furthermore, no survival d ifferences could be found between CB Group and IC Group in any subgroup of patients. Conclusions, Both of these regimens were feasible. However, we have not obs erved any survival benefit in the CB Group in any subgroup, so far. Inducti on therapy, new chemotherapeutic agents, or anti-angiogenetic agents may im prove the survival of surgically treated lung cancer patients.