A randomized prospective study of radiation versus radiation plus ACNU in inoperable non-small cell carcinoma of the lung. Japan Radiation-ACNU Study Group.

Between February 1983 and January 1986, 77 evaluable patients with non-small cell lung cancer were randomized to receive radiotherapy with or without nimustine hydrochloride (ACNU) according to a centralized resistration system using a telephone call. The randomization was for radiation 50 to 60 Gy/5 to 6 weeks with or without ACNU (30 mg/m2 x 4 times) during irradiation. There were no significant differences in the patient characteristics of either group. The complete response rates to both regimens were statistically significantly different: 55% in radiation plus ACNU and 13.6% in radiation alone for squamous cell carcinoma. In addition, there were statistically significant differences in Stage III. The median survival time for radiation plus ACNU was 47.7 weeks, compared with 41.9 weeks for radiation alone. Overall survival did not significantly differ in either group. There was a significant decrease in the incidence of leukocyte nadirs below 2000/ml (5.7%) and platelet 50,000/ml (14.3%) with ACNU. This study confirmed that radiation with ACNU in the treatment of non-small cell lung cancer was effective and superior as compared to radiation alone.

RCT Entities:   Population Interventions Outcomes