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Randomly Controlled Study of Chemotherapy versus Chemoimmunotherapy in Postoperative Lung Cancer Patients¹

Second Department of Surgery, Kyushu University Medical School [K. Y., H. Y., K. I.], and Department of Immunology, Institute for Bioregulation, Kyushu University [K. N.], Maidashi 3-1-1, Higashi-ku, Fukuoka 812; Department of Chest Surgery, Kyushu Cancer Center, Notame 595, Minami-ku, Fukuoka 815 [M. O.]; Institute of Immunological Science, Hokkaido University, Kita 15, Nishi 5, Sapporo 060 [I. A.]; and Osaka University, Fukushima 1-1-50, Fukushima-ku, Osaka 553 [Y. Y.], Japan

A randomly controlled study of chemotherapy versus chemoimmunotherapy was performed in patients with operable lung cancer from November 1977 to June 1981. The immunotherapy consisted of an intrapleural instillation of Nocardia rubra cell wall skeleton (N-CWS) followed by serial intradermal N-CWS. A total of 119 patients were entered into this trial. There were 64 evaluable patients in the control group and 52 evaluable patients in the N-CWS group. N-CWS treatment was effective in terms of prolongation of duration of remission for all operable patients. Although significant improvement in the survival rate was not observed in patients at Stages I and II (p < 0.10), it was observed in the curative operation group (p < 0.05).

The mode of recurrence was classified as local recurrence and distant metastasis in the curative operation group. The rates of distant metastasis were 34.0 and 18.9%, respectively, in the control and the N-CWS groups. The rate of local recurrence was 14.9% in the control group; however, no local recurrence was observed in the N-CWS group.

These results indicate the clinical effectiveness of the N-CWS treatment, especially in curatively resectable lung cancer. No serious side effect was observed during this trial.

¹ Supported in part by Grant-in-Aid for Cancer Research 57010005 from the Ministry of Education, Science and Culture of Japan.

² To whom requests for reprints should be addressed.

Received 12/21/83. Accepted 11/ 9/84.