[Postoperative prevention of recurrence with intrapleural Corynebacterium parvum in patients with stage I and II bronchial carcinomas. Ludwig lung cancer study I].

The Ludwig Lung Cancer Group was created in 1977. Participants are from Austria, Denmark, Germany, Norway, Sweden, Switzerland, and Yugoslavia. 400 patients are randomized yearly. The clinical trial I investigating the role of C. parvum intrapleurally as adjuvant therapy in operable non-small cell lung cancer patients has been closed in February 1979 with a total accrual of 475 patients. The average follow-up time for these cases is approximately 8 months. It is early to make any definitive comparisons of the treatment groups (C. parvum versus placebo). However, it is possible to identify a few high-risk patient groups. Preliminary indications are that surgical T- and N-stage, type of resection, histological type of tumor as well as degree of tumor dedifferentiation (central histology review) are prognostic factors with regard to disease-free interval and survival. In the same, the disease-free interval appears to become shorter for patients experiencing high fever after C. parvum administration. The Ludwig Lung Cancer Group offers a sharp tool for investigating the possible role of adjuvant therapies in non-small cell lung cancer and for gathering new information on the biology of the disease.