Intralymphatic BCG in the treatment of gynecologic malignancies: a phase I study.

Thirteen patients with a variety of advanced gynecologic malignancies were administered BCG via the dorsal lymphatics of the lower extremity in addition to standard accepted forms of therapy. Prolonged febrile courses, lymphangitis and suppurative adenitis were observed along the lymphatic pathway of the injected lower limbs. There was no correlation between reaction to a standard anergy panel and survival. There was also no correlation between reaction to a standard anergy panel and the inflammatory response to intralymphatic BCG (ILP-BCG). There was, however, a positive correlation between the inflammatory response to ILP-BCG and survival. Intralymphatic administration of immunostimulants may conceivably be of value as ancillary therapy for use in gynecologic malignancy. However, complications of this approach to immunotherapy are significant and the method should not be used until complications are decreased.