Administration of BCG cell wall skeleton into malignant effusions: toxic and therapeutic effects.
Thirty-nine patients with 40 refractory malignant effusions (26 pleural and 14 peritoneal) were treated locally with a nonviable mycobacterial vaccine. The vaccine was administered into the effusion and consisted of BCG cell wall skeleton and trehalose dimycolate attached to oil microdroplets. A dose range of 150--3000 microgram was tested. The overall response rate was 44.0% (complete response [CR] plus partial response [PR]) and was not clearly dose-related. The response rates for each site were 13.6% (CR) and 31.8% (PR) for pleural effusions and 33.3% (CR) and 8.3% (PR) for peritoneal effusions. Toxic effects consisted of fever (40%), serosal pain (37.5%), and increased effusion (27.5%) and were not clearly dose-related. Gastrointestinal toxic effects were seen in 50% of patients treated for peritoneal effusions. Response correlated with prior exposure to BCG vaccine or tuberculosis, and with a febrile response to vaccine administration. This vaccine has a therapeutic effect on both pleural and peritoneal effusions.
D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000628:therapy*; D010534:Peritoneal Neoplasms / Q000628:therapy*; D010996:Pleural Effusion / Q000628:therapy*
D001500:BCG Vaccine