Prospective comparison of intralesional and multipuncture BCG in recurrent intradermal melanoma.
Fifty-nine patients with metastatic melanoma predominantly localized in the skin were randomly assigned to treatment with BCG given either intralesionally (IL-BCG) or by multiple puncture vaccination at a nontumor bearing site in the skin (MPV-BCG). Half the patients with IL-BCG experienced moderate fever, chills and malaise, suggesting systemic exposure to this live organism. However, only three of these patients required systemic antituberculous chemotherapy and all responded to it. MPV-BCG treated patients experienced significantly less systemic toxicity. Among fully evaluable patients 45% objective response rate was seen in the IL-BCG group and a 9% response rate in the MPV-BCG group, a significant difference. The only complete responses were seen in the IL-BCG group. Among fully evaluable patients, median survival was 21.1 months in the IL-BCG group and 13.3 months in the MPV-BCG groups (NSD). No patients with pretreatment anergy to all skin tests utilized, experienced objective response to BCG.
D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D005334:Fever / Q000209:etiology; D006801:Humans; D008545:Melanoma / Q000276:immunology / Q000628:therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011677:Punctures; D012878:Skin Neoplasms / Q000276:immunology / Q000628:therapy*; D012882:Skin Tests; D013921:Thrombocytopenia / Q000209:etiology
D001500:BCG Vaccine