Over the past 7 years, 151 patients with malignant melanoma have been treated with BCG immunotherapy alone or as an adjunct to surgical therapy. Direct injection of metastatic melanoma lesions limited to skin resulted in 90% regression of injected lesions and 17% regression of uninjected lesions in immunocompetent patients. Approximately 25% of these patients remained free of disease for 1 to 6 years. Direct injections of BCG into nodules of patients with subcutaneous or visceral metastases resulted in a lower incidence of local control and no long term survivors. Attempts to improve the results of immunotherapy in these patients by palliative surgical resection of large metastatic lesions to lower tumor burden followed by BCG immunotherapy significantly improved the results although many patients still developed recurrent disease. Early results of a clinical trial combining BCG immunotherapy with regional lymphadenectomy in patients with melanoma metastatic to lymph nodes have been encouraging and promising. Further controlled clinical trials are necessary to elucidate the role of BCG in immunotherapy. However, since BCG is but one of a number of potential immunologic adjuvants, even more effective immunotherapy will be possible as further knowledge of the interactions of cellular and humoral immunity is acquired.

Fifty women receiving adjuvant chemotherapy after surgery for Stage II breast carcinoma were interviewed in an effort to describe the psychosocial effect of the treatment. Perceptions of emotional distress and behavioral disruption were rated in five areas, yielding a rating of overall level of disruption and distress. Results showed that all women experienced adverse changes while receiving adjuvant treatments. Of the 50 women, 88% described a decrease in activities related to the effects of adjuvant chemotherapy; 54% reported an increased financial burden; and 41% claimed that their family and/or sexual life had been adversely affected. Despite these adverse changes, 74% of these patients "would definitely" recommend the treatment to friends in a similar situation. Results from this preliminary study may provide useful information to potential participants in adjuvant trials and to the physicians who conduct such trials.

Despite current surgical therapy, about 80 per cent of patients with malignant melanoma metastatic to lymph nodes succumb to systemic metastatic disease. To determine if postoperative adjuvant immunization with BCG was an effective systemic treatment in these patients with microscopic subclinical metastatic disease, the clinical course of 42 patients treated by operation alone was compared with that of 84 treated by operation and BCG. At two years, the incidence of metastasis in BCG-treated patients was half that of the control group. BCG was more effective in patients with a smaller tumor burden at the time of initial surgical treatment. In patients receiving BCG adjuvant therapy, 90 per cent with microscopic disease in one lymph node appeared free of disease as compared to 40 per cent with macroscopic disease in multiple nodes. In patients with recurrences, an immunotherapeutic effect was demonstrated by a delay of six months in the time to recurrence. Thus, BCG immunotherapy appears to have an inhibiting effect on the "micrometastases" of malignant melanoma.

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