BACKGROUND: The long-term prognosis of patients with stage IV AJCC melanoma is extremely poor. We have previously published short-term clinical outcome and immunological responses to a heat killed Mycobacterium vaccae-based vaccine. RESULTS: In this study we report on a better than expected long-term survival (3-y DSS 29·6%, 5-y, and 7-y DSS both 23·9%) relative to historical controls in the patients who received the vaccine in these trials, published in 1999 and 2003. Although the complete or partial response was only 10%, it was the remarkable response to other interventions upon relapse, such as surgery and radiotherapy followed by stable disease that was previously unexpected. METHODS: We reviewed the outcome of 72 patients who were treated with M. vaccae for metastatic melanoma between January 1996 and July 2004. CONCLUSION: Given this remarkable outcome in stage IV metastatic melanoma and its lack of toxicity we propose that this would make a promising candidate for randomized trials for stage III fully resected melanoma.
BACKGROUND: The long-term prognosis of patients with stage IV AJCC melanoma is extremely poor. We have previously published short-term clinical outcome and immunological responses to a heat killed Mycobacterium vaccae-based vaccine. RESULTS: In this study we report on a better than expected long-term survival (3-y DSS 29·6%, 5-y, and 7-y DSS both 23·9%) relative to historical controls in the patients who received the vaccine in these trials, published in 1999 and 2003. Although the complete or partial response was only 10%, it was the remarkable response to other interventions upon relapse, such as surgery and radiotherapy followed by stable disease that was previously unexpected. METHODS: We reviewed the outcome of 72 patients who were treated with M. vaccae for metastatic melanoma between January 1996 and July 2004. CONCLUSION: Given this remarkable outcome in stage IV metastatic melanoma and its lack of toxicity we propose that this would make a promising candidate for randomized trials for stage III fully resected melanoma.
Entities:
Keywords:
long-term survival; mycobacterial vaccine; stage IV melanoma
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