PMID: 7037155Mar 15, 1982Paper

A randomized prospective clinical trial of adjuvant C. parvum immunotherapy in 260 patients with clinically localized melanoma (Stage I): prognostic factors analysis and preliminary results of immunotherapy

Cancer
C M BalchJ R Durant

Abstract

A total of 260 patients with clinically localized melanoma (Stage I) from 18 medical institutions in the Southeastern Cancer Study Group were randomized to receive either surgical treatment alone, or surgery plus Corynebacterium parvum immunotherapy. A multivariant analysis (Cox regression model) of nine prognostic factors was performed on 110 patients with a minimum of two years follow-up. The dominant prognostic variables were thickness (P = 0.0007) and anatomic location of the melanoma (trunk versus other, P = 0.015). Disease-free survival curves were then calculated for 204 surgically evaluable patients. Overall, there was no significant difference in three-year survival for the two-treatment arms, which was 81% for the adjuvant immunotherapy group compared to 67% for the surgical control group (P = 0.10). The median follow-up period was 24 months (range, 1-60 months). However, when the data was subgrouped by tumor thickness, an apparent benefit of immunotherapy was observed in 49 patients with melanomas greater than 3 mm in thickness. Only five of 23 such patients relapsed after receiving C. parvum. Their three-year disease-free survival was 73%. In contrast, 13 of 26 patients who did not receive immunotherapy have relapse...Continue Reading

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