Low-dose integrated chemoimmunohormonotherapy with cisplatin, subcutaneous interleukin-2, α-interferon and tamoxifen for advanced metastatic melanoma - A pilot study

Recently, Khayat at al. reported that high-dose recombinant interleukin-a (rlL-2) i.v. may induce tumour regressions in metastatic melanoma patients through an association with cisplatin (CDDP) and α-interferon (α-IFN). Treatment-related toxicities are, however, important. Previous studies have demonstrated that rlL-2 toxicity may be reduced through a subcutaneous Injection. In order to evaluate the effectiveness of low subcutaneous rlL-2 doses in a chemoimmuno-hormonotherapeutic combination, 36 metastatic melanoma patients were treated with CDDP, rlL-2, α-IFN and tamoxifen (TAM). The overall response rate was 47.2%: five patients had complete response (14%), 12 partial response (33%) and 13 stable disease (36%). Median response duration was 6.4 months (range: 2-29+). Median overall survival was 10 months (range: 3-36 +). The CDDP/rlL-2/α-IFN/TAM regimen was effective both on soft tissue and visceral metastases. Toxicity was low and patient management did not require an intensive care unit. A statistically significant increase in both percentage and absolute values of lymphocytes, eosinophils, CD3+/CD4+, CD25+, CD16/56+ and HLA-DR+ cells was found in all patients after two treatment courses. This study shows that lower doses of subcutaneous rlL-2, as well as CDDP and α-IFN, associated with TAM, may have similar anticancer efficacy with respect to Khayat's schedule but lower toxicity.