CVD BIO biochemotherapy of metastatic melanoma - one center clinical experience

Abstract

7563 Background: Patients with histologically confirmed skin metastatic melanoma were treated with CVD BIO biochemotherapy regimen with subcutaneously administrated IL-2. We analyzed safety, response rate and survival. Methods: Between Dec 1996 and Mar 2003 39 patient were treated with CVD (DTIC 800 mg/m2d.1, CDDP 20 mg/m2 d.1–4 and vinblastine 1,6 mg/m2 d. 4 and 5) IV combined with SC interleukin-2 (9 mlnU/m2 d.1–4) and interferon alpha (5mlnU/m2 d.1–5)(BIO). We planned sequential treatment schedule: 3 cycles CVD (d.1–5, 22–26, 43–47) and 3 cycles BIO ( d. 6–10, 17–21, 27–31). Results: Median age was 44 years (22–62). Ten patients (26%) before biochemotherapy had metastasectomy (NED before treatment), twenty (51%) had metastases only in lymph nodes, soft tissue and lungs. Toxicities were recorded according WHO criteria for all patients receiving at least one cycle of CVD chemotherapy and one immunotherapy (BIO) -39 pts (100%). Patients received total 119 cycles of CVD and 121 cycles of BIO. 35 patients (90%) received full CVD-BIO treatment, as was planned. 25 pts (64%) with measurable disease were evaluable for response. We observed 6 CR (24%) and 8 PR (32%). 34 pts (87%) were evaluable for time to progression (TTP), progression free survival (PFS) and overall survival (OS) . Non-hematological grade 3 or 4 toxicity was moderate: fever 7 pts (17,7%), nausea and vomiting 3 pts (7,7%), anorexia 3 pts (7,7%), flu-like syndrome 3 pts (7,7%). Grade 3 or 4 neutropenia was confirmed in 9 pts (23,1%), thrombocytopenia in 5 pts (12,8%) and anemia in 3 pts (7,7%). There were no treatment-related deaths. Median TTP (months) was 6,5 (2–49), PFS 7 (2–49) and OS 11,5 (5–64+). In small group (10 pts) after surgical cytoreduction of distant visceral metastases we note median OS 21 month ( 9–64+) p=0,03, and OS 14 month ( 5–57) p=0,11 for patients with metastases only in lymph nodes, soft tissue and lungs. Conclusions: CVD BIO with subcutaneously administrated of IL-2 is effective, well tolerated and accepted for patients. Treatment was beneficial predominantly for patients with good performance status before treatment, with minimal residual disease or with lymph nodes, soft tissue or lungs metastases. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Servier