ABSTRACT
INTRODUCTION: Bioimmunochemotherapy (BCT) is a combination of biological agents and cytostatics that has shown an increase in response rate (RR) in metastatic melanoma patients. The aim of the study is to evaluate RR, progression- free survival (PFS), overall survival (OS) and treatment toxicity. MATERIALS AND METHODS: Retrospective analysis of 11 metastatic melanoma patients treated from January 2002 to June 2008 with cisplatin 20 mg/m(2) i.v. days 1.4, dacarbazine 800 mg/m(2) i.v. day 1, vinblastine 1.5 mg/m(2) i.v. days 1.4, interleukin (IL)-2 9 MIU/m(2) s.c. 5.8 days and interferon (IFN)-alpha-2b 5 MIU/m2 s.c. days 5.9, 11, 13 and 15, with the support of granulocyte colony-stimulating factor (G-CSF) and antibiotics. Patients with ECOG 0, age < or = 65 years and with measurable disease were included. The planned number of courses was 4. RR was measured by Revised Evaluation Criteria in Solid Tumour (RECIST) criteria (computed tomography [CT]+/-proton emission tomography [PET]). Toxicity was measured according to the National Cancer Institute (NCI) common toxicity criteria. RESULTS: Observed RRs were 18% complete response (CR), 27% partial response (PR), 9% stable disease (SD) and 46% disease progression. The median PFS was 4 months (95% CI, 0.10 m), with a 23% one-year PFS. Median OS was 4.6 months (95% CI, 0.9.19 m), with a 29% one-year OS. Eighty-three percent of patients experienced grade 3-4 toxicity, mainly due to neutropenia, thrombocytopenia and flu-like syndrome. CONCLUSIONS: Treatment with BCT shows an increase in RR, some achieving durable CR; nevertheless it cannot be considered a standard treatment and should be employed only in selected patients (AU)