Endostar combined with chemotherapy as first line therapy for the treatment of stage IV melanoma, a phase II clinical study.

Objective:To observe the efficacy and safety of rh-endostatin injection(Endostar) combined with chemotherapy as first line therapy on stage Ⅳ melanoma patients.Methods:Endostar combined with dacarbazine(250mg/m2 d1-d5)/ temozolomide(300mg d1-d5) and fotemustine(100mg/m2 d6) were administrated to 20 metstatic malignant malenoma patients,which had been confirmed by histopathology.Endostar(15mg) was intravenously dropped from day 1 to day 14,repeated after 14 days later.The chemotherapy agents were given simultaneously.The regimen was repeated every 28days.Response,toxicity and progression free survival were analysed.Results:The mean cycle given was 2.7±0.80.Among 20 evaluable cases,four cases achieved partial response,six stable disease,and tumor progressed in ten patients.The objective response rate was 20.0%(4/20) and clinical benefit rate was 50.0%(10/20).The median progression free survival(PFS)had reached 3.76 months and overall survival 8.5 months,with the 6 months PFS rate 35%(7/20),and 6 months survival rate 65%(13/20).The Grade 3/4 toxicity was mainly myelosuppression,with occurrence rates of 40%(8/20).There was one patient ceased the treatment because of sinus bradycardia.The VEGFR,PDGFR,EGFR of the tumor tissue in 11 patients,but there was no relationship with its efficacy was found.Conclusion:Endostar combined with chemotherapy on melanoma has more efficacy and prolong the PFS for about 2.5 months than DTIC single agent chemotherapy(the recommended regimen nowadays).It is well tolerated,and worthy of clinical generalization and further clinical observation.