Pilot study of adjuvant immuno‐chemotherapy for high risk uveal melanoma

Purpose Despite successful in local control of uveal melanoma,30‐50%of high risk patients with medium and high tumor size will develop metastatic disease of the liver which is highly resistant to systemic therapy Methods Mar01‐Dec07, 31high risk patients with uveal melanoma(10medium;21high tumor size)were enrolled into a pilot trial of adjuvant immuno‐chemotherapy.We measured tyrosinase mRNA levels by real time quantitativeRT‐PCR in blood of all patients during a period of 5years.Results were correlated with clinical data and with the number of CTC evaluated by ISET.The therapeutic regimen consisted of fotemustine100mg/m2 e.v. on days1‐8 of the first month and every 4weeks for 6months.Interleukin‐2 s.c. at the dose of 4,5millionIU daily for 5days a week for 2weeks every month for 6months as immunotherapy Results 30patients,treated and evaluated for the trial,received a median of 5,6cycles and were evaluable for toxicity and response.After a follow‐up period of 5years,25of30 treated patients(83%)were still alive without recurrences,4died for liver metastases(17%).The toxicity was low and the treatment could be administered on an outpatients basis.A significant correlation was found between mRNA tyrosinase levels and tumor size(p<0.01),disease free and overall survival(p<0.05).5patients who developed liver metastases and died,all of them showed an increase in tyrosinase mRNA levels and was correlated to the number of circulating tumor cells Conclusion Our data indicate that the fotemustine and interleukine‐2 as adjuvant treatment of high risk uveal melanoma patients is well tolerate and is associated with a very low rate of metastatic recurrences.Although our data suggest a survival benefit further studies are recommended in a large,coordinate,prospective randomized trial