A PHASE-II TRIAL OF DACARBAZINE, FLUOROURACIL AND EPIRUBICIN IN PATIENTS WITH NEUROENDOCRINE TUMORS - A STUDY BY THE ITALIAN TRIALS IN MEDICAL ONCOLOGY (ITMO) GROUP

Background: Previous experiences in the treatment of neuroendocrine tu mours have demonstrated some activity of single agents such as adriamy cin, fluorouracil (FU), streptozotocin and dacarbazine (DTIC). Opinion s concerning the usefulness of polychemotherapy in carcinoid tumours a re discordant, whereas better results have been achieved in other endo crine pancreatic neoplasms. Based on this background, we used multidru g chemotherapy with DTIC, FU and epirubicin in the treatment of differ ent neuroendocrine tumours. Methods: The study involved 38 pts with pr ogressive and measurable disease. The treatment schedule was FU 250 mg /m(2) i.v., epirubicin 25 mg/m(2) i.v., and DTIC 200 mg/m(2) i.v. on d ays 1, 2 and 3 every 3 weeks. Results: The responses achieved by histo logic types were carcinoids 2/20, medullary thyroid carcinoma 1/7, neu roendocrine tumours 1/6; and Merkel cell carcinoma 3/5. The median dur ation of response was 5 months (range 2-11). Stable disease was observ ed in 13 cases (34%). Out of the 18 cases in progression, 17 had not r esponded to previous medical treatment. No symptom control was observe d in 4 pts with carcinoid syndrome. Treatment toxicity was moderate an d included nausea and vomiting, alopecia, leukopenia and mucositis. Co nclusions: Our results document the moderate efficacy of the regimen i n all of the histologic types. The major difference in comparison with previous studies was the lower response rate observed in patients wit h neuroendocrine tumours.