Mặc dù hiệu lực tạm thời trên DFS đã được quan sát trong nhóm điều trị, trong phân tích cuối cùng không có DFS hoặc lợi ích hệ điều hành đã được quan sát trong nghiên cứu của WHO 16-[13]. Một LDI (1 MU, tiêm dưới da, vào những ngày thay thế cho 1 năm) chế độ đã được đánh giá trong các thử nghiệm 18871/DKG-80 EORTC, cho thấy thậm chí không một xu hướng cho một lợi ích | 200 CHAPTER 15 the observation arm or the LDI treatment arm 3MU subcutaneously . for 3 years . Although a temporary effect on DFS was observed in the treatment arm in the final analysis no DFS or OS benefit was observed in the WHO-16 study 13 . Another LDI 1MU subcutaneously on alternative days for 1 year regimen was evaluated in the EORTC 18871 DKG-80 trial showing not even a trend for a benefit 9 . Unfortunately the impact on OS by HDI therapy was not confirmed by the recently unblinded ECOG 1690 study in spite of a significant benefit on DFS 14 . Low-dose IFN treatment at 3 MU for 2 years in the ECOG 1690 trial did not demonstrate a benefit for either DFS or OS just as in the WHO-16 trial. Conclusions on stage III Overall it can be stated that observations have been inconsistent on the efficacy of IFN-a in the adjuvant setting for high-risk melanoma. Dose intensity as well as duration of treatment are not clearly defined and the efficacy of any regimen has yet to be demonstrated or confirmed by more than one trial. Table summarizes the experience with IFN in adjuvant Phase III trials up to 1999. Trials in stage II In stage II patients with primary melanomas mm clinically nodenegative three trials in Europe have completed accrual. These three trials are similar in dosage all using IFN-2a at low doses of 3 MU for 6 months Scottish trial 12 months Austrian trial or 18 months French trial . A preliminary report on the Scottish trial has not demonstrated a benefit in DFS or OS 1 whereas use for 12 months has been reported to result in a significant benefit on relapse rate 15 . The Austrian study has not reached maturity and so far no significant impact on OS has been observed. The French trial has reached maturity and a significantly prolonged DFS was observed in the IFN arm. The impact on OS failed to reach significance but demonstrated a favourable trend 16 . The NCCTG trial which evaluated the impact of HDI intramuscularly . for 3 months was .
