Tas Faruk, Kurul Sidika, Camlica Hakan, Topuz Erkan
Institute of Oncology, Istanbul University, Turkey.
Med Oncol. 2006;23(4):471-7. doi: 10.1385/MO:23:4:471.
Interferon is widely used as the most effective agent in the adjuvant therapy of patients with melanoma. However, little is known about the effect of intermediate dose interferon (IDI) in adjuvant therapy. We conducted this study to determine whether intermediate doses of interferon-alpha 2 could be beneficial for these patients. A series of 84 melanoma patients with high-risk relapse potential (stage II-III) after excisional biopsy were enrolled for adjuvant therapy with IDIs, either IFN-alpha 2a, 9 MU or IFN alpha 2b, 10 MU per day, subcutaneously, for 1 yr consisted of an induction period (5 d/wk for 4 wk) followed by 48 wk of same dose administered three times per week. The median follow-up was 25.9 mo with range 4-90.4 mo. Thirty-three (39%) patients had progressed; 18 (55%) of them while on treatment. The median (range) time of the failure occurrence was 9.1 mo (1.7-47.3 mo). Distribution of failure site was identical and the majority of the recurrences were found as single metastasis. For distant metastasis-free interval, mean (+/- SE) value was 28.8+/-3.6 mo; 1- and 2-yr survival rates were 87.8+/-5.7% and 61.6+/-9.3%, respectively. Twenty-two deaths were observed. Five-year survival rates of progression-free survival and overall survival were 50% and 60%, respectively. Generally, the treatment was found well-tolerated; drug-induced dose reduction or treatment discontinuation due to toxicity was minimal. Severe toxicity was rare. In conclusion, the small number of patients and the short follow-up does not permit any conclusion. However, the preliminary data seem to show that treatment with IDI was usually well tolerated with low toxicity of the patients during the adjuvant therapy.
干扰素作为黑色素瘤患者辅助治疗中最有效的药物被广泛应用。然而,关于中等剂量干扰素(IDI)在辅助治疗中的效果却知之甚少。我们开展这项研究以确定中等剂量的α-2干扰素对这些患者是否有益。一系列84例切除活检后具有高复发风险潜力(II-III期)的黑色素瘤患者入组接受IDI辅助治疗,即α-2a干扰素9 MU或α-2b干扰素10 MU,每天皮下注射,共1年,包括诱导期(每周5天,共4周),随后48周以相同剂量每周给药3次。中位随访时间为25.9个月,范围为4 - 90.4个月。33例(39%)患者病情进展;其中18例(55%)在治疗期间进展。失败发生的中位(范围)时间为9.1个月(1.7 - 47.3个月)。失败部位分布相同,大多数复发为单个转移灶。对于无远处转移生存期,平均(±标准误)值为28.8±3.6个月;1年和2年生存率分别为87.8±5.7%和61.6±9.3%。观察到22例死亡。无进展生存期和总生存期的5年生存率分别为50%和60%。总体而言,该治疗耐受性良好;因毒性导致的药物剂量减少或治疗中断极少。严重毒性罕见。总之,患者数量少且随访时间短无法得出任何结论。然而,初步数据似乎表明,在辅助治疗期间,IDI治疗通常耐受性良好,患者毒性低。