Rudolf Z, Strojan P
Institute of Oncology, Ljubljana, Slovenia.
Neoplasma. 1996;43(2):93-7.
In our study we evaluated and compared the therapeutic success in 70 patients with cutaneous metastatic malignant melanoma (MM) treated at the Institute of Oncology in Ljubljana during the period 1985-1994. Twenty-nine patients received DTIC in a single 800 mg/m2 i.v. dose (Group 1) and 41 patients were receiving i.m. applications of IFN-alpha in 2 MU daily doses from days 1 to 4, completing the treatment with a DTIC application on day 5, given at the same dosage as in Group 1 (Group 2). The applications were repeated in three-week intervals until progression, or-in the case of a complete response-for up to 6 months. The rate and median duration of treatment response were higher in the group of patients treated by IFN-alpha plus DTIC (17% vs. 27%; 2.7 vs. 6.1 months), though the difference was not statistically significant. The survival of responders was either significantly higher (Group 2: p = 0.0007) or borderline-significantly higher (Group 1; p = 0.078) than that of non-responders. These patients also had significantly longer median survival (Group 1: 13.7 vs. 5.1 months, p = 0.019; Group 2: 19.3 vs. 4.9 months, p = 0.0003). The patients treated with IFN-alpha plus DTIC survived significantly better than those treated with DTIC alone (p = 0.043). There were no differences in the median duration of survival between both groups (6.6 vs. 6.7 months), and neither in the median duration of survival of responders (13.7 vs. 19.3 months) or non-responders (5.1 vs. 4.9 months) from both groups. The toxicity of combined therapy was higher than that of chemotherapy alone, though it was still moderate and acceptable. In view of our results, the addition of IFN-alpha to DTIC has shown an advantage over DTIC along.
在我们的研究中，我们评估并比较了1985年至1994年期间在卢布尔雅那肿瘤研究所接受治疗的70例皮肤转移性恶性黑色素瘤（MM）患者的治疗效果。29例患者接受了单次800mg/m²静脉注射达卡巴嗪（DTIC）（第1组），41例患者从第1天至第4天每天接受200万单位肌肉注射α-干扰素（IFN-α），并在第5天以与第1组相同的剂量应用DTIC完成治疗（第2组）。治疗每三周重复一次，直至病情进展，或在完全缓解的情况下持续6个月。接受IFN-α加DTIC治疗的患者组的治疗缓解率和中位缓解持续时间更高（分别为17%对27%；2.7个月对6.1个月），尽管差异无统计学意义。缓解者的生存率显著高于（第2组：p = 0.0007）或临界显著高于（第1组；p = 0.078）未缓解者。这些患者的中位生存期也显著更长（第1组：13.7个月对5.1个月，p = 0.019；第2组：19.3个月对4.9个月，p = 0.0003）。接受IFN-α加DTIC治疗的患者比单独接受DTIC治疗的患者生存情况显著更好（p = 0.043）。两组的中位生存期无差异（6.6个月对6.7个月），两组缓解者（13.7个月对19.3个月）或未缓解者（5.1个月对4.9个月）的中位生存期也无差异。联合治疗的毒性高于单纯化疗，但仍属中度且可接受。鉴于我们的研究结果，在DTIC基础上加用IFN-α已显示出优于单纯DTIC的优势。
