Institut d'Oncologie Gustave Roussy, Villejuif, France.
Semin Oncol. 2010 Oct;37(5):455-9. doi: 10.1053/j.seminoncol.2010.09.009.
Thus far the development of adjuvant therapies in melanoma has suffered greatly from the lack of effective drugs in stage IV melanoma. Chemotherapy, cytokines, vaccines, and combinations of drugs have been used with minimal success. This has led to adjuvant therapies that are not used uniformly or widely because of the rather marginal benefits, as no consistent and clinically significant impact on survival has been demonstrated. A new development for interferon-based adjuvant therapy seems to be the observation that better effects are observed in patients with lower tumor load and in patients with an ulcerated primary melanoma. A benefit for patients with more advanced lymphnodal involvement is quite unsure, clearly requiring new drugs to be explored. A new era in the treatment of melanoma treatment has arrived with the anti-cytoxic T-lymphocyte antigen-4 (anti-CTLA-4) monoclonal antibodies. The randomized trial in advanced metastatic melanoma demonstrated a clear benefit with prolongation of survival. The anti-CTLA-4 monoclonal antibody ipilimumab has finally changed the landscape. It is therefore only logical that a worldwide adjuvant trial with ipilimumab versus placebo, the European Organization for Research and Treatment of Cancer (EORTC) 18071, is ongoing in patients with lymph node metastases, and that another adjuvant trial with ipilimumab compared to high-dose interferon (HDI) is planned in the United States. The EORTC 18071 trial will reach full accrual in 2011 and thus results are expected in 2013 or 2014.
迄今为止,由于缺乏 IV 期黑色素瘤的有效药物,辅助疗法的发展在黑色素瘤中受到了极大的阻碍。化疗、细胞因子、疫苗和药物联合应用取得了最小的成功。这导致了辅助疗法没有被广泛使用,因为其益处相当有限,因为没有一致的、具有临床意义的生存影响得到证实。基于干扰素的辅助治疗的一个新进展似乎是观察到,在肿瘤负荷较低和原发性黑色素瘤溃疡的患者中观察到更好的效果。对于淋巴结受累更广泛的患者是否有益尚不确定,显然需要探索新的药物。随着抗细胞毒性 T 淋巴细胞抗原-4(抗 CTLA-4)单克隆抗体的出现,黑色素瘤治疗的新时代已经到来。一项晚期转移性黑色素瘤的随机试验显示,生存时间延长,疗效明显。抗 CTLA-4 单克隆抗体伊匹单抗最终改变了这一局面。因此,在淋巴结转移患者中进行伊匹单抗与安慰剂的全球辅助试验(EORTC 18071),以及在美国进行伊匹单抗与高剂量干扰素(HDI)的另一个辅助试验是合乎逻辑的。EORTC 18071 试验将于 2011 年达到完全入组,因此预计在 2013 年或 2014 年得出结果。