Liszkay Gabriella
Onkodermatológiai Osztály, Országos Onkológiai Intézet, Budapest, Hungary.
Magy Onkol. 2013 Jun;57(2):110-3. Epub 2013 May 14.
The incidence of malignant melanoma is continuously rising, but the therapy of advanced melanoma remains insufficient. Advances in the understanding of the immunological and genetical background resulted in the development of a new target therapeutic agent, vemurafenib (Zelboraf) accepted by the FDA in 2011 and by the EMA in 2012. Vemurafenib improved the overall and progression-free survival of untreated melanoma with the mutation BRAF V600E. In a phase III study vemurafenib was associated with a 63% reduction in the risk of deaths compared with dacarbazine and of 74% in the risk of either death or disease progression. Objective response was 48% in the vemurafenib and 5% in the dacarbazine arm. Vemurafenib has special side effects, surprisingly even secondary skin tumors. Additional research is needed to understand the mechanism of drug resistance and to find new targeted therapeutic agents and combinations.
恶性黑色素瘤的发病率持续上升,但晚期黑色素瘤的治疗仍然不足。对免疫和遗传背景认识的进展促成了一种新型靶向治疗药物维莫非尼(佐博伏)的研发,该药物于2011年获美国食品药品监督管理局(FDA)批准,2012年获欧洲药品管理局(EMA)批准。维莫非尼改善了BRAF V600E突变的未经治疗的黑色素瘤患者的总生存期和无进展生存期。在一项III期研究中,与达卡巴嗪相比,维莫非尼使死亡风险降低了63%,使死亡或疾病进展风险降低了74%。维莫非尼组的客观缓解率为48%,达卡巴嗪组为5%。维莫非尼有特殊的副作用,令人惊讶的是甚至会引发继发性皮肤肿瘤。需要进一步研究以了解耐药机制,并寻找新的靶向治疗药物及联合用药方案。