Leyvraz S, Spataro V, Bauer J, Pampallona S, Salmon R, Dorval T, Meuli R, Gillet M, Lejeune F, Zografos L
Centre Pluridisciplinaire d'Oncologie and Department of Ophthalmology, University Hospital, Lausanne, Switzerland.
J Clin Oncol. 1997 Jul;15(7):2589-95. doi: 10.1200/JCO.1997.15.7.2589.
Ocular melanoma is characterized by a high rate of liver metastases and is associated with a median survival time less than 5 months. There is no standard treatment available. Treatment strategies have, without success, relied on the experience with metastatic cutaneous melanoma. The only effective treatment is chemoembolization using cisplatin and polyvinyl sponge, which has never become accepted on a large scale. The objective of the study was to establish prospectively the efficacy and toxicity of hepatic intraarterial fotemustine, a third-generation nitrosourea, in patients with liver metastases from ocular melanoma.
Thirty-one patients were subjected to laparotomy to place a totally implantable catheter into the hepatic artery and received fotemustine 100 mg/m2 as a 4-hour infusion, first once a week for four times and then, after a 5-week rest period, every 3 weeks until progression or toxicity. Cox regression models were used to assess the prognostic role of patient survival characteristics.
Objective responses were observed in 12 of 30 assessable patients (40%; 95% confidence interval, 22% to 59%). The median duration of response was 11 months and the median overall survival time, 14 months. Lactate dehydrogenase (LDH) appeared to be the strongest prognostic factor for survival. Toxicity was minimal and treatment could be administered on an outpatient basis.
The results of hepatic arterial chemotherapy with fotemustine produced a high response rate and survival similar to chemoembolization therapy. It involves no major toxicity and preserves the quality of life. To assess further its effectiveness, a randomized study to compare hepatic intraarterial versus intravenous chemotherapy is being planned.
眼黑色素瘤的特征是肝转移率高，且中位生存时间不足5个月。目前尚无标准治疗方法。治疗策略一直依赖于转移性皮肤黑色素瘤的经验，但未获成功。唯一有效的治疗方法是使用顺铂和聚乙烯海绵进行化疗栓塞，但该方法从未被广泛接受。本研究的目的是前瞻性地确定第三代亚硝基脲类药物肝动脉注射福莫司汀对眼黑色素瘤肝转移患者的疗效和毒性。
31例患者接受剖腹手术，在肝动脉置入完全植入式导管，并接受100mg/m²的福莫司汀，静脉滴注4小时，开始时每周1次，共4次，然后在休息5周后，每3周1次，直至病情进展或出现毒性反应。采用Cox回归模型评估患者生存特征的预后作用。
30例可评估患者中有12例（40%；95%置信区间为22%至59%）观察到客观缓解。缓解的中位持续时间为11个月，中位总生存时间为14个月。乳酸脱氢酶（LDH）似乎是生存的最强预后因素。毒性极小，治疗可在门诊进行。
肝动脉注射福莫司汀化疗的结果产生了较高的缓解率和与化疗栓塞治疗相似的生存率。它没有重大毒性，且能维持生活质量。为进一步评估其有效性，正在计划进行一项比较肝动脉化疗与静脉化疗的随机研究。
