Hochster H, Hunt M, Green M, Parkinson D, Smith T
New York University Medical Center, New York.
Invest New Drugs. 1990 Aug;8(3):329-32. doi: 10.1007/BF00171849.
In this phase II trial, twenty patients with advanced, measurable melanoma from ECOG institutions were treated with esorubicin 30 mg/m2 iv every three weeks. Doses were escalated or reduced based on nadir counts. The dose limiting toxicity was leukopenia with no significant thrombocytopenia or anemia. Other toxicities were mild. One patient had skin necrosis with extravasation. Two patients with soft tissue disease had partial remissions and were treated with 9 and 17 courses. One patient was stable for 8 courses. No cardiac toxicity was seen in three patients receiving more than 150 mg/m2. The response rate was 10% (90% CI = 2 to 30%). Low level activity was seen, but it is unlikely that this drug has sufficient activity to warrant further development in melanoma.
在这项II期试验中,来自东部肿瘤协作组(ECOG)机构的20例晚期、可测量的黑色素瘤患者接受了表柔比星治疗,剂量为30mg/m²,静脉注射,每三周一次。剂量根据最低点计数进行调整。剂量限制性毒性为白细胞减少,无明显血小板减少或贫血。其他毒性较轻。1例患者出现外渗导致皮肤坏死。2例软组织疾病患者部分缓解,分别接受了9个和17个疗程的治疗。1例患者病情稳定8个疗程。3例接受超过150mg/m²剂量的患者未出现心脏毒性。缓解率为10%(90%可信区间=2%至30%)。观察到低水平活性,但该药物不太可能具有足够的活性以保证在黑色素瘤治疗中进一步研发。