Planting A S, van der Burg M E, Goey S H, Schellens J H, Vecht C, de Boer-Dennert M, Stoter G, Verweij J
Department of Medical Oncology, Rotterdam Cancer Institute/Daniel den Hoed Kliniek, The Netherlands.
Eur J Cancer. 1996 Oct;32A(11):2026-8. doi: 10.1016/0959-8049(96)00187-6.
The results of cytostatic therapy in metastatic melanoma are very disappointing. In phase II studies with high-dose cisplatin regimens, a remarkably high response rate was observed. In a phase I study with a short course of weekly cisplatin, combined with oral etoposide, we were able to reach, in most patients, a cisplatin dose intensity of 60 mg/m2/week. We performed a phase II study with this schedule in metastatic malignant melanoma. 15 consecutive patients were entered in the study. Treatment consisted of cisplatin 70 mg/m2 on days 1, 8, 15 and days 29, 36, 43 combined with oral etoposide 50 mg daily, days 1-15 and days 29-43. Patients with a response or stable disease continued treatment with oral etoposide 50 mg/m2 daily, days 1-21 every 4 weeks. All patients were evaluable for response and toxicity. The majority of the patients received six cycles of cisplatin with the planned cisplatin dose intensity of 60 mg/m2/week. A partial response was observed in 2 patients (13%; 95% confidence interval (CI) 2-44%) of, respectively, 22 and 12 weeks; stable disease was observed in 6 patients. Toxicity consisted mainly of alopecia and bone marrow suppression. 4 patients had tinnitus, one patient had neurotoxicity grade 1. The regimen studied has only limited activity in metastatic melanoma in spite of the high-dose intensity of cisplatin reached with this schedule.
细胞毒性疗法治疗转移性黑色素瘤的结果非常令人失望。在高剂量顺铂方案的II期研究中，观察到了非常高的缓解率。在一项每周一次顺铂短疗程联合口服依托泊苷的I期研究中，我们在大多数患者中能够达到顺铂剂量强度为60mg/m²/周。我们用这个方案对转移性恶性黑色素瘤进行了II期研究。15名连续患者进入该研究。治疗方案为在第1、8、15天以及第29、36、43天给予顺铂70mg/m²，同时在第1 - 15天以及第29 - 43天每天口服依托泊苷50mg。有缓解或疾病稳定的患者继续接受治疗，即每4周在第1 - 21天每天口服依托泊苷50mg/m²。所有患者均可评估疗效和毒性。大多数患者接受了六个周期的顺铂治疗，计划的顺铂剂量强度为60mg/m²/周。2例患者（13%；95%置信区间（CI）2 - 44%）分别出现了22周和12周的部分缓解；6例患者疾病稳定。毒性主要包括脱发和骨髓抑制。4例患者出现耳鸣，1例患者有1级神经毒性。尽管该方案达到了高剂量强度的顺铂，但所研究的方案在转移性黑色素瘤中的活性有限。
