Schmittel Alexander, Scheulen Max E, Bechrakis Nikolaos E, Strumberg Dirk, Baumgart Joachim, Bornfeld Norbert, Foerster Michael H, Thiel Eckhard, Keilholz Ulrich
Department of Internal Medicine III (Haematology, Oncology and Transfusion Medicine), Charité, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.
Melanoma Res. 2005 Jun;15(3):205-7. doi: 10.1097/00008390-200506000-00010.
Gemcitabine plus treosulfan (GeT) is under investigation in metastatic uveal melanoma. In this phase II trial, cisplatin was added to a GeT regimen to investigate the efficacy and toxicity of two alkylating agents in combination with gemcitabine. Patients received 30 or 40 mg/m of cisplatin, 1000 mg/m of gemcitabine and 3000 mg/m of treosulfan on days 1 and 8. Therapy was repeated on day 29. A maximum of six cycles was administered. Nineteen patients were included in the trial, of whom 17 were evaluable for response. No objective response was observed; seven patients (41%) had stable disease and 10 (59%) progressed. The median progression-free survival of all 19 patients was 3.0 months [95% confidence interval (CI), 1.8-3.1]; the median overall survival was 7.7 months (95% CI, 1.9-13.8). Grade 3 and 4 thrombopenia and leucopenia occurred in eight and nine of the 19 patients, respectively. The addition of cisplatin to the GeT regimen results in excessive haematological toxicity without improvement in efficacy.
吉西他滨联合曲奥舒凡（GeT）正在转移性葡萄膜黑色素瘤中进行研究。在这项II期试验中，顺铂被添加到GeT方案中，以研究两种烷化剂与吉西他滨联合使用的疗效和毒性。患者在第1天和第8天接受30或40mg/m²的顺铂、1000mg/m²的吉西他滨和3000mg/m²的曲奥舒凡。在第29天重复治疗。最多给予六个周期。19名患者纳入试验，其中17名可评估反应。未观察到客观反应；7名患者（41%）疾病稳定，10名（59%）进展。所有19名患者的无进展生存期中位数为3.0个月[95%置信区间（CI），1.8 - 3.1]；总生存期中位数为7.7个月（95%CI，1.9 - 13.8）。19名患者中分别有8名和9名发生3级和4级血小板减少症和白细胞减少症。在GeT方案中添加顺铂导致血液学毒性过大且疗效未改善。
